ii

Gothenburg, Sweden

The 2019 compilation of the International Continence Society

Standardisations, Consensus statements, Educational
modules, Terminology and Fundamentals documents, with the
International Consultation on Incontinence algorithms

ICS Standards 2019


 1

ICS STANDARDS 2019

ICS Standards 2019 brings together many of the major initiatives of the Internation-
al Continence Society in its role of supporting healthcare professionals to deliver
care and develop knowledge.

Contained here are the current documents developed by the organisation. These
include the ICS Consensus Statements, which reflect leading opinion in challenging
areas of practice. The Fundamentals of Assessment section is a compilation of suc-
cinct reviews setting out the most important components for acquiring or consoli-
dating clinical knowledge, with examples, in lower urinary tract symptoms, inconti-
nence and prolapse. The Standardisations are the state-of-the-art reference sources
for the specialist professional, developed by expert working groups overseen by the
ICS Standardisation Steering Committee. The International Consultation on Inconti-
nence algorithms are therapy pathways derived by expert committees responsible
for detailed literature review and interpretation as part of the regular Consultations
process- published most recently in 2017. These documents are a powerful resource
intended to help all healthcare professionals dealing with the broad scope of this
clinical area.

Sherif Mourad
ICS General Secretary


2

CONTENTS

1. ICS Standardisations................................................................................ 4 An International Urogynecological Association (IUGA)/

International Continence Society (ICS) Joint Report on
An International Urogynecological Association (IUGA)/ the Terminology for Reporting Outcomes of Surgical
International Continence Society (ICS) Joint Report on the Procedures for Pelvic Organ Prolapse............................................................ 256
Terminology for Female Pelvic Floor Dysfunction..................................... 5
An International Urogynecological Association (IUGA)/
The International Continence Society (ICS) report on the International Continence Society (ICS) Joint Terminology
terminology for adult male lower urinary tract and pelvic and Classification of the Complications Related Directly
floor symptoms and dysfunction.................................................................... 22 to the Insertion of Prostheses (Meshes, Implants, Tapes)
and Grafts in Female Pelvic Floor Surgery.................................................... 263
An International Continence Society (ICS) report on the
terminology for adult neurogenic lower urinary tract Developing Evidence-Based Standards for Diagnosis and
dysfunction (ANLUTD)......................................................................................... 67 Management of Lower Urinary Tract or Pelvic Floor Dysfunction....... 274

International Continence Society (ICS) report on the

terminology for nocturia and nocturnal lower urinary
tract function.......................................................................................................... 77 2. Fundamentals........................................................................................... 278

A Standard for Terminology in Chronic Pelvic Pain Fundamental Assessment of Lower Urinary Tract Dysfunction............ 279
Syndromes: A Report Fromthe Chronic Pelvic Pain
Working Group of the International Continence Society....................... 87 A commentary on expectations of healthcare
professionals when applying the international continence
An International Urogynecological Association (IUGA) / society standards to basic assessment of lower urinary
International Continence Society (ICS) Joint Report on the tract function.......................................................................................................... 283
Terminology for Female Pelvic Organ Prolapse (POP)............................. 112
Fundamentals of terminology in lower urinary tract function............. 289
An International Urogynecological Association (IUGA)/
International Continence Society (ICS) Joint Report on the Basic concepts in nocturia, based on international
Terminology for Female Anorectal Dysfunction........................................ 144 continence society standards in nocturnal lower urinary
tract function.......................................................................................................... 296
International Continence Society Good Urodynamic
Practices and Terms 2016: Urodynamics, uroflowmetry, Neurological lower urinary tract dysfunction essential terminology.301
cystometry, and pressure-flow study............................................................. 169
The fundamentals of chronic pelvic pain assessment,
Good Urodynamic Practices: Uro£owmetry, Filling based on international continence society recommendations............ 308
Cystometry, and Pressure-Flow Studies........................................................ 187
How to use the Pelvic Organ Prolapse Quantification
International Continence Society Guidelines on (POP-Q) system?..................................................................................................... 315
Urodynamic Equipment Performance........................................................... 200
The fundamentals of uroflowmetry practice, based on
International Continence Society Guidelines on International Continence Society good urodynamic
Urodynamic Equipment Performance........................................................... 201 practices recommendations.............................................................................. 320

An International Urogynecological Association (IUGA)/ Fundamentals of urodynamic practice, based on

International Continence Society (ICS) joint report on International Continence Society good urodynamic
the terminology for the assessment of sexual health of practices recommendations.............................................................................. 326
women with pelvic floor dysfunction............................................................ 211
Basics of videourodynamics for adult patients with lower
An International Urogynecological Association urinary tract dysfunction.................................................................................... 337
(IUGA)/ International Continence Society (ICS) joint
report on the terminology for the conservative and Why ICS standardization of lower urinary tract symptoms matters... 343
nonpharmacological management of female pelvic floor
dysfunction.............................................................................................................. 232 Critical steps in developing professional standards for the
International Continence Society.................................................................... 345

ICS Standards 2019


 3

3. The International Consultation on Incontinence Algorithms.......... 351 Detrusor Leak Point Pressures in Patients With Relevant
Neurological Abnormalities............................................................................... 654
Evaluation and treatment of urinary incontinence, pelvic
organ prolapse and faecal incontinence...................................................... 352 Electromyography in the assessment and therapy of
lower urinary tract dysfunction in adults..................................................... 672
Evaluation................................................................................................................. 355
Cystometry (basic module)................................................................................ 688
Management Conseneue Stements............................................................... 360
Measurement of Post-Void Residual Urine................................................... 706
Recommendations for Further Research in Epidemiology.................... 409
Pad Weight Testing in the Evaluation of Urinary Incontinence............ 722
Recommendations for Primary Prevention, Continence
Promotion, Models of Care and Education.................................................. 411 Artefacts in Urodynamic Pressure Traces (Basic Module)....................... 734

Recommendations for Translational and Clinical REsearch................... 413 Long-term Urinary Catheter Users Self-Care Practices and
Problems................................................................................................................... 746
International Consultation on Incontinence Modular
Questionaire (ICIQ ):Questionnaires and Bladder Diary.......................... 416 A Web-Based Self-Management Intervention for
Intermittent Catheter Users............................................................................... 816

Cystometry in children........................................................................................ 833

4. ICS Consensus Documents..................................................................... 423
Pressure flow study in children......................................................................... 849
Artificial Urinary Sphincter: Executive Summary of the
2015 Consensus Conference............................................................................. 424

International Continence Society consensus on the 6. ICS Glossary............................................................................................... 862

diagnosis and treatment of nocturia.............................................................. 427
A....................................................862 M...................................................892
International continence society white paper regarding
female genital mutilation/cutting................................................................... 448 B....................................................867 N...................................................898

International Continence Society Best Practice Statement C....................................................868 O...................................................903

for Use of Sacral Neuromodulation................................................................. 459
D...................................................874 P....................................................906
The clinical role of LASER for vulvar and vaginal
treatments in gynecology and female urology: An ICS/ E....................................................877 Q...................................................920
ISSVD best practice consensus document................................................... 504
F....................................................879 R....................................................920
Terminology report from the International Continence
Society (ICS) Working Group on Underactive Bladder (UAB)................ 519 G...................................................887 S....................................................922

H...................................................888 T....................................................925

5. ICS Education Modules............................................................................ 523 I.....................................................889 U...................................................926

Ambulatory Urodynamic Monitoring............................................................ 524 J.....................................................891 V....................................................932

Analysis of Voiding, Pressure Flow Analysis (Basic Module)................... 542 L....................................................892

Guideline for Prevention of Catheter-associated Urinary

Tract Infections 2009............................................................................................ 558

Cough stress test in the evaluation of female urinary

incontinence: Introducing the ICS-Uniform Cough Stress Test............ 639


4

1. ICS STANDARDISATIONS

The Standardisations are flagship ICS documents that are the reference point for
all terminology and practice in the relevant clinical areas, developed by the ICS,
often in partnership with other professional bodies. They ensure that the term for
a symptom, condition or disease has the same meaning for all healthcare profes-
sionals. They are a series of evidence-based pragmatic documents, developed by
experts following a defined process (1), and covering the substantial majority of all
relevant areas. Such terminology strength underpins the advancement of research
and clinical practice. This compilation incorporates the current ICS Standardisations
applicable in 2019. For a quick search on individual terms, the ICS also has a search-
able glossary: www.ics.org/glossary

The ICS also has a historical compilation of older Standardisations that have been
superseded.

Marcus Drake
ICS Trustee

ICS Standards 2019

1. ICS Standardisations
 5

Neurourology and Urodynamics 29:4–20 (2010)

REVIEW ARTICLE

An International Urogynecological Association

(IUGA)/International Continence Society (ICS) Joint Report
on the Terminology for Female Pelvic Floor Dysfunction
Bernard T. Haylen,1*,y,§ Dirk de Ridder,2,{,§ Robert M. Freeman,3y,{,§ Steven E. Swift,4y,§ Bary Berghmans,5{,§
Joseph Lee,6y Ash Monga,7{,§ Eckhard Petri,8y Diaa E. Rizk,9y Peter K. Sand,10y,{,§ and Gabriel N. Schaer11y
1
University of New South Wales, Sydney, New South Wales, Australia
2
University Hospital, UZ Leuven, Belgium
3
Derriford Hospital, Plymouth, Devon, UK
4
Medical University of South Carolina, Charleston, South Carolina
5
Maastricht University Hospital, Maastricht, the Netherlands
6
Mercy Hospital for Women, Melbourne, Victoria, Australia
7
Princess Anne Hospital, Southampton, UK
8
Klinikum Schwerin, Schwerin, Germany
9
Ain Shams University, Cairo, Egypt
10
Evanston Continence Centre, Evanston, Illinois
11
Kantonsspital, Aarau, Switzerland

Introduction: Next to existing terminology of the lower urinary tract, due to its increasing complexity, the
terminology for pelvic floor dysfunction in women may be better updated by a female-specific approach and clinically
based consensus report. Methods: This report combines the input of members of the Standardization and
Terminology Committees of two international organizations, the International Urogynecological Association (IUGA),
and the International Continence Society (ICS), assisted at intervals by many external referees. Appropriate core
clinical categories and a subclassification were developed to give an alphanumeric coding to each definition. An
extensive process of 15 rounds of internal and external review was developed to exhaustively examine each
definition, with decision-making by collective opinion (consensus). Results: A terminology report for female pelvic
floor dysfunction, encompassing over 250 separate definitions, has been developed. It is clinically based with the six
most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by
practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Female-
specific imaging (ultrasound, radiology, and MRI) has been a major addition while appropriate figures have been
included to supplement and help clarify the text. Ongoing review is not only anticipated but will be required to keep
the document updated and as widely acceptable as possible. Conclusion: A consensus-based terminology report for
female pelvic floor dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus
for research. Neurourol. Urodynam. 29:4–20, 2010.  2009 Wiley-Liss, Inc.

Key words: consensus; diagnosis; female pelvic floor dysfunction; symptomatology; terminology; urodynamics

INTRODUCTION floor dysfunction in a comprehensive way. Indeed, the

diagnoses themselves have not been all completely defined.
There is currently no single document addressing all The term ‘‘diagnosis’’ is defined as ‘‘the determination of
elements required for diagnoses in the area of female pelvic the nature of a disease; clinical: made from a study of the

Conflicts of interest: y
Standardization and Terminology Committees IUGA.
B.T. Haylen: Assistance from Boston Scientific to attend London Terminology {
Standardization and Terminology Committees ICS.
Meeting. D. De Ridder: Advisor for Astellas, Allegan, Ipsen, Bard, American §
Joint IUGA/ICS Working Group on Female Terminology.
Medical Systems, Xention. Speaker for Astellas, Allegan, American Medical *Correspondence to: Bernard T. Haylen, Associate Professor, St. Vincent’s Clinic,
Systems, Bard, Pfizer. Investigator for Ipsen, American Medical Systems, Allergan, Suite 904, 438 Victoria Street, Darlinghurst, 2010 NSW, Australia.
Astellas, Johnson & Johnson. R.M. Freeman: Past Advisory Boards: Lilly/BI, E-mail: haylen@optusnet.com.au
Astellas, Pfizer. S.E. Swift, B. Berghmans, J. Lee, E. Petri, D.E. Rizk: No disclosures. Received 16 July 2009; Accepted 16 July 2009
A. Monga: Consultant for Gynecare. Advisor for Astellas and Pfizer. P.K. Sand: Published online 15 December 2009 in Wiley InterScience
Advisor for: Allergan, Astellas, GSK, Coloplast, Ortho, Pfizer, Sanofi, Aventis, (www.interscience.wiley.com)
Watson. Speaker for: Allergan, Astellas, GSK, Ortho, Pfizer, Watson. Investigator DOI 10.1002/nau.20798
for: Boston Scientific, Pfizer, Watson, Ortho, Bioform. G.N. Schaer: Advisor (in
Switzerland) for Astellas, Novartis, Pfizer.

 2009 Wiley-Liss, Inc.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Report on the Terminology for Female Pelvic Floor
Dysfunction
6

Terminology for Female Pelvic Floor Dysfunction 5

symptoms, signs of a disease; laboratory’’: multiple options As in earlier ICS reports,2,3 when a reference is made to the
mentioned.1 Such a specific report would require a full outline whole anatomical organ, the vesica urinaria, the correct term
of the terminology for all symptoms, signs, urodynamic is the bladder. When the smooth muscle structure known as
investigations for female pelvic floor dysfunction, the imaging the m. detrusor urinae is being discussed, then the correct
associated with those investigations, and the most common term is detrusor.
diagnoses. It is suggested that acknowledgement of these standards in
It may have been possible in the past to combine all the written publications related to female pelvic floor dysfunc-
terminologies for lower urinary tract function in men, women, tion, being indicated by a footnote to the section ‘‘Methods
and children into one report. The International Continence and Materials’’ or its equivalent, to read as follows: ‘‘Methods,
Society (ICS) has provided leadership in terminology for lower definitions and units conform to the standards jointly
urinary tract dysfunction over decades employing combined recommended by the International Incontinence Society
or generic reports. The 1988 report by the Committee on the (ICS) and the International Urogynecological Association,
Standardization of Terminology2 is one such example. With except where specifically noted.’’
the increasing specificity and complexity of female diagnoses,
a combined report may now be an anachronism. The 2002 SYMPTOMS
report3 still provided the traditional core terminology and
some useful modifications, many of which are repeated in Symptoms: Any morbid phenomenon or departure from the
this document. However, it also revealed evidence that (i) a normal in structure, function, or sensation, experienced by
coherent and user-friendly combined report may be starting to the woman and indicative of disease1 or a health problem.
become too difficult and (ii) the terminology for women, due Symptoms are either volunteered by, or elicited from the
to the absence of specific diagnoses as well as other female- individual, or may be described by the individual’s caregiver.2,3
specific terminology, may not have been advantaged by this
approach.4 The need for standardized terminology in female Urinary Incontinence Symptoms
pelvic floor dysfunction to enable accurate communication for
clinical and research purposes has been highlighted for (i) Urinary incontinence (symptom): Complaint of involun-
some time.5 There is indeed the need for a general terminol- tary loss of urine.i
ogy, forming a ‘‘backbone’’ or ‘‘core’’ terminology to which (ii) Stress (urinary) incontinence: Complaint of involuntary
more specific terminologies can be attached. loss of urine on effort or physical exertion (e.g., sporting
A female-specific terminology report should be activities), or on sneezing or coughing. N.B.: ‘‘activity-
related incontinence’’ might be preferred in some
(1) As user-friendly as possible: It should be able to be languages to avoid confusion with psychological stress.
understood by all clinical and research users. (iii) Urgency (urinary) incontinence: Complaint of involun-
(2) Clinically based: Symptoms, signs, and validated investiga- tary loss of urine associated with urgency.ii
tions should be presented for use in forming workable (iv) Postural (urinary) incontinence: (NEW) Complaint of
diagnoses. The second, third, and fourth sections will address involuntary loss of urine associated with change of
symptoms, signs, and urodynamic investigations and body position, for example, rising from a seated or lying
current associated pelvic imaging modalities routinely used position.iii
in the office or urodynamic laboratory to make those (v) Nocturnal enuresis: Complaint of involuntary urinary
diagnoses, respectively. A number of related radiological loss of urine which occurs during sleep.3
investigations as well as magnetic resonance imaging (MRI) (vi) Mixed (urinary) incontinence: Complaint of involuntary
have also been included. The detailed description of electro- loss of urine associated with urgency and also with
myography and related nerve conduction, reflex latency, and effort or physical exertion or on sneezing or coughing.
other sensory studies contained in Ref.2 will again3 not be re- (vii) Continuous (urinary) incontinence: Complaint of con-
instated here. This report does not specifically address tinuous involuntary loss of urine.3,6
terminology for neurogenic pelvic floor dysfunction. (viii) Insensible (urinary) incontinence: (NEW) Complaint
The fifth section will address the most common diagnoses of urinary incontinence where the woman has been
of pelvic floor dysfunction. The terms3 ‘‘urodynamic observa- unaware of how it occurred.
tion’’ and ‘‘condition’’ (non-medical) have not been used in (ix) Coital incontinence: (NEW) Complaint of involuntary
this report. The scope of the report will exclude (i) more loss of urine with coitus. This symptom might be
invasive investigations requiring an anesthetic and (ii) further divided into that occurring with penetration or
evidence-based treatments for each diagnosis. intromission and that occurring at orgasm.

Bladder Storage Symptoms

(3) Able to indicate origin and to provide explanations: Where
a term’s existing definition (from one of multiple sources (i) Increased daytime urinary frequency: Complaint that micturi-
used) is deemed appropriate, that definition will be tion occurs more frequently during waking hours than
included and duly referenced. A large number of terms in previously deemed normal by the woman. iv
female pelvic floor function and dysfunction, because of
their long-term use, have now become generic, as apparent
i
by their listing in medical dictionaries. ‘‘Continence’’ is defined as the voluntary control of bladder and bowel function.
ii
‘‘Urgency’’ replaces ‘‘urge’’ as the ‘‘accepted’’ terminology for the abnormal
rather than the normal phenomenon.
Where a specific explanation is deemed appropriate to iii
This is a common symptom, the mechanism of which has not been adequately
explain a change from earlier definitions or to qualify the researched. It is uncertain whether it should be linked to Urinary Incontinence
Symptoms Section (ii) or (iii).
current definition, this will be included as an addendum to iv
Traditionally seven episodes of micturition during waking hours have been
this paper (footnotes i, ii, iii, . . . ). Wherever possible, evidence- deemed as the upper limit of normal, though it may be higher in some
based medical principles will be followed. populations.7

Neurourology and Urodynamics DOI 10.1002/nau

ICS Standards 2019

1. ICS Standardisations
 7

6 Haylen et al.
(ii) Nocturia: Complaint of interruption of sleep one or example, leaning forwards or backwards on the toilet
more times because of the need to micturate.3 v Each seat or voiding in the semi-standing position.
void is preceded and followed by sleep. (x) Dysuria: Complaint of burning or other discomfort
(iii) Urgency: Complaint of a sudden, compelling desire to during micturition. Discomfort may be intrinsic to the
pass urine which is difficult to defer.vi lower urinary tract or external (vulvar dysuria).
(iv) Overactive bladder (OAB, Urgency) syndrome: Urinary (xi) (Urinary) retention: (NEW) Complaint of the inability to
urgency, usually accompanied by frequency and noctu- pass urine despite persistent effort.
ria, with or without urgency urinary incontinence, in the
absence of urinary tract infection (UTI) or other obvious Pelvic Organ Prolapse (POP) Symptoms
pathology.
Prolapse symptoms: A departure from normal sensation,
structure, or function, experienced by the woman in reference
Sensory Symptoms to the position of her pelvic organs. Symptoms are generally
Sensory symptoms: A departure from normal sensation or worse at the times when gravity might make the prolapse
function, experienced by the woman during bladder filling.1 worse (e.g., after long periods of standing or exercise) and
Normally, the individual is aware of increasing sensation with better when gravity is not a factor, for example, lying supine.
bladder filling up to a strong desire to void.3 Prolapse may be more prominent at times of abdominal
straining, for example, defecation.

(i) Increased bladder sensation: Complaint that the desire to

void during bladder filling occurs earlier or is more (i) Vaginal bulging: Complaint of a ‘‘bulge’’ or ‘‘something
persistent to that previous experienced. N.B.: This differs coming down’’ towards or through the vaginal introitus.
from urgency by the fact that micturition can be The woman may state she can either feel the bulge by
postponed despite the desire to void. direct palpation or see it aided with a mirror.
(ii) Reduced bladder sensation: Complaint that the definite (ii) Pelvic pressure: Complaint of increased heaviness or
desire to void occurs later to that previously experienced dragging in the suprapubic area and/or pelvis.
despite an awareness that the bladder is filling. (iii) Bleeding, discharge, infection: Complaint of vaginal bleed-
(iii) Absent bladder sensation: Complaint of both the absence ing, discharge, or infection related to dependent ulceration
of the sensation of bladder filling and a definite desire to of the prolapse.
void.3 (iv) Splinting/digitation: Complaint of the need to digitally
replace the prolapse or to otherwise apply manual
pressure, for example, to the vagina or perineum (splint-
Voiding and Postmicturition Symptoms ing), or to the vagina or rectum (digitation) to assist
Voiding symptoms: A departure from normal sensation or voiding or defecation.
function, experienced by the woman during or following the (v) Low backache: Complaint of low, sacral (or ‘‘period-like’’)
act of micturition.1 backache associated temporally with POP.

Symptoms of Sexual Dysfunction

(i) Hesitancy: Complaint of a delay in initiating micturition.
(ii) Slow stream: Complaint of a urinary stream perceived as A departure from normal sensation and/or function
slower compared to previous performance or in experienced by a woman during sexual activity.
comparison with others.
(iii) Intermittency: Complaint of urine flow that stops and (i) Dyspareunia: Complaint of persistent or recurrent pain or
starts on one or more occasions during voiding. discomfort associated with attempted or complete vagi-
(iv) Straining to void: Complaint of the need to make an nal penetration.vii
intensive effort (by abdominal straining, Valsalva or (ii) Superficial (introital) dyspareunia: Complaint of pain or
suprapubic pressure) to either initiate, maintain, or discomfort on vaginal entry or at the vaginal introitus.
improve the urinary stream. (iii) Deep dyspareunia: Complaint of pain or discomfort on
(v) Spraying (splitting) of urinary stream: Complaint that the deeper penetration (mid or upper vagina).
urine passage is a spray or split rather than a single (iv) Obstructed intercourse: Complaint that vaginal penetra-
discrete stream. tion is not possible due to obstruction.
(vi) Feeling of incomplete (bladder) emptying: Complaint that (v) Vaginal laxity: Complaint of excessive vaginal laxity.
the bladder does not feel empty after micturition. (vi) Other symptoms: Refs. 9,10.viii
(vii) Need to immediately re-void: Complaint that further
micturition is necessary soon after passing urine. Symptoms of Anorectal Dysfunction
(viii) Postmicturition leakage: Complaint of a further involun-
tary passage of urine following the completion of (i) Anal incontinence (symptom): Complaint of involuntary
micturition. loss of feces or flatus.ix
(ix) Position-dependent micturition: (NEW) Complaint of vii
Dyspareunia, the symptom most applicable to female pelvic floor dysfunction,
having to take specific positions to be able to micturate will depend on many factors including a woman’s introital relaxation and/or
spontaneously or to improve bladder emptying, for pain tolerance and her partner’s hesitancy or insistence.
viii
Other symptoms of female sexual dysfunction including (i) decreased sexual
desire, (ii) decreased sexual arousal, (iii) decreased orgasm, and (iv) abstention
are less specific for female pelvic floor dysfunction and will not be defined here.
v
It is common to void during the night when sleep is disturbed for other The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) is a
reasons—for example, insomnia, lactation—this does not constitute nocturia.8 measure of sexual function in women with urinary incontinence or pelvic organ
vi
The use of the word ‘‘sudden,’’ defined as ‘‘without warning or abrupt,’’ used in prolapse.9
ix
earlier definitions2,8 has been subject to much debate. Its inclusion has been Symptoms of defecatory dysfunction are commonly associated with pelvic
continued. Grading of ‘‘urgency’’ is being developed. organ prolapse, particularly posterior vaginal prolapse.

Neurourology and Urodynamics DOI 10.1002/nau

An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Report on the Terminology for Female Pelvic Floor
Dysfunction
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Terminology for Female Pelvic Floor Dysfunction 7

(ii) Fecal incontinence: Complaint of involuntary loss of the diagnosis of pudendal neuropathy13: (a) pain in the
feces.11 anatomical region of pudendal innervation; (b) pain that is
(a) Solid. worse with sitting; (c) no waking at night with pain; (d) no
(b) Liquid. sensory deficit on examination; (e) relief of symptoms
(c) Passive fecal incontinence: such as soiling without with a pudendal block.
sensation or warning or difficulty wiping clean. (ix) Chronic lower urinary tract and/or other pelvic pain
(d) Coital fecal incontinence: occurring with vaginal syndromes.xi
intercourse.
(iii) Flatal incontinence: Complaint of involuntary loss of
Lower Urinary Tract Infection
flatus.11
(iv) Fecal (rectal) urgency: Sudden, compelling desire to (i) Urinary tract infection (UTI): Scientific diagnosis of a UTI is
defecate that is difficult to defer. the finding of microbiological evidence of significant
(v) Fecal (flatal) urgency incontinence: Involuntary loss of bacteriuria and pyuriaxii usually accompanied by symp-
feces (flatus) associated with urgency. toms such as increased bladder sensation, urgency,
(vi) Straining to defecate: Complaint of the need to make an frequency, dysuria, urgency urinary incontinence, and/or
intensive effort (by abdominal straining or Valsalva) to pain in the lower urinary tract.
either initiate, maintain, or improve defecation. (ii) Recurrent urinary tract infections (UTIs): At least three
(vii) Feeling of incomplete (bowel) evacuation: Complaint that symptomatic and medically diagnosed UTI in the previous
the rectum does not feel empty after defecation. 12 months.xiii The previous UTI(s) should have resolved
(viii) Diminished rectal sensation: Complaint of diminished or prior to a further UTI being diagnosed.
absent sensation in the rectum.11 (iii) Other related history: For example, hematuria, cathe-
(ix) Constipation: Complaint that bowel movements are terization.
infrequent and/or incomplete and/or there is a need for
frequent straining or manual assistance to defecate SIGNS
(Rome II Criteria).x Sign: Any abnormality indicative of disease or a health
(x) Rectal prolapse: Complaint of external protrusion of the problem, discoverable on examination of the patient; an
rectum. objective indication of disease1 or a health problem.
(xi) Rectal bleeding/mucus: Complaint of the loss of blood or
mucus per rectum.
Urinary Incontinence Signs
Lower Urinary Tract Pain and/or Other Pelvic Pain All examinations for urinary incontinence are best per-
formed with the woman’s bladder comfortably full.
(i) Bladder pain: Complaint of suprapubic or retropubic
pain, pressure, or discomfort, related to the bladder, and
usually increasing with bladder filling. It may persist or (i) Urinary incontinence: Observation of involuntary loss of
be relieved after voiding.3 xi urine on examination: this may be urethral or extraure-
(ii) Urethral pain: Complaint of pain felt in the urethra and thral.3
the woman indicates the urethra as the site.3 (ii) Stress (urinary) incontinence (clinical stress leakage):
(iii) Vulval pain: Complaint of pain felt in and around the Observation of involuntary leakage from the urethra
vulva.3 synchronous with effort or physical exertion, or on
(iv) Vaginal pain: Complaint of pain felt internally within sneezing or coughing.3
the vagina, above the introitus.3 (iii) Urgency (urinary) incontinence: Observation of involun-
(v) Perineal pain: Complaint of pain felt between the tary leakage from the urethra synchronous with the
posterior fourchette (posterior lip of the introitus) and sensation of a sudden, compelling desire to void that is
the anus.3 difficult to defer.
(vi) Pelvic pain: The complaint of pain perceived to arise in (iv) Extraurethral incontinence: Observation of urine leakage
the pelvis, not associated with symptoms suggestive of through channels other than the urethral meatus, for
lower urinary tract, sexual, bowel, or gynecological example, fistula.
dysfunction. It is less well defined than the above types (v) Stress incontinence on prolapse reduction (occult or latent
of localized pain. stress incontinence): (NEW) Stress incontinence only
(vii) Cyclical (menstrual) pelvic pain: Cyclical pelvic pain observed after the reduction of co-existent prolapse.xiv
related to menses that raises the possibility of a
gynecological cause.
(viii) Pudendal neuralgia: Burning vaginal or vulval (anywhere
between anus and clitoris) pain associated with tender- xii
Commonly suggested criteria for: (i) bacteriuria are >100,000 CFU/ml on
ness over the course of the pudendal nerves. Recently, five voided specimen or >1,000 CFU/ml on catheterized specimen; (ii) pyuria are
essential criteria (Nantes criteria) have been proposed for >10 WBC/mm3.
xiii
Recurrent urinary tract infections (UTIs) have not been consistently defined.
There is the difficulty of balancing the practical clinical definition and the
scientific one. Records of diagnostic tests are often inaccessible over the medium
x
Rome II Criteria for Symptoms of Anorectal Dysfunction Section (ix): Complaint to longer term. With a bias toward the former category, a definition might be the
that bowel movements are infrequent (<3/week) and need to strain, lumpy or presence of at least three medically diagnosed UTI over the previous 12 months.
hard stool bloating, sensation of incomplete evacuation, sensation of anorectal ‘‘Recur’’ strictly means to ‘‘occur again’’ or ‘‘be repeated.’’ This would imply
obstruction, or blockage abdominal pain, need for manual assistance, in more a minimum of (i) two or more or the more commonly accepted, (ii) three or more
than one-quarter of all defecations.12 UTI in the previous 12 months.
xi xiv
The definitions of pelvic pain and especially chronic pelvic pain are being Stress incontinence on prolapse reduction is a sign frequently alluded to but
debated in several societies with a view to simplification and restructuring of not properly defined to date. The means of reducing the prolapse will vary.
the classification. The chronic (present for at least 3 months) pain syndromes A pessary or ring might, at times, obstruct the urethra, giving a false negative for
have not been included till consensus is reached. this sign.

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Signs of Pelvic Organ Prolapse
All examinations for POP should be performed with the
woman’s bladder empty (and if possible an empty rectum). An
increasing bladder volume has been shown to restrict the
degree of descent of the prolapse.14 The choice of the woman’s
position during examination, for example, left lateral (Sims),
supine, standing, or lithotomy, is that which can best
demonstrate POP in that patient and which the woman can
confirm, for example, by use of a mirror or digital palpation.
The degree of prolapse may be worse later in the day (after a
lengthy time in the erect position) than it is earlier in the day.
The hymen remains the fixed point of reference for prolapse
description.15

(i) Pelvic organ prolapse (definition): The descent of one or

more of the anterior vaginal wall, posterior vaginal wall,
the uterus (cervix), or the apex of the vagina (vaginal vault
or cuff scar after hysterectomy). The presence of any such
sign should be correlated with relevant POP symptoms.
More commonly, this correlation would occur at the level of
the hymen or beyond.
(ii) Pelvic organ prolapse (POPQ) (Staging 3, 15):
Stage 0: No prolapse is demonstrated.
Stage I: Most distal portion of the prolapse is more than
1 cm above the level of the hymen.
Stage II: Most distal portion of the prolapse is 1 cm or
less proximal to or distal to the plane of the
hymen.
Stage III: The most distal portion of the prolapse is more
than 1 cm below the plane of the hymen.
Stage IV: Complete eversion of the total length of the lower
genital tract is demonstrated.xv
(iii) Uterine/cervical prolapse: Observation of descent of the
uterus or uterine cervix.
(iv) Vaginal vault (cuff scar) prolapse: Observation of descent
of the vaginal vault (cuff scar after hysterectomy).18 xvi
(v) Anterior vaginal wall prolapse: Observation of descent of
the anterior vaginal wall. Most commonly this would be
due to bladder prolapse (cystocele, either central, para-
vaginal, or a combination). Higher stage anterior vaginal
wall prolapse will generally involve uterine or vaginal
vault (if uterus is absent) descent. Occasionally, there
might be anterior enterocele (hernia of peritoneum and
possibly abdominal contents) formation after prior recon- Fig. 1. A,B: Prolapse staging—0, I, II, III, and IV (uterine—by the position of
structive surgery.18 xvi the leading edge of the cervix).
(vi) Posterior vaginal wall prolapse: Observation of descent of
the posterior vaginal wall. Most commonly, this would
be due to rectal protrusion into the vagina (rectocele).
Higher stage posterior vaginal wall prolapse after prior
hysterectomy will generally involve some vaginal vault
(cuff scar) descent and possible enterocele formation.18 xvi
xv
The ICS POP quantification system which describes the topographic position of Enterocoele formation can also occur in the presence of an
six vaginal sites is the subject of a review by the IUGA Standardization and intact uterus.
Terminology Committee with a view to simplification. These sites and the
methodology behind the measurement format15 have therefore not been
included here. Consensus was not reached on inserting a valuation of the
Other Pelvic Examinations/Signs2,3,19
different prolapse stages into the report, though it will be subject to ongoing
discussion: for example, considering Stage 0 or 1 as different degrees of normal The internal examinations are generally best performed
support. Considering Stage 2 or more, where the leading edge is at or beyond the
hymen as definite prolapse.16,17
with the woman’s bladder empty.
xvi
Most gynecologists are generally comfortable with the terms cystocele,
rectocele, vaginal vault prolapse, and enterocele. Coupled with the brevity of
these terms and their clinical usage for up to 200 years,18 the inclusion of these (i) Vulval examination: Abnormalities include cysts, other
terms is appropriate. Some regard it as important to surgical strategy to tumors, atrophic changes, or lichen sclerosis.
differentiate between a central cystocele (central defect with loss of rugae due to
(ii) Urethral inspection/palpation:
stretching of the subvesical connective tissue and the vaginal wall) and a
paravaginal defect (rugae preserved due to detachment from the arcus (a) Urethral mucosal prolapse: Prolapse, generally circum-
tendineous fascia pelvis). ferential and larger, of the distal urethral urothelium.

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(b) Urethral caruncle: Smaller eversion of the urethral (b) Anal sphincter tear: May be recognized as a clear ‘‘gap’’
urothelium, generally involving the posterior lip. in the anal sphincter on digital examination.
(c) Urethral diverticulum: The presence of a sac opening (c) Confirm presence or absence of rectocele and if possible,
from the urethra. It might be suspected by a lump or differentiate from enterocele. Diagnose perineal body
tenderness along the line of the urethra or external deficiency.
urethral discharge on urethral massage. (d) Confirm presence or absence of fecal impaction.
(iii) Vaginal examination: Examination for vaginal length (e) Other rectal lesions: Intussusception, rectovaginal
and mobility, presence of scarring and/or pain, and fistula, or tumor.
estrogenization. The location of any vaginal pain should (f) Anal lesions: Hemorrhoids, fissure.
be noted. Included here is any tenderness over the course (g) Other perianal lesions: Anocutaneous fistula.
of the pudendal nerve (see Lower Urinary Tract Pain and/
or Other Pelvic Pain Section (viii)).
(iv) Bimanual pelvic examination: Observations for any
pelvic mass or unusual tenderness by vaginal examina- Other Relevant Examinations/Signs2
tion together with suprapubic palpation. The following general examinations and signs may be
(v) Pelvic floor muscle function3,19: Can be qualitatively relevant:
defined by the tone at rest and the strength of a voluntary
or reflex contraction as strong, normal, weak or absent, or
by a validated grading symptom. Voluntary pelvic floor (i) Neurological signs: For patients with possible neurogenic
muscle contraction and relaxation may be assessed by lower urinary tract or pelvic floor dysfunction, there should
visual inspection, by digital palpation (circumferentially), be particular note of those neurological signs related to S2–
electromyography, dynamometry, perineometry, or ultra- S4, but these should be complemented by a more general
sound. Factors to be assessed include muscle strength neurological examination as indicated.
(static and dynamic), voluntary muscle relaxation (absent, (ii) Abdominal signs: Among numerous possible abdominal
partial, complete), muscular endurance (ability to sustain signs are:
maximal or near maximal force), repeatability (the (a) Bladder fullness/retention: The bladder may be felt by
number of times a contraction to maximal or near abdominal palpation or suprapubic percussion.
maximal force can be performed), duration, coordination, (b) Other abdominal masses or distension (e.g., ascites).
and displacement. It is desirable to document findings for (c) Scars: Indicating previous relevant surgery or traumas.
each side of the pelvic floor separately to allow for any (d) Renal area: Examination for tenderness, masses.
unilateral defects and asymmetry. The ICS report into the
standardization of terminology of pelvic floor muscle
function and dysfunction19 provides a fuller description
of the assessment of pelvic floor muscle function including Frequency volume chart/Bladder diary
the following: (i) Frequency-volume chart (FVC): The recording of the time of
(a) Normal pelvic floor muscles: Pelvic floor muscles which each micturition and the volume voided for at least 24 hr.
can voluntarily and involuntarily contract and relax. Two or 3 days of recording (not necessarily consecutive)
(b) Overactive pelvic floor muscles: Pelvic floor muscles will generally provide more useful clinical data.
which do not relax, or may even contract when Information obtained will confirm:
relaxation is functionally needed, for example, during
micturition or defecation. (a) Daytime urinary frequency: Number of voids by day
(c) Underactive pelvic floor muscles: Pelvic floor muscles (wakeful hours including last void before sleep and
which cannot voluntarily contract when this is first void after waking and rising).
appropriate. (b) Nocturnal frequency/nocturia: Number of times sleep
(d) Non-functioning pelvic floor muscles: Pelvic floor is interrupted by the need to micturate. Each void is
muscles where there is no action palpable. preceded and followed by sleep.
(vi) Examination for levator (puborectalis) injury: The pubor- (c) Twenty-four-hour frequency: Total number of daytime
ectalis muscle may be assessed for the presence of major voids and episodes of nocturia during a specified 24-hr
morphological abnormalities by palpating its insertion period.
on the inferior aspect of the os pubis. If the muscle is (d) Twenty-four-hour urine production: Summation of all
absent 2–3 cm lateral to the urethra, that is, if the bony urine volumes voided in 24 hr.
surface of the os pubis can be palpated as devoid of (e) Maximum voided volume: Highest voided volume
muscle, an ‘‘avulsion injury’’ of the puborectalis muscle recorded.
is likely.20 (f) Average voided volume: Summation of volumes voided
(vii) Perineal examination19: When the patient is asked to divided by the number of voids.
cough or Valsalva, the perineum should show no down- (g) Median functional bladder capacity: Median maximum
ward movement; ventral movement may occur because voided volume in everyday activities.
of the guarding actions of the pelvic floor muscles. (h) Polyuria: Excessive excretion of urine resulting in
(a) Perineal elevation: This is the inward (cephalad) profuse and frequent micturition.3 It has been defined
movement of the vulva, perineum, and anus. as over 40 ml/kg body weight during 24 hr or 2.8 L
(b) Perineal descent: This is the outward (caudal) move- urine for a woman weighing 70 kg.21
ment of the vulva, perineum, and anus. (i) Nocturnal urine volume: Cumulative urine volume
(viii) Rectal examination: Observations can include: from voids after going to bed with the intention of
(a) Anal sphincter tone and strength: Assessment on sleeping to include the first void at the time of waking
digital examination, as good or poor in the absence with the intention of rising (excludes last void before
of any quantitative assessment. sleep).

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Fig. 2. Example of a bladder diary.

(j) Nocturnal polyuria: Excess (over 20–30% age depend- Pad Testing
ent) proportion of urine excretion (nocturnal voided
Quantification of the amount of urine lost over the duration
volume/total 24 hr voided volume  100%) occurs at
of testing, by measuring the increase in the weight of the
night (or when patient is sleeping).xvii
perineal pads (weighed pre- and posttesting) used. This may
(ii) Bladder diary: Adds to the FVC above, the fluid intake, pad
give a guide to the severity of incontinence. Different
usage, incontinence episodes, and the degree of incon-
durations from a short (1 hr) test to a 24- and 48-hr tests have
tinence. Episodes of urgency and sensation might also be
been used with provocation varying from normal everyday
recorded, as might be the activities performed during or
activities to defined regimens.
immediately preceding the involuntary loss of urine.
Additional information obtained from the bladder diary
involves severity of incontinence in terms of leakage
URODYNAMIC INVESTIGATIONS AND ASSOCIATED
episodes and pad usage.
PELVIC IMAGING
Urodynamics: Functional study of the lower urinary tract.
Clinical sequence of testing: Urodynamic investigations
generally involve a woman attending with a comfortably full
bladder for free (no catheter) uroflowmetry and postvoid
xvii
More than 20% (young adults) to 33% (over 65 years) have been suggested as residual urine volume (PVR) measurement prior to filling and
excessive.3 voiding (with catheter) cystometry.

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Terminology for Female Pelvic Floor Dysfunction 11

Uroflowmetry
(i) Ideal conditions for free (or spontaneous—no catheter)
uroflowmetry: Ideally, all free uroflowmetry studies should
be performed in a completely private uroflowmetry room.
Most modern uroflowmeters have a high degree of
accuracy (�5%) though regular calibration is important.22
(ii) Urine flow: Voluntary urethral passage of urine which
may be:
(a) Continuous: No interruption to flow.
(b) Intermittent: Flow is interrupted.
(iii) Flow rate: Volume of urine expelled via the urethra per
unit time. It is expressed in ml/sec.2,3
(iv) Voided volume (ml): Total volume of urine expelled via
the urethra.2,3
(v) Maximum (urine) flow rate (MUFR, ml/sec)—Qmax: Max-
imum measured value of the flow rate2,3 correcting for
artifacts.3
(vi) Flow time (sec): The time over which measurable flow
actually occurs.2,3
(vii) Average (urine) flow rate (AUFR, ml/sec)—Qave: Voided Fig. 4. Liverpool nomogram for maximum urine flow rate in women.
volume divided by the flow time (Fig. 3).2,3 Equation: Ln(maximum urine flow rate) ¼ 0.511 þ 0.505 � Ln(voided vol-
(viii) Voiding time (sec): This is the total duration of mictur- ume); root mean square error ¼ 0.34022,24 (reproduced with permission).
ition, that is, includes interruptions. When voiding is
completed without interruption, voiding time is equal to
flow time.2,3 Ultrasonic techniques (transvaginal, abdominal, Doppler
(ix) Time to maximum flow (sec): This is the elapsed time planimetry) allow immediate (within 60 sec of mictur-
from the onset of urine flow to maximum urine flow.2,3 ition) measurement.27 A short plastic female catheter
(x) Interpretation of the normality of free uroflowmetry: provides the most effective bladder drainage for PVR
Because of the strong dependency of urine flow rates on measurement.27
voided volume,23 they are best referenced to nomograms (iii) Assessment of normality of PVR: Quoted upper limits of
where the cutoff for abnormally slow (MUFR, AUFR) has normal may reflect the accuracy of measurement. Studies
been determined and validated,22,24,25 as under the 10th using ‘‘immediate’’ PVR measurement (e.g., transvaginal
centile of the respective Liverpool nomogram.25 Refer- ultrasound) suggest an upper limit of normal of 30 ml.28
ences to a specific urine flow rate as the lower limit of Studies using urethral catheterization (up to 10 min delay)
normal provided a specific volume has been voided quote higher upper limits of normal of 5026 or 100 ml.28
require further validation studies (Fig. 4).26 An isolated finding of a raised PVR requires confirmation
before being considered significant.

Postvoid Residual (Urine Volume)

Cystometry—General2,3,29
(i) Postvoid residual: Volume of urine left in the bladder at the
completion of micturition.1,3 (i) Cystometry: Measurement of the pressure/volume rela-
(ii) Conditions for PVR measurement: PVR reading is erro- tionship of the bladder during filling and/or pressure flow
neously elevated by delayed measurement due to addi- study during voiding.2,29
tional renal input (1–14 ml/min) into bladder volume.27 (ii) Cystometrogram (CMG): Graphical recording of the blad-
der pressure(s) and volume(s) over time.2,29
(iii) Urodynamic studies: These usually take place in a special
clinical room (urodynamic laboratory) and involve (artifi-
cial) bladder filling with a specified liquid at a specified
rate.3,29
(iv) Conditions for cystometry2,3,29:
(a) Pressures: All systems are zeroed at atmospheric
pressure.
(b) External pressure transducers: Reference point is the
superior edge of the pubic symphysis.
(c) Catheter mounted transducers: Reference point is the
transducer itself.
(d) Initial bladder volume: Bladder should be empty.
(e) Fluid medium: Usually water or saline (or contrast if
radiology involved).
(f) Temperature of fluid: Should ideally be warmed to body
temperature.
(g) Position of patient: Sitting position is more provocative
for abnormal detrusor activity than the supine posi-
tion. At some point in the test, filling might desirably
Fig. 3. A schematic representation of urine flow over time. take place with the woman standing.

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(h) Filling rate: The filling rate, including any changes (iii) Bladder sensation during filling cystometry: This is usually
during testing, should be noted on the urodynamic assessed by questioning the woman in relation to the
report. fullness of the bladder during cystometry.2
(v) Intravesical pressure (pves): The pressure within the (a) First sensation of bladder filling: The feeling when the
bladder.1 – 3 woman first becomes aware of bladder filling.3
(vi) Abdominal pressure (pabd): The pressure surrounding (b) First desire to void2: The first feeling that the woman
the bladder. It is usually estimated from measuring the may wish to pass urine.
rectal pressure, though vaginal and infrequently the (c) Normal desire to void: The feeling that leads the
pressure though a bowel stoma can be measured as woman to pass urine at the next convenient moment,
an alternative. The simultaneous measurement of but voiding can be delayed if necessary.
abdominal pressure is essential for interpretation of the (d) Strong desire to void: The persistent desire to pass urine
intravesical pressure trace2,3. Artifacts on the detrusor without the fear of leakage.
pressure trace may be produced by an intrinsic rectal (e) Urgency: Sudden, compelling desire to pass urine
contraction. which is difficult to defer.3 f
(vii) Detrusor pressure (pdet): The component of intravesical (f) Bladder oversensitivity—also referred to as either
pressure that is created by forces in the bladder wall ‘‘increased bladder sensation’’3 or ‘‘sensory urgency’’
(passive and active). It is estimated by subtracting (2—now obsolete): Increased perceived bladder sensa-
abdominal pressure from intravesical pressure.3 tion during bladder filling with: an early first desire to
(viii) Ambulatory urodynamics: These investigations are a void; an early strong desire to void, which occurs at low
functional test of the lower urinary tract, performed bladder volume; a low maximum cystometric bladder
outside the clinical setting, involving natural filling and capacity (Filling Cystometry Section (iv:b)); no abnor-
reproducing the woman’s everyday activities. mal increases in detrusor pressure.
(g) Reduced bladder sensation: Bladder sensation is per-
ceived to be diminished during filling cystometry.
Filling Cystometry2,3,29
(h) Absent bladder sensation: The woman reports no
(i) Filling cystometry: This is the pressure/volume relation- bladder sensation during filling cystometry.
ship of the bladder during bladder filling.1,2 It begins with (i) Pain: The complaint of pain during filling cystometry is
the commencement of filling and ends when a ‘‘permis- abnormal. Its site, character, and duration should be
sion to void’’ is given by the urodynamicist.3 noted.
(ii) Aims of filling cystometry: These are to assess bladder (iv) Bladder capacity during filling cystometry:
sensation, bladder capacity, detrusor activity, and bladder (a) Cystometric capacity: Bladder volume at the end of
compliance.2,3 filling cystometry, when ‘‘permission to void’’ is

Fig. 5. Filling cystometry—normal detrusor function. Forty-eight-year-old female with urinary frequency. No
phasic activity during filling. Voided with normal urine flow rate at normal detrusor voiding pressure. Normal
study. FD, First desire to void; ND, Normal desire to void; SD, Strong desire to void; U, Urgency; CC, Cystometric
capacity (permission to void given).

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Terminology for Female Pelvic Floor Dysfunction 13

usually given by the urodynamicist. This endpoint and idiopathic detrusor overactivity should be the term
the level of the woman’s bladder sensation at used (Fig. 6).
that time, for example, ‘‘normal desire to void’’, should (c) Neurogenic detrusor overactivity: This is where there is
be noted. detrusor overactivity and there is evidence of a
(b) Maximum cystometric capacity: In patients with relevant neurological disorder.
normal sensation, this is the bladder volume when (vi) Bladder compliance2,3: This describes the relationship
she can no longer delay micturition. between a change in bladder volume and change in
(v) Detrusor function during filling cystometry: detrusor pressure3. Compliance is calculated by dividing
(a) Normal (previously ‘‘stable’’) detrusor function: There is the volume change (DV) by the change in detrusor
little or no change in detrusor pressure with filling. pressure (DPdet) during that change in bladder volume
There are no involuntary phasic contractions despite (C ¼ DV/DPdet). Compliance is expressed as ml per cmH2O.
provocation with activities such as postural changes, Bladder compliance can be affected by:
coughing, hearing the sound of running water, hand- (a) Bladder filling: Faster filling is more provocative. An
washing. artifact may be produced which settles when filling is
(b) Detrusor overactivity: The occurrence of involuntary interrupted.
detrusor contractions during filling cystometry. These (b) Contractile/relaxant properties of the detrusor: For
contractions, which may be spontaneous or provoked, example, postradiation changes of the detrusor wall.
produce a wave form on the cystometrogram, of (c) Starting point for compliance calculations3: Usually the
variable duration and amplitude. The contractions detrusor pressure at the start of bladder filling and the
may be phasic or terminal. Symptoms, for example, corresponding bladder volume (usually zero).
urgency and/or urgency incontinence may or may not (d) End point for compliance calculations3: The detrusor
occur. If a relevant neurological cause is present, then pressure (and corresponding bladder volume) at
neurogenic detrusor overactivity is noted, otherwise cystometric capacity or immediately before the start

Fig. 6. Filling cystometry—detrusor overactivity. Fifty-two-year-old female with urgency and frequency. Phasic
detrusor activity during filling. Leakage is associated with urgency and detrusor contractions. FD, First desire to
void; ND, Normal desire to void; SD, Strong desire to void; U, Urgency; L, Leakage; MCC, Maximum cystometric
capacity.

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of any detrusor contraction that causes significant obtained. During ‘‘cough profiles,’’ the amplitude of the
leakage (and therefore causes the bladder volume cough should be stated if possible.
to decrease, affecting compliance calculations). (ii) Urethral closure mechanism3:
Both points are measured excluding any detrusor (a) Normal urethral closure mechanism: A positive urethral
contraction. closure pressure is maintained during bladder filling,
even in the presence of increased abdominal pressure,
although it may be overcome by detrusor overactivity.
Urethral Function During Filling Cystometry (b) Incompetent urethral closure mechanism: Leakage of
(Filling Urethro-Cystometry)
urine occurs during activities which might raise intra-
abdominal pressure in the absence of a detrusor
(i) Urethral pressure measurement2,3,29: Urethral pressure and contraction.
urethral closure pressure are idealized concepts which (c) Urethral relaxation incompetence (‘‘urethral instabil-
represent the ability of the urethra to prevent leakage. ity’’): Leakage due to urethral relaxation in the absence
Urethral pressure is currently measured by a number of of raised abdominal pressure or a detrusor contraction.
different techniques which do not tend to have consistent (d) Urodynamic stress incontinence: This is the involuntary
results, either between methods or for a single method.30 leakage of urine during filling cystometry, associated
For example, the effect of catheter rotation will be with increased intra-abdominal pressure, in the
relevant when urethral pressure is measured by a catheter- absence of a detrusor contraction.
mounted transducer. Urethral pressure might, nonetheless, (iii) Leak point pressures2,31,32: There are two types of leak
be measured: point pressure measurement. The pressure values at
. At rest, with the bladder at a given volume. leakage should be measured at the moment of leakage.
. During coughing or straining. (a) Detrusor leak point pressure (detrusor LPP): This a static
. During the process of voiding. test. The pressure is the lowest value of the detrusor
(a) Urethral pressure (intraluminal): This is the fluid pressure at which leakage is observed in the absence of
pressure needed to just open a closed urethra. increased abdominal pressure or a detrusor contrac-
(b) Urethral pressure profile (UPP): This is a graph indicating tion. High detrusor LPP (e.g., over 40 cmH2O31) may put
the intraluminal pressure along the length of the patients at risk for upper urinary tract deterioration,
urethra. or secondary damage to the bladder in the cases of
. Resting UPP: The bladder and subject are at rest. known underlying neurological disorders such as
. Stress UPP: Defined applied stress (e.g., cough, strain, paraplegia or MS. There are no data on any correlation
Valsalva). between detrusor LPP and upper tract damage in non-
neurogenic patients.
All systems are zeroed at atmospheric pressure. For external (b) Abdominal leak point pressure (abdominal LPP): This is
transducers, the reference point is the superior edge of the a dynamic test. It is the lowest value of the intention-
symphysis pubis. For catheter-mounted transducers, the ally increased intravesical pressure that provokes
reference point is the transducer itself. Intravesical pressure urinary leakage in the absence of a detrusor contrac-
should be measured to exclude a simultaneous detrusor tion.32 The increase in pressure can be induced by a
contraction. Methodology should be noted2 including: patient cough (cough LPP) or Valsalva (Valsalva LPP). Multiple
position; catheter type; transducer orientation; fluid and rate estimates at a fixed bladder volume (200–300 ml) are
of infusion (if fluid-filling system); bladder volume; rate of desirable. Catheter size will influence LPP values and
catheter withdrawal. should be standardized. LPP values might also be
affected by many other factors such as the technique
(c) Maximum urethral pressure (MUP): Maximum pressure to confirm urine loss, location of catheter, type of
in the UPP. pressure sensor, bladder volume, rate of bladder filling,
(d) Urethral closure pressure profile (UCPP): The relevant and patient position. A low abdominal LPP is sugges-
pressure is the urethral closure pressure (urethral tive of poor urethral function.xviii
pressure minus the intravesical pressure).
(e) Maximum urethral closure pressure (MUCP): Maximum
Voiding Cystometry (Pressure Flow Studies)
pressure in the UCPP, that is, the maximum difference
between the urethral pressure and the intravesical
(i) Voiding cystometry: This is the pressure volume relation-
pressure.
ship of the bladder during micturition.1 It begins when the
(f) Functional profile length: The length of the urethra along
‘‘permission to void’’ is given by the urodynamicist and
which the urethral pressure exceeds intravesical pres-
ends when the woman considers her voiding has finished.3
sure in a woman.
Measurements to be recorded should be the intravesical,
(g) Functional profile length (on stress): The length over
intra-abdominal, and detrusor pressures and the urine
which the urethral pressure exceeds the intravesical
flow rate.
pressure on stress.
(ii) Measurements during voiding cystometry2,3,29:
(h) Pressure ‘‘transmission’’ ratio: This is the increment in
(a) Premicturition pressure: The pressure recorded imme-
urethral pressure on stress as a percentage of the
diately before the initial isovolumetric contraction.
simultaneously recorded increment in intravesical pres-
(b) Opening time: The time elapsed from initial rise in
sure. For stress profiles obtained during coughing,
pressure to the onset of flow. This is the initial
pressure transmission ratios can be obtained at any
isovolumetric contraction period of micturition. It re-
point along the urethra. If single values are given, the
position in the urethra should be stated. If several
transmission ratios are defined at different points along xviii
The correlation between MUCP and abdominal LPP may depend on the
the urethra, a pressure transmission ‘‘profile’’ is catheter type used.

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Terminology for Female Pelvic Floor Dysfunction 15

Fig. 7. A schematic diagram of voiding cystometry.

flects the time taken for the fluid to pass from the point (b) Detrusor underactivity: Detrusor contraction of reduced
of pressure measurement to the uroflow transducer. strength and/or duration, resulting in prolonged
Flow measurement delay should be taken into account bladder emptying and/or a failure to achieve complete
when measuring the opening time. bladder emptying within a normal time span.
(c) Opening pressure: The pressure recorded at the onset of (c) Acontractile detrusor: The detrusor cannot be observed
measured flow (consider time delay). to contract during urodynamic studies resulting in
(d) Maximum pressure: Maximum value of the measured prolonged bladder emptying and/or a failure to achieve
pressure. complete bladder emptying within a normal time span.
(e) Pressure at maximum flow: Pressure recorded at The term ‘‘areflexia’’ has been used where there is a
maximum measured flow rate. neurological cause but should be replaced by neuro-
(f) Closing pressure: Pressure recorded at the end of measured genic acontractile detrusor.
flow.
(g) Contraction pressure at maximum flow: This is the
difference between pressure at maximum flow and the Urethral Function During Voiding Cystometry
premicturition pressure. (Voiding Urethro-Cystometry2,3,29)
(h) Flow delay: This is the delay in time between a change in
pressure and the corresponding change in measured flow This technique may assist in determining the nature of
rate. urethral obstruction to voiding. Pressure is recorded in the
urethra during voiding. This may be at one specific point,
Figure 7 shows a schematic diagram of voiding cystometry. for example, high-pressure zone or it may be measured as a
profile. A voiding urethral pressure profile (VUPP) uses a
(iii) Detrusor function during voiding2,3: similar technique to that described above for the UPP
(a) Normal detrusor function: Normal voiding in women is measured during bladder filling. Simultaneous intravesical
achieved by an initial (voluntary) reduction in intra- pressure measurement is required. Localization of the site of
urethral pressure (urethral relaxation).33 This is gen- the intraurethral pressure measurement is desirable.
erally followed by a continuous detrusor contraction (i) Normal urethral function: The urethra opens and is
that leads to complete bladder emptying within a continuously relaxed to allow micturition at a normal
normal time span. Many women will void successfully pressure, urine flow, and PVR.xix
(normal flow rate and no PVR) by urethral relaxation
alone, without much of a rise in detrusor pressure.34
xix
Symptomatic women with normal detrusor function do not have to rely as
much on an increase in detrusor pressure to achieve successful voiding as men.
The amplitude of the detrusor contraction will tend to
With a shorter urethra (3–4 cm vs. 20 cm), urethral relaxation might suffice. The
increase to cope with any degree of bladder outflow concept of urethral relaxation, prior to detrusor contraction, is a change from
obstruction.35 prior definitions.2,3

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Fig. 8. Ultrasound parameters: according to the recommendations of the German-speaking countries. g (gamma),
angle between the inferior edge of the symphysis and the urethrovesical junction (UVJ); h, distance between the
UVJ and the horizontal; p, distance between the inferior edge of the symphysis and the UVJ; x and y, distance
between the UVJ and the x- and y-axis; X, axis of the symphysis, with 0 at its lower edge; Y, axis perpendicular to
that of the symphysis.36

(ii) Bladder outflow obstruction: This is the generic term for (iii) Current routine possible uses of ultrasound in urogyne-
obstruction during voiding. It is a reduced urine flow rate cology and female urology:
and/or presence of a raised PVR and an increased detrusor (a) Bladder neck descent/mobility/opening:
pressure.xx It is usually diagnosed by studying the . Position of bladder neck at rest and on Valsalva.xxi
synchronous values of urine flow rate and detrusor
pressure and any PVR measurements. A urethral stricture N.B.: Ideally the Valsalva should be standardized but it
or obstruction due to higher degrees of uterovaginal is appreciated that at present a reliable non-invasive
prolapse or obstructed voiding after stress incontinence method is lacking. Consensus has not been reached on
procedures are among possible causes. criteria for excessive bladder neck mobility nor the relation-
(iii) Dysfunctional voiding: This is characterized by an inter- ship of this finding to a diagnosis of urodynamic stress
mittent and/or fluctuating flow rate due to involuntary incontinence.37
intermittent contractions of the peri-urethral striated or
levator muscles during voiding in neurologically normal . Position of bladder neck during pelvic floor
women. This type of voiding may also be the result of an contraction.
acontractile detrusor (abdominal voiding) with electro- . Retrovesical angle (RVA): That is, angle between
myography (EMG) or video-urodynamics required to proximal urethra and trigonal surface of the bladder.
distinguish between the two entities. . Urethral rotation: That is, rotation of the proximal
(iv) Detrusor sphincter dyssynergia (DSD): This is incoordina- urethra on Valsalva.xxii
tion between detrusor and sphincter during voiding due to . Angle gamma: That is, angle defined by lines from the
a neurological abnormality (i.e., detrusor contraction infero-posterior symphyseal margin to the bladder
synchronous with contraction of the urethral and/or neck at rest and on Valsalva.xxi
periurethral striated muscles). This is a feature of neuro- . Urethral funneling: That is, opening of the proximal
logical voiding disorders. Neurological features should be third of the urethra during coughing or on Valsalva.v
sought. Videocystourethrography (VCU—Radiological . Urine loss: Full urethral opening during coughing,
Imaging Section (i:a)) is generally valuable to conclude Valsalva,xxi bladder contraction, or micturition.
this diagnosis.
Figure 8 demonstrates schematically some of the ultra-
Ultrasound Imaging36 sound parameters.

(i) Ultrasound in urogynecology: Ultrasound has become an (b) Postvoid residuals: See the Postvoid Residual (Urine
increasingly frequent adjunct investigation in urogynecol- Volume) Section.
ogy and female urology both in the office and in the (c) Intercurrent pelvic pathology: For example, uterine and
urodynamic laboratory. adnexal pathology.
(ii) Modalities in current routine clinical use: (d) Uterine version: Anteverted or retroverted; flexion at
(a) Perineal: Curved array probe applied to the perineum. level of isthmus.38 xxii
This term incorporates transperineal and translabial (e) Bladder abnormalities: For example, tumor, foreign
ultrasound. body.
(b) Introital: Sector probe applied to the vaginal introitus. (f) Urethral abnormality: For example, diverticulum.
(c) Transvaginal (T-V): Intravaginal curvilinear, linear
array, or sector scanning.
(d) Transabdominal (T-A): Curvilinear scanning applied to
the abdomen.
xxi
In scientific studies, consideration should be given to standardization of the
xx
In symptomatic women, detrusor voiding pressure, urine flow (rate), and PVR Valsalva strength, for example, by using an intrarectal pressure transducer.
xxii
are important markers of bladder outflow obstruction. In the original definition, The use of transvaginal ultrasound with an empty bladder optimizes this
only detrusor pressure and urine flow rate were included. assessment.39

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(g) Postoperative findings: For example, bladder neck Magnetic Resonance Imaging45,46
position and mobility, position of meshes, tapes, or
(i) MRI in urogynecology and female urology:
implants.
(h) Pelvic floor/levator defects: Bladder neck elevation MRI provides the opportunity to examine the soft tissue
during pelvic floor contraction. structures of the pelvic support apparatus in toto. It is non-
(i) Descent of pelvic organs: Visualization of descent of the invasive, has excellent soft tissue contrast resolution without
bladder, uterine cervix, and rectum during Valsalva and exposure to ionizing radiation, and allows the study of
coughing. function of pelvic floor structures under different dynamic
(iv) 3D and 4D ultrasound: The potential of 3D ultrasound in conditions such as increased abdominal pressure during
urogynecology and female urology is currently being Valsalva.44,45 Several anatomical landmarks used for pelvic
researched with validated applications likely to be measurements are also easily identified in MRI and most
included in future updates of this report and/or separate measurements are thus highly reproducible. Currently, the
ultrasound reports. Applications with the most current clinical value of these examinations is still under investigation
research include: (i) major morphological abnormalities with its impact on therapeutic decisions not yet fully
such as levator defects39 and (ii) excessive distensibility of evaluated.
the puborectalis muscle and levator hiatus (‘‘balloon-
ing’’40). The additional diagnostic potential of 4D (i.e., the (ii) Current possible measurements using MRI in urogynecol-
addition of movement) ultrasound awaits clarification by ogy and female urology44,45:
further research. (a) Bladder neck and cervical descent/mobility:
(v) Other assessments: Synchronous ultrasound screening of . Position of bladder neck and cervix at rest and on
the bladder and/or urethra and measurement of the Valsalva.
bladder and abdominal pressure during filling and voiding . Pubo-coccygeal line: A line extending from the
cystometry. inferior border of the pubic symphysis to the last
(vi) Anal ultrasound (endosonography)41: This is the gold- joint of the coccyx. Bladder neck or cervical descent
standard investigation in the assessment of anal sphincter >2 cm below this line with straining indicates weak-
integrity. There is a high incidence of defecatory symp- ness of the pelvic floor. If alternative landmarks are
toms in women with anal sphincter defects. used in scientific papers they should be clearly
described.

Radiological Imaging Figure 9A shows a number of possible measurements using

MRI imaging.
(i) Modalities in current routine clinical use:
(a) Videocystourethrography (VCU)42: Synchronous radio- (b) Intercurrent pelvic pathology: For example, fibroids,
logical screening of the bladder and measurement of the ovarian pathology.
bladder and abdominal pressure during filling and (c) Uterine version: Anteverted or retroverted; flexion at the
voiding cystometry. When indicated for complex cases, isthmus.47
VCU allows direct observation of the effects of bladder (d) Bladder abnormalities: For example, tumor; foreign
events, the position and conformation of the bladder body.
neck in relation to the pubic symphysis, bladder neck (e) Urethral abnormality: For example, diverticulum.
closure during rest and stress, diverticula of the bladder (f) Postoperative findings: For example, bladder neck
and urethra, vesico-vaginal and urethro-vaginal fistulae, mobility.
vesico-ureteric reflux and voiding events. (g) Pelvic floor measurements/levator defects: Assessment
(ii) Other modalities: None of these are office or urodynamic of the configuration of pelvic floor muscles, in partic-
laboratory based. ular, the levator ani.
(a) Intravenous urography (IVU)42: This provides an ana- (h) Descent of pelvic organs:
tomical outline of the urinary tract including a nephro-
gram prior to passage of the contrast to the calyces, renal N.B.: Diagnostic ability may be enhanced by the use of 3D
pelvis, ureter, and bladder. MRI. New techniques with high-speed sequence of pictures
(b) Micturating cystogram (MCU)43: The principal use is the allow a functional MRI.
detection of vesico-ureteric reflux, some fistulae and
diverticula.
DIAGNOSES (MOST COMMON)
(c) Defecography41: This demonstrates normal anatomy
of the anorectum as well as disorders of rectal This reportxxiii again2,3 highlights the need to base
evacuation. Barium paste is inserted rectally prior diagnoses for female pelvic floor dysfunction on the correla-
to defecation over a translucent commode. Measure- tion between a woman’s symptoms, signs, and any relevant
ment of the anorectal angle is allowed with evidence of diagnostic investigations.
the presence, size, or emptying of any rectocele. Enter-
oceles, rectal intusssusception, and mucosal prolapse
might be diagnosed as well as a spastic pelvic floor Urodynamic Stress Incontinence
(anismus).
(d) Colporecto-cystourethrography:(Colpo-cystodefecography)42: Definition: As noted in the Urethral Function During
This involves the instillation of radio-opaque media into Filling Cystometry Section (ii:d), this diagnosis by symptom,
bladder, vagina, and rectum simultaneously for pelvic xxiii
The most common diagnoses are those where there is evidence for a
floor evaluation with images obtained during rest and prevalence of 10% or more in women presenting with symptoms of pelvic floor
straining. dysfunction.

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Fig. 9. A: Axial T2-weighted image of the pelvic floor of a healthy nulliparous Caucasian woman showing
measurement of the antero-posterior diameter of the genital hiatus between the arrows from mid-urethra to mid-
anus at the level of the lower border of the pubic symphysis. Transverse diameter (width) of the levator hiatus was
measured between the stars at the point of maximum extension of the levator muscles at the level of the urinary
bladder and proximal urethra. Reproduced from Am J Obstet Gynecol with the permission from the Publisher.46
B: An example of a unilateral levator defect of the pubococcygeus muscle (right image) seen on MRI imaging
(reproduced with kind permission from Mr. Olubenga Adekanmi; Image reviewed by Prof. John DeLancey).

sign, and urodynamic investigations involves the finding of volume. Also referred to as ‘‘increased bladder sensation,’’3
involuntary leakage during filling cystometry, associated bladder oversensitivity replaces the now obsolete term of
with increased intra-abdominal pressure, in the absence of a ‘‘sensory urgency.’’50,51 As noted in the Filling Cystometry
detrusor contraction.xxiv Section (iii:f), it can be defined as an increased perceived
bladder sensation during bladder filling (Sensory Symptoms
Section (i)) with specific cystometric findings of: (i) an early
Detrusor Overactivity
first desire to void (Filling Cystometry (iii:b)); (ii) an early
Definition: As noted in the Filling Cystometry Section (v:b), strong desire to void, which occurs at low bladder volume
this diagnosis by symptoms and urodynamic investigations (Filling Cystometry (iii:d)); (iii) a low maximum cystometric
is made in women with lower urinary tract symptoms bladder capacity (Filling Cystometry (iv:b)); no abnormal
(more commonly OAB-type symptoms—the Bladder Storage increases in detrusor pressure.51,52 Specific bladder volumes
Symptoms Section (iv)) when involuntary detrusor muscle at which these findings occur will vary in different popula-
contractions occur during filling cystometry.xxv tions. There should be no known or suspected UTI.xxvi

Bladder Oversensitivity Voiding Dysfunction

Definition: Bladder oversensitivity, a diagnosis made by
symptoms and urodynamic investigations, is more likely to (i) Definition: Voiding dysfunction, a diagnosis by symptoms
occur in women with symptoms of frequency and nocturia, and urodynamic investigations, is defined as abnormally
and a voiding diary showing a clearly reduced average voided slow and/or incomplete micturition.53 Abnormal slow
urine flow rates and abnormally high postvoid residuals,
xxiv
This is the most common urogynecological diagnosis, occurring in up to 72%
the basis of this diagnosis, are outlined in the Uroflow-
patients presenting for the first time.49 This diagnosis may be made in the
absence of the symptom of stress (urinary) incontinence in women who have
xxvi
the sign of occult or latent stress incontinence. The prevalence of the oversensitive bladder in urogynecology and female
xxv
The prevalence of detrusor overactivity can vary widely between 13%48 and urology patients (from studies on the now obsolete term ‘‘sensory urgency’’) is
40%49 of patients undergoing urodynamic studies at different centers. around 10–13%.51,52

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Terminology for Female Pelvic Floor Dysfunction 19

metry Section (x) and Postvoid Residual Section (iii). This
diagnosis should be based on a repeated measurement to
confirm abnormality.xxvii
(ii) Further evaluation—pressure/flow studies (voiding cysto-
metry). Pressure: flow studies are indicated to evaluate the
cause of any voiding dysfunction. Some possible causes
have been already defined: Voiding Cystometry Section
(iii:b)detrusor underactivity and (iii:c) acontractile detru-
sor; Urethral Function During Voiding Cystometry
Section (ii) bladder outflow obstruction.
(iii) Alternative presentations:
(a) Acute retention of urine3: This is defined as a generally
(but not always) painful, palpable, or percussable
bladder, when the patient is unable to pass any urine
when the bladder is full.
(b) Chronic retention of urine: This is defined as a non-
painful bladder, where there is a chronic high PVR.xxviii

Pelvic Organ Prolapse

Definition: This diagnosis (Signs of pelvic organ prolapse (i))
by symptoms and clinical examination, assisted by any
relevant imaging, involves the identification of descent of
one or more of the anterior vaginal wall (central, paravaginal,
or combination cystocele), posterior vaginal wall (rectocele),
the uterus (cervix), or the apex of the vagina (vaginal vault or
cuff scar) after hysterectomy.xxix The presence of any such sign Fig. 10. Different types and stages of pelvic organ prolapse. A: Stage II
anterior vaginal wall prolapse; (B) stage III uterine prolapse; and (C) stage IV
should correlate with relevant POP symptoms.
vaginal vault prolapse.
Figure 10 demonstrates different types and stages of
clinical presentations of prolapse. Figure 10A does not
distinguish cystocele type. (and figures—Version 14). Following web site publication,
there have been a further two rounds to review the comments
made. Versions 7, 9, 11, and 17 were subject to live Meetings in
Recurrent Urinary Tract Infections
London (June 2008), Taipei (September 2008), Cairo (October
Definition: This diagnosis by clinical history assisted by the 2008), Lake Como, Italy (June 2009) and San Francisco
results of diagnostic tests involves the determination of the (September 2009). The co-authors acknowledge the input to
occurrence of at least three symptomatic and medically an early version of the document by Professor Don Wilson and
diagnosed UTIs over the previous 12 months.xxx Dr. Jenny King. Versions 9, 10, and 12 were subject to external
review. The extensive comments by those reviewers, Professor
ACKNOWLEDGMENTS/ADDENDUM Gunnar Lose (Version 9), Dr. Sǿren Brostrǿm (Version 10),
Mr. Philip Toozs-Hobson (Version 10), Mr. Ralph Webb,
No discussion on terminology should fail to acknowledge Dr. Kristene Whitmore, and Professor Cor Baeten (Version 12)
the fine leadership shown by the ICS over many years. The are also gratefully acknowledged. The comments by the
legacy of that work by many dedicated clinicians and following reviewers in response to web site publication
scientists is present in all the reports by the different (December 2008 to January 2009) are also much appreciated:
Standardization Committees. It is pleasing that the ICS Dr. Kiran Ashok, Dr. Rufus Cartwright, Dr. Johannes Coetzee,
leadership has accepted this joint IUGA/ICS initiative as a Professor Peter Dietz, Dr. Howard Goldman, Mr. Sharif Ismail,
means of progress in this important and most basic area. Mrs. Jane Meijlink, Professor. Don Ostergard. Version 16 was
subject to a further invited external review by Professor Ted
Arnold, Professor Jacques Corcos, Dr. Harry Vervest, and
Professor Jean-Jacques Wyndaele, and the consideration of
comments by Professor Paul Abrams and Professor Werner
Schaefer. Version 17 will be for web site and dual journal
publication.

xxix
Around 61%48 of women presenting for initial urogynecological assessment
will have some degree of prolapse, not always symptomatic. Objective findings
This document has involved 12 rounds of full review, by co- of prolapse in the absence of relevant prolapse symptoms may be termed
‘‘anatomic prolapse.’’ Approximately half of all women over the age of 50 years
authors, of an initial draft, with the collation of comments
have been reported to complain of symptomatic prolapse.55 There is a 10%
lifetime incidence for women of undergoing surgery to correct pelvic organ
xxvii
Depending on definition, voiding dysfunction has a prevalence of 14%54 to prolapse.56
39%,48 the latter figure making it either the third or fourth most common xxx
Using this definition, two or more and three or more UTIs can occur with a
urodynamic diagnosis (after urodynamic stress incontinence, pelvic organ prevalence of 19% and 11%, respectively, in women presenting with symptoms
prolapse, and possibly detrusor overactivity). of pelvic floor dysfunction.57 This then becomes a significant, generally
xxviii
Approximately 2% of postvoid residual measurements are over 200 ml.28 intercurrent, diagnosis likely to require treatment additional to that planned
This is a suggested cut off. for the other diagnoses found.

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urodynamic patients compared with the Liverpool nomograms. Br J Urol 61:36–9.
1990;65:483–8. 55. Swift SE. The distribution of pelvic organ support in a population of female
26. Costantini E, Mearini E, Pajoncini C, et al. Uroflowmetry in female voiding subjects seen for routine gynaecologic health care. Am J Obstet Gynecol
disturbances. Neurourol Urodyn 2003;22:569–73. 2000;183:277–85.
27. Haylen BT, Lee J. The accuracy of measurement of the post-void residual in 56. Brown JS, Waetjen LE, Subak LL, et al. Pelvic organ prolapse surgery in United
women (Editorial). Int Urogynecol J 2008;19:603–6. States. Am J Obstet Gynecol 1997;186:712–6.
28. Haylen BT, Lee J, Logan V, et al. Immediate postvoid residuals in women with 57. Haylen BT, Lee J, Husselbee S, et al. Recurrent urinary tract infections in
symptoms of pelvic floor dysfunction: Prevalences and associations. Obstet women with symptoms of pelvic floor dysfunction. Int Urogynecol J 2009;
Gynecol 2008;111:1305–12. 20:837–42.

Neurourology and Urodynamics DOI 10.1002/nau

An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Report on the Terminology for Female Pelvic Floor
Dysfunction
22

Received: 4 November 2018

DOI: 10.1002/nau.23897
| Accepted: 7 November 2018

REVIEW ARTICLE

The International Continence Society (ICS) report on the

terminology for adult male lower urinary tract and pelvic floor
symptoms and dysfunction

Carlos D’Ancona1 | Bernard Haylen2 | Matthias Oelke3 |

Luis Abranches-Monteiro4 | Edwin Arnold5 | Howard Goldman6 |
Rizwan Hamid7 | Yukio Homma8 | Tom Marcelissen9 | Kevin Rademakers9 |
Alexis Schizas 10
| Ajay Singla11 | Irela Soto12 | Vincent Tse13 |
Stefan de Wachter14 | Sender Herschorn15 |
On behalf of the Standardisation Steering Committee ICS and the ICS Working Group on
Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction

1 Universidade Estadual de Campinas, São

Paulo, Brazil Introduction: In the development of terminology of the lower urinary tract, due to its
2 University of New South Wales, Sydney, increasing complexity, the terminology for male lower urinary tract and pelvic floor
Australia symptoms and dysfunction needs to be updated using a male-specific approach and
3 St. Antonius Hospital, Gronau, Germany via a clinically-based consensus report.
4 Hospital Beatriz Ângelo Loures, Lisbon,
Methods: This report combines the input of members of the Standardisation
Portugal
5 University
Committee of the International Continence Society (ICS) in a Working Group with
of Otago, Christchurch, New
Zealand recognized experts in the field, assisted by many external referees. Appropriate core
6 Cleveland Clinic, Cleveland, Ohio clinical categories and a subclassification were developed to give a numeric coding to
7 University
College Hospitals, London, each definition. An extensive process of 22 rounds of internal and external review was
United Kingdom
developed to exhaustively examine each definition, with decision-making by
8 Japanese Red Cross Medical Centre,
collective opinion (consensus).
Tokyo, Japan
9 Maastricht University, Maastricht, The
Results: A Terminology Report for male lower urinary tract and pelvic floor
Netherlands symptoms and dysfunction, encompassing around 390 separate definitions/
10 Guy's& St Thomas's Hospitals, London, descriptors, has been developed. It is clinically-based with the most common
United Kingdom
diagnoses defined. Clarity and user-friendliness have been key aims to make it
11 Massachusetts General Hospital, Harvard,
interpretable by practitioners and trainees in all the different specialty groups
Boston
12 Complejo Hospitalario, Panama City,
involved in male lower urinary tract and pelvic floor dysfunction. Male-specific
Panama imaging (ultrasound, radiology, CT, and MRI) has been a major addition whilst
13 University of Sydney, Sydney, Australia appropriate figures have been included to supplement and help clarify the text.
14 University of Antwerp, Antwerp, Conclusions: A consensus-based Terminology Report for male lower urinary tract
Belgium
and pelvic floor symptoms and dysfunction has been produced aimed at being a
15 University of Toronto, Ontario, Canada
significant aid to clinical practice and a stimulus for research.

Carlos D’Ancona (Content) and Bernard Haylen (Production) are equal first authors.

Neurourology and Urodynamics. 2019;1–45. wileyonlinelibrary.com/journal/nau © 2019 Wiley Periodicals, Inc. | 1

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| D’ANCONA, HAYLEN ET AL.

Correspondence KEYWORDS
Carlos D’Ancona, MD, PhD, Universidade
lower urinary tract dysfunction, lower urinary tract symptoms, male, male urinary tract imaging, male
Estadual de Campinas, Rua Dr Miguel
urodynamics, terminology
Penteado 1073, Campinas − SP. CED
13020-118, Brazil.
Email: cdancona@uol.com.br

INTRODUCTION forming a “backbone” or “core” terminology, to facilitate an

update of the other subcategories of male-specific terminolo-
There is currently no single document addressing all elements gies. There have been seven other (IUGA-ICS) female PF-
required for diagnoses applicable to adult (fully grown and related terminology documents,6–12 all published, following
physically mature1 − new) male lower urinary tract and pelvic the production of the initial joint IUGA/ICS document on
floor dysfunction. Indeed, the diagnostic entities themselves female pelvic floor dysfunction.5 The authors of that
may have not been all completely defined. The term document5 have kindly permitted the template of that Report
“diagnosis” is defined as “the determination of the nature to be used as the basis for the current Report. Four other male
of a disease; clinical: made from a study of the symptoms and terminology reports have been initiated: (i) male anorectal
signs of a disease1; “laboratory:” investigative options to be dysfunction; (ii) surgical management of male LUT
mentioned. Such a specific report would require a full outline dysfunction; (iii) sexual health in men with LUT/PF
of the terminology for all symptoms, signs, urodynamic dysfunction and (iv) conservative management of male
investigations for male lower urinary tract (LUT) and pelvic LUT/PF dysfunction, to follow the publication of this “core”
floor (PF) dysfunction, the imaging associated with those report.
investigations and the most common diagnoses. This Terminology Report is inherently and appropriately
It may have been possible in the past to combine all a definitional document, collating the definitions of those
terminology for lower urinary tract function for men, women terms, that is, words used to express a defined concept in a
and children into one Report. The International Continence particular branch of study,1 here core male terminology.
Society (ICS) has provided leadership in terminology for Emphasis has been on comprehensively including those terms
lower urinary tract dysfunction over decades employing in current use in the relevant peer-reviewed literature. The
combined or generic reports. The 19882 and 20023 Reports by aim is to assist clinical practice and research. Explanatory
the Committee on Standardization of Terminology are such notes on definitions have been referred, where possible, to the
examples. With the increasing specificity and complexity of “Footnotes section.” Table 1 lists the number of definitions:
the diagnoses in both sexes, combined reports, let alone (i) new; (ii) changed; (iii) total by section, compared with the
attempting to cover “all patient groups from children to the previous male-inclusive Reports.2,3
elderly,”3 may now be an anachronism. With evidence that As with its female terminology equivalent, qualities for a
the absence of specific female diagnoses as well as other male-specific terminology report should be:
female specific terminology, may not have been advantaged
by a combined approach,4 there occurred the development (1) User-friendly: It should be able to be understood by all
and 2010 publication of an International Urogynecological clinical and research users.
Association (IUGA)/ICS Joint Report on the Terminology for (2) Clinically-based: Symptoms, signs, validated investiga-
Female Pelvic Floor Dysfunction.5 The 2002 Report3 still tions and imaging should be presented for use in forming
provides the traditional core male terminology and some diagnoses. Sections 1-4 will address symptoms, signs,
useful modifications, many of which are repeated in this urodynamic investigations and current associated imag-
document. The current report, with the large number of new ing modalities routinely used in the office, urodynamic
and changed definitions, acknowledges that a male-specific laboratory, or imaging department to make those
update of terminology for LUT and PF symptoms and diagnoses. Readership is not assumed to be limited to
dysfunction is now timely. medical specialists, accounting for a more extended
It is hoped that some of the advantages noted in the “basic” physical examination (Section 2). Related
female-specific document5 might be seen here in this male radiological investigations, computerized tomography
document: (i) more comprehensive coverage of male-specific (CT) and magnetic resonance imaging (MRI) as well as a
terminology; (ii) greater coherency and user-friendliness; (iii) description of electromyography (EMG) has been
greater specificity of male diagnoses; and (iv) more accurate included. This report limits terminology for neurogenic
communication for clinical and research purposes. It is also an lower urinary tract dysfunction (LUTD) as this is covered
aim in this document, to develop a general male terminology, by a separate ICS Report.13

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TABLE 1 Total, new and changed definitions (compared with previous male-inclusive Reports2,3)
Section New definitions/descriptors Changed definitions/descriptors Total
Introduction & Symptoms 60 23 118
Signs 73 14 98
Investigations 23 25 106
Imaging 42 n/a 42
Diagnoses 14 9 26
Total 211 (54%) 71 (18%) 390

(3) Section 5 will address the most common diagnoses of volunteered by, or elicited from the individual, or may be
male lower urinary tract and pelvic floor dysfunction. The described by the individual's partner or caregiver2,3,5
terms3 “urodynamic observation” and “condition” (non- Complaint: The description of the symptom.1 (NEW)
medical) have not been used in this report. The scope of Main (Chief) Complaint: The symptom that a patient
the report will exclude (i) diagnostic pathology (blood, states as the main reason for seeking medical advice.1 (NEW)
urine, histology); (ii) more invasive investigations The degree of “bother (worry, concern)” for other symptoms
requiring an anesthetic; (ii) evidence-based treatments can be variable.14 (NEW)
for each diagnosis. Lower urinary tract symptom (LUTS): A symptom
(4) Origin: Where a term's existing definition (from one of related to the lower urinary tract; it may originate from the
multiple sources used) is deemed appropriate, that bladder, prostate, urethra, and/or adjacent pelvic floor or
definition will be included and duly referenced. Many pelvic organs, or at times be referred from similarly
terms in male lower urinary tract and pelvic floor innervated anatomy, for example, lower ureter. (NEW)
function, because of their long-term use, have now
STORAGE SYMPTOMS
become generic, as apparent by their listing in medical
dictionaries.
1.1 Storage Symptoms: Lower urinary tract symptoms
(5) Able to provide explanations: Where a specific explana-
occurring during the bladder storage phase. (NEW)
tion is deemed appropriate to explain a change from
General Storage symptoms
earlier definitions or to qualify the current definition, this
will be included as an addendum to this paper (Footnote 1.1.1 Increased urinary frequency: Complaint that
[FN] 1,2,3 . . ..). Wherever possible, evidence-based voiding occurs more frequently than deemed normal
medical principles will be followed. by the individual (or caregivers).3,5 Time of day and
number of voids are not specified. (NEW)
As in earlier ICS Reports,2,3,5 when a reference is made to 1.1.2 Increased daytime urinary frequency: Com-
the whole anatomical organ, the vesica urinaria, the correct plaint that voiding occurs more frequently during
term is the bladder. When the smooth muscle structure known waking hours than previously deemed normal by
as the m. detrusor vesicae is being discussed, then the correct the individual (or caregivers).3,5 FN1.1 NB polla-
term is detrusor. kiuria FN1.2 (CHANGED)
It is suggested that acknowledgement of these standards 1.1.3 Nocturia: The number of times urine is passed
in written publications related to male lower urinary tract during the main sleep period. Having woken to pass
and pelvic floor symptoms and dysfunction, be indicated by urine for the first time, each urination must be
a footnote to the section “Methods and Materials” or its followed by sleep or the intention to sleep. This
equivalent, to read as follows: “Methods, definitions and should be quantified using a bladder diary.18
units conform to the standards recommended by the 1.1.4 Polyuria (global symptom): Complaint that the
International Continence Society, except where specifically urine excretion volume over 24 h is noticeably
noted.” larger than the previous experience.FN1.4 (NEW)
1.1.4.1 Diurnal polyuria: Complaint that daytime
SECTION 1: SYMPTOMS urine excretion volume is noticeably larger
than the previous experience. (NEW)
Symptom: Any morbid phenomenon or departure from the 1.1.4.1 Nocturnal polyuria (symptom)18: Com-
normal in structure, function, or sensation, possibly indicative plaint of passing large volumes of urine at
of a disease or health problem. Symptoms are either night-time. (NEW)

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| D’ANCONA, HAYLEN ET AL.

Sensory symptoms loss of urine associated with urgency as

1.1.5 Bladder filling (sensory) symptoms: Abnormal well as with effort or physical exertion
sensations experienced during bladder filling.1 including sporting activities or on sneez-
(NEW) ing or coughing (stress).3,5
1.1.5.1 Increased bladder filling sensation: 1.1.6.5 Enuresis: Complaint of intermittent (non-
Complaint that the sensation of bladder continuous) incontinence that occurs dur-
filling occurs earlier or is more intense or ing periods of sleep.18 (CHANGED)
persistent to that previously experienced.3,5 1.1.6.6 Continuous urinary incontinence:
(CHANGED) N.B. This differs from Complaint of continuous involuntary
urgency by the fact that micturition can loss of urine.3,5 (CHANGED)
be postponed despite the desire to void. 1.1.6.7 Insensible urinary incontinence: Com-
1.1.5.2 Urgency: Complaint of a sudden, compel- plaint of urinary incontinence where the
ling desire to pass urine which is difficult to individual is aware of urine leakage but
defer.3,5 FN1.5, FN1.6 unaware of how or when it occurred.5
1.1.5.3 Reduced bladder filling sensation: Com- (CHANGED)
plaint that the sensation of bladder filling is 1.1.6.8 Postural urinary incontinence: Com-
less intense or occurs later in filling than plaint of urinary incontinence during
previously experienced. (CHANGED) change of posture or position, for exam-
1.1.5.4 Absent bladder filling sensation: Com- ple, from supine or seated to stand-
plaint of both the absence of the sensation ing.FN1.12 (NEW)
of bladder fullness and a definite desire to 1.1.6.9 Disability associated incontinence:
void3 Complaint of urinary incontinence in the
1.1.5.5 Non-specific (atypical) bladder filling presence of a functional inability to reach
sensation (bladder dysesthesia): Com- a toilet/urinal in time because of a
plaint of abnormal bladder filling sensation physical (eg, orthopedic, neurological)
such as the perception of vague abdominal and/or mental impairment. (NEW)
bloating, vegetative symptoms (nausea, 1.1.6.10 Overflow incontinence: Complaint of
vomiting, faintness), or spasticity. urinary incontinence in the symptomatic
(CHANGED) F1.7 It differs from normal presence of an excessively (over-) full
bladder filling sensation or pain, pressure bladder (no cause identified). (NEW)
or discomfort of the bladder. 1.1.6.11 Sexual arousal incontinence19: Com-
plaint of involuntary loss of urine during
sexual arousal, foreplay and/or masturba-
Incontinence symptoms tion. (NEW)
1.1.6 Urinary incontinence symptoms16: Involuntary 1.1.6.12 Climacturia19: Complaint of involuntary
loss of urine experienced during the bladder storage loss of urine at the time of orgasm. (NEW)
phase FN1.8, FN1.9 .(NEW)
1.1.6.1 Urinary incontinence (symptom): Com- Storage symptom syndrome
plaint of involuntary loss of urine.3,5 FN 1.9 1.1.7 Overactive bladder (OAB, urgency) syndrome:
1.1.6.2 Urgency urinary incontinence (UUI)3,5: Urinary urgency, usually accompanied by in-
Complaint of involuntary loss of urine creased daytime frequency and/or nocturia, with
associated with urgency. urinary incontinence (OAB-wet) or without (OAB-
1.1.6.3 Stress urinary incontinence (SUI): dry), in the absence of urinary tract infection or
Complaint of involuntary loss of urine other detectable disease.3,5 (CHANGED)
on effort or physical exertion including
sporting activities, or on sneezing or VOIDING SYMPTOMS
coughing.3,5 N.B. “activity (effort)-re-
lated incontinence” might be preferred 1.2 Voiding symptoms: Lower urinary tract symptoms
in some languages to avoid confusion during the voiding phase (experienced during micturi-
with psychological stress. FN1.10 tion). (NEW)
1.1.6.4 Mixed urinary incontinence (MUI): 1.2.1. Hesitancy: Complaint of a delay in initiating
Complaints of both stress and urgency voiding (when the individual is ready to pass
urinary incontinence, that is, involuntary urine). (CHANGED)

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1.2.2. Paruresis (“bashful” or “shy bladder”): Com- 1.2.16 Urinary retention: Complaint of the inability to
plaint of the inability to initiate voiding in public empty the bladder completely.1 (NEW)
(i.e. voiding in the presence of other persons) 1.2.16.1 Acute urinary retention (AUR): Com-
despite there being no difficulty in private.20 plaint of a rapid onset, usually painful
FN1.13 (NEW) suprapubic sensation (from a full blad-
1.2.3 Episodic inability to void: Complaint of occa- der) due to inability to void (non-
sional inability to initiate voiding despite relaxa- episodic), despite persistent intensive
tion and/or an intensive effort (by abdominal effort.FN1.16 (NEW)
straining, Valsalva maneuver or suprapubic 1.2.16.2 Chronic urinary retention (CUR):
pressure). (NEW) Complaint of chronic or repeated
1.2.4 Straining to void: Complaint of the need to make inability to empty the bladder, despite
an intensive effort to either initiate, maintain or the ability to pass some urine. This may
improve voiding or the urinary stream.3,5 result in the frequent passage of small
(CHANGED) amounts of urine or urinary inconti-
1.2.5 Slow (urinary) stream: Complaint of a urinary nence and a distended bladder FN1.17
stream perceived as overall slower than previous (NEW)
performance or in comparison with others.3,5
1.2.6 Intermittency: Complaint of urine flow that stops POST-VOIDING SYMPTOMS
and starts on one or more occasions during one
voiding episode.3,5 1.3 Postvoiding Symptom: Lower urinary tract symptom
1.2.7 Terminal dribbling: Complaint that during the experienced after voiding has ceased. (NEW)
final part of voiding there is noticeable slowing of 1.3.1 Feeling of incomplete (bladder) emptying:
the flow to drops or a trickling stream. Complaint that the bladder does not feel empty
(CHANGED) after voiding has ceased.3,5 (CHANGED)
1.2.8 Spraying (splitting) of urinary stream: Com- 1.3.2 Need to immediately re-void (“Encore” or
plaint that the urine passage is a spray or split “Double” voiding): Complaint that further voiding
rather than a single directional stream.3,5 is necessary soon after passing urine (cessation of
(CHANGED) flow).3,5 (CHANGED)
1.2.9 Position-dependent voiding: Complaint of having 1.3.3 Post-voiding incontinence: Complaint of a further
to adopt specific positions to be able to void involuntary passage (incontinence) of urine or
spontaneously or to improve bladder emptying, for dribbling following the completion of voiding3,5
example, needing to void in a seated position. (NEW) FN1.18. (NEW)
1.2.10 Dysuria: Complaint of pain, burning, other 1.3.4 Post-micturition urgency: Complaint of persis-
discomfort, or difficulty during voiding. Discom- tent urgency post-voiding. (NEW)
fort may be intrinsic to the lower urinary tract (eg,
bladder or urethra), external, or referred from Voiding symptom syndrome (proposal for further research)
other adjacent similarly innervated structures, for − Underactive bladder syndrome: FN1.19
example, lower ureter. FN1.14 (CHANGED)
1.2.11 Stranguria: Complaint of voiding which is slow, 1.4 Lower Urinary Tract Pain and/or Other Pelvic Pain
difficult and spasmodic (at times “drop by drop”), 1.4.1 Pain: A variably unpleasant sensation.1 It may be
usually associated with pain. (NEW)FN1.15 described as pressure or discomfort by the patient.
1.2.12 Hematuria: Complaint of passage of visible Pain should be characterized by site, type,
blood mixed with urine. This may be initial (at the frequency, duration, precipitating, and relieving
beginning), terminal (at the end) or total (through- factors.FN1.20; FN 1.21 (CHANGED)
out bladder emptying). (NEW) 1.4.2 Bladder pain: Complaint of suprapubic or
1.2.13 Pneumaturia1: Complaint of the passage of gas retropubic pain, pressure or discomfort related
(or air) from the urethra during or after voiding. to the bladder, and usually associated with bladder
(NEW) filling. It may persist or be relieved after
1.2.14 Fecaluria1: Complaint of passage of feces (per voiding.3,5 (CHANGED)
urethram) in the urine. (NEW) 1.4.3 Urethral pain: Complaint of pain, pressure or
1.2.15 Chyluria (albiduria)1: Complaint of passage of discomfort felt in the urethra3,5 before, during
chyle (pale or white, milky cloudy) in the urine.1 and/or after voiding and the man indicates the
(NEW) urethra as the site. (CHANGED)

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| D’ANCONA, HAYLEN ET AL.

1.4.4 Scrotal pain: Complaint of pain, pressure or diagnosed UTI in the previous 12 months.FN1.25
discomfort felt in and around the scrotum.3 It may The previous UTI(s) should have resolved prior to a
be localized to the testis, epididymis, cord further UTI being diagnosed. (CHANGED).
structures, or scrotal skin. 1.5.3 Urethral discharge: Of mucus, pus, or blood, from
1.4.5 Perineal pain: Complaint of pain, pressure, or the urethral meatus. (NEW)
discomfort felt on the surface or in the depth of the
tissue between the scrotum and the anus.3
1.4.6 Pelvic pain: Complaint of pain, pressure, or 1.6 Symptoms of sexual dysfunction: Abnormal sensation
discomfort related to the pelvis but not clearly and/or function experienced by a man during sexual
related to the bladder, urethra, scrotum, or activity. (NEW)
perineum.3 1.6.1 Altered Libido: Change in interest in sexual
1.4.7 Ejaculatory pain: Complaint of pain, pressure, or activity. (NEW)
discomfort felt in the perineum, suprapubic region 1.6.1.1 Decreased libido: Complaint of decreased
and/or penis during ejaculation, but may continue interest in sexual activity in comparison to
for a time afterwards. (NEW)FN 1.22 previous experience. (NEW)
1.4.8 Anorectal pain symptoms: Complaint of pain, 1.6.1.2 Increased libido: Complaint of increased
pressure or discomfort particularly during defe- interest in sexual activity in comparison to
cation or straining to defecate but can occur at any previous experience. (NEW)
time. (NEW) 1.6.2 Erectile dysfunction25: Complaint of inability to
1.4.8.1 Pain during straining /defecation: Pain achieve and sustain an erection firm enough for
during defecation or straining to defecate. satisfactory sexual performance. (NEW)
1.4.8.2 Inflammatory anorectal pain: Pain 1.6.3 Ejaculatory dysfunction: Complaint of alteration
characterized by burning or stinging of the emission of seminal fluids during ejacula-
(inflammation, radiation, sepsis). (NEW) tion. (NEW)
1.4.8.3 Non-inflammatory anorectal pain: 1.6.3.1 Anejaculation: Complaint of absence of
Blunted anorectal pain (proctalgia fugax, seminal fluid emission. May be associated
Levator ani syndrome, pudendal neural- with the absence of the sensation of orgasm
gia). (NEW) or anorgasmia. (NEW)
1.4.9 Coccygeal pain (coccydynia): Complaint of 1.6.3.2 Delayed ejaculation: Complaint of an
pain, pressure, or discomfort in the coccygeal increase in the time taken for ejaculation
region. (NEW) to occur. (NEW)
1.4.10 Pudendal pain (neuralgia): Complaint of pain, 1.6.3.3 Premature ejaculation: Complaint of a
pressure, or discomfort in one or more of the areas persistent or recurrent pattern of too rapid
innervated by the pudendal nerve (may be caused achievement of ejaculation during part-
by inflammation or entrapment of the pudendal nered sexual activity,1 that is, before the
nerve and involving its dermatome). individual wishes it. FN 1.26 (NEW)
(CHANGED) 1.6.3.4 Decreased (low) semen volume**: Com-
1.4.11 Chronic pelvic pain syndromes: See ICS plaint of smaller amount of seminal fluid
standard for terminology in chronic pelvic pain than normal or previously experienced
syndromes.23 FN1.21 FN1.27. (NEW)
1.6.3.5 Increased (high) semen volume: Com-
plaint of higher amount of seminal fluid
1.5 Urinary tract infection (UTI) than normal or previously experienced.
1.5.1 Symptoms of acute urinary tract infection: (NEW)FN1.27
Symptoms such as increased bladder sensation, 1.6.4 Hematospermia: Complaint of the appearance of
urgency, frequency, dysuria/stranguria, pain in the visible blood in the seminal fluid. Color of the
lower urinary tract with or without urgency urinary seminal fluid may be red or brown. (NEW)
incontinence might suggest lower urinary tract 1.6.5 Penile pain with intercourse (male dyspareu-
infection. Confirmation of a UTI requires evidence nia): Complaint of any penile discomfort occurring
of significant microorganisms and pyuria. (FN1.23, during intercourse. May be caused by penile
FN 1.24) (CHANGED) disease, vaginal anatomy (eg, vaginal tightening,
1.5.2 Recurrent urinary tract infections (UTIs): A scarring, or exposed mesh) and/or may relate to
history of at least two symptomatic and medically various positions with intercourse. FN1.28 (NEW)

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1.6.6 Obstructed intercourse: Complaint that vaginal involuntary straining and the passage of
intercourse is not possible due to perceived little fecal matter.1
obstruction. Whilst this may be a partner issue, it 1.7.3 Defecatory or post-defecatory symptoms: Symp-
can occur in cases of penile curvature (Peyronie's toms experienced during or following the act of
disease) or penile carcinoma. (NEW) defecation. (NEW)
1.7.3.1 Constipation: Complaint that bowel
movements are infrequent and/or incom-
1.7 Symptoms of anorectal dysfunction5,10,27: FN1.29 plete and/or there is a need for frequent
1.7.1 Anorectal incontinence (symptoms): Complaint straining or manual assistance to defecate.
of involuntary loss of flatus or feces.5,10 Can be (Rome IV criteria28) FN1.30.
further subdivided into: 1.7.3.1.1 Slow transit: infrequent bowel
1.7.1.1 Flatal incontinence: Complaint of invol- motions due to delay in transit of
untary loss of flatus (gas).5,10 bowel contents to reach rectum.
1.7.1.2 Fecal incontinence: Complaint of invol- 1.7.3.1.2 Obstructed defecation: Com-
untary loss of feces.5,10 plaint of difficulty in evacuation
- when feces is solid and/or due to a mechanical obstruction.
- when feces is liquid 1.7.3.2 Feeling of incomplete bowel evacuation:
1.7.1.3 Fecal (rectal) urgency: Complaint of a Complaint that the rectum does not feel
sudden, compelling desire to defecate that empty after defecation. May be accompa-
is difficult to defer.5,10 nied by a desire to defecate again.5,10
1.7.1.4 Fecal (flatal) urgency incontinence: Com- 1.7.3.3 Straining to defecate: Complaint of the
plaint of involuntary loss of feces (flatus) need to make an intensive effort (by
associated with fecal urgency.5,10,27 abdominal straining or Valsalva) or to
1.7.1.5 Passive (insensible) fecal incontinence: use abdominal massage to either initiate,
Complaint of involuntary soiling of liquid maintain, or improve defecation.5,10
or solid stool without sensation or warning. 1.7.3.4. Manual defecatory assistance
(NEW) 1.7.3.4.1 Internal: Anorectal Digitation:
1.7.1.6 Overflow fecal incontinence: Complaint Complaint of the need to use of
of involuntary loss of stool due to an fingers in the rectum to manually
overfull rectum or fecal impaction. (NEW) assist in evacuation of stool
1.7.1.7 Coital fecal incontinence: Complaint of contents by scooping, stretching
involuntary loss of stool occurring with and/or stimulation.5 (NEW)
intercourse.5,10 1.7.3.4.2 External: Perineal pressure or
1.7.1.8 Stress fecal incontinence (SUI): Com- buttock separation: Complaint
plaint of involuntary loss of feces on effort of the need to press on the
or physical exertion including sporting perineum or separate the but-
activities, or on sneezing or coughing. tocks to assist defecation.
(NEW) (NEW)
1.7.2 Anorectal sensory symptoms 1.7.3.5 Post defecatory soiling: Complaint of
1.7.2.1 Diminished rectal sensation (rectal hy- soiling occurring after defecation. (NEW)
posensitivity): Complaint of diminished or 1.7.3.6 Rectal bleeding/mucus: Complaint of the
absent sensation of filling in the rectum. loss of blood or mucus per rectum.
(CHANGED) 1.7.4 Anorectal prolapse: Complaint of external pro-
1.7.2.2 Increased rectal sensation (rectal hyper- trusion (bulge) of the anus or rectum (differentia-
sensitivity): Complaint of a desire to tion on subsequent examination between rectal
defecate (during rectal filling) that occurs mucosal prolapse and full thickness rectal wall
earlier or more persistent to that previously prolapse which includes muscle and serosal layers).
experienced. (NEW) (CHANGED)
NB: for 1.7.2.1 and 1.7.2.2, can be to (i)
first sensation; (ii) urge sensation; (iii)
maximum tolerated volume. 1.8 Other Relevant History
1.7.2.3 Tenesmus: Complaint of an urgent desire Current medications, previous urological operations,
to evacuate the bowel, accompanied by radiotherapy, and catheterization should be noted.

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| D’ANCONA, HAYLEN ET AL.

Footnotes for Section 1 1.15: The symptom of “stranguria” is poorly understood,

1.1: Milsom et al.15 first reported that frequency caused by overlapping at times with urethral pain, dysuria, and pelvic
an overactive bladder was arbitrarily defined as more than pain.
eight micturitions per 24 h, given that the normal voiding 1.16: The bladder is distended, palpable, and possibly
frequency in healthy individuals is typically under six tender. A significantly increased residual is present.
micturitions per 24 h. It was higher than previously reported 1.17: Non-neurogenic chronic urinary retention (CUR) in
for healthy women using a frequency/volume chart (median men (AUA consensus21 supported by the current authors) can
5.5 micturitions per 24 h).15–17 be defined as an elevated post-void residual of greater than
1.2: Pollakiuria: Complaint of abnormally (extraordi- 300 mL that has persisted for at least 6 months and is
nary1) frequent micturition (rarely used definition). documented on two or more separate occasions. Evidence is
1.3: It is common to void during the night when sleep is not strong. CUR can be caused by different pathologies that
disturbed for other reasons—eg, insomnia—this does not create detrusor underactivity and/or result in chronic bladder
constitute nocturia. outlet obstruction.21
1.4: Polyuria is more fully defined in the “Signs” section. 1.18: May occur after clothing has been adjusted, due to
1.5: “Urgency” replaces “urge” as the “accepted” some “pooling” of urine in the urethra if underwear, or
terminology for the abnormal rather than the normal clothing has caused some restriction during voiding or a
phenomenon. urethral stricture or diverticulum.
1.6: The use of the word “sudden,” defined as “without 1.19: Complaints of a slow urinary stream, hesitancy and
warning or abrupt,” used in earlier definitions2,3,5 has been straining to void, with or without sense of incomplete bladder
subject to much debate. Its inclusion has been continued. emptying and dribbling, sometimes with storage symptoms:
1.7: This symptom generally occurs where there is some symptom grouping proposed to be suggestive of detrusor
form of neurological disease. underactivity22 (DU). Diagnosis of actual detrusor underac-
1.8: “Continence” is defined as absence of involuntary tivity depends on urodynamic findings as discussed in Section
leakage of bowel and bladder contents (i.e. normal voluntary 5 on Diagnoses.
control of bowel and bladder function). 1.20: It is often difficult to localize pain precisely, so
1.9: In each specific circumstance, urinary incontinence descriptions as to location of the pain may be imprecise. For
should be further described by specifying relevant factors example, the term “bladder pain” does not necessarily
such as type, severity, precipitating factors, social impact, indicate that the bladder is the cause. Pain thought to be
effect on hygiene, and quality of life, the measures used to arising from the bladder, or felt in the urethra, scrotum or
contain the leakage, and whether or not the individual seeks or perineum might be referred from the lower ureter, or bladder
desires help because of urinary incontinence. base or other pelvic organs.
1.10: This change is to accommodate for ambiguity in 1.21. The definitions of pelvic pain and especially chronic
some languages between stress and anxiety. This symptom pelvic pain had been debated in several societies with a view to
would most commonly occur in men who have undergone simplification and restructuring of the classification. The ICS has
(radical) prostatectomy. Men who had radical prostatectomy now published a report from chronic pelvic pain syndromes.23
may experience activity-related incontinence and/or during 1.22. Painful ejaculation (previously termed “odynorgas-
sex.19 mia”), is a poorly characterized syndrome. It may be
1.11: Small amounts of urine may be leaked without associated with urethritis, BPH, acute or chronic prostatitis,
warning. CPPS, seminal vesiculitis, seminal vesicular calculi or
1.12: Men with post-prostatectomy incontinence do ejaculatory duct obstruction. Often, no obvious etiologic
report this. It also happens in men after artificial sphincter factor can be found.
placement. When they get up, they leak. Can be due to stress 1.23: Commonly suggested criteria for: (i) Bacteriuria
and without urge or other associated symptoms in the standing are>100 000 CFU/mL on voided specimen or >1000 CFU/
or upright position. mL on catheterized specimen; (ii) Pyuria are >10 WBC/mm3
1.13: The term “pareuresis” is not in common usage, in uncentrifuged urine. The presence of nitrites in the urine is
although the symptom is well-recognised.20 Paruresis is supportive of a UTI involving a common organism (E. Coli,
defined as the fear of being able to urinate in situations where Klebsiella).
other persons are present. Diagnostic and statistical manual of 1.24: Those symptomatic patients with fewer colony
mental disorders. Arlington, VA: American Psychiatric counts may still harbor organisms detectable by mRNA
Association; 2013. analyses not widely available at present.24 Testing for urinary
1.14: Dysuria is a type of urethral pain but could be microbiome is being explored but it is not widely available.
urethral in origin or referred there from a pathological process 1.25: Recurrent urinary tract infections (UTIs) has not
in bladder, lower ureter or prostate. been consistently defined. They are far less common in men

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than women but perhaps more significant. There is the If a neurological diagnosis is suspected, then a focused
difficulty of balancing the practical clinical definition and the neurological examination with evaluation of perianal crude
scientific one. Records of diagnostic tests are often and pinprick sensations need to be tested. Also, the anal
inaccessible over the medium to longer term. With a bias muscle tone can be assessed with finger in the rectum and
towards the former category, a definition might be the asking the patient to squeeze. (NEW)
presence at least two symptomatic and medically diagnosed
UTIs in 12 months. “Recur” strictly means to “occur again” or 2.1 General (visual) observations
“be repeated.” 2.1.1 Mobility: generalized muscle strength and ability
1.26: This symptom must have been present for at least 6 to ambulate independently or with assistance.
months and must be experienced on almost all or all (NEW)
(approximately 75-100%) occasions of sexual activity. It 2.1.2 Skin: jaundice or pallor or skin irritation due to
causes clinically significant distress in the individual. It has urinary loss. (NEW)
been called early ejaculation, rapid ejaculation, rapid climax 2.1.3 Nutritional Status: cachexia (possible underlying
or premature climax. There is no uniform cut-off defining malignancy); obesity (possible endocrine abnor-
“premature,” but a consensus of experts at the International mality29 including metabolic syndrome). (NEW)
Society for Sexual Medicine endorsed a definition of around 2.1.4 Edema of genitalia and lower extremities:
1 min after penetration. The International Classification of Possible cardiac decompensation, renal failure,
Diseases (ICD-10) applies a cut-off of 15 s from the nephrotic syndrome, or pelvic and/or retroperito-
beginning of sexual intercourse. neal lymphatic obstruction.29–31 (NEW)
1.27: Mean semen volume is 3.9 mL (5th centile 1.5 mL;
95th centile 6.8 mL). Low semen volume is under 1.5 mL;
high semen volume is over 6.8 mL.25,26 2.2 Abdominal examination3,5: Among numerous possible
1.28: Dyspareunia (“hispareunia”), the symptom most abdominal signs are:
applicable to male discomfort on sexual intercourse, will 2.2.1 Bladder fullness/retention: The bladder may be
depend on many factors including a woman's introital felt by abdominal palpation or detected by supra-
relaxation and/or anatomical factors. pubic percussion. FN2.2 (CHANGED)
1.29. Symptoms of defecatory dysfunction are not 2.2.2 Other abdominal masses: or distension (eg,
uncommon in men, particularly those who have undergone ascites). (NEW)
anal sphincterotomies for fissure-in-ano. 2.2.3 Scars: Indicating previous relevant surgery, trau-
1.30. Rome IV Criteria for 1.8.3.1 Constipation28: mas, or evidence of previous radiotherapy. (NEW)
Complaint that bowel movements are (i) infrequent (<3/ 2.2.4 Renal Area: Examination for tenderness, masses.
wk); (ii) need to strain; (iii) lumpy or hard stool bloating; (iv) (NEW)
sensation of incomplete evacuation; (v) sensation of anorectal
obstruction or blockage abdominal pain, (vi) need for manual
assistance, in more than one quarter of all defecation. 2.3 Lower Urinary Tract/Genital Examinations/Signs
2.3.1 Genital skin:
2.3.1.1 Excoriation, redness, irritation secondary
SECTION 2: SIGNS to urinary incontinence and the effect of
pads or diapers. (NEW)
Sign: Any abnormality indicative of disease or a health 2.3.1.2 Mycotic infections (balanoposthitis, inter-
problem, discoverable on examination of the patient; an trigo, or scrotal): Moist, red pruritic skin
objective indication of disease or a health problem.1 usually in men with urinary or fecal
(CHANGED) incontinence, immune suppression or
General principles of examination for male with poorly controlled diabetes mellitus.32
symptoms of LUT/PF dysfunction29: A comprehensive (NEW)
physical examination is done to seek potential influences on 2.3.1.3 Skin pigmentation: balanitis xerotica ob-
symptoms.FN2.1 It should include abdominal examination, literans (BXO − syn. lichen sclerosus) and
focussing on the suprapubic area to detect an enlarged vitiligo may cause depigmentation (penile
bladder, or other abdominal mass, and digital examination of skin, scrotum, glans). (NEW)
the rectum (prostate) as well as examination of the external 2.3.1.4 Cutaneous manifestations of sexually
genitalia, the perineum and lower limbs. The hernia orifices transmitted diseases: vesicles, ulcers.
should also be evaluated. Penile lesions including meatal (NEW)
stenosis, phimosis, and penile cancer must be excluded.29–31 2.3.2 Penile examination:

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2.3.2.1 Foreskin abnormalities: stricture34 or sexually transmitted

2.3.2.1.1 Tumor or infection (balanopos- disease. (NEW)
thitis, ie, inflammation of the 2.3.2.3.3 Meatal stenosis: narrowing
glans penis and overlying fore- changes of the distal urethra;
skin1). (NEW) post-infection, post-surgery.
2.3.2.1.2 Phimosis33: Partial or complete (NEW)
inability to retract the prepuce 2.3.2.4 Examination of the glans and shaft
due to adhesion between the 2.3.2.4.1 Penile plaque: palpation of
glans and the prepuce or a node or plaque in the tunica
preputial ring. FN2.3 (NEW) usually on the dorsal aspect
2.3.2.1.3 Paraphimosis33: Entrapment of (perhaps related to Peyronie's
the prepuce behind the disease). (NEW)
glans.FN2.3 (NEW) 2.3.2.4.2 Lichen sclerosus: tight foreskin,
2.3.2.2 Position of the urethral meatus31: cracking, and bleeding.
2.3.2.2.1 Hypospadias: Refers to the ure- 2.3.2.5 General examination: redness, ulcers,
thral meatus sited on ventral warts, (NEW)
surface of the penis, either 2.3.3 Scrotal examination: (NEW)
congenital or acquired, proximal 2.3.3.1 Normal: The scrotum is a loose sac
to its normal position on the tip of containing the testes and spermatic cord
the glans. External urethral mea- structures. The epididymis is palpable
tus may be on the glans penis applied to the posterior surface of the testis
(glandular hypospadias), sulcus as a ridge although occasionally it is sited
(coronal hypospadias), shaft (pe- on the anterior surface. FN 2.4 (NEW)
nile hypospadias), scrotum 2.3.3.2 Inflammation: The epididymis may be
(scrotal hypospadias), or peri- swollen and tender, and if severe, the
neum (perineal hypospadias). inflammatory process may involve the
(NEW) whole scrotal content (i.e. testis and
2.3.2.2.2 Epispadias: Refers to the ure- epididymis [epididymo-orchitis]) and the
thral meatus sited on dorsal scrotal skin as well. FN2.5 (NEW)
surface of the penis, either 2.3.3.3 Cystic dilatations of the epididymis:
congenital or acquired, proximal (epididymal cysts or spermatocele) and
to its normal position on the tip of hydroceles (fluid collections between the
the glans. (NEW) visceral tunica albuginea and parietal layer
2.3.2.2.3 Neoplastic or inflammatory le- of the testicular peritoneum)—usually
sions within the fossa navicula- benign. The examination of these structures
ris.34 (NEW) would be generally non-tender and without
2.3.2.2.4 Post-hypospadias/epispadias pain (as opposed to 2.3.3.2). FN2.6 (NEW)
repair: including post-urethro- 2.3.3.4 Inguinal bulge: Examination and differ-
plasty urethral fibrosis: palpated entiation of hernia from hydrocele or cyst
near the meatus or in the penile of spermatic cord or groin lymph nodes.
shaft. (NEW) (NEW) (use of transillumination may assist
2.3.2.2.5 Postoperative fistula: Urine is though ultrasound is generally diagnostic)
visible at or near the incision FN2.7
lines. (NEW) 2.3.4 Perineal examination: this is generally performed
2.3.2.3 Urethral examination: with the patient in the lateral supine or in the
2.3.2.3.1 Palpation: along the ventral lithotomy position. (NEW)
aspect of the penis and inferiorly 2.3.4.1 Perianal dermatitis: Skin infection at the
into the perineum to detect perineum around the anus, usually associ-
fibrosis, lumps or tenderness ated with fecal incontinence or diarrhoea.
along the shaft. (NEW) (NEW)
2.3.2.3.2 Tenderness: suggestive of ure- 2.3.4.2 Fissures: A break or tear in the skin of the
thral or periurethral inflamma- perineum, anal sphincter or distal rectum
tion, often secondary to a urethral usually associated with anal pain. (NEW)

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2.3.5 Rectal and prostate examination: Digital rectal Neuropathy may impact also on management
examination (DRE) is recommended35–37 as part of options.38 FN2.10 (CHANGED)
the physical examination. Generally done with the 2.4.2 Level of neurologic abnormality: can occasion-
patient standing and bent over the examining table, ally be localized by the pattern of sensory or motor
or with the patient in the left lateral knees bent deficit noted during physical examination using a
position, or in the lithotomy position. DRE is dermatome map.30 (NEW)
usually pain-free. (NEW) 2.4.3 Penile, scrotal, or perianal sensory deficits: may
2.3.5.1 Anal examination: This can detect the indicate damage or injury to sacral roots or nerves.
following findings in the anal sphincter or Reflex testing in the genital area may also be
distal rectum: (NEW) performed. The most important of these is the
2.3.5.1.1 Benign diseases: hemorrhoids, BSR.39 (NEW)
fissure, anal sphincter injury, 2.4.4 Bulbospongiosus reflex (BSR)39 a reflex con-
levator discomfort, or pain. traction of the striated muscle of the pelvic floor
(NEW) (anal sphincter) and the bulbo-spongiosus muscle
2.3.5.1.2 Possible malignant diseases: that occurs in response to various stimuli in the
anal, distal rectal, and prostate perineum or genitalia. FN2.11 (NEW)
carcinoma. (NEW) 2.4.5. Cremasteric reflex: contraction of the ipsilateral
2.3.5.1.3 Anal tone: increased or de- cremaster muscle, drawing the testis upwards,
creased anal sphincter tone might when the upper inner aspect of the thigh is stroked
suggest similar changes in the longitudinally. (NEW)
urinary sphincter and may indi-
cate neurologic disease. (NEW)
2.3.5.1.4 Anal stricture: a circumscribed 2.5 Urinary Incontinence Signs3,5,40,41: All examinations
narrowing or stenosis of the anal for the evaluation of urinary incontinence are best
canal. (NEW) performed with the individual's bladder comfortably full.
2.3.5.2 Prostate gland characteristics: size, sym- 2.5.1 Urinary incontinence3,5: observation of involun-
metry, firmness, nodules, and its relation to tary loss of urine on examination.
the pelvic sidewall and rectum can be 2.5.2 Stress urinary incontinence (clinical stress
assessed.35–37 The gland is about the size of leakage)3,5: observation of involuntary leakage
a walnut and has a consistency similar to from the urethral orifice synchronous with effort or
that of the contracted thenar eminence of physical exertion, or on sneezing or coughing.
the thumb FN2.8. (NEW) 2.5.3 Urgency urinary incontinence3,5: observation of
2.3.5.3 Nodularity and/or firmness − May indi- involuntary leakage from the urethral orifice
cate possible abnormality requiring further associated with the individual reporting a sudden,
investigation.37 (NEW) compelling desire to void. (CHANGED)
2.3.5.4 Prostate tenderness: prostate palpation, as 2.5.4 Extra-urethral incontinence3,5: observation of
part of a DRE, is usually pain-free. Pain urine leakage through channels other than the
with prostatic palpation is variable though urethral meatus, for example, fistula. FN2.12
if present, it may be helpful in differentiat-
ing prostate/pelvic pain syndromes.34
(NEW) 2.6 Pelvic floor muscle (PFM) function.3,5,42,43 The
2.3.5.5 Rectal examination (circumferential): following signs of PFM function may be assessed via
this might lead to the detection of non- the perineum (visual or tactile examination) or per rectum
urological diseases such as rectal carci- (digital palpation) examination. Digital rectal examina-
noma, fistula and fecal impaction.FN2.9 tion (DRE) may be less useful in male urinary
(NEW) dysfunctions where the urethral sphincter, inaccessible
to DRE, has a more important role.44 (NEW)
2.6.1 Perineal examination3,5,42,43—when the patient
2.4 Focused neurological exam3,5 is asked to cough or bear down, the perineum
2.4.1 Overall neurological status: abnormalities of should only show limited downward movement;
speech, gait as well as upper and lower extremity ventral movement may occur because of the
dexterity should be noted as they may indicate a guarding actions of the pelvic floor muscles.
neurological cause for the urological symptoms. (CHANGED)

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| D’ANCONA, HAYLEN ET AL.

2.6.1.1 Perineal elevation43,44: This is the inward the upper side and appear as
(ventro-cephalad) movement of the peri- asymmetrical. This may affect
neum and anus. FN2.13 Look for testicular PFM tone. Not so common in
lift and penile retraction. These need to be men. (NEW)
checked against movement of the scrotum 2.6.2.1.6 PFM injury: for example, pal-
and the whole penis. Correct movement pable anal sphincter gap though
occurs with the PFM only: the shaft of the overall not common unlike
penis draws in and the testes lift in a women. (NEW)
cephalad direction. These movements may 2.6.2.2 PFM contractile function: Aspects to
be better visualized in standing than supine assess
position.45–47 (NEW) 2.6.2.2.1 Voluntary contractility43: the
2.6.1.2 Perineal descent43: This is the outward individual is able to contract the
(dorso-caudal) movement of the perineum PFM on demand. A contraction
and anus. is felt as a tightening, lifting, and
squeezing action under/around
the finger. (NEW)
2.6.2 Examinations43 2.6.2.2.2 Strength43: Force-generating
2.6.2.1 PFM state at rest; aspects to assess. capacity of a muscle. It is
FN2.13 generally expressed as maxi-
2.6.2.1.1 Myalgia: provoked by palpa- mum voluntary contraction.
tion. Levator muscle pain/ten- (NEW)
derness may be elicited by 2.6.2.2.3 Endurance43: the ability to
palpation of these muscles via sustain near maximal or maxi-
rectal examination.43 FN 2.14 mal force, assessed by the time a
(NEW) patient is able to sustain a
- Tender point: Tenderness to maximal static or isometric
palpation at a specific soft contraction. (NEW)
tissue body site. (NEW) 2.6.2.2.4 Repeatability43: the ability to
2.6.2.1.2 Tone: state of the muscle, repeatedly develop near maxi-
usually defined by its resting mal or maximal force, deter-
tension, clinically determined mined by assessing the
by resistance to passive move- maximum number of repetitions
ment. Muscle tone has two the patient can perform before
components, the contractile detectable decline in force. Re-
component and the viscoelas- cord number of contractions in a
tic component. Muscle tone row. (NEW)
may be altered in the presence 2.6.2.2.5 Co-contraction: contraction or
or absence of pain. activation of two or more
(CHANGED) muscles at the same time. Iden-
2.6.2.1.3 Increased PFM tone (non- tify which muscles are co-con-
neurogenic hypertonicity): in- tracting and whether the co-
creased tone in a patient without contraction is synergistic.
an intercurrent neurological di- (NEW)
agnosis. (CHANGED) 2.6.2.2.6 Relaxation ability: return of the
2.6.2.1.4 Decreased PFM tone (non- PFM to its original resting tone
neurogenic hypotonicity): de- following the voluntary contrac-
creased tone in a patient without tion. Also includes the ability to
an intercurrent neurological di- maintain PFM relaxation in
agnosis. (CHANGED) anticipation of or during any
2.6.2.1.5 Symmetry: if examining in the type of touch. (NEW)
left lateral, there will be a 2.6.2.3 PFM response to increased intra-ab-
gravity effect and the dependent dominal pressure: for example, strain/
side will have a different feel to Valsalva/cough aspects to assess

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2.6.2.3.1 Direction of contraction (ele- and signs that occur at night.18

vation, descent) (CHANGED)
2.7.2.5 Daytime (urinary) frequency:3,5
Number of voids during daytime
2.6.3 Diagnoses related to PFM examinations (awake hours including first void
2.6.3.1 Overactive pelvic floor muscles: Pelvic after waking up from sleep and
floor muscles which do not relax, or may last void before sleep)**.
even contract when relaxation is function- 2.7.2.6 Night-time (urinary) fre-
ally needed, for example, during voiding quency:18 Total number of night-
or defecation. (CHANGED) time voids irrespective of sleep.**
2.6.3.2 Underactive pelvic floor muscles: Pelvic 2.7.2.7 Nocturia: The number of times
floor muscles which cannot voluntarily an individual passes urine during
contract when instructed to do so or when their main sleep period, from the
required. (CHANGED) time they have fallen asleep up to
the intention to rise from that
2.7 Frequency-Volume Chart/Bladder Diary period. This is derived from the
2.7.1 Frequency-volume chart (FVC):3,5,18,48 bladder diary.18
The recording of the time of each micturi- 2.7.2.8 24-hour (urinary) fre-
tion together with the volume voided for at quency:3,5,18,48 Total number of
least 24 h. Ideally a minimum of three days daytime and night-time voids
of recording (not necessarily consecutive) during a specified 24-hour pe-
will generally provide more useful clinical riod.** (CHANGED)
data. It is relevant to discriminate daytime 2.7.2.9 24-hour urine volume:18 Sum-
and nighttime micturition. mation of all urine volumes
2.7.2 Bladder diary: Adds to the FVC above, the during a specified 24 h period.
fluid intake, pad usage, incontinence episodes, The first void after rising is
the degree of incontinence and the circum- discarded and the 24-hour period
stances at the time of the leakage. ** Signs begins at the time of the next void
where FVC or Bladder diary are important. and is completed by including the
Episodes of urgency and sensation might first void, after rising, the follow-
also be recorded, as might be the activities ing day.** (CHANGED)
performed during or immediately preceding 2.7.2.10 Maximum voided volume: High-
the involuntary loss of urine. Additional est voided volume recorded dur-
information obtained from the bladder diary ing the assessment period.
involves: Severity of incontinence in terms (CHANGED) This usually equals
of leakage episodes and pad usage. bladder capacity.**
2.7.2.1 Daytime:18 the period between wak- 2.7.2.11 Average voided volume: Sum-
ing up with the intention of arising mation of volumes voided di-
until going to bed with the intention vided by the number of voids
of sleeping (awake hours). (NEW) during the assessment period.**
2.7.2.2 Night-time:18 The individual's (CHANGED)
main daily period of sleep. It 2.7.2.12 Mean maximum voided volume
commences at the time of going (functional capacity): Mean
to bed with the intention of sleeping maximum voided volume in ev-
and concludes when the individual eryday activities.**
decides to no longer attempt to sleep 2.7.2.13 Polyuria: Excessive production
and rise for the next day. of urine.1,3,5 It has been defined as
(CHANGED) FN2.15, FN2.16 more than 40 mL urine/kg body
2.7.2.3 Main sleep period:18 The period weight during 24 h or 2.8 L urine
from the time of falling asleep to for a man weighing 70 kg.48
the time of rising for the next day. 2.7.2.14 Nocturnal urine volume:18 Total
2.7.2.4 Nocturnal: Occurring or active at volume of urine produced during
night.1 For example, symptoms the night. Volume measurement

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| D’ANCONA, HAYLEN ET AL.

begins after last void preceding - >20% in younger individuals

sleep and concludes after the first - 20-33% in “middle age”
day-time void (when the individ- Figure 1 (below): provides an
ual decides to no longer attempt to example of a bladder diary.
sleep).FN2.16 ** 2.7.2.16 Pad Testing: For individuals with urinary
2.7.2.15 Nocturnal (night-time) poly- (fecal) incontinence symptoms, the quantifi-
uria:18,48 ** Increased propor- cation of the amount of urine (feces) lost over
tional production of urine during the duration of testing, by measuring the
the night-time compared with the increase in the weight of the pads (weighed
24 h urine volume. FN2.17 pre- and post-testing) used. This may give a
(CHANGED). Nocturnal poly- guide to the severity of incontinence. Differ-
uria index (NPi) is most com- ent durations from a short (1 h) test to a 24 and
monly used definition (Night- 48-hour tests have been used with provoca-
time urine volume/24 h urine tion varying from normal everyday activities
volume) × 100%. to defined regimens. FN2.18
- 33% in elderly, eg, >65 years;

FIGURE 1 Bladder diary: This simple chart allows you to record the fluid you drink and the urine you pass over 3 days (not necessarily
consecutive) in the week prior to your clinic appointment. This can provide valuable information. (i) Please fill in approximately when and how
much fluid you drink, and the type of liquid. (ii) Please fill in the time and the amount (in mLs) of urine passed, and mark with a star if you have
leaked or mark with a “PC” if you have needed to change your pad (Please find below an example of how to complete this form).
Frequency = 9; Nocturia = 1; Urine production/24hr = 1250 mL; maximum voided volume = 300 mL; average voided volume = 125 mL

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Footnotes for Section 2 of the anal sphincter should be felt and/or observed.39 The
2.1: There is little evidence from clinical trials that BSR tests the integrity of the spinal cord-mediated reflex arc
carrying out a clinical examination improves care, but involving S2-S4 and may be absent in the presence of sacral
general consensus suggests that it remains an essential cord or peripheral nerve abnormalities.39
part of assessment of men with urinary incontinence2 or 2.12: If the patient has had previous urethral or
other LUTS. bladder surgery or trauma, the examiner should ascertain
2.2: A normal bladder in the adult cannot be palpated whether urinary leakage occurs through a fistula in a scar,
or percussed until there is at least a volume of 150 mL of or at any other site in the penis, perineum, groins, or lower
urine. At larger volumes of about ≥500 mL, a distended abdomen.
bladder may be visible in thin patients as a lower midline 2.13: Normally there is inward (cephalad) movement
abdominal mass. Percussion is better than palpation for of the perineum and anus.
diagnosing a distended bladder. The examiner begins by 2.14: This is all part of doing a DRE, assessing anal
percussing just above the symphysis pubis and continues sphincters and puborectalis.
cephalad until there is a change in tone from dull to 2.15: For the purposes of the nocturia terminology,
resonant.30 night-time is therefore defined by the individual's sleep
2.3: If phimosis is severe, this can cause voiding cycle, rather than the solar cycle (from sunset to sunrise).
symptoms. Most penile cancers occur in uncircumcised Thus, some shift workers may have their “night” period
men and arise on the prepuce or glans and may be during the daylight hours, as it is the time of their main
associated with voiding symptoms.33 sleep period.18
2.4: Scrotal abnormalities can help in elucidating 2.16: Volume measurement begins after the last void
lower urinary tract symptoms in men. For example, men preceding sleep and concludes after the first daytime
with epididymitis may have associated urinary infection void. The first daytime void follows the individual's
symptoms secondary to coliform bacteriuria.34 decision they will no longer attempt to sleep.18
2.5: Isolated orchitis secondary to UTI is rare, 2.17: There are several definitions in the literature that
however, mycobacterial infection, mumps, and BCG could be used to indicate nocturnal polyuria including:18
treatment may cause orchitis.34 Nocturnal urine production based on body weight of
2.6: If very large they may distort the scrotum and greater than 10 mL/kg.49
urethra and interfere with normal voiding. A hydrocele is
sometimes secondary to testis tumor or inflammatory
processes in the epididymis or orchitis. 1. Rate of nocturnal urine production >90 mL/hr.50 This
2.7: The presence of hernias, cystic swellings in the is suggestive of nocturnal polyuria in men (about
scrotum, and testicular tumors should be excluded by 450 mL per 8 h’ sleep).51 There are no studies looking
careful clinical examination. at the rate of nocturnal urine production in women and
2.8: During the DRE, prostate size and consistency this may well be different from that in men.
can be estimated, although DRE tends to underestimate 2. Nocturnal polyuria index is the most commonly used
true prostate size.35,36 definition for nocturnal polyuria52 (nocturnal urine
2.9: In patients with recto-urethral fistulas, the fistula volume/24-hour voided volume) based on nocturnal
can occasionally be palpated in the anterior rectal wall. urine volume as part of total 24-hour urine volume
The site of the fistula at or above the anal sphincter can (age dependent).
occasionally be noted along with the degree of induration 3. Nocturia index (nocturnal urine volume/maximum
of the anterior rectal wall. With large fistulas the urethra voided volume)53 >1: nocturia occurs because maxi-
can be palpated, especially if there is a Foley catheter in mum voided volume is smaller than nocturnal urine
place. volume. >1.5: nocturia secondary to nocturnal urine
2.10: For example, a person with Parkinson's may be over-production in excess of maximum bladder
unable to perform intermittent catheterization because of capacity, that is, nocturnal polyuria.
tremor. A focused neurological exam is also recommended,
especially in patients suspected of having neurogenic 2.18: A pad test quantifies the severity of incontinence
bladder dysfunction.38 Decreased perineal sensation and and may be the most objective measure of the inconti-
anal sphincter tone may be signs of neuropathy.41 nence. Severity of incontinence (quantified by pad weight)
2.11: This reflex is most commonly tested by placing a affects surgery outcomes. The 24-hour pad test and
finger in the rectum and then squeezing the glans penis. If a micturition diary are reliable instruments for assessing the
Foley catheter is in place, the BSR can also be elicited by degree of urinary loss and number of incontinent episodes,
gently pulling on the catheter. If the BSR is intact, tightening respectively. Increasing test duration to 48 and 72 h

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| D’ANCONA, HAYLEN ET AL.

FIGURE 2 A schematic representation of urine flow over time and parameters of uroflowmetry

increases reliability but is associated with decreased 3.1.4 Voided volume (VV − unit: mL): Total
patient compliance.54 Overall, the 24-hour home test is the volume of urine expelled via the urethra
most accurate pad test for quantification and diagnosis of during a single void.2,3,5 (CHANGED)
urinary incontinence because it is the most reproducible.55 3.1.5 Maximum (urine) flow rate (MUFR − unit:
The 1-hour pad test may be used because it is easily done mL/s) − Qmax: Maximum measured value of
and standardized, however, there is no strict parallel with the urine flow rate2,3,5 corrected for
the 24-hour pad test and it may underestimate the artefacts.3,5
weakness of the sphincter in the later part of the day. 3.1.6 Flow time (FT − unit: s): Time over which
measurable flow actually occurs.2,3,5
SECTION 3: URODYNAMIC 3.1.7 Average (urine) flow rate (AUFR − unit:
INVESTIGATIONS mL/s) − Qave: Voided volume divided by the
flow time.2,3,5
Urodynamics: Measurement of all the physiological 3.1.8 Voiding time (VT − unit: s): Total duration
parameters relevant to the function and any dysfunction of micturition, including interruptions. When
of the lower urinary tract.56,57 FN3.1, FN3.2. (NEW) voiding is completed without interruption,
Clinical sequence of testing:3,5 Urodynamic inves- voiding time is equal to flow time.2,3,5
tigations generally involve an individual attending with a 3.1.9 Time to maximum urine flow rate (tQmax
comfortably full bladder for free (no catheter) uroflow- − unit: s): Elapsed time from the onset of
metry and post-void residual (PVR) measurement prior to urine flow to maximum urine flow.2,3,5
filling cystometry and pressure-flow study. (NEW) 3.1.10 Interpretation of the normality of free
uroflowmetry: Because of the strong de-
3.1 Uroflowmetry pendency of urine flow rates in men on
3.1.1 Ideal conditions for free (no catheter) voided volume59,60 and age,60 they are best
uroflowmetry: All free uroflowmetry studies referenced to nomograms60–63 where the
should be performed in a completely private cutoff for normality has been determined
uroflowmetry room. Most modern uroflow- and validated. The individual should com-
meters have a high degree of accuracy ment whether voiding was representative of
(+/−5%) though regular calibration is important his usual urine flow and whether he has
(Figure 2) .58 diurnal variation in urine flow (Figure 3A,
3.1.2 Urine flow: Urethral passage of urine where B). (NEW)
the pattern of urine flow may be:2,3,5
3.1.2.1 Continuous: no interruption to urine Figure 3A: the Liverpool nomograms60 for the
flow. maximum urine flow (Qmax) in men aged up to 50 years
3.1.2.2 Intermittent: urine flow is interrupted. (mean 35 years). (NEW)
3.1.3 Urine flow rate (UFR − unit: mL/s): Figure 3B: the Liverpool nomograms60 for the
Volume of urine expelled via the urethra maximum urine flow rate (Qmax) in men aged over 50
per unit time.2,3,5 years (mean 60 years). (NEW)

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FIGURE 3 A and B, show the Liverpool nomograms60 for the maximum urine flow rate in men (i) up to 50 years (mean 35 years) and (ii)
over 50 years (mean 60 years). Equation for the maximum urine flow rate nomogram (divided by age as above) is:
Sq Root ðMUFRÞ ¼ 2:37 þ 0:18  Sq Root ðVoid volumeÞ  0:014  age. (Root mean square error: 0.727) (NEW). References to a specific
urine flow rate as the lower limit of normal provided a specific volume has been voided require validation studies

The 25th percentile appeared to be most appropriate catheter for bladder drainage can still provide
lower limits of normality for both urine flow rates to an effective and accurate PVR measurement.
identify those men more likely to have voiding All urethral catheters, however, may not be of
dysfunction (more commonly bladder outlet obstruction equal drainage efficacy FN3.6. Ultrasound PVR
[BOO]).64 Higher urine flow rate percentiles occurred in measurement should ideally be repeated at
men with detrusor overactivity.64 FN3.3 Some racial least once if PVR is present. (NEW) An
differences in urine flow rates have been reported. FN3.4 overdistended rather than “comfortably full”
Ideally, abnormal uroflowmetry studies should be bladder might lead to a falsely elevated initial
repeated. (NEW) PVR, assessed further by repeat voiding/ repeat
PVR.
3.2 Post-void residual (urine volume, PVR − unit: 3.2.2 Assessment of normality of PVR: Upper
mL): Volume of urine left in the bladder at the limits in normal community dwelling men
completion of voiding2,3,5 without LUTS are age dependent with studies
3.2.1 Conditions for PVR measurement: PVR reporting a cut-off value of 10–30 mL67–70.
reading is erroneously elevated by delayed There are no adequate currently available data
measurement due to additional renal input (1- from which to quote expected/typical ranges of
14 mL/min) into the bladder. FN3.5 Ultrasonic PVR in men with symptoms of lower urinary
techniques allow immediate (within 60 s of tract dysfunction. Such studies would need to
micturition) measurement to minimize the reflect the accuracy of measurement, including
error. Immediate insertion of a transurethral whether the PVR measurement is “immediate”

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| D’ANCONA, HAYLEN ET AL.

(eg, by ultrasound) or by urethral catheteriza- with neuropathic bladder. A higher

tion (unless also “immediate”). In the absence filling rate is greater than 50 mL/min.
of such studies, our consensus view is that a (CHANGED)
PVR (ultrasound) over 50 mL, following 3.3.5 Intravesical pressure (Pves - unit: cm H2O):
double voiding, might prompt the suspicion The pressure within the bladder (as directly
of voiding dysfunction. (NEW) measured by the intravesical catheter).2,3,56,57
3.3.6 Abdominal pressure (Pabd - unit: cm H2O):
The pressure in the abdominal cavity surround-
3.3 Cystometry − General2,3,5,56,57 ing the bladder. It is usually estimated from
3.3.1 Urodynamic studies: These usually take place measuring the rectal pressure, though the
in a special clinical room (urodynamic labora- pressure through a bowel stoma can be
tory) and involve (artificial) bladder filling measured as an alternative. FN3.11 The simulta-
with a specified liquid (ICS recommends neous measurement of abdominal pressure is
physiological saline solution or X-ray contrast essential for interpretation of the intravesical
if video studies) at a specified rate2,3,56,57. FN3.7 pressure trace.2,3,5 Artifacts on the detrusor
3.3.2 Cystometry: Measurement of the pressure- pressure trace may be produced by a rectal
volume relationship of the bladder during contraction.2,3,56,57 (CHANGED)
filling.2,3,56,57 FN3.7 3.3.7 Detrusor pressure (Pdet - unit: cm H2O):
3.3.3 Cystometrogram (CMG): Graphical record- The component of intravesical pressure that is
ing of the bladder pressure(s) and volume(s) created by forces in the bladder wall (passive
over time.2,3,56,57 and active). It is calculated by subtracting
3.3.4 Conditions for cystometry including abdominal pressure from intravesical pressure
3.3.4.1 Pressures (zeroing);* (Pdet = Pves-Pabd).2,3,56,57 FN3.12
3.3.4.2 Pressure transducers;*
3.3.4.3 Catheter mounted transducers; *
3.3.4.4 Initial bladder volume;* 3.4 Filling Cystometry2,3,56,57
3.3.4.5 Fluid medium* FN3.7 * Covered in 3.4.1 Filling cystometry: Pressure-volume relation-
references56,57 ship of the bladder during bladder filling. It
3.3.4.6 Temperature of fluid: Fluid at room begins with the commencement of filling and
temperature is mostly used. It can be ends when a “permission to void” is given by
warmed to body temperature but the urodynamicist2,3,5,56,57 or with inconti-
without evidence that this influences nence (involuntary loss) of the bladder content
results.71,72 FN3.8 (CHANGED) (Figure 4) .71 (CHANGED)
3.3.4.7 Position of patient: Sitting (standing) 3.4.2 Aims of filling cystometry: To assess bladder
position is more provocative for ab- sensation, bladder capacity, detrusor activity
normal detrusor activity (ie, overactiv- and compliance as well as to document (the
ity) than the supine position. At some situation of and detrusor pressures during)
point in the test, filling might desirably urine leakage. (CHANGED)
take place with the patient standing (in 3.4.3 Bladder sensation during filling cystometry:
those patients able to do so).71,73 FN3.9 Usually assessed by questioning the individual
(CHANGED) Many men will void in relation to the fullness of the bladder during
standing. cystometry.
3.3.4.8 Filling rate: The filling rate, including 3.4.3.1 First sensation of bladder filling: The
any changes during testing, should be feeling when the individual first feels
noted on the urodynamic re- bladder filling.3,5,71,75 FN3.13
port3,56,57,71,73–76 FN3.10. A medium 3.4.3.2 First desire to void: The first feeling
fill rate (25-50 mL/min) should be that the individual may wish to pass
applicable in most routine studies. urine.3,5 FN3.13
Much slower filling rates (under 3.4.3.3 Normal desire to void: The feeling
25 mL/min) are appropriate in men that leads the individual to pass urine
where there are concerns for poor at the next convenient moment, but
compliance or with a bladder diary voiding can be delayed if
showing low bladder capacity or those necessary.3,5

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3.4.3.4 Strong desire to void: The persistent 3.4.4 Bladder capacity during filling cysto-
desire to pass urine without the fear of metry3,5,56,57
leakage.3,5,71 FN 3.13 3.4.4.1 Cystometric capacity (units: mL):
3.4.3.5 Urgency: Sudden, compelling desire Bladder volume at the end of filling
to void which is difficult to defer.3,5 cystometry, when a “permission to
FN1.4, FN1.5 void” is usually given by the urody-
3.4.3.6 Bladder oversensitivity5–Increased namicist. This endpoint and the level of
bladder sensation during bladder filling the individual's bladder sensation at
with: (NEW − male) that time, for example, “normal desire
- earlier first desire to void; to void,” should be noted. This end-
- earlier strong desire to void, which point might be higher than normal in
occurs at low bladder volume; men with reduced bladder sensation.
- lower maximum cystometric bladder 3.4.4.2 Maximum cystometric capacity
capacity (3.4.4.2); (units: mL): In individuals with
- no abnormal increases in detrusor normal sensation, this is the volume
pressure. when one can no longer delay micturi-
3.4.3.7 Reduced bladder sensation: Bladder tion during filling cystometry. FN3.14,
sensation perceived to be diminished FN3.15, FN3.16
during filling cystometry. 3.4.5 Detrusor function during filling cystometry
3.4.3.8 Absent bladder sensation: No blad- 3.4.5.1 Normal detrusor activity/function:3,5
der sensation during filling cystometry, There is little or no change in pressure
at least to expected capacity of 500 mL. with filling. There are no detrusor
3.4.3.9 Pain: the complaint of pain during contractions, spontaneous or provoked
filling cystometry is abnormal. Its site, with activities such as postural changes,
character and duration should be coughing or hearing the sound of
noted. running water. FN3.17 (CHANGED)

FIGURE 4 Normal filling cystometry on multichannel urodynamics. (first desire 132 mL, normal desire to void 175 mL, strong desire to
void 280 mL, urgency 340 mL. Detrusor contraction is absent during filling cystometry). Cough artefacts and good subtraction of Pabd from Pves
to get Pdet are demonstrated

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| D’ANCONA, HAYLEN ET AL.

3.4.5.2 Detrusor overactivity (DO):3,5 The An identifiable possible non-

occurrence of detrusor contraction(s) neurological cause exists for
during filling cystometry. These con- involuntary detrusor contrac-
tractions, which may be spontaneous or tion(s) during bladder filling.
provoked, produce a wave form on the For example, functional (ob-
cystometrogram, of variable duration struction); stone, tumor (eg,
and amplitude. The contractions may carcinoma in situ), UTI.
be phasic or terminal. They may be FN3.18 (CHANGED)
suppressed by the patient or uncontrol- 3.4.6 Bladder (detrusor) compliance (unit: mL/
lable (CHANGED). Symptoms, for cm H2O)3,5,56,57,77–79
example, urgency and/or urgency in- 3.4.6.1 Description: Relationship between
continence or perception of the con- the change in bladder volume and
traction may (note if present) or may simultaneous change in detrusor pres-
not occur. sure as a measure for the distensibility
3.4.5.2.1 Idiopathic (primary) de- of the bladder.3,5
trusor overactivity: No 3.4.6.2 Calculation: Divide the change of
identifiable cause for invol- volume (ΔV) by the simultaneous
untary detrusor contraction change in detrusor pressure (Δ Pdet)
(s). (CHANGED) (Figure 5) during filling cystometry − (C = ΔV/
3.4.5.2.2 Neurogenic (secondary) ΔPdet). The compliance reflects the
detrusor overactivity:3,5,13, amount of fluid in the bladder to
Detrusor overactivity and increase bladder pressure by 1 cm H20
evidence (history; visible or and is expressed as mL per cm H2O.
measurable deficit) of a rele- 3.4.6.3. Factors affecting the measurement of
vant neurological disorder. bladder compliance:
(CHANGED) 3.4.6.3.1 Bladder filling speed: The
3.4.5.2.3 Non-neurogenic (second- bladder should be filled at up
ary) detrusor overactivity: to 50 mL/min if there is no

FIGURE 5 Filling cystometry demonstrating detrusor overactivity: First desire to void occurred at 62 mL together a contraction; normal
desire to void at 357 mL; urgency at 380 mL followed by a detrusor contraction There is also high pressure − slow flow during voiding

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reason to suspect poor blad- women) as bladder compliance

der compliance. Faster fill- <10 mL/cm H2O (neurogenic) or
ing is more provocative and <30 mL/cm H20 (non-neurogenic).
may artificially reduce blad- Normal compliance is >30 mL/cm
der compliance. This artifact H2O (neurogenic) and 40 mL/cm H20
may settle when filling is (non-neurogenic).79 Recommended
interrupted or repeated with values in men have not been well-
slower speed. (CHANGED) defined. FN3.19 (CHANGED)
3.4.6.3.2 Contractile/relaxant prop- 3.4.7 Repeat Cystometry: FN3.20 The repetition of
erties of the detrusor (de- the urodynamic testing when abnormal bladder
creased compliance): function, discrepancies between history and
Properties of the bladder suspected urodynamic findings, technical er-
wall may reduce compliance, rors and/or artifacts have been observed at
for example, pelvic radiation immediate post-test analysis. (CHANGED)
or chemotherapy or bladder 3.4.8 ICS Standard Urodynamic Test:57 Free
overstretch. (CHANGED) uroflowmetry, postvoid residual, cystometry,
Bladder outlet obstruction and pressure-flow study are termed ICS
can result in detrusor muscle standard urodynamic test (ICS-SUT).FN3.21
hypertrophy, intramural col- (CHANGED)
lagen and elastin deposition
and contribute to reduced
compliance. (NEW) 3.5 Urethral function during filling cystometry (fill-
3.4.6.3.3 Other factors affecting ing urethro-cystometry): As filling urethro-cyst-
bladder compliance78 (in- ometry is less well-explored in men than women,
creased compliance): Blad- readers are referred to other reports for
der diverticula (also methodology.56,57,80
pseudodiverticula) and ves- 3.6 Urethral closure mechanism
ico-ureteric reflux (high 3.6.1 Normal urethral closure mechanism: A
grade). (NEW) positive urethral closure pressure is maintained
3.4.6.4 Starting point for compliance cal- during bladder filling, even in the presence of
culations: Usually the detrusor pres- increased abdominal pressure, although it may
sure at the start of bladder filling and be overcome by detrusor overactivity.
the corresponding bladder volume 3.6.2 Incompetent urethral closure mechanism:
(usually zero).3 Special attention Leakage of urine occurs during activities which
should be made to ensure bladder is might raise intra-abdominal pressure in the
emptied at the commencement of absence of a detrusor contraction.
measurement; incomplete emptying 3.6.2.1 Urodynamic stress incontinence
may artificially decrease bladder com- (USI): Involuntary leakage of urine
pliance. (CHANGED) during filling cystometry, associated
3.4.6.5 End point for compliance calcula- with increased intra-abdominal pres-
tions: Detrusor pressure (and corre- sure, in the absence of a detrusor
sponding bladder volume) at contraction.
cystometric capacity (allow time for 3.6.2.2 Subtype: Intrinsic sphincter defi-
pressure to settle after cessation of ciency (ISD): Very weakened urethral
filling). Both points are measured closure mechanism.
excluding detrusor contraction. In the 3.6.3 Leak point pressures:2,3,5,80,81,82 There are
case of detrusor overactivity with two types of leak point pressure measurement.
leakage, both points should be mea- The pressure values at leakage should be
sured or immediately before the start of measured at the moment of leakage.
any detrusor contraction (and therefore 3.6.3.1 Detrusor leak point pressure (DLPP
causes the bladder volume to decrease, − unit: cm H2O): This is a static test.
affecting compliance calculations). The pressure is the lowest value of the
Low compliance has been defined (in detrusor pressure at which leakage is

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| D’ANCONA, HAYLEN ET AL.

observed during cystometry in the measurement to the uroflow trans-

absence of increased abdominal pres- ducer. FN3.23 (CHANGED)
sure. DLPP is a reflection of the 3.7.2.3 Urethral opening pressure (Pdet.uo–
resistance of the bladder outlet or unit: cm H2O): Detrusor pressure
urethral sphincter. High DLPP (eg, recorded at the onset of measured
over 40 cm H2080) may put patients at flow (consider time delay − usually
risk for upper urinary tract deteriora- under 1 s).
tion, or secondary damage to the 3.7.2.4 Maximum detrusor pressure (Pdet-
bladder in the cases of known underly- max– unit: cm H20): Maximum regis-
ing neurological disorders such as tered detrusor pressure during voiding.
spinal cord injury or MS.81 There are 3.7.2.5 Detrusor pressure at maximum flow
no data on any correlation between (Pdet.Qmax – unit: cm H2O): Detrusor
DLPP and upper tract damage in non- pressure recorded at maximum urine
neurogenic patients. (CHANGED) flow rate.
3.6.3.2 Abdominal leak point pressure 3.7.2.6 Detrusor pressure at end of flow
(ALPP − unit: cm H2O): This is a (Pdet.ef– unit: cm H2O): Detrusor
dynamic test. It is the intentionally pressure recorded at the end of urine
increased abdominal pressure that flow.
provokes urinary leakage in the 3.7.2.8 Postvoiding detrusor contraction:
absence of a detrusor contraction.82 An increase in detrusor pressure
The patient can achieve this by (Pdet) following the cessation of uri-
coughing (CLPP) or straining (Val- nary flow (NEW)
salva Leak Point Pressure − VLPP). 3.7.3 Detrusor function during voiding2,3,5,56,57
The VLPP allows measuring the 3.7.3.1 Normal detrusor contractile func-
lowest pressure (measured by the tion: Normal voiding in men is
bladder or abdominal pressure) that achieved by an adequate continuous
causes urine leakage. detrusor contraction that leads to
complete bladder emptying within a
normal time span. It depends on central
3.7 Pressure-Flow Studies2,3,5,56,57 FN3.24 initiation and stimulation of the re-
3.7.1 Pressure-flow studies: Pressure-volume (uri- flexes involved. The amplitude of the
nary flow) relationship of the bladder during detrusor contraction (detrusor contrac-
voiding.1–3,5,56,57 It begins when the “permis- tion strength/power) tends to increase
sion to void” is given by the urodynamicist and in response to any increased urethral
ends when the man considers his voiding has resistance until the bladder is empty.83
finished. Measurements to be recorded should (CHANGED)
be the intravesical (Pves) and abdominal (Pabd) 3.7.3.2 Detrusor underactivity (DU): Low
pressures and calculate the detrusor pressure detrusor pressure or short detrusor
(Pdet) as well as the urine flow rate. FN3.22 contraction time, usually in combina-
(CHANGED) tion with a low urine flow rate resulting
3.7.2 Detrusor pressure and other measurements in prolonged bladder emptying and/or
during pressure-flow studies (Figure a failure to achieve complete bladder
6)2,3,5,56,57 emptying within a normal time span.
3.7.2.1 Detrusor opening pressure (unit: cm (c.f. the term “hypocontractile detru-
H2O): Detrusor pressure recorded sor” or detrusor hypocontractility de-
immediately before the commence- scribes a detrusor contraction of
ment of urine flow. (CHANGED) reduced strength). Detrusor underac-
3.7.2.2 Flow delay (unit: s): The time elapsed tivity can be of neurogenic13,84 or non-
from initial rise in pressure to the onset neurogenic origin. (CHANGED)
of flow. This is the initial isovolumetric 3.7.3.3 Acontractile detrusor: The detrusor
contraction period of micturition. It cannot be observed to contract (ie, no
reflects the time necessary for the fluid increase in Pdet) during urodynamic
to pass from the point of pressure studies resulting in failure to void

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FIGURE 6 A schematic diagram of a pressure-flow study

(CHANGED). Limited voiding may pressure. Bladder emptying may be complete

occur by straining. The possibility of or incomplete (PVR present).
“inhibition” of a detrusor voiding 3.8.2.1 Bladder outlet obstruction (BOO):87,88
contraction must be considered if the This is the generic term for obstruction
man subsequently voids normally post- during voiding. It is a reduced urine flow
cystometry. An acontractile detrusor rate with a simultaneously increased
can be of neurogenic or non-neuro- detrusor pressure FN3.27. The Bladder
genic origin. Neurogenic acontractile Outlet Obstruction Index (BOOI = Pdet.
detrusor should replace the term “de- Qmax – 2Qmax) will give a guide to the
trusor areflexia.” likelihood of obstruction being present.87
BOOI <20 cm H20 = non-obstruction;
BOOI 20-40 cm H20 = equivocal;
3.8 Urethral function during voiding: This can be BOOI >40 cm H20 = obstruction)
interpreted by the pressure-flow trace assisted at (CHANGED)
times by video cysto-urethrography (video-urody- 3.8.2.2 Dysfunctional voiding: is character-
namics − 4.3.4) and electromyography (EMG − 3.9) ized by an intermittent and/or fluctuat-
as available. ing flow due to inadequate or variable
3.8.1 Normal urethral function during voiding: relaxation generally of the sphincters
Initiation of voiding begins with voluntary during voiding in neurologically nor-
relaxation of the pelvic floor and striated mal men (i.e. no historical, visible or
sphincters (rhabdosphincter). The bladder then measurable evidence of neurological
contracts with the bladder neck, the latter then disease). (CHANGED) Dysfunctional
opening due to its spiral arrangement of fibres. voiding may cause functional bladder
Voiding is prompted with the urethra being outlet obstruction. This type of voiding
continuously relaxed to allow micturition at a may also be the result of an acontractile
normal detrusor pressure and urine flow, or underactive detrusor (voiding with
resulting in complete bladder emptying.85,86 abdominal straining). Video-urody-
FN3.24, FN3.25, FN3.26 namics is required to diagnose primary
3.8.2 Abnormal urethral function during voiding: bladder neck obstruction and/or rhab-
The urethral sphincter(s) do not relax dosphincter discoordination.87
completely or they are (temporarily) contracted 3.8.2.3 Detrusor sphincter dyssynergia
during voiding, resulting in increased detrusor (DSD):88 Dyscoordination between

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FIGURE 7 Primary bladder neck obstruction in non-neurogenic patient: Urodynamic trace plus imaging

detrusor and rhabdosphincter function helpful where facilities for video-urody-

during voiding due to a neurological namics are unavailable.
abnormality (ie, detrusor contraction 3.8.2.4 Primary Bladder Neck Obstruction
synchronous with contraction of the (non-neurogenic): During voiding,
urethral and/or periurethral striated mus- the bladder neck smooth muscle fails
cle). This is a feature of neurological to adequately open. The detrusor
voiding disorders. Neurological features pressure increases to try to overcome
should be sought.88 Video-urodynamics the resistence of the bladder neck and
(4.3.4) is generally valuable to conclude allow urine to flow (Figure 7).
this diagnosis. DSD generally occurs due 3.8.3 Pressure-Flow Analysis Graphical presenta-
to a lesion above the sacral level 3 but tion of the results or calculations based on the
below pons. Sphincter EMG might be pressure-flow measurement (passive urethral

FIGURE 8 ICS Nomogram89

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FIGURE 9 Schäfer Nomogram90,91

pressure relationship, PURR) have been determination of bladder outlet resis-

developed into nomograms. Different nomo- tence). Depending on the position of
grams use a variable amount of information of this point on the nomogram, the patient
the pressure-flow plot. Figures 8–10 are can be categorised as “unobstructed,”
available to assess bladder outlet obstruction “equivocal,” or “obstructed.” The cal-
in men89–92 culation of BOOI is used to express
3.8.3.1 ICS Nomogram89: Only Pdet at Qmax is bladder outlet resistence as a continuous
plotted into the nomogram (one point variable. BOOI can be extracted from

FIGURE 10 CHESS Nomogram92 for the two-dimensional classification of bladder outlet obstruction (assessment of compressive and/or
constrictive BOO). The entire information of the pressure-flow plot is used to calculate the passive urethral resistance relation (quadratic PURR,
ie, the lowest detrusor pressure for each urine flow during the recorded void; multiple point determination of bladder outlet resistance). The
PURR footpoint (ie, crossing-point of the PURR with the pressure-axis) and PURR curvature (ie, PURR ascent) are used to determine bladder
outlet resistance. In total, 16 different fields are generated by using the threshold values indicated in the figure. Only field A1 testifies “non-
obstruction”; field A2 and B1 indicate “equivocal obstruction” and all other fields indicate different types of obstruction. The increase in the
footprint (A to D) indicates compressive BOO whilst the increase in the curvature (1 to 4) indicates constrictive BOO. (NEW)

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the nomogram by drawing a line evidence of a neurological disorder (either

between Pdet.Qmax and the cutting point visible or measurable neurological deficit or a
of the Y-axis (n.b. the line must be history of neurological disease). The classifi-
parallel to the lines drawn into the cation of DSD can be divided into two groups
nomogram (ie, those for “unob- continuous versus intermittent. DSD type and
structed,” “equivocal,” or “obstruc- degree of SCI lesions seem to correlate.93,94
ted”).FN3.28,FN3.29,FN3.30 (NEW) (NEW)
3.8.3.2 Schäfer Nomogram90,91: Pdet.muo (min- 3.9.3.1 Type 1 DSD occurs in patients with
imal urethral opening detrusor pressure) incomplete neurological lesions. Type
and Pdet.Qmax (detrusor pressure at 1 − there is a progressive increase in
maximum urine flow) together with external urinary sphincter (EUS) con-
corresponding urine flow rates are traction activity that peaks at maximal
plotted into the nomogram (2-point detrusor contraction followed by sud-
determination of the bladder outlet den relaxation of the EUS as the
resistance). The line between the two detrusor pressure declines allowing
points represents the linearized passive urination (Figure 12). (NEW)
urethral resistance relationship (lin- 3.9.3.2 Type 2 DSD occurs more often in
PURR) and the location of the linPURR patients with complete lesions. Type 2
in the nomogram indicates the amount − occurs with continuous EUS contrac-
of bladder outlet resistance of the tion throughout the entire detrusor
patient. The nomogram differentiates contraction resulting in urinary obstruc-
7 grades of bladder outlet resistance tion or inability to urinate.93,94 (NEW)
(grades 0 and I = no bladder outlet
resistance); grades II to VI indicate
increasing grades of BOO. The length 3.10 Ambulatory urodynamics: A functional test of the
(endpoint) of linPURR indicates detru- lower urinary tract for which a transurethral catheter
sor contraction strength that can be very is placed in the bladder (and, in some protocols,
weak (VW), weak (W), normal (N), or another one in the rectum as is typical for a
strong (ST). (NEW) urodynamic study) performed outside the clinical
setting, involving natural bladder filling by drinking
and continuous recording of the bladder pressure
3.9 Electromyography (EMG) (Pves) for a longer period of time (eg, 12 h).
3.9.1 Purpose: Reflects the activity of the striated Ambulatory urodynamics can reproduce bladder
musculature (peri-urethral, rhabdosphincter function and urine loss during the individual's
and pelvic floor). EMG is poorly standardized normal everyday activities. (CHANGED)
with variance in the type of needle, needle 3.11 Non-invasive urodynamics: The penile cuff95 and
versus patch electrode, and electrode place- condom catheter96 and urethral device97 have been
ment.93 Perineal patch electrodes are often developed as non-invasive alternatives to pressure-
preferred for easier placement, patient toler- flow studies. The principle of these tests is to interrupt
ance and allow greater mobility. However, they the flow and measure the bladder pressure. The
measure all the above striated musculature. In detrusor contraction is maintained and the urethral
contrast, needle electrodes can be placed in the sphincter remains open; the column of fluid from the
area of interest and measure activity of defined urethra to the bladder is sufficient to measure the
muscles or muscle groups for example, bladder pressure (isovolumetric pressure). The exter-
rhabdosphincter. (NEW) nal pressure on the urethra, which is needed to
3.9.2 Interpretation: May be difficult due to interrupt the flow, should be identical to the pressure in
artifacts introduced by other equipment. In the bladder (ie, isovolumetric bladder pressure − Pves.
the urodynamic setting, an EMG is useful as a iso). Therefore, Pves.iso provides information on
gross indication of the patient's ability to bladder pressure during voiding and, when urinary
control the pelvic floor. (NEW) flow is also measured, it is able to distinguish between
3.9.3 Detrusor-sphincter dyssynergia (DSD): Si- obstruction and non-obstruction (Figure 11). (NEW)
multaneous contraction of the detrusor and 3.12 Videourodynamics (Fluorourodynamics): Func-
(rhabdosphincter) urethral sphincters with the tional test of the lower urinary tract in which filling

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3.12.1 Bladder neck at rest: Shut and competent

on coughing and straining, possible excep-
tion post-prostatectomy.
3.12.2 Bladder neck during voiding: Bladder
neck opens like a funnel.
3.12.3 Bladder neck obstruction during voiding:
Bladder neck remains closed.

Footnotes for Section 3

3.1: Urodynamics is the general term to describe all the
measurements that assess the function or dysfunction of
the LUT by the measurement of relevant physiological
parameters.56,57
3.2: Urodynamic tests: Over the years, a variety of
terms have been developed for the group of diagnostic
tests that evaluate LUT function: uroflowmetry, post void
residual (PVR), cystometry, pressure-flow studies,
electromyography (EMG), urethral pressure profile
(UPP), and videourodynamics (videocystourethrography
FIGURE 11 Isometric and isotonic pressure are indirectly related to
− VCU) are the terms most frequently used in the
the condition of the muscles fibers (detrusor). The isometric contraction
of the detrusor, that is contraction without length modification or without
scientific literature.56,57
shortening of the muscle fibers. Isovolumetric pressure is established by 3.3: Men with detrusor overactivity had the
the isometric contraction of the detrusor (no flow). Isotonic contraction is highest urine flow rates. Detrusor overactivity (previ-
developing force with length modification and therefore, shortening the ously “instability”) was present in 71% of men with
muscle fibers. In this case, the isotonic pressure is referring to the fact centile rankings for the maximum urine flow rate over
that it is being developed in the voiding phase 50 mL/s.64
3.4: There is a notable difference between the
cystometry and pressure-flow studies (and possibly available nomograms (Liverpool, Siroky, and Bristol),
EMG) are combined with real-time imaging of the particularly between race and in older patients.60–63
lower urinary tract (Figure 12). (see 4.3.3). 3.5: These are figures for maximal diuresis in women
(CHANGED) in response to fluid loads of 500 mL and 1000 mL.

FIGURE 12 Videourodynamics with EMG: During the voiding phase, high detrusor pressure, slow urine flow, increased electrical muscle
activity and the image shows dilatation of the proximal urethra and narrowing of the membranous urethra (rhabdosphincter)

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Equivalent male diuresis data is unavailable.65 However, 3.14: Maximum cystometric capacity that should be
maximum diluting capacity of urine is generally regarded in healthy adult men, mean 552 mL (range 317-
as 20 L/day which converts to 13.9 mL/min (exactly the 927 mL).76
same as female data65). 3.15: Filling of more than 800 mL is seldom useful71.
3.6: Not all catheters empty with similar efficacy. 3.16: Maximum bladder capacity under anaesthetic
There is evidence in women that a less-compressible (“anatomical bladder capacity”) − the volume to which
(silicone or plastic) catheter is much more effective than a the bladder can be filled under deep general or spinal
more compressible (latex) catheter in draining the anaesthetic, without urinary leakage, is rarely reported in
bladder.66 Such evidence in men is unavailable. scientific literature but may be of relevance in interstitial
3.7 Continuous fluid filling of the bladder via a cystitis.71
transurethral (or other route, eg, cystostomy or 3.17: “Normo-active detrusor” as several studies have
Mitrofanoff) catheter, at least with intravesical and demonstrated detrusor overactivity during filling in
abdominal pressure measurement and display of detrusor healthy individuals.
pressure, including cough (stress) testing. Cystometry 3.18: UTI is a very uncommon cause of DO. Most
ends with “permission to void” or with incontinence of centres do not do urodynamic studies in the presence of an
the total bladder content. The fluid type and temperature, active infection because of the risk of septicaemia.
filling method and rate, catheter sizes, pressure recording 3.19: Normal values of bladder compliance in men
technique, and patient position should all be specified in have not been well-defined. Bladder compliance in the
the urodynamic protocol. volunteers was higher than usually considered normal in
3.8: Body temperature fluid and room temperature adults during cystometric bladder filling.76 In 28 healthy
fluid do not differently affect bladder sensory thresholds volunteers, men with mean age of 24 years (range 19-28),
and do not unequally provoke detrusor overactivity or the mean compliance was 56.1 mL/cm H2O (SD 37.3).
lower urinary tract irritation.71,72 Since no precise figures exist for normal compliance in
3.9: Detrusor overactivity would have been missed in men, a prospective study of a large normal population is
76% of cases of cystometry was done in the supine needed.
position and 60% would have been missed if the study 3.20: There is no convincing evidence that the clinical
was done supine compared to seated71,73. The sitting or diagnosis on the basis of the first cystometry is often
standing position is the most representative for daily life changed on repetition of the test. There is no definite
situations and is probably the least uncomfortable and/or evidence that immediate repetition of an adequately
embarrassing for the patient.73 performed urodynamic test “for confirmation” is required.
3.10: Filling rate, especially when very fast and the The recommendation of immediate repetition of the test: (i)
volume infused is much larger than the functional bladder when doubt exists as to whether the test has answered the
capacity, may influence the results or the representative- clinical question; (ii) when technical errors and artifacts
ness of the cystometry. Evidence that filling rate should have been observed at immediate post-test analysis.
be changed during the cystometry is lacking. Diuresis, 3.21: Cystometry and pressure-flow study, free
during cystometry, adds volume that is not recorded by uroflometry and PVR are termed ICS standard urody-
the urodynamic system with automated filling volume namic test (ICS-SUT). This may be supplemented with
recording, but that is relevant for interpretation of the other tests such as EMG, imaging, continuous urethral
results. pressure(s), and/or urethral pressure profile measure-
3.11: There is no specific evidence, but the position of ments. All tests are performed in the patient's preferred or
the catheter-tip is usually above the bladder in a stoma, most usual position: comfortably seated and/or standing
and bowel activity may much more likely cause artifacts if possible.56,57
in those cases, hampering measurement of absolute 3.22: Voiding physiology depends on central neural
abdominal pressures, detrusor subtraction pressure, and activation, bladder contractility and coordinated urethral
therefore, the interpretation. relaxation throughout the process. There remains much to
3.12: The urodynamic pressure is the excess pressure learn about these components including central activation
above atmosphere at the hydrostatic level of the upper and its potential grading, and its role and interactions in
edge of the symphysis pubis. This is valid for all pressures detrusor underactivity and dysfunctional voiding.
recorded with fluid-filled lines. 3.23: It is usually between 0.5 to 0.8 s depending on
3.13: Values evaluated in healthy men75,76 the individual's position and the distance to the
(mean ± SD) are (i) First sensation of bladder filling: uroflowmeter.
222 mL ± 150 mL; (ii) First desire to void: 3.24: The first “event” in voiding is relaxation of the
325 ± 140 mL; (iii) Strong desire to void: 453 ± 94 mL. pelvic floor. This may mean a drop in intra-abdominal

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pressure in the rectal line, and an associated increase in voiding tests and mathematical or graphical analysis
the detrusor pressure which does not imply a detrusor methods of pressure, flow and or other parameters. Cut-
contraction. off values or a continuous scale of contractility can then
3.25: As any other muscular contraction, detrusor be drawn. Independently of the magnitude of the detrusor
contraction has an isometric and an isotonic component. contraction, it can be fading before the total emptying
The isometric component means that detrusor fibers do leading to incomplete voiding; “unsustained contraction”
not shorten and intravesical pressure rises. The isotonic or “fading contraction” may then be used.
component produces changes in fiber length; there is 3.29: “ICS Nomogram” ® formerly known as
shortening and a flow ensues. The first is represented Abrams-Griffiths Nomogram and “Abrams-Griffiths
externally as Pves or Pdet and the second by flow. In number” (now BOOI) is more commonly used.
voiding cystometry, in the presence of flow, detrusor 3.30: Catheter flow should be compared with free
pressure is a function of these two variables, governed by flow to ascertain whether dysfunctional voiding might
urethral resistance to flow. only occur during urodynamics due to catheter
3.26: Voluntary interruption of voiding: If the need to placement.
interrupt the flow were to arise, contraction of the pelvic
floor and urethral sphincters can do this, resulting in an
isometric detrusor pressure rise. Urine in the proximal SECTION 4: IMAGING
urethra is milked back into the bladder.
3.27: In men with symptoms of lower urinary tract 4.1 Overview: Imaging has become increasingly impor-
dysfunction, urine flow (rate) and PVR are important tant in the assessment of male lower urinary tract and
markers of bladder outlet obstruction, but are also pelvic floor dysfunction. Table 2 indicates possible
dependent on the central initiation and continuation of imaging modalities by site and the main goals from
the detrusor contraction and pressure. In the original kidney to pelvic floor. (NEW)
definition, only pressure and urine flow were included. Application of the individual imaging technique is
3.28: Voiding cystometry graphic presentation: It has dependent on the suspected abnormality, ability of
been recommended to present pressure-flow studies with the imaging technique to visualize this abnormal-
a plot of the flow rate (mL/s) on the X-axis and the ity and image resolution. In case of competing
synchronous detrusor pressure (cm H2O) on the Y-axis in imaging techniques, non-radiological techniques
addition to the time-based graphs but the axis can be should be preferred to avoid radiation exposure.
reversed. These plots can be added a cut-off value or a (NEW)
range of normality and equivocal zones. These cut-off 4.2 Ultrasound Imaging
values are population specific, varying widely among 4.2.1 Ultrasound in the assessment of the lower
male patients. urinary tract: As noted in Table 2, ultrasound
The relation between detrusor pressure and generated imaging has become a relevant imaging
synchronous flow indicate “urethral resistance.” With modality in all sites that might be subject to
computing, these plots can be drawn since the beginning investigation of male lower urinary tract and
to the end of flow. Urethral resistance is then appreciated pelvic floor dysfunction both in the office and in
graphically throughout the whole emptying phase. Most the urodynamic suite. (NEW)
of these resistance points are considered to be driven by 4.2.2 Modalities in current routine clinical use:
urethral muscular activity. The point of less calculated 4.2.2.1 Transrectal: Linear array or sector
resistance should be taken as an approximation to the scanning per rectum. (NEW)
urethral resistance free of active muscular urethral and 4.2.2.2 Transabdominal: Curved or linear
peri-urethral contractions. This concept of “passive arrays applied to the abdomen. (NEW)
urethral resistance relation” is then taken as an 4.2.2.3 Perineal: Curved or linear array probe
“anatomical obstruction” caused by fixed structures as applied to the perineum (transperi-
the prostate or strictures. neal). (NEW)
Pressure-flow plots as a measure of detrusor voiding 4.2.2.4 Scrotal: Linear array probe applied to
contraction. “Detrusor contractility” can be used for any scrotum looking at testes, epididymes
method that diagnoses or aims to diagnose “intrinsic” and intrascrotal abnormalities. (NEW)
detrusor muscle properties (eg, potential [maximum] 4.2.3 Current routine uses of ultrasound in male
force or velocity), by any method. LUT/PF dysfunction
In a given group of patients the detrusor contractility 4.2.3.1 Post-void residual (PVR): Transabdo-
can be calculated upon series of stop-flow or interrupted- minal98,99 or transrectal100 (see section

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TABLE 2 Imaging modalities by site and goal

Location Imaging technique Purpose
Upper Urinary Tract • Renal ultrasound detects the presence and degree of hydronephrosis,
• IVU with X-ray or CT urothelial carcinoma/tumors, stones, other renal or
• IVU with MRI ureteric abnormalities/ diseases.
Bladder • Ultrasound bladder scanner measurement of post-void residual (PVR), detrusor or
• Transabdominal ultrasound bladder wall thickness, intravesical prostatic
• Transrectal ultrasound protrusion (IPP) or bladder weight (to help judge
• CT BOO) or calcification. Evaluate the presence of other
• MRI diagnoses such as neoplasm, stones or foreign bodies.
Prostate • Transrectal ultrasound (3D, evaluate prostate volume, prostate anatomy, BOO.
contrast-enhanced, Doppler) MRI: Evaluation for prostate cancer
• Transabdominal ultrasound
• MRI (T2-weighted,
multiparametric, prostate
segmentation, functional
MRI).
Scrotum • Scrotal ultrasound Testis, epididymis, tunica vaginalis
Urethra • X-Ray (retrograde or evaluate congenital abnormalities, fistula, diverticula,
antegrade urethrography) (post-surgical) stricture, neoplasm
• MRI
• Ultrasound
Ano-rectum • Endoanal ultrasound (10-13- Anal sphincter integrity; peri-anal sepsis, pelvic floor
16 Hz axial and sagittal array) coordination during defecation
• Defecography
• MRI
Penis • Ultrasound Peyronie's disease, corpora cavernosa rupture.
• CT
• MRI
Lower urinary tract • Video-cystourethrography Evaluate of the bladder during filling and/or voiding,
• Video-urodynamic vesico-ureteric reflux; bladder morphology −
trabeculation, diverticulum; anatomical site; BOO;
type of stress incontinence; urethral diverticulum;
strictures, fistulae

3.2.2) ultrasound measurement of the nal, intraabdominal, retroperitoneal, or

bladder volume. The following formula intrapelvic tumor, hydronephrosis).
shows the lowest transabdominal mea- (NEW)
surement error when compared with 4.2.3.3 Bladder abnormalities: For example,
catheterization.99 PVR calculation (by tumor, foreign body, overdistension,
abdominal ultrasound) is done by stones. (NEW)
multiplying the width (left to right 4.2.3.4 Detrusor wall thickness (DWT) or
borders), depth (anterior to posterior bladder wall thickness (BWT):
borders) and length (cranial to caudal Transabdominal visualization of the
borders) and multiplying this result with anterior bladder wall with a (linear)
0.52 (there are different multiplication high frequency ultrasound scanner for
factors available but 0.52 is the most the detection of BOO if DWT is
common one) (Figure 13). (NEW) ≥2 mm in bladders filled with
≥250 mL (Figure 14) or BWT is
Volume ¼ ðwidth  depth  length½cmÞ  0:52½mL ≥5 mm in bladders filled with 150
mL (Figure 14).101–105 (NEW)
4.2.3.2 Intercurrent abnormalities: For ex- 4.2.3.5 Ultrasound-estimated bladder
ample, prostate volume (transabdomi- weight (UEBW): can be calculated

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FIGURE 13 Determination of bladder (post-void residual) volume by transabdominal ultrasound imaging

by measuring the urine volume in the filling over 400 mL will lower IPP
bladder and BWT and applying the values.108 The IPP measurement can be
following formula (Figure 15).106,107 divided into three grades: grade I = 0-
(NEW) 4.9 mm; grade II = 5-10 mm; grade
4.2.3.6 Intravesical Prostatic Protrusion III = >10 mm.109 IPP grade III is
(IPP): Transabdominal measurement associated with prostate-related BOO.
of the distance of the bladder base until 4.2.3.7 Urethral abnormality: For example,
the tip of the prostate in the bladder diverticulum, urethral stenosis, degree,
lumen108 (Figure 16A and B). It is and depth of spongiofibrosis. (NEW)
recommended to fill the bladder with 4.2.3.8 Postoperative findings: For example,
100-200 mL of fluid in order to receive post-prostatectomy (urethral shape),
representative measurements; bladder male sling position, artificial urinary

FIGURE 14 Ultrasound measurement of detrusor wall thickness (DWT) at the anterior bladder wall with a linear 7.5 MHz ultrasound array
in a bladder filled >250 mL; the hypoechogenic detrusor (black bar) is sandwiched between the hyperechogenic (white) mucosa (bottom) and
adventitia (top).101,102 DWT is measured from the inner border of the mucosa to the inner border of the adventitia as demonstrated in the figure,
whereas BWT is measured from the outer border of the mucosa to the outer border of the adventitia

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FIGURE 15 UEBW106,107 FN 4.1. IV = inner volume; ID = inner radius; OD = outer radius; T = (bladder wall) thickness; TV = total volume.
Note again, “D” refers to “radius” not “diameter”. Volume of bladder wall itself should be 4/3pi times (Rt3-Rid3)

sphincter −placement of cuff and 4.2.7 Anal ultrasound (Endosonography110,111):

reservoir, bulking agents. (NEW) This is the gold standard investigation in the
4.2.3.9 Prostate ultrasound: determination of assessment of anal sphincter integrity. There is a
prostate and transition zone volume, high incidence of defecatory symptoms in men
prostate shape and visualization of the with anal sphincter defects (Figure 18). (NEW)
prostate parenchyma for calcifications, 4.2.7.1 Endoanal ultrasonography (EAUS)
cysts, abscesses, or enlargement (Figure or Anal Endosonography (AES):
17). (NEW) Ultrasound of the anal canal performed
4.2.4 Pelvic floor: For example, anal sphincter with a pole-like ultrasound probe
defects (see below) placed in the anal canal giving a 360
4.2.5 3D and 4D Ultrasound: research modalities at degree image of the anal canal. It is
present FN 4.2 usually performed with the patient
4.2.6 Other assessments: Synchronous ultrasound placed in the lithotomy, prone position
screening of the bladder and/or urethra and or sometime left lateral. Two dimen-
measurement of the bladder and abdominal sional AES; three dimensional AES −
pressure during filling cystometry and pressure three-dimensional reconstruction of
flow study (Video-ultrasound-urodynamics). the anal canal is performed using either
(NEW) axial or sagittal images. (NEW)

FIGURE 16 A: Transabdominal ultrasound measurement of intravesical prostatic protrusion (IPP). B: How to measure IPP – base of bladder
(line A) to the most cranial part of the prostate (line B)

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FIGURE 17 Prostatic volume by transrectal ultrasound

4.2.7.2 Anal Canal − The anal canal in adults 4.2.7.2.2 Middle level: corresponds to
is between 2.5 and 5 cm in length and the superficial part of the
begins as the rectum narrows, passing EAS (concentric band of
posteriorly between the levator ani. mixed echogenicity), the
Three levels of assessment in the axial conjoined longitudinal layer,
plane.111 (NEW) the IAS (concentric hypo-
4.2.7.2.1 Upper level: the hyper- echoic ring), and the trans-
echoic sling of the puborec- verse superficial perinei
talis muscle (PR) and the muscles. (NEW)
complete ring of the internal 4.2.7.2.3 Lower level: corresponds to
anal sphincter (IAS). (NEW) the subcutaneous part of the
EAS where the IAS is absent.
(NEW)
4.2.7.3 Internal anal sphincter − The caudal
continuation of the circular smooth
muscle of the rectum forms the internal
anal sphincter, which terminates cau-
dally in a clearly defined edge, at a
variable distance from the anal verge.
(NEW)
4.2.7.4 Longitudinal muscle − Comprises
smooth muscle cells continuous with
the outer layer of the rectal wall, and
striated muscle from various pelvic
floor muscles. The longitudinal muscle
lies between the internal and external
anal sphincters in the inter-sphincteric
space. (NEW)
4.2.7.5 External anal Sphincter − It is made
up of striated muscle and surrounds the
longitudinal muscle forming the outer
FIGURE 18 Normal anal canal anatomy as seen on anal border of the inter-sphincteric space.
endosonography (AES) The external sphincter is divided into

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deep, superficial and subcutaneous

parts, with the deep and subcutaneous
parts of the sphincter forming rings of
muscle, between them elliptical fibres
from the superficial part of the external
anal sphincter run anteriorly from the
perineal body to the coccyx posteri-
orly. (NEW)
4.2.7.6 Puborectalis − is formed from the
most anterior fibres of the pubococcy-
geus muscle, this forms a sling pulling
the rectum forward. (NEW)

4.3 Radiography
4.3.1 Modalities in current routine clinical use
4.3.1.1 Intravenous urography (IVU): This
provides an anatomical outline of the
upper urinary tract, ureters and bladder
as well as the evaluation of the kidney FIGURE 19 Retrograde urethrocystography of a patient with a
function and excretion of contrast penile urethral stricture
media. IVU consists of at least 3–4
abdominal images: one plain x-ray, one
logical screening of the blad-
almost immediately after injection to
der and urethra during filling
evaluate for renal vascular uptake, one
and voiding (Figure 21). The
image 7 min and one image 15 min
only difference between
after infusion of contrast media (and
bladder emptying). The preliminary
plain x-ray may show calcification in
kidney, ureter, bladder, seminal
vesicles or vasa. (NEW)
4.3.1.2 Retrograde urethrocystography
and voiding cystourethrography:
Unidirectional or combined contrast
imaging of the urethra in a patient in
the 30 degree oblique position to
visualize the lumen, mainly to diag-
nose urethral strictures or diverticula
(Figure 19). It is also of use to
diagnose and stage urethral trauma.
(NEW)
4.3.1.3 Voiding cystourethrography: im-
aging of the bladder neck, urethra
and prostate during voiding (Figure
20). The principal use is determining
the site of any obstruction, for
example, bladder neck or prostate.
It can detect vesico-ureteric reflux,
vesical or urethral fistulae, vesical or
urethral diverticula and strictures.
(NEW) FIGURE 20 Voiding cystourethrography: Shows bladder
4.3.1.3.1 Videocystourethrography diverticula, open bladder neck and prostatic urethra till stricture of
(VCU): Synchronous radio- penile urethra

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paste is inserted rectally prior to

defecation over a translucent com-
mode. (NEW)

4.4 Computerized Tomography (CT)

4.4.1 CT Urogram (CT-U): CT study of the urinary
tract system using injected contrast, used to
clarify diagnoses such as (i) tumors; (ii) renal
disease; (iii) abnormal fluid collections/ab-
scesses (iv) bladder diseases. (NEW)
4.4.2 CT Kidneys, ureter, bladder (CT-KUB):
Non-contrast study aimed primarily at identi-
fying stones but may identify other diseases.
Aka “stone protocol.” (NEW)

4.5 Magnetic Resonance Imaging113

4.5.1 Magnetic resonance imaging (MRI) in male
FIGURE 21 Example of Videocystourethrography
lower urinary tract and pelvic floor dysfunc-
tion: MRI provides the opportunity to exam-
ine the soft tissue structures of the pelvic
VCU and 4.3.1.3. is continu- support apparatus. It is non-invasive, has
ous image capture. (NEW) excellent soft tissue contrast resolution with-
4.3.4 Videourodynamics112: Videourody- out exposure to ionizing radiation and allows
namics refers to videocystourethrog- the study of function of pelvic floor structures
raphy with synchronous pressure and under different dynamic conditions. Several
flow rate recordings. It is a dynamic anatomical landmarks used for pelvic meas-
study with function, during bladder urements are also easily identified in MRI and
filling and emptying. (NEW) See also most measurements are thus highly reproduc-
Figure 12. ible. T-weighting assists enhancement of
Video-urodynamics has two defining fluid-filled structures. (NEW)
characteristics: 4.5.2 Current possible measurements using MRI
▪ It is a kinetic technique that records in male lower urinary tract and pelvic floor
morphological and functional dysfunction. FN4.2
changes of the lower urinary tract 4.5.2.1 Bladder abnormalities: For example,
as a function of time. This feature tumor, foreign body, bladder wall
distinguishes this technique from the abnormalities, intestine-vesical fistu-
static images obtained by lae. (NEW)
cystography. 4.5.2.2 Urethral abnormality: For example,
▪ It is a technique that is applied diverticulum, recto-urethral fistulae.
simultaneously with conventional (NEW)
urodynamic studies. 4.5.2.3 Urethral sphincter length:114 predic-
Image acquisition for the urinary tract tion of post-prostatectomy inconti-
can be performed with X-rays (fluo- nence. (NEW)
roscopy) or by ultrasound. Although in 4.5.2.4 Prostate abnormalities: For example,
a strict sense, the “video” prefix refers benign enlargement, cancer, cysts,
to the recording of the images and not prostato-rectal fistulae. (NEW)
to their acquisition. 4.5.2.5 Intercurrent abnormalities: For ex-
4.3.5 Defecography (Evacuation proctog- ample, rectum − rectal dynamics are
raphy): This demonstrates the anat- assessed during evacuation after adding
omy of the anorectum as well as ultrasound gel to the rectum. Anorectal
disorders of rectal evacuation. Barium and pelvic floor motion can be imaged

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| D’ANCONA, HAYLEN ET AL.

FIGURE 22 MRI (sagittal) of male lower abdomen and pelvis

providing pelvic images at rest and currently being researched with validated applications
when the subject strains. (NEW) likely to be included in future updates of this Report and/
4.5.2.6 Congenital abnormalities: Detection of or separate ultrasound reports.
Mullerian duct remnants, aberrantly 4.3: Diagnostic ability may be enhanced by the use of
inserted ureters and duplicated pelvic 3D MRI. New techniques with high speed sequence of
structures. (NEW) pictures allows for a functional MRI.
4.5.2.7 Standardised MRI prostate imaging: 4.4: Prostate imaging has over the last 5 years become
PI-RADS − prostate imaging reporting more standardised with the introduction of PI-RADS
and data system (Figures 22–24).FN4.4, (Prostate Imaging Reporting and Data System), currently
FN4.5 (NEW) version 2. The recommended MRI prostate protocol
consists of multiparametric study which consists at least
Footnotes for Section 4 of a diffusion sequence (DWI), high resolution anatomi-
4.1: The “cut-off” value for obstruction has been cal sequences (T2 weighted) and dynamic contrast
suggested as 35 g (adult Asian men).106 enhanced sequences (perfusion imaging). A score is
4.2: The potential of 3D and 4D ultrasound in male given according to each sequence finding and an overall
lower urinary tract and pelvic floor dysfunction is PI-RADS score is finally given based on a structured

FIGURE 23 MRI of prostate showing low grade inflammatory changes in the peripheral zone

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5.1.1.1 Definition: Bladder oversensitivity, a

clinical diagnosis made by symptoms
and urodynamic investigations, most
likely to occur in individuals with
symptoms of increased daytime fre-
quency and nocturia. A frequency-
volume chart shows a clearly reduced
average voided volume (by day and
night). As noted in section (3.4.3.6), it
can be defined as: increased perceived
bladder sensation during bladder filling
with specific cystometric findings of:
(i) early first desire to void (3.4.3.2);
(ii) early strong desire to void, which
occurs at low bladder volume (3.4.3.4);
(iii) low maximum cystometric bladder
capacity (3.4.4.2); and (iv) no abnor-
mal increases in detrusor pressure.
Specific bladder volumes at which
these findings occur vary in different
FIGURE 24 MRI of prostate showing prostate cancer in the right
populations. FN5.3
posterolateral peripheral zone
5.1.2 Detrusor Overactivity (DO) FN 5.1 FN5.4 FN5.5
reporting scheme. A score of 1–5 is given with one being FN5.6
benign and five being highly suspicious of malignancy. 5.1.2.1 Definition: As noted in section 3.4.5.2,
Ideally the MR studies are performed on a three Tesla this diagnosis by symptoms and urody-
strength MR scanner negating the need for an endorectal namic investigations is made in indi-
coil to achieve adequate resolution. MR spectroscopy viduals with lower urinary tract
imaging on the prostate is now rarely performed as it symptoms (more commonly OAB
rarely adds value to the above multiparametric study. symptoms − section 1.1.7) when de-
trusor muscle contractions occur during
SECTION 5: DIAGNOSES (MOST filling cystometry. (CHANGED)
COMMON) 5.1.2.2 Subtypes
(i) Idiopathic (primary) detrusor
This report, like previous ones,2,3,5 highlights the need to overactivity: As noted in
base diagnoses for male lower urinary tract and pelvic 3.4.5.2.1, no identifiable cause
floor dysfunction on the correlation between a man's for the involuntary detrusor con-
symptoms, signs and any relevant diagnostic investiga- traction(s). (CHANGED)
tions. We include EMG and imaging as possible (ii) Neurogenic (secondary) detru-
diagnostic investigations. The diagnoses are categorized sor overactivity:3,5,13 As noted in
according to three subgroups that reflect the function of 3.4.5.2.2, there is detrusor over-
the lower urinary tract, namely storage, voiding dysfunc- activity and evidence (history;
tion and mixed storage and voiding dysfunction. It should visible or measurable deficit) of
be noted that prevalence data for the relative frequency of a relevant neurological disorder.
the different male diagnoses are scarce. FN5.1 More (CHANGED)
studies are required. (NEW) (iii) Non-neurogenic (secondary) de-
trusor overactivity: As noted in
STORAGE DYSFUNCTION (SD) FN5.1 Those diagnoses 3.4.5.2.3, an identifiable possible
related to abnormal changes in bladder sensation, detrusor non-neurological cause exists for
pressure or bladder capacity during filling cystometry. (NEW) involuntary detrusor contraction
(s) during bladder filling. For
5.1 Bladder Factor example, functional (obstruction);
5.1.1 Bladder Oversensitivity (BO)5 FN5.2 FN 5.3 stone, tumor (eg, carcinoma in
(NEW − Male) situ), UTI. (CHANGED)

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5.1.3 Reduced compliance storage dys- der emptying and/or a failure to

function (RCSD): this diagnosis by achieve complete bladder emptying
symptoms and urodynamic investiga- within a normal time span, with or
tions is made in individuals with lower without a high postvoid residual
urinary tract symptoms, more com- (3.2.2) (c.f. “hypocontractile detru-
monly storage symptoms, when there sor” − detrusor contraction of re-
is a non-phasic (at times linear or duced strength) (CHANGED)
exponential) rise in detrusor pressure 5.3.2 Detrusor Acontractility (DAC) FN5.11
during filling cystometry with gener- 5.3.2.1 Definition of DAC: As per 3.7.3.3. a
ally reduced capacity indicating re- diagnosis by urodynamic investiga-
duced compliance (section 3.4.6). tion, generally (but not always) with
(NEW) relevant symptoms, signs manifest
5.1.3.1 Reduced compliance (RCSD) incon- by the absence of an observed
tinence: urinary incontinence directly detrusor contraction during voiding
related to the RCSD. (NEW) studies resulting in prolonged blad-
der emptying and/or a failure to
achieve complete bladder emptying
5.2 Outlet Factor (Urethra/Sphincter Dysfunction − within a normal time span. Voiding
decreased urethral resistance − incompetence in men with DAC is usually achieved
/insufficiency) by straining or manual pressure on
5.2.1 Urodynamic Stress Incontinence (USI) FN5.7 the bladder resulting generally in an
5.2.1.1 Definition: As noted in section abnormally slow urine flow rate
(3.6.2.1), this clinical diagnosis by (3.1.10) and/or an abnormally high
symptom, sign and urodynamic inves- postvoid residual (3.2.2)
tigations involves the finding of invol- (CHANGED)
untary leakage during filling 5.3.2.2 Subtypes:
cystometry, associated with increased - Neurogenic detrusor acontractility
intra-abdominal pressure, in the ab- (See 3.7.3.3.1)
sence of a detrusor muscle contraction. - Non-neurogenic detrusor acontrac-
FN5.7–FN5.10 tility (See 3.7.3.3.2)
5.2.1.2 Subtype: Intrinsic sphincter defi-
ciency (ISD (See 3.6.2.1.1): Very 5.4 Outlet Factor (Urethral/Sphincter dysfunction)
weakened urethral closure mechanism.
(CHANGED) 5.4.1 Bladder Outlet Obstruction (BOO) FN 5.1 FN5.12
5.4.1.1 Definition of BOO: A diagnosis based on
VOIDING DYSFUNCTION (VD) Those diagnoses urodynamic investigations (pressure-flow
related to abnormally slow and/or incomplete bladder studies ± imaging), generally (but not
emptying manifest as an abnormally slow urine flow always) with relevant symptoms and/or
rate (3.1.10) and/or an abnormally high post-void signs, manifest by an abnormally slow
residual (3.2.2), with confirmation by pressure-flow urine flow rate (3.1.10) FN5.12 with evi-
studies (including any related imaging). (NEW − Male) dence of abnormally high detrusor voiding
pressures and abnormally slow urine flow
5.3 Bladder factor − (poor or absent detrusor (3.8.2.1) during voiding cystometry with or
activity) without an abnormally high PVR. (3.2.2).
5.3.1 Detrusor Underactivity (DUA) FN5.11 FN5.13 (CHANGED)
5.3.1.1 Definition of DU: As per 3.7.3.2 A 5.4.1.2 Possible sites/causes of BOO: Can be:
diagnosis based on urodynamic in- 5.4.1.2.1 Functional
vestigations generally (but not al- bladder neck obstruction, detru-
ways) with relevant symptoms, signs sor sphincter dysfunctions, pelvic
manifest by low detrusor pressure or floor overactivity. (NEW)
short detrusor contraction in combi- 5.4.1.2.2 Mechanical: benign prostatic en-
nation with a low urine flow rate largement, urethral stricture, mea-
(3.1.10) resulting in prolonged blad- tal stenosis). FN5.14-FN5.19

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Imaging of the lower urinary tract Footnotes for Section 5

especially video-urodynamics 5.1: Large series data on the relative frequency of
and EMG can be required to diagnoses in men presenting with symptoms of LUT/PF
evaluate location/cause. (NEW) dysfunction are scarce. The relative prevalence of six
main diagnoses is known in women.4,5 In a series of 504
consecutive men64 aged 49-94 years, referred for
urodynamic studies including videocystourethrography
5.4.2 Alternate presentations of Voiding Dysfunction (VCU) and department review of results because of
5.4.2.1 Acute retention of urine: An individual is urological symptoms. The following diagnoses were
unable pass any urine despite having a full made:
bladder, which on examination is painfully
distended, and readily palpable and/or percus- Detrusor overactivity (DO) 149 (29.6%)
sible. (CHANGED)
DO plus obstruction (BOO) 124 (24.6%)
5.4.2.2 Chronic retention of urine: Generally (but not
always) painless and palpable or percussible i.e. Total DO (54.2%)
bladder, where there is a chronic high PVR. The
patient experiences slow flow and chronic Obstruction (BOO) alone 161 (31.9%)
incomplete bladder emptying but can be asymp-
i.e. Total Obstruction (56.5%)
tomatic. Overflow incontinence can occur. Some
men with retention present with impaired renal Normal/ No Specific Dx 70 (13.9%) Some more recent
function and/or hydronephrosis. (CHANGED) diagnoses may not have been present in 1990.
5.4.2.3 Acute on chronic retention: An individual
with chronic retention goes into acute retention 5.2: Prevalence of Bladder Oversensitivity (BOS): In the
and is unable to void. (NEW) EPIC study,115 the prevalence rate for men who void with
5.4.2.4 Retention with overflow: Involuntary loss of frequencies of greater than eight times per day is approxi-
urine directly related to an excessively full mately 12%. The presence of bladder oversensitivity in
bladder in retention. (NEW) urogynaecology patients is 10-13%.5
5.3: There should be no known or suspected urinary tract
infection. Bladder oversensitivity is often a diagnosis after
5.5 MIXED STORAGE AND VOIDING DYSFUNCTION other more serious conditions such as lower urinary tract
5.5.1 Bladder Outlet Obstruction and Detrusor malignancy, including carcinoma-in-situ of the bladder, are
Underactivity (BOO-DU) excluded.
5.5.1.1 Definition: Urodynamic BOO (3.8.2.1) 5.4: Prevalence of overall urinary incontinence in men by
occurring synchronous with urodynamic age:116 19-44 (4.8%); 45-64 (11.2%); 65-79 (21.1%); >80
DU (3.7.3.2) in pressure-flow analyses. (32.2%)
FN5.20 (NEW) 5.5: Prevalence of urgency (urinary) incontinence in men
5.5.2 Detrusor Overactivity and Bladder Outlet by age117: 19-44 (3.1%); 45-64 (7.8%); 65-79 (11.7%); >80
Obstruction (DO-BOO)FN5.1 (18.1%)
5.5.2.1 Definition: Urodynamic DO (3.4.5.2) on 5.6: Abnormal detrusor contractions can be, at times,
filling cystometry in the presence of BOO observed during filling cystometry without the patient being
(3.8.2.1) on pressure-flow studies. FN5.21 symptomatic.
(NEW) 5.7: Prevalence of urodynamic stress incontinence (USI):
5.5.3 Detrusor Overactivity with Detrusor Underac- Prevalence of stress (urinary) incontinence in men by age:115
tivity (DO-DU) 19-44 (0.7%); 45-64 (3.8%); 65-79 (2.7%); >80 (N/A) or
5.5.3.1 Definition: Urodynamic DO (3.4.5.2) on overall for men over 18 years117 (1.4%).
filling cystometry) in combination with 5.8: Men, unlike women, do not develop significant
urodynamic DU (3.7.3.2) on pressure-flow urethral hypermobility (with radical prostatectomy a
studies. This diagnosis is intended to possible exception), and hence urodynamic stress inconti-
supersede the old expression “detrusor nence is most often associated with intrinsic sphincter
hyperactivity with impaired contractility” deficiency, rather than urethral hypermobility. Sphincter
(DHIC) and detrusor overactivity with deficiency is most commonly a result of either pelvic
impaired contractility (DOIC). It is most trauma or post-prostatectomy, either transurethral or
common in the elderly group. (NEW) radical, or neurological disorder.

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| D’ANCONA, HAYLEN ET AL.

5.9 Prevalence for urinary incontinence after transurethral definition because there is currently no consensus on defining
prostatectomy (TURP) for benign prostatic disease appears detrusor underactivity. There is a Maastricht-Hannover
between 0.5% and 3%.118–122 Nomogram126 may be used to diagnose reduced detrusor
5.10: Prevalence for post radical prostatectomy: The rates contractility in the presence of obstruction (or vice versa).
of post radical prostatectomy incontinence varies depending 5.21: Up to 83%127 of men with urodynamic BOO may
on the definition used and the duration of follow-up. have concomitant urodynamic DO. Both BOO-grade and
However, the long-term incidence ranges between 4% and advancing age were independent factors of DO in men. The
8%.117–122 more severe BOO, the higher the chance of DO.
5.11: Prevalence of either detrusor underactivity (DU) or
acontractility (DAC): In a study involving a review of
urodynamic data of 1179 patients aged 65 and older, Jeong AREAS FOR FURTHER RESEARCH
et al. reported the prevalence of DUA of 40.2 % in men.123
5.12: Urodynamic BOO can be diagnosed using the ICS In the preparation of this document, the following “gaps” in
Nomogram89. The formula used, known as the bladder outlet knowledge in male LUT/PF dysfunction have been noted
obstruction index (BOOI) is calculated by detrusor pressure at compared to the equivalent for female LUT/PF dysfunction:5
maximum flow (Pdet.Qmax) minus two times the maximum
urinary flow (BOOI = Pdet.Qmax-2 Qmax). A BOOI with a  Post-void residuals in men with symptoms of LUT/PF
value of >40 defines BOO, less than 20 defines absence of dysfunction.
BOO, and in between denotes equivocal BOO. Alternative  Male diuresis data.
classifications for BOO are the Schäfer grades (0-VI)90,91 and  Bladder compliance − normal and abnormal values in men.
CHESS classification.92  Additional large patient series for the prevalence data and
5.13 The evidence in men regarding PVR and BOO is not the relative frequency of the most common male
clear. Urodynamic studies in adult male patients with clinical diagnoses.64
BPH demonstrated that approx. 30% of men with PVR ≥50 mL
do not have BOO/BPO, independent on the magnitude of
PVR124 and, vice versa, 24% of men with urodynamically ACKNOWLEDGMENTS/ADDENDUM
confirmed BOO/BPO have PVR <50 mL or even 0 mL.124–125
No discussion on terminology should fail to acknowledge the
5.14: The level of obstruction can usually be diagnosed
fine leadership shown by the ICS over many years. The legacy
during voiding video cysto-urethrography. It may be aided by
of that work by many dedicated clinicians and scientists is
sphincter or pelvic floor EMG during voiding.
present in all the Reports by the different Standardization
5.15: Bladder outlet obstruction from an enlarged
Committees and Working Groups. It is pleasing that the ICS
prostate: BOO where the cause is benign prostatic enlarge-
leadership has accepted this vital initiative as a means of
ment (BPE) with clinical or imaging evidence.
progress in this important and most basic area of Terminology
5.16: Bladder outlet obstruction from the bladder neck:
and its Standardization.
BOO where the cause is at the level of the bladder neck
(clinical or radiological). The pelvic floor electromyogram
(EMG) trace should be quiet during voiding in these patients.
5.17: Bladder outlet obstruction from pelvic floor muscular
overactivity: Bladder outflow obstruction where the cause is at
the level of the pelvic floor musculature (clinical, urodynamic
or radiological). The pelvic floor electromyogram (EMG) trace
may not be positive during voiding. This document has involved 22 rounds of full review, by co-
5.18: Bladder outlet obstruction from the rhabdosphincter authors, of an initial draft (BH) with the collation of
(external urinary sphincter): BOO where the cause is at the comments and figures. Included in the review process were
level of rhabdosphincter (clinical, urodynamic or radiologi- as follows: (i) 8 external expert reviewers; (ii) an open ICS
cal). The pelvic floor electromyogram (EMG) trace may not website review; (iii) ICS Standardisation Steering Committee
be positive during voiding. review and (iv) ICS Board of Trustees review. The process
5.19: Bladder outlet obstruction from stenosis of bladder was subject to live Meetings in Tokyo (Sept 2016 −
neck or urethra due to fibrosis: Bladder neck stenosis may planning), and Working Group Meetings in Florence
occur secondary to prostate surgery for benign disease, (September 2017), Copenhagen (March 2018) and Philadel-
radical prostate surgery, radiotherapy or trauma. phia (August 2018). There were also teleconferences in June,
5.20: Currently, although many experts in this field agree July and August 2018. The co-authors acknowledge the input
that this entity exists, there is currently no consensus on its and extensive comments by those external reviewers of

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D’ANCONA, HAYLEN ET AL.

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version 18: Craig Comiter, Dirk De Ridder, David Ginsberg, floor dysfunction. Neurourol Urodyn. 2010;29:4–20; Interna-
John Heesakkers, Michael Kennelly, Richard Millard, Victor tional Urogynecology J. 2010,21:5-26.
Nitti, and Gommert van Koeveringe. Thanks to Dr Pascal 6. Haylen BT, Freeman RM, Swift SE, et al. An International
Urogynecological Association (IUGA)/International Continence
Bou-Haidar for his assistance with the MRI section. Version
Society (ICS) Joint Terminology and Classification of complica-
19 was subject to ICS website publication and an open public
tions related directly to the insertion of prostheses (meshes,
forum discussion at ICS Philadelphia. Thanks to those who implants, tapes) and grafts in female pelvic floor surgery. Int
provided formal, in particular Werner Schäfer, and informal Urogynecol J. 2011;22:3–15.
comments. Version 22 was sent for ICS Board review. As 7. Haylen BT, Freeman RM, Lee J, et al. An International
there were no significant changes, Version 22 was submitted Urogynecological Association (IUGA)/International Continence
to Neurourology and Urodynamics in late October 2018 to Society (ICS) joint terminology and classification of the
appear in the Journal in early 2019. complications related to native tissue female pelvic floor surgery.
Int Urogynecol. 2012;23:515–526; Neurourol Urodyn. 2012, 31
(4):406–414.
AUTHORS’ DISCLOSURES 8. Toozs-Hobson P, Freeman R, Barber M, et al. An International
Urogynecological Association (IUGA) / International Continence
Carlos D’Ancona: Clinical trial − Ipsen. Bernard Haylen: No Society (ICS) joint report on the terminology for reporting outcomes
disclosures. Matthias Oelke: Speaker, consultant and/or trial of surgical procedures for pelvic organ prolapse. Int Urogynecol.
participant for Apogepha, Astellas, Duchesnay, Glaxo Smith 2012;23:527–535; Neurourol Urodyn. 2012,31(4): 415–421.
Kline, Ferring, Lilly & Pfizer. Grant from Astellas in 2012 on 9. Haylen BT, Maher CF, Barber MD, et al. International
the investigation of detrusor underactivity. Luis Abranches- Urogynecological Association (IUGA)/International Continence
Society (ICS) Joint Report on the Terminology for pelvic organ
Monteiro: Trial participant: Ipsen, Allergan, Bayer, Lilly.
prolapse (POP). Int Urogynecol J. 2016;4:655–684; Neurourol
Advisory Board: Astellas. Edwin Arnold: No disclosures. Urodyn, 2016,35(2):137–168.
Howard Goldman: Medtronic: consultant, study support. 10. Sultan AH, Monga A, Lee J, et al. An International Urogyneco-
Consultant: Allergan, Nuvectra, Axionics, NewUro. Study logical Association (IUGA)/International Continence Society
participant: Cook, Ipsen, Bioness. Rizwan Hamid: Consultant: (ICS) Joint Report on the Terminology for Anorectal Dysfunction
Allergan, Wellspect. Speaker: Astellas, Allergan, Pfizer, in Women. Int Urogynaecol J. 2017;28:5–31; Neurourol Urodyn.
Laborie. Travel/Research grants: Allegan, Astellas, Pfizer, 2017, 36:10–34.
Wellspect. Yukio Homma: Honorarium: Astellas, Pfizer, 11. Bo K, Frawley H, Haylen BT, et al. International Urogyneco-
logical Association (IUGA) / International Continence Society
Kissei, Daiichi-Sankyo, Glaxo-Smith Kline, Nippon Shi-
(ICS) Joint Report on the Terminology for the Conservative and
nyaku. Tom Marcelissen: No disclosures. Kevin Rademakers: Non-pharamacological Management of Female Pelvic Floor
No disclosures. Alexis Schizas: No disclosures. Ajay Singla: Dysfunction. Int Urogynecol J. 2017;28:191–213; Neurourol
No disclosures. Irela Soto: No disclosures. Vincent Tse: Urodyn. 2017, 36: 221-244.
Consultant: Astellas, Allergan, Ferring. Stefan de Wachter: 12. Rogers R, Thakar R, Petri E, et al. International Urogynecological
Research grants: Medtronic, Astellas, Wellspect, Coloplast, Association (IUGA)/International Continence Society (ICS) joint
Boston Scientific. Consultant: Medtronic, Astellas. Sender report on the terminology for the sexual health in women with
pelvic floor dysfunction. Int Urogynecol J. 2018;29:647–666;
Herschorn: Consultant for Astellas, Allergan, Pfizer, Ipsen.
Neurourol Urodyn, 37: 1220-1240, 2018.
13. Gazewski JB, Schurch B, Hamid R, et al. An International
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Research Group, Maastricht & Hannover. Development of a

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Received: 20 July 2017

DOI: 10.1002/nau.23397
| Accepted: 3 August 2017

SOUNDING BOARD

An International Continence Society (ICS) report on the

terminology for adult neurogenic lower urinary tract
dysfunction (ANLUTD)

Jerzy B. Gajewski1 | Brigitte Schurch2 | Rizwan Hamid3 |

Márcio Averbeck4 | Ryuji Sakakibara5 | Enrico F. Agrò6 |
Tamara Dickinson7 | Christopher K. Payne8 | Marcus J. Drake9 | Bernie T. Haylen10

1 Dalhousie University, Halifax, Nova

Scotia, Canada Introduction: The terminology for adult neurogenic lower urinary tract dysfunction
2 Neurourology Unit, Department of (ANLUTD) should be defined and organized in a clinically based consensus Report.
Clinical Neurosciences, CHUV, University Methods: This Report has been created by a Working Group under the auspices and
Hospital, Lausanne, Switzerland
guidelines of the International Continence Society (ICS) Standardization Steering
3 Department of Neuro-Urology, Spinal
Injuries Unit, RNOH, Stanmore/London, Committee (SSC) assisted at intervals by external referees. All relevant definitions
United Kingdom for ANLUTD were updated on the basis of research over the last 14 years. An
4 Departmentof Urology, Moinhos de extensive process of 18 rounds of internal and external review was involved to
Vento Hospital, Porto Alegre, Brazil
exhaustively examine each definition, with decision-making by collective opinion
5 Neurology,Internal Medicine, Sakura
Medical Center, Toho University, Sakura,
(consensus).
Japan Results: A Terminology Report for ANLUTD, encompassing 97 definitions
6 Department of Experimental Medicine and (42 NEW and 8 CHANGED, has been developed. It is clinically based with the most
Surgery, Tor Vergata University, Rome, Italy
common diagnoses defined. Clarity and user-friendliness have been key aims to make
7 Department of Urology, UT Southwestern
it interpretable by practitioners and trainees in all the different groups involved not
Medical Center Dallas, Texas
8 VistaUrology & Pelvic Pain Partners, San
only in lower urinary tract dysfunction but additionally in many other medical
Jose, California specialties.
9 BristolUrological Institute, Southmead Conclusion: A consensus-based Terminology Report for ANLUTD has been
Hospital, Westbury-on-Trym Bristol, United
produced to aid clinical practice and research.
Kingdom
10 University
of New South Wales, Sydney, KEYWORDS
New South Wales, Australia
adult, dysfunction, neurogenic, terminology, urinary tract

Correspondence
Jerzy B. Gajewski, Urology Consultants,
620-5991 Spring Garden Road, Halifax.
B3H 1Y6, Nova Scotia, Canada.
Email: jgajew@dal.ca

Rizwan Hamid, Marcus J. Drake, and Bernie Haylen belongs to

1 | INTRODUCTION
Standardization Steering Committee ICS.
“Adult” refers to “a fully grown and physically mature
Jerzy B. Gajewski, Brigitte Schurch, Rizwan Hamid, Márcio Averbeck,
Ryuji Sakakibara, Enrico Finazz Agrò, Tamara Dickinson, Christopher K.
individual”1,2 “Neurogenic” refers to “originating in the
Payne, Marcus J. Drake, Bernie Haylen belongs to ICS SSC Working nervous system.”2 “Lower Urinary Tract (LUT)” refers to
Group on Adult Neurogenic Lower Urinary Tract Dysfunction. the bladder, urethra (and prostate in men).2 “Dysfunction”
Neurourology and Urodynamics. 2017;1–10. wileyonlinelibrary.com/journal/nau © 2017 Wiley Periodicals, Inc. | 1

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2
| GAJEWSKI ET AL.

refers to abnormal or difficult function. “Adult neurogenic possible, to the “Footnotes” section. Like all the other joint
lower urinary tract dysfunction (ANLUTD)” refers to ICS terminology reports, every effort has been made to
abnormal or difficult function of the bladder, urethra (and/ ensure this Report is:
or prostate in men) in mature individuals in the context of
clinically confirmed relevant neurologic disorder. There is 1. User-friendly: It should be able to be understood by all
currently no single document focusing on the definitions clinical and research users.
related to ANLUTD. Many ANLUTD symptoms and signs 2. Clinically based: Refers to the relevant clinical practice.
have been defined in core current terminology reports for 3. Origin: Where a term's existing definition (from one of
lower urinary tract and pelvic floor dysfunction.3,4,5 With multiple sources used) is deemed appropriate, that
the advantage of ongoing research into ANLUTD definition will remain and be duly referenced. A large
epidemiology, pathophysiology as well as pharmacologi- number of these, because of their long-term use, have now
cal initiatives by generalist and specialist medical become generic, as apparent by their listing in medical
practitioners, it is timely to reconsider the different dictionaries.
definitions. 4. Able to provide explanations: Where a specific explana-
tion is deemed appropriate to describe a change from
earlier definitions or to qualify the current definition, this
2 | METHODOLOGY will be included as Footnote to this paper. Wherever
possible, evidence-based medical principles will be
This document was developed according to the published followed.
methodology of the International Continence Society Stan-
dardization Steering Committee.6 This document aligns with This document has involved 18 rounds of full review, by
the previous standardizations of the ICS on lower urinary tract co-authors, of an initial draft (Version 1) completed
dysfunction and is adapted to a group of patients with 16.09.2014. Comments for each round of review were
ANLUTD. Thus, ANLUTD can be diagnosed in the presence collated and debated as necessary in order to form a
of neurological disease only. The intent is to supersede older subsequent version. Live meetings on the document took
terminology of “Neurogenic Bladder” or “Neurogenic place in Zurich and Tokyo.*
Bladder Dysfunction”: these definitions are misleading, This document covers symptoms, signs, urodynamic
because the dysfunction(s) may involve not only the bladder observations and definitions, clinical diagnoses, and
but also the urethral sphincter competence or relaxation. treatment.
Furthermore, using a single term to indicate a broad spectrum
of dysfunctions is restrictive and unclear. For instance, there
are many differences, in terms of investigations needed, 3 | RESULTS
treatment and prognosis, between a male patient with spinal
cord injury (SCI) at cervical level and a female patient with 1 ANLUTD SYMPTOMS:
Parkinson's disease, both complaining of Lower Urinary Symptom: Any morbid phenomenon or departure from
Tract Symptoms (LUTS) and “labeled” as having a the normal in structure, function, or sensation,
“Neurogenic Bladder.” Finally, these definitions could lead experienced by individual and indicative of disease
to the conviction that the dysfunction may be due to a problem or a health problem.2 Symptoms are either volunteered
of the bladder, whilst the primary defect is in the central or by, or elicited from the individual or may be described
peripheral nervous system. The document contains some by the patient's caregiver.3,4,5 LUTS are classified as
original standardization of LUTS-related definitions, some neurogenic in the presence of a relevant neurological
modified with designation “CHANGED” and some newly disease ONLY. Symptoms are a subjective indicator
defined — “NEW.” of, or change in disease as perceived by the patient,
This Terminology Report is inherently and appropri- carer, or partner that may lead the patient to seek help
ately a definitional document, collating the definitions of from healthcare professionals. They are usually
those terms, that is, “words used to express a defined qualitative. In general, LUTS cannot be used to
concept in a particular branch of study,”7 here ANLUTD. make a definitive diagnosis. LUTS in people with
Emphasis has been on comprehensively including those neurological disease can also indicate pathologies
terms in current use in the relevant peer-reviewed literature. other than NLUTD, such as urinary infection.
The definitions of those terms will be reviewed with all
available evidence. The aim is to assist clinical practice and
research. Some new and revised terms have been included. *
14th International Neuro-Urology Meeting, Zürich 2016 and International
Explanatory notes on definitions have been referred, where Continence Society Meeting, Tokyo, 2016.

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Three groups of LUTS are: storage, voiding, and post reports to have occurred without being aware
micturition symptoms. of it. (NEW)
1.1. Storage Symptoms are experienced during 1.1.4.7. Impaired mobility urinary incontinence:
the storage phase of the bladder, Complaint of inability to reach the toilet on
(CHANGED).† time for voiding because of physical or
1.1.1. Increased daytime urinary fre- medical disability (NEW).||
quency: Complaint that micturition oc- 1.1.4.8. Sexual activity urinary incontinence is the
curs more frequently during waking hours individual report of urinary incontinence
than previously deemed normal.5 associated with or during sexual activity
1.1.2. Nocturia is waking to pass urine during (NEW).¶
the main sleep period.8 (CHANGED) 1.1.4.9. Other situational types of urinary inconti-
1.1.3. Urgency is the complaint of a sudden nence may exist, for example giggle inconti-
compelling desire to pass urine, which nence, or incontinence associated with
is difficult to defer.4 epileptic seizures, sphincter denervation in
1.1.4. Urinary incontinence: Complaint of cauda equina and in the Onuf's nuclei lesions
involuntary loss of urine.5 ‡ in Multiple system atrophy (NEW).
1.1.4.1. Stress Urinary Incontinence is the complaint 1.1.5. Bladder Sensation can be defined, during
of involuntary leakage on effort or exertion, or history taking by following categories.
on sneezing or coughing.4 1.1.5.1. Normal: the individual is aware of
1.1.4.2. Urgency Urinary Incontinence is the com- bladder filling and increasing sensa-
plaint of involuntary loss of urine associated tion up to a strong desire to void.4
with urgency.5 1.1.5.2. Increased: Increased bladder sensa-
1.1.4.3. Mixed Urinary Incontinence is the com- tion: complaint that the desire to void
plaint of involuntary leakage associated with during bladder filling occurs earlier
urgency and also with exertion, effort, or is more persistent to that previous
sneezing, or coughing.5 experienced. N.B. This differs from
1.1.4.4. Enuresis: Complaint of intermittent inconti- urgency by the fact that micturition
nence that occurs during periods of sleep8 can be postponed despite the desire to
(NEW). void.5
1.1.4.4.1. Primary enuresis has been present 1.1.5.3. Reduced: Reduced bladder sensa-
lifelong (NEW). tion: complaint that the definite desire
1.1.4.4.2. Acquired enuresis is an enuresis to void occurs later to that previously
developed in adults (NEW).§ experienced despite an awareness
1.1.4.5. Continuous (urinary) incontinence: Com- that the bladder is filling.5
plaint of continuous involuntary loss of urine5 1.1.5.4. Absent: the individual reports no
1.1.4.6. Impaired cognition urinary incontinence: sensation of bladder filling or desire
Complaint of periodic urinary incontinence to void.4
that the individual with cognitive impairment 1.1.5.5. Non-specific bladder awareness:
the individual reports no specific
bladder sensation, but may perceive,
†
Some symptoms in NLUTD cannot be defined properly when there is for example, abdominal fullness,
a significant reduction in motor and/or sensory function. “Complaint”
is intended to mean the patient (or sometimes caregiver) expresses the
symptom is present, regardless of whether it also causes them bother.
‡ ||
Loss of urine can result from: (a) incontinence; (b) involuntary passing This inability includes (any combination of) the individual's physical as
of urine; (c) incontinence that is not derived from an abnormality in the well as social causes or reasons. Other signs or symptoms of LUTD
lower urinary tract or its innervation, but from immobility, cognitive should not be present, or should be reported by the professional (as
disability, and decreased motivation impaired patient's mobility enhances primary or as accessory) (eg, “Urgency urinary incontinence” with
likelihood of being incontinent. “mobility impairment”; or “Mobility impairment urinary incontinence”
§
Mature CNS regulation ensures voiding (detrusor contraction with outlet with “stress urinary incontinence.”
relaxation) is under voluntary control. Abnormal voiding reflexes, or ¶
Sexual activity urinary incontinence may be reported as a single
disinhibition, may result in the person passing urine without voluntary symptom, but may also be reported in association with other LUTD.
control. Confirming the precise underlying mechanism(s) is often not Sexual activity urinary incontinence is documented (in combination with
possible in routine clinical practice. Enuresis is considered different from other symptoms) as being the primary or the as the associated symptom
urgency urinary incontinence. (or vice versa) based on the individual's expression of predominance.

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vegetative symptoms, urethral sensa- 2 ANLUTD SIGNS

tions or spasticity as bladder filling Sign: Any abnormality indicative of disease or a health
awareness or a sign of bladder problem, discoverable on examination of the patient; an
fullness. (CHANGED). objective indication of disease2 or a health problem. Signs are
1.1.5.6. Abnormal sensations: awareness of observed by the physician including simple means to verify
sensation in the bladder, urethra or symptoms and quantify them.
pelvis, described with words like Measuring the frequency, severity and impact of lower
“tingling,” “burning,” or “electric urinary tract symptoms by asking the patient to record
shock,” in the setting of a clinically micturitions and symptoms for a period of days provides
relevant neurologic disorder (eg, invaluable information. The recording of “micturition events” can
incomplete spinal cord lesion) be in three main forms.**
(NEW).
1.1.5.7. Bladder Pain: Complaint of supra- 2.1. Micturition Time Chart: this records only the times of
pubic or retropubic pain, pressure or micturitions, day and night, for at least 24 h.4
discomfort, related to the bladder, and 2.2. Frequency Volume Chart (FVC): this records the
usually increasing with bladder fill- volumes voided as well as the time of each micturition,
ing. It may persist or be relieved after day and night, for at least 24 h.4
voiding.4 2.3. Bladder Diary: this records the times of micturitions
1.2. Voiding symptoms: A departure from normal sensa- and voided volumes, incontinence episodes, pad usage,
tion or function, experienced by a person during the act and other information such as fluid intake, the degree of
of micturition.2 # urgency, and the degree of incontinence.4,9 ††
1.2.1. Slow stream: Complaint of a urinary stream
perceived as slower compared to previous 3 ANLUTD URODYNAMIC OBSERVATIONS AND
performance or in comparison with others.5 DEFINITIONS
1.2.2. Spraying (splitting) of the urinary stream:
Complaint that the urine passage is a spray or 3.1 Filling cystometry definitions
split rather than a single discrete stream.5 Bladder storage function should be described according
1.2.3. Intermittent stream (Intermittency) is the to bladder sensation, detrusor activity, bladder compli-
term used when the individual describes urine ance and bladder capacity. Storage abnormalities identi-
flow, which stops and starts on one or more fied may or may not be the result of a clinically relevant
occasions, during micturition.4 neurologic disorder.
1.2.4. Hesitancy: Complaint of a delay in initiating 3.1.1. Bladder sensation during filling cystometry
micturition.5 3.1.1.1. Normal bladder sensation can be judged
1.2.5. Straining to void: Complaint of the need to by three defined points (as per ICS
make an intensive effort (by abdominal straining, recommendations) noted during filling
Valsalva or suprapubic pressure) to either cystometry: First sensation of bladder
initiate, maintain or improve the urinary stream.5 filling, First desire to void and Strong
1.2.6. Terminal dribble is the term used when an desire to void, and evaluated in relation to
individual describes a prolonged final part of the bladder volume at that moment and in
micturition, when the flow has slowed to a relation to the patient's symptomatic
trickle/dribble.4 complaints.4,7
1.3. Post Micturition Symptoms are experienced imme- 3.1.1.2. Reduced Bladder Sensation: Bladder
diately after micturition.4 sensation perceived to be diminished
1.3.1. Feeling of incomplete emptying: Complaint that the during filling cystometry.5
bladder does not feel empty after micturition.5
1.3.2. Post micturition leakage: Complaint of a further
**
involuntary passage of urine following the completion Validated questionnaires are useful for recording symptoms, their
of micturition.4,5 frequency, severity and bother, and the impact of LUTS on QoL. The
instrument used should be specified. Some instruments were not validated
in NLUTD or are impossible to implement because of sensory or motor
deficiency in NLUTD.
††
Recommended minimum duration of 3 days.9 Some information could
#
Some symptoms in NLUTD cannot be defined properly when there is a be difficult or impossible to collect because of sensory or motor
significant reduction in motor and/or sensory function. deficiency in NLUTD.

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3.1.1.3. Absent Bladder Sensation: The patient 3.1.3. Detrusor function during filling cystometry
reports no bladder sensation during filling 3.1.3.1. Neurogenic detrusor overactivity is an
cystometry.5 urodynamic observation characterized
3.1.1.4. Bladder oversensitivity: Increased per- by involuntary detrusor contractions
ceived bladder sensation during bladder during the filling phase which may be
filling with: an early first desire to void; spontaneous or provoked in the setting
an early strong desire to void, which of a clinically relevant neurologic
occurs at low bladder volume; a low disease.4 ||||
maximum cystometric bladder capacity Specific types of neurogenic detrusor overactivity
and no abnormal increases in detrusor include:
pressure.5 3.1.3.1.1. Phasic detrusor overactivity is defined
3.1.1.5. Abnormal sensations: awareness of by a characteristic wave form, and may
sensation in the bladder, urethra or pelvis, or may not lead to urinary inconti-
described with words like “tingling,” nence.4 ¶¶
“burning,” or “electric shock,” in the 3.1.3.1.2. Terminal detrusor overactivity is de-
setting of a clinically relevant neurologic fined as involuntary detrusor contrac-
disorder (eg, incomplete spinal cord tion occurring near or at the maximum
lesion) (NEW). cystometric capacity, which cannot be
3.1.1.6. Non-specific bladder awareness: per- suppressed, and results in incontinence
ception of bladder filling as abdominal or even reflex bladder emptying (reflex
fullness, vegetative symptoms, spasticity voiding) (CHANGED). ##
or other “non-bladder awareness,” in the 3.1.3.1.3. Sustained detrusor overactivity is
setting of a clinically relevant neurologic defined as a continuous detrusor con-
disorder (eg, incomplete spinal cord traction without returning to the detru-
lesion) (NEW). sor resting pressure (NEW).
3.1.1.7. Bladder Pain: An unpleasant sensation 3.1.3.1.4. Compound detrusor contraction is
(pain, pressure, discomfort) perceived to defined as a phasic detrusor contrac-
be related to the urinary bladder. tion with a subsequent increase in
(CHANGED). ‡‡ detrusor and base pressure with each
3.1.2. Bladder capacity during filling cystometry subsequent contraction (NEW).
3.1.2.1. Cystometric capacity is the bladder 3.1.3.1.5. High pressure detrusor overactivity is
volume at the end of the filling cystom- defined as a phasic, terminal, sustained
etry, when “permission to void or to or compound high maximal detrusor
empty the bladder” is usually given. The overactivity with the high detrusor
end point should be specified, for pressure perceived by investigator to
example, if filling is stopped when the be potentially detrimental to the pa-
patient has a normal desire to void. The tient's renal function and/or health and
cystometric capacity is the volume the value should be defined in the report
voided together with any residual (NEW).
urine.4§§

||||
Provoked contraction may be elicited by cough, change of position etc.,
‡‡
The pain may be felt suprapubically or retropubically. It usually or by urethral/sphincter to bladder reflex.
¶¶
increases with bladder filling, and may persist after voiding. Bladder pain Phasic detrusor contractions are not always accompanied by any
may or may not relate to clinically relevant neurologic disorder. sensation, or may be interpreted as a first sensation of bladder filling, or
§§
In certain types of dysfunction including neurogenic LUTD, the as a normal desire to void. In neurogenic LUTD phasic detrusor
cystometric capacity cannot be defined in the same terms. In the absence of contraction may elicit autonomic dysreflexia or abnormal bladder
sensation, the cystometric capacity is the volume at which the clinician sensation.
##
decides to terminate filling. The reason(s) for terminating filling should be Terminal detrusor overactivity is typically associated with reduced
defined in the report, for example, high detrusor filling pressure, large bladder sensation, for example in the elderly stroke patient when urgency
infused volume or pain. If there is uncontrollable voiding/bladder emptying, may be felt as the voiding contraction occurs. However, in neurogenic
it is the volume at which this begins. In the presence of sphincter LUTD phasic detrusor contraction may elicit autonomic dysreflexia or
incompetence the cystometric capacity may be significantly increased by abnormal bladder sensation and in complete spinal cord injury patients
occlusion of the urethra, for example, by a Foley catheter balloon.4 there may be no sensation whatsoever.

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3.1.3.1.6. Neurogenic Detrusor Overactivity and change in detrusor pres-

Incontinence is incontinence due to sure.4 ‡‡‡
involuntary neurogenic detrusor over-
activity (NEW).*** 3.2. Pressure Flow Study Definitions
3.2.1. Detrusor function during the voiding phase
3.1.3.2. Leak point pressures: in people that can initiate voluntary voiding
3.1.3.2.1. Detrusor Leak Point 3.1.3.2.1. Normal detrusor function is a
Pressure (DLPP) is defined voluntarily initiated continuous
as the lowest detrusor pressure detrusor contraction that leads to
at which urine leakage occurs complete bladder emptying
in the absence of either a within a normal time span, and
detrusor contraction or in- in the absence of obstruction. For
creased abdominal pressure.4 a given detrusor contraction,
3.1.3.2.2. Detrusor Overactivity Leak magnitude of the recorded pres-
Point Pressure (DOLPP) is sure rise will depend on the
defined as the lowest detrusor degree of outlet resistance.4
pressure rise with detrusor 3.1.3.2.2. Neurogenic detrusor underac-
overactivity at which urine tivity is defined as a contraction
leakage first occurs in the of reduced strength and/or dura-
absence of voluntary detrusor tion, resulting in prolonged blad-
contraction or increased ab- der emptying and/or a failure to
dominal pressure (NEW). achieve complete bladder empty-
3.1.3.2.3. Detrusor Leak Point Volume ing within a normal time span in
(DLPV) is defined as a blad- the setting of a clinically relevant
der volume at which first urine neurologic disorder (NEW).
leakage occurs, either with 3.1.3.2.3. Neurogenic acontractile detrusor
detrusor overactivity or low is one that cannot be demon-
compliance (NEW). strated to contract during urody-
3.1.3.2.4. Abdominal Leak Point Pres- namic studies in the setting of a
sure (ALPP) is the intravesical clinically relevant neurologic le-
pressure at which urine leakage sion (NEW).
occurs due to increased abdom- 3.1.3.2.4. Balanced bladder emptying is a
inal pressure in the absence of a bladder emptying with physio-
detrusor contraction.4 ††† logical detrusor pressure and low
3.1.3.2.5. Bladder compliance during residual as perceived by the
filling cystometry describes investigator, and should be de-
the relationship between fined in the report (NEW).
change in bladder volume
‡‡‡
Compliance is calculated by dividing the volume change (ΔV) by the
change in detrusor pressure (Δpdet) during that change in bladder volume
(C = ΔV/Δpdet). It is expressed in mL/cm H20. The normal value are not
well defined however any report on compliance must include reference to
the rate of filling and position of patient. A variety of means of calculating
bladder compliance has been described. The ICS recommends that three
standard points should be used for compliance calculations: the investigator
may wish to define additional points. These points are measured
excluding any detrusor contraction. The standards points are: (1) The
detrusor pressure at the start of bladder filling and the corresponding
bladder volume (usually zero). (2) The detrusor pressure at the bladder
volume when the bladder pressure rises significantly and decreased
compliance commences (Low compliance starting volume). (3) The
***
Incontinence can occur with or without any sensation of urgency or detrusor pressure (and corresponding bladder volume) at cystometric
awareness. capacity or immediately before the start of any detrusor contraction that
†††
This test can be applied to both neurogenic and non-neurogenic patients causes significant leakage (and therefore causes the bladder volume to
with stress urinary incontinence. decrease, affecting compliance calculation).

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3.2.2. Detrusor function during pressure flow This depends on the extent of loss of
studies in people that cannot initiate volun- neurological function and depends on which
tary voiding. part(s) of the nervous system is affected.
3.2.2.1. Initiated reflex bladder emptying is Neural lesions are described according to
an artificially elicited LUT reflex time of onset, risk of neurological progres-
comprised of various manoeuvres sion, completeness, and neurological level.
(exogenous stimuli) performed by 4.1. Spinal Shock Phase is usually temporary
the patient or the therapist, result- following acute neurologic insult or SCI
ing in complete or incomplete that is characterized by loss of sensory,
bladder emptying (NEW).§§§ motor and reflex activity below the level of
3.2.3 Sphincter function during pressure flow injury. NLUTD in Spinal Shock: is usually a
studies temporary complete painless urinary reten-
3.2.3.1. Detrusor-Sphincter Dyssynergia tion (NEW).
(DSD): describes a detrusor con- 4.2. Suprapontine Lesion (SPL) is a neurolog-
traction concurrent with an invol- ical lesion above the pons (forebrain or
untary contraction of the urethral midbrain). NLUTD in SPL: there is a reflex
and/or periurethral striated muscle. contraction of the detrusor with impaired
Occasionally flow may be pre- cerebral regulation and central inhibition
vented altogether.4|||||| and usually synergistic voiding/bladder
3.2.3.2. Non-relaxing urethral sphincter is emptying (NEW)****
characterized by a non-relaxing, 4.3. Suprasacral spinal cord/pontine lesion
obstructing urethral sphincter re- (SSL) is a neurological lesion in suprasacral
sulting in reduced urine flow.4¶¶¶ spine and/or pons. NLUTD in SSL: Detrusor
3.2.3.3. Delayed relaxation of the ure- overactivity (DO) and DO incontinence are
thral sphincter is characterized by common, with or without detrusor-urethral
impaired and hindered relaxation sphincter dyssynergia (DSD), often resulting
of the sphincter during voiding in a significant post void residual (PVR) and
attempt resulting in delay of urine “high pressure” bladder (NEW).††††
flow (NEW).### 4.4. Sacral Spinal Cord Lesion (SSCL) is a
4 ANLUTD CLINICAL DIAGNOSES neurological lesion in the sacral spinal cord.
Clinical diagnoses are the clinical mani- NLUTD in SSCL; findings include acon-
festation of symptoms and signs, which are tractile detrusor with or without decreased
characterized by specific urodynamic find- bladder compliance and usually with im-
ings and/or non-urodynamic evidence de- paired sphincter activity. (NEW).‡‡‡‡
fined by the presence of urodynamic
observations associated with characteristic ****
Lesions resulting from cerebral or brainstem lesion with preservation
symptoms or signs and/or non-urodynamic of the pontine micturition center (PMC), that is, cerebrovascular disease,
evidence of relevant pathological process. degenerative disease, hydrocephalus, intracranial neoplasms, traumatic
brain injury (the list is incomplete). This may lead to inability to initiate
voiding, inappropriate timing of bladder emptying, detrusor overactivity
(DO), and DO incontinence.
§§§
Spontaneous reflex bladder emptying is termed Detrusor Overactivity ††††
Lesion persists after resolution of the spinal shock. Bladder
Incontinence
sensation may be somewhat preserved (incomplete lesions) but
||||||
Neurological disease that impairs the ability of the PMC or its pathways voluntary control of the micturition reflex arc is lost. Altered function
to co-ordinate function of the LUT spinal centres, leading to detrusor of the sympathetic spinal centre in the thoraco-lumbar spinal cord
contraction against a contracting outlet. Detrusor sphincter dyssynergia may alter blood pressure control. Complete SSL above T6 may be
(DSD) typically occurs in patients with a supra-sacral lesion, and is associated with autonomic dysreflexia when there is residual sympa-
uncommon in lesions of the lower cord. DSD is responsible for bladder thetic nucleus function; this should be included in the description of
outlet obstruction and occasionally flow may be prevented altogether. the lesion.
¶¶¶
Non-relaxing sphincter obstruction is found in individuals with a ‡‡‡‡
There is a loss of parasympathetic control of the detrusor and a
neurological lesion (sacral and infra-sacral lesions such as meningomyelo- somatic denervation of the external urethral sphincter. Sensory impairment
coele) and after radical pelvic surgery. It may relate to both smooth and is typically associated with a complete lesion. Some afferent pathways
striated muscle sphincter. remain intact due to potential preservation of hypogastric afferents. Some
###
This can occur in some patients with Parkinson's disease or muscular patients may have stress urinary incontinence (SUI) due to sphincter
dystrophy deficiency (loss of Onuf's nuclei).

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4.5. Infrasacral (cauda equina and peripheral when awake, without intention to void
nerves) Lesion (CEPNL) is a neurological (NEW).*****
lesion affecting the cauda equina and/or 4.11. Urinary retention is an inability to prop-
peripheral nerves. NLUTD in CEPNL: acon- erly empty the bladder and can be divided
tractile detrusor and/or SUI may be present. In into acute, chronic, complete and incom-
diabetic neuropathy, detrusor overactivity can be plete (NEW).
seen in combination with the above (NEW).§§§§ 4.11.1. Acute retention of urine is defined
4.6. Mixed Neuronal Lesion is resulting from as an acute event of painful, palpa-
lesions of the neural pathway at different levels of ble or percussable bladder, when
the central nervous system concurrently (NEW) the patient is unable to pass any
4.7. Autonomic Dysreflexia is a syndrome urine when the bladder is full.5 †††††
resulting from upper thoracic or cervical 4.11.2. Chronic retention of urine is
spinal cord injury above T6, elicited by a defined as a non-painful bladder,
stimulus in the field of distribution of the which remains palpable or percuss-
autonomous sympathetic nucleus, charac- able after the patient has passed
terized by unregulated sympathetic function urine. Such patients may be
below the lesion and compensatory auto- incontinent.4‡‡‡‡‡
nomic responses (NEW).|||||||| 4.11.3. Complete urinary retention is an
4.7.1. Asymptomatic Autonomic Dysre- inability to empty any amount of
flexia:increase of blood pressure bladder volume (or the requirement
without any other symptoms for use of a catheter, consciously or
(NEW).¶¶¶¶ unconsciously due to anatomical or
4.8. Neurogenic Overactive Bladder is char- functional bladder outlet obstruction,
acterized by urgency, with or without detrusor underactivity or both (NEW).
urgency urinary incontinence, usually with 4.11.4. Incomplete urinary retention is
increased daytime frequency and nocturia in impaired bladder emptying due to
the setting of a clinically relevant neuro- anatomical or functional bladder out-
logic disorder with at least partially pre- let obstruction, detrusor underactivity
served sensation (NEW).#### or both, when the voided volume is
4.9. Voiding dysregulation is urination in smaller than Post Void Residual.
situations which are generally regarded as 4.11.5. Post void residual (PVR) is de-
socially inappropriate, such as while still fined as the volume of urine left in
fully dressed, or in a public setting away the bladder at the end of
from toilet facilities (NEW). micturition.4
4.10. Involuntary voiding is both a symptom and
a diagnosis of sporadic bladder emptying
*****
Usually the voiding reflex is preserved, and there is only lack of
proper inhibition of the voiding reflex. If that happens when asleep it is
§§§§
The peripheral nerves and the lower spinal centres are often grouped called Acquired Enuresis.
under the term “lower motor neurones,” as damage to these structures †††††
Although acute retention is usually thought of as painful, in certain
causes loss of contractile function. Elsewhere, the neurological lesions are
circumstances pain may not be a presenting feature, for example, when
termed “upper motor neuron lesions,” where the consequences are
due to prolapsed intervertebral disc, post-partum, or after regional
impaired co-ordination and reflex function. This is a considerable
anaesthesia such as an epidural anaesthetic. The retention volume should
simplification, and anatomically inaccurate, so the committee considers
be significantly greater than the expected normal bladder capacity. In
categorization into lower versus upper motor neuron lesions should no
patients after surgery, due to bandaging of the lower abdomen or
longer be supported.
abdominal wall pain, it may be difficult to detect a painful, palpable, or
||||||||
It is potentially a medical emergency characterized by hypertension, percussable bladder.4
bradycardia, severe headaches, and flushing above, with pallor below the ‡‡‡‡‡
The ICS no longer recommends the term “overflow incontinence”
cord lesion, and sometimes convulsions.10
This term is considered confusing and lacking a convincing definition. If
¶¶¶¶
This can happen during routine urodynamic bladder studies or bowel used, a precise definition and any associated pathophysiology, such as
program.11 reduced urethral function, or detrusor overactivity/low bladder compli-
####
These symptom combinations in case of preserved sensation, are ance, should be stated. The term chronic retention, excludes transient
suggestive of urodynamically demonstrable detrusor overactivity, but can voiding difficulty, for example, after surgery for stress incontinence, and
be due to other forms of LUTD. These terms can be used if there is no implies a significant residual urine; a minimum figure of 300 mls has been
proven infection or other obvious non neurological disease. previously mentioned.4

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5 ANLUTD TREATMENTS DEFINITIONS are used to handle the catheter without

directly touching the sliding surface of the
5.1 Bladder Reflex Triggering comprises hydrophilic catheter (NEW).******
various manoeuvres performed by the
patient or the therapist to elicit reflex 5.4 Electrostimulation
bladder emptying by exteroceptive stim- 5.4.1. Direct electrical neurostimulations a
uli (relating to, being, or activated by direct stimulation of the nerves or neural tissue
stimuli received from outside of the to effect function of the end organ. It is done
bladder).4 §§§§§ through electrodes implanted directly or near
5.2 Bladder Expression refers to various the nerve or neural tissue (NEW).††††††
compression manoeuvres aimed at increas- 5.4.2. Electrical neuromodulation is the stimu-
ing intravesical pressure to facilitate bladder lation of the nerves or neural tissue to
emptying with or without obvious sensation modulate function and induce therapeutic
from the bladder. (CHANGED).|||||||||| response of the LUT (NEW).‡‡‡‡‡‡
5.3 Catheterization is a technique for blad- 5.4.3. Transcutaneous electrical nerve stimula-
der emptying employing a catheter to tion (TENS) is electrical stimulation of the
drain the bladder or a urinary reservoir.4 nerves through intact skin to modulate
5.3.1. Indwelling catheterization; an indwell- function and induce therapeutic response
ing catheter remains in the bladder, of the LUT (NEW).§§§§§§
urinary reservoir or urinary conduit for a 5.4.4. Pelvic electrical stimulation is the applica-
period longer than one emptying.4 ¶¶¶¶¶ tion of electrical current to stimulate the pelvic
5.3.2. Intermittent Catheterization (IC) is viscera or their nerve supply (NEW).||||||||||||
defined as drainage of the bladder or a
urinary reservoir with subsequent re-
moval of the catheter mostly at regular 4 | CONCLUSIONS
intervals. (CHANGED)
5.3.2.1. Clean IC (CIC): use of a clean technique. Standardized terminology is an important aspect on research
This implies ordinary hand and genitals and communication in NLUTD. The International Conti-
washing techniques and use of disposable or nence Society (ICS) continues to have a key role in
cleansed reusable catheters. (CHANGED) standardizing terminology related to lower urinary tract and
5.3.2.2. Aseptic IC: This implies genital antisep- pelvic organ dysfunction.
tic preparation and the use of sterile
(single-use) catheters and instruments/
gloves in a designated clean area. (NEW) ******
The ICS Working Group recognizes that there is a lack of uniformity
5.3.2.3. Sterile IC: Complete sterile setting, includ- and consensus on the classification of aseptic technique in previously
ing genital skin antisepsis, sterile gloves, published studies, especially with regard to genital hygiene. Thus, it is
forceps, gown and mask (NEW).##### strongly recommended that all aspects related to the technique of
5.3.2.4. No-touch technique IC: This was intro- intermittent catheterization are described as completely as possible in the
context of clinical research, including the environment in which catheteri-
duced as an easier way for the patient to zation is performed, the type of lubricant, the catheter characteristics, the
perform self-intermittent catheterization use of gloves, as well as the genital hygiene mode.
with a ready-to-use catheter (pre-lubri- ††††††
For example, stimulation of the anterior sacral roots, that is,
cated catheter, usually a hydrophilic Brindley's stimulator.
catheter). A pull-in aid or special packages ‡‡‡‡‡‡
It is done through electrodes implanted directly on or near the nerves
or neural tissue: Sacral Neuromodulation (SNM), Pudendal Nerve
Stimulation (PNS), Percutaneous Tibial Nerve Stimulation (PTNS), Spinal
§§§§§
The most commonly used manoeuvres are; suprapubic tapping, thigh cord stimulation (SCS), Deep brain stimulation (DBS).
scratching, and anal/rectal manipulation. §§§§§§
This is done by skin surface electrode(s), as touch plate(s) or
||||||||||
The most commonly used manoeuvres are; abdominal straining superficial needle(s). Long-term or chronic electrical stimulation is
(Valsalva's manoeuvre) and exerting manual suprapubic pressure (Crede's delivered below the sensory threshold. Maximal electrical stimulation is
manoeuvre). using a high-intensity stimulus (just below the pain threshold). This can
¶¶¶¶¶
Indwelling catheterization may be performed transurethral, supra- be done intermittently.
pubic or trans-conduit. ||||||||||||
The aim of electrical stimulation may be to directly induce a
#####
Usually performed in the surgical theatre or during diagnostic therapeutic response or to modulate lower urinary tract, bowel, or sexual
procedures. dysfunction through transvaginal or transrectal stimulation.

An International Continence Society (ICS) report on the terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD)
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ACKNOWLEDGMENTS Society (ICS) joint report on the terminology for female pelvic floor
dysfunction. Int Urogynecol J. 2010;21:5–26.
We would like to thanks ICS Standardization Steering 6. Rosier PF, de Ridder D, Meijlink J, Webb R, Whitmore K, Drake MJ.
Committee for reviewing the manuscript and ICS Office for Developing evidence-based standards for diagnosis and management of
helping our subcommittee administratively. lower urinary tract or pelvic floor dysfunction. Neurourol Urodyn.
2012;31:621–624.
7. D'Ancona CA, Gomes MJ, Rosier PF. ICS teaching module:
cystometry (basic module). Neurourol Urodyn. 2016;9999:1–4.
ORCID
8. Hashim H, Blanker MH, Drake MJ, et al. An International
Jerzy B. Gajewski http://orcid.org/0000-0003-0769-583X Continence Society (ICS) report on the terminology for nocturia
Brigitte Schurch http://orcid.org/0000-0003-4965-6898 and nocturnal lower urinary tract function. Neurourol Urodyn.
Márcio Averbeck http://orcid.org/0000-0002-8127-7153 Submitted in 2017.
9. Bright E, Cotterill N, Drake M, Abrams P. Developing a
Ryuji Sakakibara http://orcid.org/0000-0002-5803-169X
validated urinary diary: phase 1. Neurourol Urodyn. 2012;31:
625–633.
10. Curt A, Nitsche B, Rodic B, Schurch B, Dietz V. Assessment of
REFERENCES autonomic dysreflexia in patients with spinal cord injury. J Neurol
Neurosurg Psychiatry. 1997;62:473–477.
1. Concise Oxford English Dictionary. 9th Edition. Oxford: Clar- 11. Kirshblum SC, House JG, O'Connor KC. Silent autonomic
endon Press; 1995. 1438. dysreflexia during a routine bowel program in persons with
2. Stedman's Medical Dictionary. 28th Edition Maryland USA: traumatic spinal cord injury: a preliminary study. Arch Phys Med
Lippincott William and Wilkins Baltimore; 2006. 1884. Rehabil. 2002;83:1774–1776.
3. Abrams P, Blaivas JG, Stanton SL, et al. Sixth Report on the
Standardisation of Terminology of Lower Urinary Tract Function.
Procedures related to neurophysiological investigations: electro-
myography, nerve conduction studies, reflex latencies, evoked
potentials and sensory testing. The International Continence How to cite this article: Gajewski JB, Schurch B,
Society. Br J Urol. 1987;59:300–304. Hamid R, et al. An International Continence Society
4. Abrams P, Cardozo L, Fall M, et al. The standardisation of (ICS) report on the terminology for adult neurogenic
terminology of lower urinary tract function: report from the
lower urinary tract dysfunction (ANLUTD).
Standardisation Sub-committee of the International Continence
Society. Am J Obstet Gynecol. 2002;187:116–126.
Neurourology and Urodynamics. 2017;1–10.
5. Haylen BT, de Ridder D, Freeman RM, et al. An International https://doi.org/10.1002/nau.23397
Urogynecological Association (IUGA)/International Continence

ICS Standards 2019

1. ICS Standardisations
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Received: 25 November 2018

DOI: 10.1002/nau.23917
| Accepted: 27 November 2018

SOUNDING BOARD

International Continence Society (ICS) report on the

terminology for nocturia and nocturnal lower urinary tract
function

Hashim Hashim1 | Marco H. Blanker2 | Marcus J. Drake3 |

4 5 6
Jens Christian Djurhuus | Jane Meijlink | Vikky Morris | Peter Petros7 |
8 9
Jian Guo Wen | Alan Wein

1 Bristol Urological Institute, Bristol, United

Kingdom Introduction: The terminology for nocturia and nocturnal lower urinary tract
2 Universityof Groningen, University function is reviewed and updated in a clinically and practically-based consensus
Medical Center Groningen, Groningen, The report.
Netherlands
Methods: This report has been created by a Working Group under the auspices and
3 Universityof Bristol and Bristol
Urological Institute, Bristol, United guidelines of the International Continence Society (ICS) Standardisation Steering
Kingdom Committee (SSC). All relevant definitions were updated on the basis of research over
4 University of Aarhus, Aarhus, Denmark the last 16 years since the publication of the first nocturia standardization document in
5 International Painful Bladder Foundation,
2002. An extensive process of 16 rounds of internal and external reviews was
The Netherlands
involved to examine each definition exhaustively, with decision-making by collective
6 Musgrove Park Hospital, Taunton, United

Kingdom opinion (consensus).

7 University of New South Wales, Sydney, Results: A clinically-based terminology report for nocturia and nocturnal lower
Australia urinary tract function, encompassing five key definitions divided into signs and
8 First Affiliated Hospital of Zhengzhou
symptoms has been developed. Clarity and user-friendliness have been key aims to
University, Zhengzhou, China
make it interpretable by healthcare professionals and allied healthcare practitioners
9 University of Pennsylvania, Philadelphia,

Pennsylvania involved in the care of individuals with nocturnal lower urinary tract function.
Conclusion: A consensus-based terminology report for nocturia and nocturnal lower
Correspondence
urinary tract function has been produced to aid clinical practice and research.
Hashim Hashim, Bristol Urological
Institute, Brunel Building, Southmead
KEYWORDS
Hospital, Bristol, BS10 5NB, United
Kingdom. enuresis, International Continence Society, nocturia, nocturnal polyuria, terminology
Email: h.hashim@gmail.com

1 | INTRODUCTION publication, several studies have been conducted looking at

the epidemiology, pathophysiology and treatment of nocturia,
In 2002, the International Continence Society (ICS) defined leading to a wealth of new information.2,3 The time has now
nocturia as the complaint that the individual has to wake at come to review the terminology in the original publication
night one or more times to void.1 Since that original since it has been established that nocturia may not be a

Hashim Hashim, Marco H. Blanker, Marcus J. Drake, Jens Christian Djurhuus, Jane Meijlink, Vikky Morris, Peter Petros, Jian Guo Wen, and Alan Wein:
ICS Terminology Working Group on Nocturia and Nocturnal Lower Urinary Tract Function.
Marcus J. Drake and Jane Meijlink: Standardisation Steering Committee ICS. At time of publication, Marcus Drake was an ICS Trustee.

Neurourology and Urodynamics. 2019;1–10. wileyonlinelibrary.com/journal/nau © 2019 Wiley Periodicals, Inc. | 1

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| HASHIM ET AL.

complaint and that people can get up at night to void for Able to provide explanations: Where a specific explana-
various reasons which may or may not be pathological.4 tion is deemed appropriate to describe a change from earlier
Nocturia can also occur as a clinical entity in its own right due definitions or to qualify the current definition, this will be
to non-medical reasons such as a baby crying, or a partner included as an addendum to this paper (Footnote [FN]
snoring, causing the individual to wake up at night to pass 1,2,3. . ..). Wherever possible, evidence-based medical prin-
urine. In these latter scenarios, nocturia would have been ciples will be followed.
excluded in the 2002 definition as the person would have not It is suggested that acknowledgement of these standards in
woken up to void due to a complaint, but rather due to a written publications related to nocturia and nocturnal lower
convenience void. urinary tract function be indicated by a footnote to the section
Nocturia may also be present as part of other “Methods and Materials” or its equivalent, to read as follows:
conditions which may or may not be directly related to “Methods, definitions and units conform to the standards
the urinary tract, for example, heart failure or sleep apnea. recommended by the International Continence Society
Therefore, patients can present to and consult not only Nocturia and Nocturnal Lower Urinary Tract Function
urologists but also other clinicians such as gynecologists, Terminology Standard 2018, except where specifically
geriatricians, neurologists, sleep experts, endocrinologists, noted”.
cardiologists, immunologists, rheumatologists, and/or Relevant ICS 2002 and 2010 definitions are highlighted
general practitioners. Each specialist is likely to approach for ease of reference and comparison. The 2018 definitions
nocturia in a different way depending on the presentation. (Table 1) will be added if there are any changes to the
However, it is important that all healthcare providers speak previous definitions.
the same “language” and refer to the same condition using
specific definitions, in order to avoid confusion and any
2 | GENERAL DEFINITIONS
misunderstandings.
The ICS therefore formed a new working group to revise
2.1 | Symptom(s)
and update the 2002 standardization document on nocturia
and make new recommendations on terminology based on the 2002: The subjective indicator of a disease or change in a
published literature over the last 16 years. This terminology condition as perceived by the patient, carer or partner,
report is inherently and appropriately a definitional docu- and may lead him/her to seek help from healthcare
ment, collating the definitions of those terms, that is, “words professionals. Symptoms may either be volunteered or
or phrases used to describe a thing or to express a concept, described during the patient interview. They are usually
especially in a particular kind of language or branch of qualitative. In general, Lower Urinary Tract Symptoms
study,”5 here nocturia and nocturnal lower urinary tract (LUTS) cannot be used to make a definitive diagnosis.
function. Emphasis has been on comprehensively including LUTS can also indicate pathologies other than lower
those terms in current use in the relevant peer-reviewed urinary tract dysfunction (LUTD), such as urinary tract
literature. The definitions of those terms will be reviewed infection.12
with all available evidence and aim to assist clinical practice 2010: Any morbid phenomenon or departure from the
and research. Some new and revised terms have been normal in structure, function, or sensation; experienced
included. Explanatory notes on definitions have been by the person and indicative of disease or a health
referred, where possible, to the “footnotes” section. This problem. Symptoms are either volunteered by, or elicited
document does not address the epidemiology, pathophysiol- from the person, or may be described by the person's
ogy or treatment of nocturia or any of its sub-categories, as caregiver.13,14
that is not the main aim of the Standardisation Steering 2018: The previous definitions have not been changed.
Committee (SSC) or the nocturia working group, is beyond
the scope of this article, and is covered in several other
2.2 | Sign(s)
publications.2,3,6–11
Like all other joint ICS terminology reports, every effort 2002: Signs are observed by the physician including simple
has been made to ensure this report is: means, to verify symptoms and quantify them. For example, a
User-friendly: It should be understandable by all clinical classic sign is the observation of leakage on coughing.
and research users. Observations from frequency/volume charts, pad tests and
Clinically-based: The definitions should be applicable to validated symptom and quality of life questionnaires are
clinical practice. examples of other instruments that can be used to verify and
Original: Where a term's existing definition (from one of quantify symptoms.12
multiple sources used) is deemed appropriate, that definition 2010: Any abnormality indicative of disease or a
will remain and be duly referenced. health problem, discoverable on examination of the

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TABLE 1 Definitions of terms related to nocturia and nocturnal lower urinary tract function (2018)
Term Definition
Main sleep period (new) The period from the time of falling asleep to the time of intending to rise for the next “day.”
First morning void The first void after the main sleep period.
(changed)
Enuresis (changed) Symptom: complaint of intermittent incontinence that occurs during periods of sleep. If it occurs during the main
sleep period, then it could be qualified by the adjective “nocturnal.”
Sign: Intermittent incontinence (“wetting”) that occurs during periods of sleep (while asleep). If it occurs during
the main sleep period then it could be preceded by the adjective “nocturnal.”
Night-time (changed) Commences at the time of going to bed with the intention of sleeping and concludes when the individual decides
they will no longer attempt to sleep and rise for the next “day.” It is defined by the individual's sleep cycle, rather
than the solar cycle (from sunset to sunrise).
Night-time frequency The number of voids recorded from the time the individual goes to bed with the intention of going to sleep, to the
(changed) time the individual ends their main sleep period with the intention of rising.
Nocturia (changed) Symptom: The number of times urine is passed during the main sleep period. Having woken to pass urine for the
first time, each urination must be followed by sleep or the intention to sleep. This should be quantified using a
bladder diary.
Sign: The number of times an individual passes urine during their main sleep period, from the time they have
fallen asleep up to the intention to rise from that period. This is derived from the bladder diary.
Nocturnal polyuria Symptom: Passing large volumes of urine during the main sleep period. This should be quantified using a bladder
(changed) diary.
Sign: Excessive production of urine during the individual's main sleep period. This should be quantified using a
bladder diary.
Nocturnal urine volume Sign: Total volume of urine produced during the individual's main sleep period including the first void after the
(changed) main sleep period. This should be quantified using a bladder diary.
24-h voided volume Sign: Total volume of urine passed during a 24-h period excluding the first morning void of the period. The first
(changed) void after rising is discarded and the 24-h period begins at the time of the next void and is completed by including
the first void, after rising, the following day.
24-h polyuria (not Excessive excretion of urine resulting in profuse and frequent micturition. Defined as >40 mL per kg body
changed) weight per 24-h.

patient; an objective indication of disease or a health 3 | NOCTURNAL SYMPTOMS

problem.14
These can be quantified by a questionnaire or bladder 3.1 | Nocturia
diary.
2002: The complaint that the individual has to wake at night
2018: The previous definitions have not been changed.
one or more times to void.1
Nocturnal: Refers to “Done, occurring, or active at
2010: Complaint of interruption of sleep one or more
night.”5 Therefore, “nocturnal” will refer to signs and
times because of the need to micturate.14 Each void is
symptoms that occur during the night-time.
preceded and followed by sleep.
Night-time (Changed): For the purposes of the nocturia
2018: The number of times urine is passed during the
2018 terminology, night-time will be defined by the
main sleep period. Having woken to pass urine for the first
individual's sleep cycle, rather than the solar cycle (from
time, each urination must be followed by sleep or the intention
sunset to sunrise). Thus, some shift workers may have their
to sleep. This should be quantified using a bladder diary.a
“night-time” period during the daylight hours, as it is the time
of their main sleep period. It commences at the time of going
to bed with the intention of sleeping and concludes when the
individual decides they will no longer attempt to sleep and
3.2 | Core reasons for change
rise for the next “day.” The 2002 and 2010 definitions of nocturia have caused much
Main sleep period (New): The period from the time of debate and controversy, including the fact that getting up once
falling asleep to the time of intending to rise for the next at night to void may not be bothersome and is therefore not a
“day.” “complaint.” Furthermore, it can be difficult to determine the
Frequency: The frequency is the number of times an event “reason for waking” and to confirm that waking was indeed in
occurs during a stated period. order to pass urine. What clinicians and researchers wanted

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| HASHIM ET AL.

was to define a clinical condition. Also, the previous ICS individual goes to bed at 10 pm and passes urine three times
definitions of nocturia did not take into account the voiding before falling asleep at 11pm, then the three episodes are not
episodes at night during the main sleep period of several part of nocturia, as nocturia starts when the person falls asleep
groups of people, including but not limited to: but these are part of night-time frequency (Figure 1).
Another, scenario that may cause confusion is if an
1. those who need to void multiple times in the night after individual wakes up at, for example, 3 am from sleep and
falling asleep, often several times in a row, small amounts could not sleep although they want to sleep, and passes urine
at a time, and may not be able to get back to sleep again, at 4 and 6 am, and then decides to end his/her sleep period at
2. those whose bladder does not empty fully, and who 7 am, then these voids are part of nocturia episodes.
consequently need to void again several times soon after In other words, nocturia episodes begins when the
going to sleep, individual falls asleep and ends with the intention of getting
3. those who suffer from insomnia or have difficulty going up for the day. These, and other scenarios, will be highlighted
back to sleep due to causes other than their bladder by careful analysis of the bladder diary, which is a mandatory
problem, first-line investigation tool for the management of patients
4. those who wake up and then are unable to sleep due to with LUTS (Figure 2). This document aims is to generalize
painful or sensitive bladders. the definitions to apply to all groups of patients with the
symptom of nocturia.b
Furthermore, while various studies have been published
on nocturia, only few have critically discussed the definition
3.3 | Analysis of bladder diary
of nocturia. In fact, nocturia has not been defined at all in
many studies. The new definition reflects the fact that 1. Nocturia by 2002/2010 definition: 1 (the only void that
nocturia is first a symptom, which may or may not be a was preceded and followed by sleep was the one at
complaint (ie, of an abnormality), with mixed and multiple 23.00). It could also be argued that nocturia could be
etiologies and a prevalence in the general population which is three episodes as the voids at 1.00am and 3.00am were
well described for men and women of different ages preceded and followed by sleep but the return to sleep
worldwide.2,15,16 was delayed. This depends on whether the definition is
Night-time frequency can sometimes be confused with strictly applied or not. Either way, the definition misses
nocturia. However night–time frequency includes voids when out on nocturia episodes.
an individual goes to bed, with the intention of sleeping, but 2. Nocturia by 2018 definition: 4 (the total number of voids
cannot sleep and needs to void at least once before falling after falling asleep at 22.30 and before the individual
asleep (2002 nocturia document). For example, if an decides to get up for the day at 08.00).

FIGURE 1 Different scenarios highlighting difference between the different definitions of night-time frequency (NF), previous nocturia
definition (N2002), and new nocturia definition (N2018). (X denotes micturition)

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HASHIM ET AL.
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FIGURE 2 Example of nocturia using a single night extracted from a bladder diaryc

3.4 | Nocturnal polyuria (NP) incontinence, etc. The timing of leakage, whether during
sleep or after being woken up and then leaking, is
2002: Not defined as a symptom.
established when taking a detailed clinical history from
2010: Not defined as a symptom.
the patient by asking them, for example, “Does the wetting/
2018: Passing large volumes of urine during the main
leakage occur while you are asleep and unaware of it or do
sleep period. This should be quantified using a bladder
you get woken up and then leak?”d
diary.

3.7 | Core reasons for change

3.5 | Core reasons for change
Enuresis is a symptom reflecting several different
The previous standardization reports have not highlighted
pathologies, previously believed to be a complete empty-
nocturnal polyuria as a symptom, but looked at it as a sign.
ing of the bladder, but later identified as both complete and
However, we know from clinical practice that patients can
incomplete emptying of the bladder. The International
report passing large volumes of urine at night, especially
Children's Continence Society (ICCS) defined nocturnal
relative to the day, and hence we have defined the symptom of
enuresis as both a symptom and a condition of intermittent
nocturnal polyuria.
incontinence that occurs during periods of sleep.17–19
Previously it was wetting in discrete portions while asleep
3.6 | Enuresis after the age of five. To ensure consistency between the
ICCS and the ICS definitions, the ICS has adapted the
2002: Any involuntary loss of urine. If it is used to denote
ICCS definition.
incontinence during sleep, it should always be qualified with
the adjective “nocturnal.”1
4 | NOCTURNAL SIGNS
2010: Complaint of involuntary loss of urine which occurs
during sleep.14
4.1 | Nocturia
2018: Complaint of intermittent incontinence that occurs
during periods of sleep. If it occurs during the main sleep 2002: Not specifically defined.
period, then it could be qualified by the adjective 2010: Not specifically defined.
“nocturnal.” The patient has to be asleep when enuresis 2018: The number of times an individual passes urine during
happens and is usually unaware of it. If the patient is woken their main sleep period, from the time they have fallen asleep
from sleep and then leaks or has incontinence then this up to the intention to rise from that period. This is derived
would be classified according to the pathophysiology of from the bladder diary.
incontinence while awake, for example, stress urinary In order to capture the frequency of nocturia, a bladder
incontinence, urgency urinary incontinence, mixed urinary diary is needed on which the patient indicates the time of

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falling asleep, the time when they decided they would no Terms that can be used to define urine production at night
longer attempt to sleep, and all intervening voids. A bladder include:
diary is needed to ascertain nocturnal urine production, with
complete recording of all volumes voided during the main 1. 24-h urine production rate (mLs/h): volume of urine
sleep period. Measurement of the frequency of nocturia produced per hour in a 24 h period.
begins after sleep and concludes before the first void 2. nocturnal urine production rate (mLs/h): nocturnal urine
following intention of getting up for the day.e The individual volume/length of time of main sleep period (mLs/h).
can also note why they went to void, for example, due to 3. nocturnal urine production rate index: nocturnal urine
urgency, pain, etc. production rate/24-h urine production rate.

Absolute and normal values are yet to be defined for the

4.2 | Nocturnal polyuria (NP)3–5 above terms, but will be dependent on fluid input, the
population defined, and the gender. There are several
2002: Nocturnal urine volume output greater than 20% of the
definitions in the literature that could be used to indicate
daily total urine output in the young and 33% in the elderly,
nocturnal polyuriaf including:
with the value for middle age probably falling somewhere in
the middle. Increased proportion of a 24-h urine output
1. Nocturnal urine production based on body weight of
occurring at night (normally during the 8 h while the patient is
greater than 10 mLs/kg.21
in bed).12
2. Rate of nocturnal urine production >90 mLs/h.22 This
2010: Excess (over 20–30%—age dependent) propor-
figure is suggestive of nocturnal polyuria in men only
tion (nocturnal voided volume/total 24 h voided vol-
(about 450 mLs per 8 h sleep).23 There are no studies
ume × 100%) occurs at night (or when patient is
looking at the rate of nocturnal urine production in women
sleeping).14
and this may well be different from that in men.
2018: Excessive production of urine during the individu-
3. Nocturnal polyuria index is the most commonly used
al's main sleep period. The definition used by the health-care
definition for nocturnal polyuria20 (nocturnal urine volume/
provider to quantify “excessive” will need to be highlighted in
24-h voided volume)1 based on nocturnal urine volume as
both clinical and research settings and should be derived from
part of total 24-h urine volume. It is age dependent; however
a bladder diary.
the age groups have not been clearly defined:
a. 33% in elderly, for example, >65.
b. >20% in younger individuals.
4.3 | Core reasons for change
c. 20–33% in “middle age.”
There have been numerous ways of classifying nocturnal 4. Nocturia index (nocturnal urine volume/maximum voided
polyuria. 20 From clinical practice, we have learned that volume).24
the 20% and 33% numbers (the nocturnal polyuria index) a. >1: nocturia occurs because maximum voided volume
are not well supported, as they were not based on normal is smaller than nocturnal urine volume.
distributions and were not properly validated. They also b. >1.5: nocturia secondary to nocturnal urine over-
assumed that the index person is 70 kg and sleeps 8 h a production in excess of maximum bladder capacity, that
day, irrespective of gender or age. Regardless of what is, nocturnal polyuria.
definition is applied, the diagnosis of NP includes a
differential diagnosis encompassing congestive heart One confounding issue is that if one uses an amount or
failure, diabetes mellitus, obstructive sleep apnea, volume as the indicator for nocturnal polyuria, then even with a
peripheral edema, excessive night-time fluid intake and normal distribution of day and night output, virtually all people
“normal” ageing. Other factors which have been with 24-h polyuria will have nocturnal polyuria. If one uses a
implicated in the causation of nocturnal polyuria are an percentage of total 24-h urine output, and if the normal circadian
abnormality in nocturnal secretion or action of arginine rhythm is preserved, they will not all have nocturnal polyuria.
vasopressin (AVP) (this describes the classical nocturnal Whatever definition is used, it has to be clearly indicated in both
polyuria syndrome) and any edema-forming state (in clinical practice and research settings (Figure 3).
addition to congestive heart failure, chronic renal
disease, nephrotic syndrome, hypoalbuminemia, liver
failure), co-morbidities such as autonomic nervous
4.4 | Enuresis
system dysfunction, Alzheimer's disease, multisystem 2002: Not defined as a sign in previous terminology documents.
atrophy, stroke, and Parkinsonism. Hence the need for 2010: Not defined as a sign in previous terminology
standardization! documents.

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FIGURE 3 Example of Nocturnal Polyuria using a one-day bladder diaryc

2018: Intermittent incontinence (“wetting”) that occurs 4.5 | Core reasons for change
during periods of sleep (while asleep).
NB. As in the symptoms section previously, this Previous definitions were not available for enuresis as a sign.
occurs while the patient is asleep and has not been woken Enuresis as a symptom has been defined as a complaint of
up from sleep and then leaks. If it occurs during the main intermittent incontinence that occurs during periods of sleep.
sleep period then it could be preceded by the adjective As a sign, enuresis could be related to or be a manifestation of
“nocturnal.” several different pathologies that the healthcare provider

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8
| HASHIM ET AL.

would need to investigate, for example, high pressure urinary 4.10 | 24-h polyuria
retention, overactive bladder, or neurogenic causes. Depend-
2002: 24-h urine output >40 mL/kg, in men and women,
ing on the severity, it could be “wetting” the underclothes,
causing daytime urinary frequency and nocturia occasioned
outer clothes, or the bed.
by a general increase in urine output, outstripping even
normal bladder capacity.1
4.6 | Nocturnal urine volume 2010: Excessive excretion of urine resulting in profuse
and frequent micturition. It has been defined as over 40 mL/kg
2002: The total volume of urine passed during the night,
body weight during 24 h or 2.8 L urine for an individual
including the first morning void.1
weighing 70 kg.14
2010: Cumulative urine volume from voids after going to
2018: The previous definitions have not been changed.
bed with the intention of sleeping to include the first void at
the time of waking with the intention of rising (excludes last
4.11 | Core reasons for change
void before sleep).14
2018: Total volume of urine produced during the Since there was no new research or information on defining
individual's main sleep period, including the first void after polyuria, the working group has decided to retain the previous
the main sleep period. definitions as volumes passed daily vary considerably, and are
Volume measurement begins after the last void preceding influenced by environmental, physiological, and pathological
sleep and concludes after the first morning void. The first factors; which can affect the amount of fluid loss by other
morning void follows the individual's decision they will no means, such as perspiration, and the amount of fluid intake.
longer attempt to sleep.
5 | CONCLUSION
4.7 | Core reasons for change
This standardization document on nocturia and nocturnal
Wording of previous definitions has been confusing. The lower urinary tract function aimed to update previous
new definition is practical and takes into account the fact standardization documents with emphasis on pragmatism
that if an individual does not empty his/her bladder before and practicality when coming up with new definitions. These
falling asleep, then for pragmatic reasons it would be new definitions can be used both clinically and in research,
reasonable to include any volume produced after the last allowing better communication and understanding between
void before falling asleep as part of nocturnal urine healthcare providers and researchers.
produced. Alternatively, it would be best to advise
individuals who are filling out a bladder diary or
frequency/volume chart to void before going to sleep to
make assessment of volumes passed easier by the healthcare
provider when analyzing the diary or chart.

4.8 | 24-h voided volume

2002: Total volume of urine voided during a 24 h period (1st
void to be discarded; 24 h begin at the time of the next This document has involved 16 rounds of full review by
void).1 co-authors of an initial draft (Version 1) completed on 3
2010: Summation of all urine volumes voided in October, 2014. Comments for each round of review were
24 h.14 collated and debated as necessary in order to form a
2018: Total volume of urine passed during a 24-h period subsequent version. Live meetings on the document took
excluding the first morning void of the period. The first void place at the ICS annual meetings in Brazil (2014) and Tokyo
after rising is discarded and the 24-h period begins at the time (2016). The document was then sent to six experts for
of the next void and is completed by including the first void, comments before the final version was produced. The
after rising, the following day. document was also subject to general ICS membership
review and reviews by the SSC and ICS Board.

4.9 | Core reasons for change

ACKNOWLEDGEMENTS
Previous definitions needed further clarification to avoid
confusion with regard to when the 24-h period begins and No discussion on terminology should fail to acknowledge the
when it ends. The new definition clarifies this matter. fine leadership shown by the ICS over many years. The legacy

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HASHIM ET AL.
| 9

of that work by many dedicated clinicians and scientists is f

The working group recognizes the limitations and difficulties that exist in
present in all the reports by the different Standardisation defining nocturnal polyuria. It believes that there is not enough data in the
Committees. literature to make a recommendation to adopt a new definition of
nocturnal polyuria as a “sign” or to recommend one method of
calculation over the other. Further research is needed into this field before
1. Bernard T. Haylen, University of New South Wales, adopting one of the methods of calculation as every definition above has
Sydney. N.S.W. Australia: Chair of SSC at the time of limitations. However, the working group believes that the way forward
publication. for new research is to have an absolute number based on rate of urine
2. Stergios Doumouchtsis, Epsom and St Helier University production during the main sleep period or when the patient has gone to
sleep, relative to the urine production rate in 24 h, for the various age
Hospitals NHS Trust, United Kingdom: SSC mentor.
groups and both genders. Ultimately, the definition will be used to aid
3. Jeffrey Weiss, SUNY Downstate College of Medicine, treatment of a bothersome condition and the treatment will target the
New York, USA: Input into an early version (version 4) of cause rather than the definition. The definition should also be easily
the document. usable in research. Whichever definition is used, the healthcare provider
or researcher should specify exactly which parameter and method of
External Reviewers calculation they have used to diagnose nocturnal polyuria.
1. Paul Abrams, Bristol Urological Institute, Southmead
Hospital, United Kingdom
2. Roger Dmochowski, Vanderbilt University School of ORCID
Medicine, USA
Hashim Hashim http://orcid.org/0000-0003-2467-
3. Philip van Kerrebroeck, University Hospital Maas-
407X
tricht, Maastricht, The Netherlands
Marco H. Blanker http://orcid.org/0000-0002-1086-
4. Dudley Robinson, King's College Hospital, London,
8730
United Kingdom
Marcus J. Drake http://orcid.org/0000-0002-6230-
5. Ruud Bosch, University Medical Centre Utrecht,
2552
Utrecht, The Netherlands
Peter Petros http://orcid.org/0000-0002-9611-3258
6. Karel Everaert, Ghent University Hospital, Ghent,
Jian Guo Wen http://orcid.org/0000-0003-0952-118X
Belgium

REFERENCES
ENDNOTES
1. van Kerrebroeck P, Abrams P, Chaikin D, et al. The standardisation
a
The first nocturia episode must be preceded by sleep. Subsequent of terminology in nocturia: report from the Standardisation Sub-
nocturia episodes must be followed by the intention of getting back to committee of the International Continence Society. Neurourol
sleep. The quality of life impact of nocturia is not an element in its Urodyn. 2002;21:179–183.
definition but will be appropriately evaluated during its assessment by 2. Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of
fully validated quality of life questionnaires. urinary incontinence, overactive bladder, and other lower urinary
b
Definition of nocturia does not take into account whether this is tract symptoms in five countries: results of the EPIC study. Eur
bothersome or not, whether it is affecting quality of life or Urol. 2006;50:1306–114. discussion 14-5.
whether it needs treatment. The aim is to have a global pragmatic 3. Cornu JN, Abrams P, Chapple CR, et al. A contemporary
definition, rather than defining or suggesting a clinical patholog- assessment of nocturia: definition, epidemiology, pathophysiology,
ical entity. For the healthcare provider, it is prudent that they state and management-a systematic review and meta-analysis. Eur Urol.
the cause of nocturia when reporting it clinically or for research 2012;62:877–890.
purposes for each individual, in other words it has to be reported 4. Bing MH, Moller LA, Jennum P, Mortensen S, Lose G.
why the nocturia occurred, for example, due to urgency, pain, Pathophysiological aspects of nocturia in a danish population of
habit, etc. men and women age 60 to 80 years. J Urol. 2007;178:552–557.
c 5. Concise Oxford English dictionary [electronic resource] Oxford:
A 3-day bladder diary is the standard of care for the assessment of
Oxford University Press; 2011 [12th ed. = 1.0.:[. https://en.
patients with lower urinary tract symptoms including nocturia and
oxforddictionaries.com/definition/term
nocturnal polyuria.
d
6. Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide
Enuresis can be primary (has been present lifelong) or acquired prevalence estimates of lower urinary tract symptoms, overactive
(developed in adults). bladder, urinary incontinence and bladder outlet obstruction. BJU
e
The frequency with which a person passes urine during their main sleep Int. 2011;108:1132–1138.
period can be used as an indicator of the severity of their nocturia. It is 7. Gratzke C, Bachmann A, Descazeaud A, et al. EAU guidelines on
known that this does not necessarily correspond with the quality of life the assessment of non-neurogenic male lower urinary tract
impact of nocturia. The first void after the main sleep period follows the symptoms including benign prostatic obstruction. Eur Urol.
individual's decision that they will no longer attempt to sleep. 2015;67:1099–1109.

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8. Marshall SD, Raskolnikov D, Blanker MH, et al. Nocturia: current update report from the Standardization Committee of the International
levels of evidence and recommendations from the international Children's Continence Society. J Urol. 2014;191:1863–5.e13.
consultation on male lower urinary tract symptoms. Urology. 19. Austin PF, Bauer SB, Bower W, et al. The standardization of
2015;85:1291–1299. terminology of lower urinary tract function in children and
9. Bosch JL, Everaert K, Weiss JP, et al. Would a new definition and adolescents: update report from the standardization committee of
classification of nocturia and nocturnal polyuria improve our the International Children's Continence Society. Neurourol
management of patients? ICI-RS 2014. Neurourol Urodyn. 2016; Urodyn. 2016;35:471–481.
35:283–287. 20. Hofmeester I, Kollen BJ, Steffens MG, et al. Impact of the
10. Pesonen JS, Cartwright R, Mangera A, et al. Incidence and International Continence Society (ICS) report on the standardisa-
remission of nocturia: a systematic review and meta-analysis. Eur tion of terminology in nocturia on the quality of reports on nocturia
Urol. 2016;70:372–381. and nocturnal polyuria: a systematic review. BJU Int. 2015;115:
11. Bower WF, Rose GE, Ervin CF, Goldin J, Whishaw DM, Khan F. 520–536.
TANGO—a screening tool to identify comorbidities on the causal 21. Homma Y, Yamaguchi O, Kageyama S, Nishizawa O, Yoshida M,
pathway of nocturia. BJU Int. 2017;119:933–941. Kawabe K. Nocturia in the adult: classification on the basis of
12. Abrams P, Cardozo L, Fall M, et al. The standardisation of largest voided volume and nocturnal urine production. J Urol.
terminology of lower urinary tract function: report from the 2000;163:777–781.
Standardisation Sub-committee of the International Continence 22. Blanker MH, Bernsen RM, Bosch JL, et al. Relation between
Society. Neurourol Urodyn. 2002;21:167–178. nocturnal voiding frequency and nocturnal urine production in
13. Stedman TL. Stedman's Medical Dictionary. 28th ed. Philadelphia: older men:a population-based study. Urology. 2002;60:
Lippincott Williams & Wilkins; 2006. xlix, 2169 p. p. 612–616.
14. Haylen BT, de Ridder D, Freeman RM, et al. An International 23. van Doorn B, Blanker MH, Kok ET, Westers P, Bosch JL.
Urogynecological Association (IUGA)/International Continence Prevalence, incidence, and resolution of nocturnal polyuria in a
Society (ICS) joint report on the terminology for female pelvic floor longitudinal community-based study in older men: the Krimpen
dysfunction. Neurourol Urodyn. 2010;29:4–20. study. Eur Urol. 2013;63:542–547.
15. Tikkinen KA, Johnson TM, Tammela TL, et al. Nocturia frequency, 24. Burton C, Weiss JP, Parsons M, Blaivas JG, Coats AC. Reference
bother, and quality of life: how often is too often? A population- values for the nocturnal bladder capacity index. Neurourol Urodyn.
based study in Finland. Eur Urol. 2010;57:488–496. 2011;30:52–57.
16. Zumrutbas AE, Bozkurt AI, Alkis O, Toktas C, Cetinel B, Aybek Z.
The prevalence of nocturia and nocturnal polyuria: can new cutoff
values be suggested according to age and sex? Int Neurourol J. How to cite this article: Hashim H, Blanker MH,
2016;20:304–310. Drake MJ, et al. International Continence Society
17. Franco I, von Gontard A, De Gennaro M. Society ICsC. Evaluation
(ICS) report on the terminology for nocturia and
and treatment of nonmonosymptomatic nocturnal enuresis: a
standardization document from the International Children's Conti-
nocturnal lower urinary tract function. Neurourology
nence Society. J Pediatr Urol 2013;9:234–243. and Urodynamics. 2019;1–10.
18. Austin PF, Bauer SB, Bower W, et al. The standardization of https://doi.org/10.1002/nau.23917
terminology of lower urinary tract function in children and adolescents:

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Neurourology and Urodynamics

A Standard for Terminology in Chronic Pelvic Pain

Syndromes: A Report From the Chronic Pelvic Pain Working
Group of the International Continence Society
Regula Doggweiler,1 Kristene E. Whitmore,2* Jane M. Meijlink,3 Marcus J. Drake,4 Helena Frawley,5
Jørgen Nordling,6 Philip Hanno,7 Matthew O. Fraser,8 Yukio Homma,9 Gustavo Garrido,10 Mario J. Gomes,11
Sohier Elneil,12 Joop P. van de Merwe,13 Alex T.L. Lin,14 and Hikaru Tomoe15
1
€
Department of Urology, Hirslanden Klinik, Zurich, Switzerland
2
Chair of Urology and Female Pelvic Medicine and Reconstructive Surgery, Drexel University College of Medicine,
Philadelphia, Pennsylvania
3
International Painful Bladder Foundation, Naarden, Netherlands
4
Department of Urology, School of Clinical Sciences, University of Bristol, Bristol, United Kingdom
5
Physiotherapy at La Trobe University, Melbourne, Cabrini Health, Melbourne, Australia
6
Department of Urology, University of Copenhagen, Herlev Hospital, Herlev, Denmark
7
Department of Urology, Division of Urology, University of Pennsylvania, Philadelphia, Pennsylvania
8
Department of Urology Surgery, Duke University and Durham Veterans Affairs Medical Centers, Durham, North Carolina
9
Department of Urology, The University of Tokyo, Tokyo, Japan
10
Head of Voiding Dysfunctions and Urodynamics Section, Urology Division, Hospital de Cl�ınicas,
University of Buenos Aires, Argentina
11
Department of Urology, St. Ant�
onio Hospital, Oporto, Portugal
12
Department of Urogynecology, University College Hospital, National Hospital for Neurology and Neurosurgery, GB
13
Department of Immunology, Erasmus MC, Rotterdam, Netherlands
14
Department of Urology, Taipei Veterans General Hospital, National Yang Ming University, Taipei, Taiwan
15
Department of Urogynecology, Chair of Pelvic Reconstructive Surgery and Urology, Tokyo Women’s Medical University
Medical Center East, Japan

Aims: Terms used in the field of chronic pelvic pain (CPP) are poorly defined and often confusing. An International
Continence Society (ICS Standard for Terminology in chronic pelvic pain syndromes (CPPS) has been developed with the
aim of improving diagnosis and treatment of patients affected by chronic pelvic pain syndromes. The standard aims to
facilitate research, enhance therapy development and support healthcare delivery, for healthcare providers, and patients.
This document looks at the whole person and all the domains (organ systems) in a systematic way. Methods: A dedicated
working group (WG) was instituted by the ICS Standardisation Steering Committee according to published procedures.
The WG extracted information from existing relevant guidelines, consensus documents, and scientific publications.
Medline and other databases were searched in relation to each chronic pelvic pain domain from 1980 to 2014. Existing ICS
Standards for terminology were utilized where appropriate to ensure transparency, accessibility, flexibility, and evolution.
Consensus was based on majority agreement. Results: The multidisciplinary CPPS Standard reports updated consensus
terminology in nine domains; lower urinary tract, female genital, male genital, gastrointestinal, musculoskeletal,
neurological aspects, psychological aspects, sexual aspects, and comorbidities. Each is described in terms of symptoms,
signs and further evaluation. Conclusion: The document presents preferred terms and definitions for symptoms, signs,
and evaluation (diagnostic work-up) of female and male patients with chronic pelvic pain syndromes, serving as a platform
for ongoing development in this field. Neurourol. Urodynam. # 2016 Wiley Periodicals, Inc.

Key words: bladder pain syndrome; chronic pelvic pain syndromes; comorbidities; condition; disease; domain; female
genital pain; gastrointestinal pain; Hunner lesion; hypersensitive bladder; interstitial cystitis; lower urinary tract pain;
male genital pain; musculoskeletal pain; neurological aspects; phenotype; psychological aspects; sign; sexual aspects;
symptom; syndrome

Dr. Alan Wein led the peer-review process as the Associate Editor responsible for the paper.
Potential conflicts of interest: Regula Doggweiler: Consultant Astellas, Consultant Bene-Arneimittel GmbH. Kristene Whitmore: Research for Allergan, Coloplast. Sohier
Elneil: Speaker Bureau for Allergan and Medtronic. Matthew O. Fraser: President at NeuroUroGastro Preclinical Research Consulting, LLC; Research for Astellas,
Medtronic, Pfizer; SAB for Amphora Medical; Ad Board for Astellas, Synergy Pharmaceuticals; Consultant for InVivo Therapeutics, Circuit Therapeutics, Sanofi. Helena
Frawley, Alex Lin, Jane Meijlink, Jørgen Nordling, and Hikaru Tomoe: no disclosure. Gustavo Garrido: Speaker for Allergan, Glaxo Smith Kline, American Medical
Systems, Ferring, Research for Pfizer. Mario Gomes: posthumous no disclosure. Philip Hanno: Afferent, Astellas, Trillium, and Taris. Yukio Homma: Consultant for
Astellas, Integral, Pfizer, Speaker Honorarium from Astellas, Pfizer, Taiho. Joop P. van de Merwe: speaker for ThermoFisher Scientific Benelux. Marcus J. Drake: speaker/
research/Ad Boards for Allergan, Apogepha, Astellas, Ferring, Pfizer.

Correspondence to: Kristenen Whitmore, Chair of Urology and Female Pelvic Medicine and Reconstructive Surgery, Drexel University College of Medicine, Philadelphia,
PA. E-mail: bladder1@aol.com
Received 7 May 2016; Accepted 23 May 2016
Published online in Wiley Online Library
(wileyonlinelibrary.com).
DOI 10.1002/nau.23072

# 2016 Wiley Periodicals, Inc.

A Standard for Terminology in Chronic Pelvic Pain Syndromes: A Report Fromthe Chronic Pelvic Pain Working Group of the International Continence Society
88

2 Doggweiler et al.
INTRODUCTION
This is the first International Continence Society (ICS published Standard of Chronic Pelvic Pain Syndromes (CPPS). Global
standardization of terms and clear definitions are essential for scientific and clinical progress. Furthermore, meaningful coding of
diseases, nationally and internationally, depends on accepted terminology. Inappropriate and unclear coding and definitions have
negative effects not only on diagnosis, but also on the patient’s ability to obtain appropriate treatment, reimbursement, and social
benefits. The International Continence Society (ICS has led the way in the development of Standards for terminology of lower
urinary tract function and dysfunction,1 and the need for a Standard in CPPS was identified by the ICS Standardisation Steering
Committee (SSC).
Chronic pelvic pain (CPP) is the most common indication for referral to women’s health services, and accounts for 20% of all
outpatient appointments in secondary care.2 This leads to a substantial burden on limited health care resources. For example,
$881.5 million are spent per year on its outpatient management in the USA, while an estimated £158 million are spent annually on
management in the United Kingdom National Health Service.2 CPPS are multifactorial and multidisciplinary conditions, and
terminology can vary according to which specialist is looking at the patient. This document is an endeavour to look at the whole
person and to consider all the domains involved. Each domain is described separately.
Pain in the pelvic area potentially includes urologic, gynecologic, gastrointestinal, musculoskeletal, neurologic and/or
rheumatologic etiology, with psycho-social aspects, and hence must be regarded as a multidisciplinary issue. A taxonomy of the
relevant elements of CPP was provided by the International Association for the Study of Pain (IASP).3,4 Complementing the
taxonomy, the European Association of Urology (EAU) Guidelines on Chronic Pelvic Pain provide a comprehensive overview of
basic science pertaining to pelvic pain, clinical workup and management of CPPS.5 This ICS Standard should be seen as
complementary to other CPPS standards and guidelines. Its aims are to:

1. Describe the nine clinical domains involved in CPPS (summarized in Tables I–XI).
2. Define terminology.
3. Develop an evaluation guideline for each domain.
4. Establish a process for evolving terminology in response to scientific and clinical development and patient need.

This Standard for CPPS Terminology should facilitate future research and therapy development, improve cost effectiveness, and
ensure access by the patient to appropriate treatment, reimbursement, and social benefits.

METHODS
The CPPS Standard was developed according to the published methodology of the ICS Standardisation Steering Committee (SSC).6
The Working Group (WG) and Chairperson were selected by an independent SSC sub-committee following an open advertisement.
The WG comprised a multi-disciplinary group of health care providers, a basic science researcher, and a patient advocate. Activities
of the WG and contributions of individual members were recorded in an open forum on the ICS website. The WG developed an
outline of proposed content at an open workshop at the ICS annual scientific meeting in Beijing (2012). Successive iterations of the
draft standard involved electronic communications, teleconferences, and face-to-face meetings. The WG reviewed documents that
provided historical and research insight into the multidisciplinary approach to the evaluation of female and male CPPS.
A literature review covered the period 1980–2015 and extracted sources from electronic database searches, including MEDLINE
and Cochrane. In addition, cross-referencing was done for existing relevant guidelines and consensus documents, notably:

� The EAU Guidelines on Chronic Pelvic Pain,5,7 which place CPP in the clinical context.
� The American Urological Association (AUA) guidelines for the diagnosis and the treatment of IC/BPS.8,9
� The International Continence Society (ICS) joint/ICS joint report on the terminology for female pelvic floor dysfunction,10 which
covers terminology for female sexual dysfunction, genital pain, and pudendal neuralgia.
� The IASP Taxonomy, which classified pain on the basis of ‘‘organ þ pain þ syndrome’’ and applied it to pain of urogenital origin.3
� In 2008, the International Society for the Study of Bladder Pain Syndrome (ESSIC) published diagnostic criteria, classification, and
nomenclature for bladder pain syndrome (BPS).11
� The East Asian IC Study Group/Society of Interstitial Cystitis of Japan (SICJ) guidelines, which revived the concept of
hypersensitive bladder.12
� The Functional Gastro-Intestinal Disorder Society (FGIDS) Rome III Diagnostic Criteria13 for gastro-intestinal disorders.

RESULTS
The WG identified the following nine domains, each of which are considered in terms of symptoms, signs, and further
evaluation.
I. Lower Urinary Tract Domain
A. Bladder.
B. Urethra.

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Chronic Pelvic Pain Syndromes 3

II. Female Genital Domain
A. Vulva, vestibule, and clitoris.
B. Intra-abdominal female genital pain.
C. Pelvic floor muscle pain.

III. Male Genital Domain

A. Prostate.
B. Scrotum.
C. Epididymis.
D. Testicle.
E. Penis.
F. Urethra.
G. Sexual Pain.

IV. Gastro-Intestinal Domain

A. Anorectum.
B. Colorectum.

V. Musculoskeletal Domain
A. Pelvic muscle pain.
B. Coccyx pain syndrome.
C. Pelvic Joint, ligament, or bony pain.

VI. Neurological Domain

A. Complex Regional Pain Syndrome (CRPS).
B. Somatic neuropathic pain.
C. Pain following mesh surgery.

VII. Psychological Domain

A. Worry, anxiety, and fear.
B. Depression and depressed mood.
C. Catastrophizing.

VIII. Sexual Domain

A. Sexual desire disorder.
B. Sexual arousal disorder.
C. Orgasmic disorder.
D. Sexual pain disorder.

IX. Comorbidities
A. Allergies.
B. Chronic pain and fatigue syndromes.
C. Systemic autoimmune syndromes/disease.
D. Extraintestinal manifestations of inflammatory bowel disease.

TAXONOMY
A. Pain—A subjective phenomenon described as an unpleasant sensory and emotional experience associated with actual or
potential tissue damage, or described in terms of such damage.14
a. Nociceptive pain: arises from actual or threatened damage to non-neural tissue and is due to the activation of
nociceptors.
b. Somatic pain: arises from bone, joints, muscles, skin, or connective tissue and is normally achy or throbbing and well
localized.
c. Visceral pain: arises from visceral organs, with involvement of the organ capsule with aching, and is localized. There is
obstruction of hollow viscus, causing intermittent cramping, which is poorly localized.15

i. Nociceptive: direct injury or lesion of an internal organ such as: bladder stone, surgical injury.
ii. Inflammatory: acute/chronic inflammation of an internal organ such as urinary tract infection, pelvic inflammatory
disease, colitis, endometriosis.
iii. Neuropathic: primary lesion of visceral nerves such as neuritis following mesh placement.

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4 Doggweiler et al.
d. Centrally generated pain/deafferentation pain: may result from injury to either the peripheral or central nervous system,
leading to burning pain below the level of the lesion. It can be sympathetic-nervous system maintained pain, which may
result in chronic regional pain syndrome (CRPS). There is increased responsiveness of nociceptive neurons in the central
nervous system to normal or sub-threshold afferent input.
e. Hypersensitivity: increased nerve activity from a standardized stimulus with an expected tissue/clinical response. The
underlying mechanism remains to be defined.
f. Central sensitization:16 nociceptor sensitization results in synaptic strengthening by incoming afferent volleys
(sensitization) and is expressed as hyperalgesia (a form of non-associative learning characterized by an increase in
responsiveness upon repeated exposure to a stimulus).17

B. Pain Experience—According to the most common views, pain constitutes the internal perception of bodily damage. It is
unknown whether chronic pelvic pain syndromes (CPPS) are primarily an abnormal perception of a normal stimulus or a normal
perception of an abnormal physiologic sensory stimulus.14 FN1

C. Psychology of Pain—Pain is modulated by cognitive factors and emotional experience, memory, attention, and context
represented in descending modulation of pain, affecting pain experience from moment to moment and longer term. Pain has an
impact on many aspects of daily life, affecting mood, sleep, relationships, and activities. Therefore, attention to the psychological
aspects of pain is an important part of effective assessment and treatment.18,19

D. Neurobiology of Pain—Alterations in gut and bladder motility, visceral perception and central processing of pain and motor
function due to abnormalities in the visceral and central nervous systems may account for the symptoms.18 FN2

E. Chronic Pelvic Pain—Chronic pelvic pain is characterized by persistent pain lasting longer than 6 months or recurrent
episodes of abdominal/pelvic pain, hypersensitivity or discomfort often associated with elimination changes, and sexual
dysfunction often in the absence of organic etiology.20

F. Symptoms and Signs of Chronic Pelvic Pain Syndromes

a. Symptoms: The subjective indicator of a disease or change in condition/syndrome/phenotype as perceived by the patient,
caregiver or partner which may lead him/her to seek help from healthcare professionals.21 The main symptom in CPPS is
pain and will be described in relation to its domain and its perception. Complaint: what the patient describes when
prompted by the physician.
b. Signs are observed by the physician including simple means to verify symptoms and quantify them. To evaluate and
discover all the signs, a full evaluation of the pelvis and body is necessary as multiple intra and extra-pelvic domains (organ
systems) are commonly involved. It is necessary to attempt to identify all of the pain generators.11,21

G. Condition, Disease, Syndrome

a. A condition is defined by the presence of observations associated with characteristic symptoms or signs and/or evidence of
relevant pathological processes.7
b. A disease is a disordered or incorrectly functioning organ, part, structure, or system of the body resulting from the effect of
genetic or developmental errors, infection, poisons, nutritional deficiency or imbalance, toxicity, or unfavourable
environmental factors; illness; sickness; ailment.
c. A syndrome is a complex of concurrent symptoms and signs that is collectively indicative of a disease, dysfunction or
disorder in the absence of obvious pathology. (NEW) Example: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is one of
the Chronic Pelvic Pain Syndromes.1 FN3

H. Characteristics
a. Duration of pain: Six months or more of persistent pain.FN4
b. Location of pain: Pelvis, lower abdomen, low back, medial aspect of thigh, inguinal area, perineum.
c. Perception of pain: Patients may describe the pain as sharp, burning, aching, shooting, stabbing, pressure or discomfort,
sexual pain (dyspareunia).22 FN5
d. Modality of pain (7): Persistent and/or continuous, recurrent and/or episodic and/or cyclic (related to menstrual cycle).

FN1
Diagnosis is often based on the presence of clinical symptoms. The diagnosis of CPP is confirmed by applying symptom-based criteria and pursuing further
diagnostic evaluation to exclude organic disease. Validation of symptom-based criteria is a process; it is not carved in stone and is easy to change as new data on its
underlying pathophysiology emerge.3
FN2
The brain-visceral axis and biopsychosocial model have been used to explain how intrinsic and extrinsic stimuli modulate disease expression.14,18
FN3
This is an update of the ICS Standardisation Sub-committee report on the Standardisation of Lower Urinary Tract Function:1
FN4
In different guidelines and standardisation documents, the duration varies from 6 weeks to 6 months.
FN5
Some patients describe pain as an ache, soreness or simply discomfort, while cultural differences may influence perception of pain. For example, some patients
describe an unpleasant sensation or pressure or discomfort, but do not consider these to be true pain. Memories, emotions, thoughts, expectations and culture are
now believed to influence how people perceive pain.22

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I. Phenotype—Subgroup of patients within a condition, disease, or syndrome that share similar expression of specific
symptoms, signs and diagnostic parameters: Example: Irritable bowel syndrome has three phenotypes: constipation, diarrhea, or
mixed constipation/diarrhea.5,23,24 FN6
Phenotyping is currently in its infancy with regard to evidence and will increase in importance in the future to aid in identifying
specific patient pools for research and treatment.5,23

J. Domain (organ system)—Lower urinary tract, female genital, male genital, gastro-intestinal, musculoskeletal, neurological,
psychological, sexual, and comorbidities are domains involved in chronic pelvic pain syndromes (CPPS).
Tables I–IX are a summary of the appropriate domain for domains I–IX and appear in the Symptoms section.25 FN7

INDIVIDUAL PATIENT ASSESSMENT

Section 1: Symptoms
The first and most important step is to obtain a thorough history of the patient’s perception of her/his pain or discomfort. The
common complaints are the most prevalent symptoms.
Ask about duration (at least 6 months), perception (identify inciting event and/or triggers), and modality (persistent/recurrent).
I. Lower Urinary Tract Domain (Table I)
A. Bladder
Common complaints include: increased urinary frequency day and night, urgency, hypersensitivity, pain, pressure,
discomfort, pain with filling, hesitancy, intermittency, feeling of incomplete emptying. Pain/hypersensitivity related to the
bladder provides an umbrella for hypersensitive bladder, interstitial cystitis/bladder pain syndrome, and interstitial cystitis
with Hunner lesion.26–28 Urgency: A compelling need to urinate which is difficult to defer (pain, pressure,
discomfort).1,5,11,21,30–33 FN8 FN9 The Working Group identified the following adjustments as applying more descriptively, for
example, to Interstitial Cystitis/Bladder Pain Syndrome patients: a compelling need to urinate, due to pain or an unpleasant
sensation, that is difficult to defer.FN10 FN11 FN12
As there are differences in symptoms as well as in the perception and experience of pain, the WG agreed to distinguish:
a. Hypersensitive Bladder (HSB)(Japanese and East Asian guidelines). Hypersensitive bladder symptoms (increased bladder
sensation, usually associated with increased urinary frequency day and night, with or without bladder pain) in the absence
of pathology explaining the symptoms.29,30 FN13
b. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Persistent or recurrent chronic pelvic pain, pressure or discomfort
perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as an urgent need
to void or urinary frequency.11
c. Interstitial Cystitis (IC) with Hunner lesion has the same symptoms as IC/BPS.31 FN14 FN15. Pain in IC/BPS and IC with
Hunner lesion may be pain, pressure or discomfort, which may increase with bladder filling. Possible locations of perceived
discomfort and pain are the pelvis, lower abdomen/suprapubic area, low back, medial aspects of the thigh, inguinal area, or
multiple pain sites.11 Descriptors/Perception of pain5 include: ‘‘Sharp, burning, ache, shooting, stabbing, pressure,
discomfort.’’

B. Urethra
Urethral pain is perceived to be in the urethra, usually when voiding, with increased day- and night-time frequency. It may be
combined with a feeling of dull pressure, and sometimes radiates toward the groin, sacrum and perineum.1,7 The terms ‘‘chronic
urethritis’’ and ‘‘urethral syndrome’’ are no longer recommended.5,23
i. Persistent or recurrent pain.
ii. No history of current infection or other obvious pathology.
iii. May be subsequent to a previous urinary tract infection.

FN6
This has been adapted from the European Association of Urology Guidelines on Chronic Pelvic Pain.5
FN7
Domains I–V involve intrapelvic organs, VI–IX involve overlying aspects including comorbidities.
FN8
In the previous ICS LUTS document of 2002, urgency was defined as: the sudden complaint of a compelling desire to pass urine, which is difficult to defer.1
FN9
This was a change from a previous definition in 1988 which stated that urgency may be associated with two types of dysfunction: (i) Overactive detrusor
function (motor urgency), and (ii) Hypersensitivity (sensory urgency).30
FN10
The change in definition in 2002 with introduction of the word ‘‘sudden’’ effectively restricted this term to overactive bladder syndrome and there was no
mention of another sensation of urgency (urgent need to void) due to pain or hypersensitivity.
FN11
The term hypersensitive bladder is a revival of an earlier ICS Document.30
FN12
Hunner lesion is preferable to Hunneŕs ulcer.
FN13
There is currently global discussion as to whether Hunner lesion should/could be completely separated from IC/BPS and if so what it should be called. It is felt
that more research is needed to provide sufficient evidence for such a step.31
FN14
The term vulvodynia is no longer recommended.3
FN15
The terms Dyesthetic vulvodynia and Essential vulvodynia are no longer recommended.3,34

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TABLE I. Lower Urinary Tract Domain

Symptoms Signs Evaluation Syndrome/disease

Increased daytime frequency Suprapubic tenderness Questionnaires Hypersensitive bladder

Increased night-time frequency Tenderness of the bladder Voiding diary Interstitial cystitis/bladder pain
syndrome
Urgency Tenderness of the pelvic floor Urine analysis Interstitial cystitis/hunner lesion
muscles
Hypersensitivity Optional: urine
culture/cytology
Pain, pressure, discomfort with Intravesical anesthetic
bladder filling challenge
Hesitancy Urodynamics
Intermittency Cystoscopy (biopsy)
Feeling of incomplete bladder
emptying
Frequency/urgency painful urination Tenderness of the urethra Urine analysis Urethral pain

II. Female Genital (Table II)

Common complaints: painful menstruation, abnormal bleeding, pain with intercourse (dyspareunia), discharge, burning,
itching, stabbing pain, voiding/defecatory pain, abdominal/pelvic pain (unilateral or bilateral, persistent or cyclic).
Female genital pain is defined as pain perceived in the pelvis, pelvic organs, the vagina and/or the female external
genitals.5,34

A. Vagina (Vulva, Vestibule, and Clitoris)

1. Pain in the vagina or the external genital organs (vulva, which includes the labia, clitoris and entrance to the vagina).5 FN14
2. Generalized vulvar pain syndrome.4
i. Diffuse vulvar pain perceived to be in the vestibule or beyond.
ii. Dyspareunia.
iii. Provocation of pain with touch, pressure or friction.3,34 FN15

3. Localized vulvar pain syndrome.4

Pain is usually provoked with touch, pressure, or friction; example: tight clothing, bicycle riding, tampon use, sexual activity.
i. Vestibular pain syndrome—Pain localized to one or more portions of the vulvar vestibule.3,34 FN16 FN17

ii. Clitoral pain syndrome—Pain localized to or perceived in the clitoris.

B. Intra-Abdominal Female Genital

1. Ovary

i. Unilateral or bilateral abdominal/pelvic pain.

ii. Persistent.
iii. Cyclic.

2. Pelvic Congestion Syndrome

i. Pressure, heaviness, dull aching pain in the pelvis and/or in the back.
ii. Dysmenorrhea.

C. Pelvic Floor Muscle5 (See Domain V Musculoskeletal Pain)

i. Urinary/defecatory dysfunction.
ii. Dyspareunia (see also VIII sexual aspects).
iii. Pain with sitting.
iv. Bulging sensation.

D. Female Sexual Pain (See Domain VIII)

FN16
The terms vulvar vestibulitis, vestibulodynia, and focal vulvitis are no longer recommended.34
FN17
Differential diagnosis and treatable diseases: A history of infection (Pelvic Inflammatory Disease, sexually transmitted diseases, endometriosis, adenomyosis or
fibroids, and Mullerian abnormalities should be excluded.

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TABLE II. Female Genital Domain

Dyspareunia Tenderness Pain Mapping Vaginal/vulvar/perineal pain

Sharp burning and/or stabbing Erythema Q-tip touch sensitivity test

Provocation of pain with touch
Dysmenorrhea Tenderness: uterine, adnexal Laboratory testing Intra-abdominal:
Abnormal menstrual bleeding Pelvic ultrasound Ovarian Pain
Dyspareunia Laparoscopy/biopsy Pelvic congestion
Itching, stabbing, burning pain CT-scan Uterine pain
Cyclic, (episodic or persistent) Tubal pain

III Male Genital Domain (Table III)

Male genital pain syndromes are often associated with symptoms suggestive of lower urinary tract and sexual dysfunction.
Common complaints: genital pain, uncomfortable urination, dysuria, sensation of residual urine, increased daytime frequency,
slow stream, urgency, dyspareunia.4,5 Absence of infection, previous operations, or other obvious pathology.

A. Prostate
Persistent or recurrent prostate pain, associated with symptoms suggestive of urinary tract and/or sexual dysfunction. No
proven infection or other obvious pathology is present to account for the symptoms.3,35 FN18 FN19 FN20
Bladder, perineal, testicular, penile and/or groin pain.
i. Perception of pain: variable.
ii. Persistent or recurrent.
iii. Dyspareunia or erectile dysfunction.
iv. Voiding and post micturition symptoms (for example: hesitancy, intermittency, feeling of incomplete emptying).

B. Scrotum
Chronic scrotal pain (generic term used when site of pain is not clearly in the testis or epididymis.23 FN21

i. Persistent or recurrent episodic pain, unilateral or bilateral.

ii. Spontaneous, or reproduced by digital pressure and physical activities.
iii. Pain is not in the skin of the scrotum but perceived within its contents.
iv. Lower urinary tract symptoms or sexual dysfunction.

C. Epididymis
Pain is specific/localized to the epididymis.FN22
i. Persistent or recurrent episodic pain.
ii. Spontaneous, or reproduced by digital pressure and physical activities.
iii. Lower urinary tract symptoms or sexual dysfunction.

D. Testicle23 FN23
i. Persistent or recurrent episodic pain.
ii. Spontaneous, or reproduced by digital pressure and physical activities.
iii. Lower urinary tract symptoms or sexual dysfunction.

E. Penis
Pain within the penis that is not primarily in the urethraFN24 and may be:
i. Persistent or recurrent.
ii. Spontaneous, or reproduced by digital pressure and physical activities.
iii. Lower urinary tract symptoms or sexual dysfunction.

F. Urethra
(See Domain I Lower Urinary Tract)

FN18
Using the National Institutes of Health classification system, prostate pain syndrome may be subdivided into type A (inflammatory) and type B (non-
inflammatory).35 Nickel JC. Prostatitis and related conditions, orchitis and epididymitis. In: Campbell-Walsh, editor. Urology. Philadelphia: Elsevier; 2012.
FN19
Based on a more general definition, the term prostate pain syndrome (PPS) is used by the European Association of Urology (EAU) instead of the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK) term chronic prostatitis/chronic pelvic pain syndrome.
FN20
The terms ‘‘Chronic Prostatitis’’ and ‘‘Prostatodynia’’ are no longer recommended.
FN21
It may be associated with a congestive epididymitis. Example: after vasectomy. It can result from a mechanical pressure more often than an inflammatory process.
FN22
It may occur at any age, but the majority of cases are in the mid to late thirties and it may be disabling and associated with anxiety about cancer.36
FN23
Pain is localized to the testis and could be explained by neural plasticity when subsequent to a trauma or disease and this phenomenon can result from the
amplification of the pain messages at all levels of nervous system.22 The previous terms ‘‘Chronic Orchitis,’’ Orchalgia,’’ or ‘‘Orchiodynia’’ are no longer recommended.
FN24
The most common site for referral to the penis is from the bladder outlet.

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TABLE III. Male Genital Domain

Symptoms Signs Evaluation Syndrome/disease

Pain Tenderness on rectal/genital examination Questionnaires Prostate pain

LUTS Urethral discharge Culture
Dyspareunia PSA/biopsy
Erectile dysfunction Cystoscopy/biopsy
Persistent or episodic Ultrasound
Tenderness on physical examination Questionnaires Scrotal pain
Scars Ultrasound Epididymal pain
Testicular pain
Penile pain

G. Sexual Pain
(dyspareunia; (see Domain VIII)
i. Penile
1. Prior to penetration (example: pain with erection).
2. With penetration.
3. Post coital.

ii. Perineal
1. During intercourse.
2. After intercourse.

iii. Orgasmic Pain (during ejaculation)

1. Penile.
2. Anorectal.
3. Pelvic.

IV Gastro-Intestinal (Table IV)

Common complaints: constipation, diarrhea and obstructive defecation, pain with defecation, bleeding, discharge, cramping
abdominal pain, recurrent rectal pain, rectal pressure, burning sensation or aching episodes.37 FN25

A. Anorectum (7) (4)

1. Chronic Proctalgia—rectal pain, more than 20 min of duration per episode, for at least 3 months with symptom onset at
least 6 months prior to diagnosis.
i. Persistent or recurrent rectal pain.
ii. Rectal pressure or aching episodes.
iii. In the absence of other causes of rectal pain.

2. Levator Ani Syndrome (the term may refer to the same syndrome as ‘‘pelvic floor muscle pain syndrome’’/‘‘tension myalgia
of the PFM’’—see Domain V).
i. Pain with sitting.
ii. Pain with defecation.

3. Proctalgia Fugax
i. Severe recurrent episodic pain localized in the anus or lower rectum.
ii. Duration seconds to minutes.
iii. No pain between episodes.

Consider the Symptoms of the Following Treatable Diseases, as They Need to Be Excluded
4. Anal Fissure38
i. Bright red bleeding with bowel movements.
ii. Anal pain or spasms that can last hours after bowel movements.38
iii. Pain with sitting.

5. Abscess
i. Pelvic rectal pain.

FN25
Chronic Gastro-Intestinal pain includes syndromes and diseases that have obvious pathologies, but similar symptoms.

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TABLE IV. Gastro-Intestinal Domain

Symptoms Signs Evaluation Syndrome/disease

Pain with defecation Tenderness on rectal examination Questionnaire Ano-rectal pain

Evacuation dysfunction Culture
Pain/pressure with sitting Colonoscopy/biopsy
Abdominal pain Abdominal tenderness Colo-rectal pain
Nausea Bloating Ultrasound
Constipation/diarrhea CT/barium enema/MRI
Persistent or episodic

ii. Tenesmus39 (persistent painful need to defecate despite an empty colon).

iii. Pain with sitting.

6. Hemorrhoids40–42
i.
Anal discomfort with engorgement.
ii.
Pain and itching.
iii.
Lump in perianal area.
iv.
Pain with defecation.
v.
Internal hemorrhoids—Painless bleeding, mucus discharge, incomplete evacuation.
vi.
External hemorrhoids—Anal discomfort with engorgement, pain, and itching.
vii.
Thrombosed External Hemorrhoids- Exquisitely painful lump in the perianal area. The pain tends to be acute at onset.
Typically following straining at the time of bowel movement or physical exertion.
7. Anorectal Crohn’s Disease—May be asymptomatic, with possible anal pain during flare.43

B. Colorectum (ROME III Criteria)

Rome III Criteria are a standard for functional gastrointestinal disorders. The Rome III Criteria are a system developed to classify
the functional gastrointestinal disorders (FGIDs) of the digestive system, in which symptoms cannot be explained by the
presence of structural or tissue abnormality, based on clinical symptoms. Some examples of FGIDs include irritable bowel
syndrome, functional dyspepsia, functional constipation, and functional heartburn.13
1. Irritable Bowel Syndrome (IBS) Functional (non-inflammatory)
i. Recurrent episodes of abdominal pain.
ii. Changes in frequency, form or consistency of the stool.
iii. Sensation of incomplete evacuation, straining, fecal urgency.44
iv. Sensation of nausea, fatigue, fullness, vomiting.
v. Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the
following:
1. Improvement of pain with defecation.
2. Onset associated with change in frequency of stool.
3. Onset associated with a change in the form (appearance) of stool.45

Note: Consider the Symptoms of the Following Disease

Inflammatory Bowel Disease (IBD)—Complaint of recurrent abdominal pain and discomfort of at least 3 days per month in the
last 3 months. The majority of IBD patients experience periods of flares and remission.
i. Abdominal and anal pain, diarrhea which may be associated with blood, suggestive of ulcerative colitis.
ii. Abdominal pain, fatigue, prolonged diarrhea with crampy abdominal pain, weight loss, and fever, with or without gross
bleeding. Irregular bowel habits, with possible blood in the stool, are suggestive of Crohn’s disease.45

V. Musculoskeletal Domain (Table V)

Musculoskeletal pain may originate from muscles, fascia, ligaments, joints, or bones.

TABLE V. Musculoskeletal Domain

Symptoms Signs Evaluation Syndrome/disease

Abdomino-pelvic-perineal pain Altered muscle tone Questionnaires Pelvic muscle pain syndrome
Tension; muscle spasms and muscle Pain mapping Coccyx pain syndrome
compliance
Pain at rest, with movement, with sitting, with sexual Stiffness muscle tightness Ultrasound Pelvic joint, ligament or bony
activity pain
Pain with voiding or bowel evacuation Trigger point tenderness
Unilateral or bilateral pain Tender taut band
Persistent or episodic Twitch response, referred pain

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Common complaints: abdominal/pelvic pain, pain with sitting or with movement or with change of posture, with sexual
activity, unilateral or bilateral pain. Possible pain with voiding or bowel evacuation.

A. Pelvic Muscle Pain10,46 (See also Domain IV)

1. Pelvic Floor Muscle Pain (Pelvic Floor Myalgia)FN26
i. Pain in the muscles of the pelvic floor (perineal or levator ani).

2. Intra-pelvic Muscle Pain

i. Pain in the pelvic side wall muscles (obturator internus, piriformis, coccygeus).

3. Anterior Pelvic/Lower Abdominal Muscle Pain

i. Pain in the rectus abdominus, oblique or transverse abdominus muscles, described below the umbilicus.

4. Posterior Pelvic/Buttock Muscle Pain

i. Pain in the gluteal muscles.

B. Coccyx Pain Syndrome

i. Complaint of chronic or recurrent pain in the coccyx or sacro-coccygeal joint.

C. Pelvic Joint, Ligament, or Bony Pain

1. Joint pain
i. Sacroiliac or pubic symphysis joint.

2. Ligament pain
i. Sacro-spinous or Sacro-tuberous ligament.

3. Bony pain
i. Pain described in or along the margins of the pubic ramus, ilium, ischial spine or ischial tuberosity.

VI Neurological Aspects Domain47 (Table VI)

Common complaints: Burning, throbbing, stabbing, electric shock-like sensation, tingling, stinging and/or paresthesia pain in
the pelvis and/or perineal region.

A. Complex Regional Pain Syndrome48 (CRPS)

Sympathetic, centrally generated pain.
1. CRPS 1- Triggered by tissue injury with no underlying nerve injury.
2. CRPS 2- Associated with nerve injury.
i. Burning pain.
ii. Increased skin sensitivity.
iii. Changes in skin temperature, color, and/or texture.

Note: Consider Differential Diagnosis:

B. Somatic Neuropathic Pain—Nerve injury (stretching, blunt trauma, compression, entrapment, suture ligature).
1. Sacral nerve (disease)49
iv. Pudendal neuralgia is a disabling form of pelvic pain. It is related to a ligamentous nerve compression mechanism. This
pain is associated with the second stage of labor, sacrospinous vault suspension, vaginal laceration repairs,
prostatectomy, straddle injuries, prolonged motorcycle riding, and laser treatment to the vulva, scrotum and/or
perineum.

1. Unilateral or bilateral.
2. Lancinating burning pain in the clitoris, penis, urethra, labia, scrotum, perineum and/or anus.
3. Worse with sitting.
4. Relieved by standing or supine position.
3. Thoracolumbar nerve (disease)50 FN27

FN26
International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative management of
female pelvic floor dysfunction (under review).51
FN27
Irritation of the thoracolumbar facet joints causes pain referred to the distribution of nerves T12, L1, and L2. This results in pain to the iliac crest and buttock.
Frequently seen after abdominal and/or pelvic surgery.50

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TABLE VI. Neurological Aspects Domain

Symptoms Signs Evaluation Syndrome/disease

Characteristic sensation descriptions: burning, throbbing, stabbing, tingling, stinging, Tenderness Questionnaires Somatic
shooting, electric shock-like sensation paresthesia, atrophy, persistent or episodic (nerve distribution) neuropathic
pain
Referred pain Quantitative Complex regional
sensory pain syndrome
testing
Possible skin change Pain mapping
(color, temp, texture) Nerve block
imaging
Ultrasound
MRI

i. Ilioinguinal nerve.

1. Pulling or throbbing that limits physical activity (groin, labia scrotum inner thigh).
ii. Iliohypogastric nerve.

1. Pulling or throbbing sensation that limits physical activity (suprapubic area and groin).
iii. Genitofemoral nerve52

1. Burning, paresthesia and pain (groin, labia or scrotum, medial thigh).

iv. Obturator nerve

1. Medial thigh or groin pain.

2. Weakness with adduction of the thigh.

C. Pain Following Mesh Surgery34,53

i. Pain during physical activity.
ii. Dyspareunia.
iii. Vaginal discharge.
iv. Exposure of mesh in vagina or elsewhere.

VII Psychological Aspects Domain (Table VII)

Common complaints: worry, anxiety, low mood, frustration, sleep disturbance, helplessness, hopelessness, difficulty in
concentrating, pain impairing enjoyment. These all have biopsychosocial aspects.54
The biopsychosocial model in pain medicine was introduced with the publication of the Gate Control Theory of Pain. It is suggested
that in the perception of pain three different inputs are involved: the sensory-nociceptive, the affective-motivational and the
cognitive-evaluation input. These could differ within individuals, but all of these are involved in the human experience of pain.55
Psychological distress as a biopsychological aspect is most often a consequence of persistent pain, although existing distress is
likely to exacerbate the experience of pain and difficulties dealing with it. Findings support growing evidence that the negative
affective, cognitive and psychosocial state of chronic pain is universal, regardless of a neuropathic, or nociceptive nature. Emotions,
thoughts and behavior involve many different locations in the brain and multiple psychological processes are involved in
neuromodulation of pain.18,54
A. Worry, anxiety, fear: Pain is interpreted as a message of something seriously wrong with the body at the point where the pain
is felt, consistent with models of severe acute pain. Without an explanation for chronic pain, anxiety is likely to persist and results
in attempts to avoid activities which exacerbate the pain or are expected to do so.
B. Depression and depressed mood: This is predominantly pain-related and concerns loss of valued activities and roles as a result
of pain. Difficulty sleeping, difficulty concentrating, helplessness, and hopelessness about finding a solution to the pain or a way of
living a worthwhile life despite pain are common.
C. Catastrophizing: a tendency to overattend (magnification) to pain stimuli, with overestimation of the threat value and
underestimation (hopelessness and helplessness) of the capacity to deal with the threat.

TABLE VII. Psychological Aspects Domain

Symptoms Signs Evaluation Syndrome/disease

Worry, anxiety, fear Helplessness Formal psychological assessment Worry/anxiety/fear

Catastrophizing Hopelessness Asking the patient what is wrong and what worries her/him about pain Depression
Persistent or episodic Avoidance of certain activities Questionnaires

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VIII Sexual Aspects Domain (Table VIII)
Common Complaints: Low sex drive, inability to become aroused, pain with intercourse, difficulty reaching orgasm.
Sexual dysfunction is a disturbance in the sexual response cycle or pain associated with sexual intercourse, and can take a heavy
psychological toll; it is associated with depression, anxiety, and debilitating feelings of inadequacy.56 It is appropriate to
investigate for possible history of sexual/physical abuse.
Dyspareunia is a biopsychosocial phenomenon that can have physical and psychosocial implications for the individual as well
for the relationship.57 Decrease in self-esteem, depression, anxiety, fatigue, and the need to use pain medication and other
medications increase the likelihood of one or more of the disorders.
Superficial or entry dyspareunia is often associated with provoked vaginal-vulvar pain syndrome. Deep or thrusting
dyspareunia often occurs in association with lower urinary tract pain, musculoskeletal pain, gastrointestinal pain, as well as
abdominal/pelvic pain.58,59
Female and male sexual function is adversely affected in most patients with chronic pelvic pain, resulting in more than one
comorbid disorder. More than 50% of partners are significantly affected and develop sexual dysfunction.

A. Sexual Desire Disorder

The following definitions form part of the DSM IV TR60,61 FN28

1. Hypoactive Sexual Desire Disorder (HSDD)

i. Low sex drive.
ii. An absence of sexual fantasizing or erotic thoughts.
iii. No longer feeling aroused or excited during sex.
iv. A substantial decrease in sexual activity with partner, persisting for more than 6 months.

2. Sexual aversion disorder

i. Persistent or recurrent aversion to, or avoidance of, sexual activity.
ii. When presented with a sexual opportunity, the individual may experience panic attacks or extreme anxiety.

B. Sexual Arousal Disorder

i. Persistent or recurrent inability to become sexually aroused.
ii. Often characterized by inadequate vaginal lubrication for penetration (female).
iii. Inability to achieve or maintain an adequate erection for penetration (male).
iv. Symptoms present for more than 6 months.

C. Orgasmic Disorder
i. Difficulty or delay in reaching orgasm, after sufficient sexual stimulation (female).
ii. Premature or delayed ejaculation (male).
iii. Present for more than 6 months.

D. Sexual Pain Disorder

1. Dyspareunia
i. Female sexual pain: Burning, ripping, tearing, or aching sensation associated with penetration. The pain can be at the
vaginal opening, deep in the pelvis, or anywhere between. It may also be felt throughout the entire pelvic area and the
sexual organs and may occur only with deep thrusting.
ii. Male sexual pain: Sexual activity may induce a central sensitization process characterized by hypersensitivity or
hyperalgesia.
History should include duration of symptoms, identification of disorder, impact on quality of life, and partner relationship.
Partner interviews may be very helpful as erectile dysfunction, delayed or premature ejaculation in males with hypoactive sexual
desire disorder result in a 4–30 times increased risk of female partner desire, arousal or orgasmic disorder.

TABLE VIII. Sexual Aspects Domain

Symptoms Signs Evaluation Syndrome/disease

Lack of desire, arousal, orgasm Depression Relationship issues Questionnaires Sexual dysfunction
Dyspareunia Laboratory (hormonal and complete metabolic panel)
Persistent or episodic Doppler ultrasound

IX Comorbidities (Table IX)

Patients with chronic pelvic pain syndromes, and in particular those with interstitial cystitis/bladder pain syndrome (IC/BPS),
have a higher prevalence of one or multiple comorbid syndromes and diseases than the general population. These include:
allergies, non-cancer chronic pain, fatigue syndromes and systemic autoimmune diseases. The risk of a comorbidity in patients

FN28
Minimal data are available utilizing DSM 5 criteria, DSM IV TR was thus utilized. The Diagnostic and Statistical Manual of Mental Disorders, published by the
American Psychiatric Association, offers a common language and standard criteria for the classification of mental disorders.60

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TABLE IX. Comorbidities

Symptoms Signs Evaluation Syndrome/disease

Allergies Fatigue General medical evaluation Allergies

Fatigue Skin lesions Laboratory Chronic pain and fatigue syndrome
Widespread muscular and joint pain Dry eye Imaging Systemic autoimmune diseases
Irritation of the eyes Muscular skeletal tenderness
Dryness
Sleep disorder

affected by IC/BPS is usually between two and ten times higher than in a healthy population. However, data from studies on
comorbidities in chronic pelvic pain patients are difficult to interpret as the composition of study populations and methodology
are highly variable. Information on the prevalence of comorbidities is therefore often obtained from studies on IC/BPS.62–66

A. Allergies
Allergies are a heterogeneous group of diseases with involvement of the airways, skin, and sometimes of other organs.
Symptoms are caused by an immunologic reaction to some kind of trigger (e.g., inhaled allergens such as dust mite allergen, pet
dander, pollen, mold, food, drugs). Nonallergic reactions to drugs or food may cause symptoms similar to allergic reactions.67
Examples include allergic asthma, allergic rhinitis (hay fever), atopic dermatitis (eczema), allergic drug reactions and allergic
food reactions (tingling mouth, swelling of the lips, tongue, face or throat), hives, anaphylaxis, and atopic dermatitis.68

B. Chronic Pain and Fatigue Syndromes

Chronic pain and fatigue syndromes are characterized by pain, often widespread; fatigue; sleep disturbances; and disability. The
symptoms are usually medically unexplained, have no known pathophysiology or organic basis and show no abnormal laboratory
or imaging investigations. The literature suggests that many of these conditions share demographic characteristics, clinical course
and psychosocial profiles.69 Examples are:
1. Fibromyalgia: symptoms are widespread musculoskeletal pain, fatigue, non-restorative sleep, psychological distress, and
regions of localized tenderness.
2. Temporomandibular Joint Disorders: symptoms consist of complaints of facial, jaw, neck, or shoulder pain. The pain is
experienced in or around the ear with chewing, speaking, or opening the mouth, with or without migraine.
3. Chronic Fatigue Syndrome: is defined as clinically evaluated, unexplained, persistent or relapsing fatigue plus four or more
specifically defined associated symptoms (self-reported impairment in short term memory or concentration; sore throat;
tender cervical or axillary nodes; muscle pain; pain in multiple joints without redness or swelling; headaches of a new
pattern or severity; unrefreshing sleep).70
C. Systemic Autoimmune Syndromes/Diseases
Systemic or generalized autoimmune diseases are a heterogeneous group of diseases with multi-organ involvement and
evidence indicating a role played by the immune system in the pathogenesis. Examples are systemic lupus erythematosus (SLE),
Sj€
ogren’s syndrome, and rheumatoid arthritis (RA). Many patients can be diagnosed with more than one of these diseases, or also
with fibromyalgia and irritable bowel syndrome.
1. Systemic Lupus Erythematosus (SLE). Most frequent symptoms are debilitating fatigue, arthritis, red skin lesions after sun
exposure such as a red butterfly lesion of the face, pericarditis and pleuritis, glomerulonephritis. The prevalence is 10
higher in females than in males and 2 more frequent in non-white people.
2. Sj€
ogren’s Syndrome is a systemic autoimmune disease characterized by a functional disorder of the tear and salivary
glands, with or without signs of inflammation. The most common symptoms are irritation of the eyes, a dry mouth, muscle
and joint pain, (debilitating) fatigue and Raynaud phenomenon.
3. Rheumatoid Arthritis (RA) is a disease characterized by chronic symmetric polyarthritis resulting in painful swelling of
the joints. Other symptoms are morning stiffness, rheumatoid nodules and typical changes on hand and wrist
radiographs.
D. Extraintestinal Manifestations of Inflammatory bowel disease (IBD) include non-destructive arthritis of large joints or axial
arthritis such as sacroiliitis, inflammation of the eyes (uveitis, scleritis), or inflammation of the skin (erythema nodosum,
pyoderma gangrenosum).71

Section 2: Signs
Generalized Physical Examination
A comprehensive physical examination should be performed, including palpation of the lower abdomen for bladder fullness and
tenderness, and a complete pelvic exam to identify pain generators and referred pain patterns:
1. Observe posture, gait and protective behavior (avoiding sitting on flat surface or standing to avoid sitting, neck folding posture).
2. Standing: kyphosis, scars, hernia.
3. Supine: abduction/adduction of the hips, hyperaesthetic areas, scars, hernia.
4. Comprehensive pelvic examination for female and male.
5. Pain mapping (identification of pain generators/trigger points and referred pain).72

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I Lower Urinary Tract

A. Bladder/Urethra
1. Suprapubic tenderness.
2. Tenderness of the bladder.
3. Tenderness of the urethra.
4. Tenderness of the pelvic floor muscles and identification of trigger points.46 (See Domain V).

II Female Genital5

A. Vulva, Vestibule, and Clitoris

Generalized vulvar pain syndrome refers to a vulvar pain syndrome where the pain/burning cannot be consistently and
precisely localized by point-pressure ‘‘mapping’’ via probing with a cotton-tipped applicator or similar instrument. Tenderness is
diffuse and may affect all locations of the vulva.FN29
1. Localized and Generalized Vulvar Pain Syndrome
i. Tenderness, Q-Tip touch sensitivity test.72
ii. Erythema (localized or generalized).
iii. Fissures.
iv. Ulcers.

B. Intra-Abdominal Female Genital

1. Uterus and Fallopian Tube
i. Uterine tenderness.
ii. Cervical discharge, cervical excoriation, tenderness, adnexal tenderness, erythema.
iii. Extrauterine tenderness, decreased uterine mobility, adnexal mass.
iv. Enlarged uterus, nonspecific tenderness.
v. Abdominal or pelvic scars, neuroma.

2. Ovary; adnexal mass, tenderness, abdomino-pelvic scar.

3. Pelvic Congestion Syndrome: Labia varicosities, non-specific abdominal tenderness.
4. Cervix: Erosion, Nabothian follicles, discharge, bleeding.

C. Pelvic Floor Muscle (See Domain V)

1. Perineal scarring, neuroma, dermal cutaneous allodynia.
2. Tenderness (local and/or referred to another pelvic location).
3. Vaginal discharge, mesh extrusion.53
4. Bulging.
5. Mass, radiation changes.

III Male Genital

A comprehensive physical examination should be performed in standing (example: exclusion of varicocele) and supine
positions, including observation and palpation with pain mapping (identification of pain generators) of the external male genitals,
and rectal examination.FN30

A. Prostate
1. Prostate tenderness on rectal examination.
2. Possible urethral discharge.

B. Scrotum
1. Tenderness on physical examination.
2. Change in color.
3. Masses on palpation.
4. Scars post-vasectomy.
5. Allodynia (increased perception of pain.

C. Epididymis
1. Tenderness.

FN29
The vulvar vestibule (part of the vulva which lies between the labia minora into which the urethral meatus and vaginal introitus open) may be involved, (but
the discomfort is not limited to the vestibule and may include referred pain from the other CPPS domains).
FN30
Tenderness might be graded as mild, moderate, or severe.

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2. Masses, nodules.

D. Testicle
1. Tenderness.
2. Masses, nodules.

E. Penis
1. Tenderness.
2. Curvature.
3. Nodules/plaque.

F. Urethra
1. Tenderness.
2. Discharge.

IV Gastro-Intestinal

A. Anorectum
1. Chronic Proctalgia—Identification of tenderness on rectal exam3
2. Levator Ani Syndrome—Identification of tenderness during posterior traction on the puborectalis.
3. Proctalgia Fugax—Usually there is no evident sign on physical examination.40
4. Anal Fissure—Identification of separation of the anoderm, sentinel tag at the external apex, exposed internal sphincter
muscle, hypertrophic anal papilla at the internal apex.38
5. Abscess—Identification of fluctuant collections in the perianal tissues, drainage (fistula).39
6. Hemorrhoids—Identification of skin tags, thrombosis, prolapse on straining (reducible and irreducible).
i. Internal: Located proximal to the dentate line and covered by columnar epithelium.
ii. External: Located distal to the dentate line and covered by modified Squamous epithelium (anoderm)
iii. Thrombosed: Painful lump in the perianal area.41,42

7. Anorectal Crohn’s Disease—Identification of skin tags, hemorrhoids, fissures, anal ulcers, strictures, abscess, fistula, severe
proctitis.43

B. Colorectum (IBS, IBD)

1. Abdominal tenderness.
2. Watery or bloody diarrhea.
3. Rectal bleeding.
4. Weight loss.
5. Fever.

V. Musculoskeletal
The musculoskeletal structures are examined for signs of tenderness and altered tension or abnormal movement.73–76 FN31

1. Muscle tone: State of the muscle, usually defined by its resting tension, clinically determined by resistance to passive movement.
Muscle tone has two components: (i) the contractile component, created by a low-frequency activation of a small number of motor
units; (ii) the viscoelastic component, which is independent of neural activity and reflects the passive physical properties of the elastic
tension of the muscle fiber elements and the osmotic pressure of cells.46 In normally innervated skeletal muscle, tone is comprised of
both ‘‘active’’ (contractile) and ‘‘passive’’ (viscoelastic) components.46,77,78 FN32

a. Hypertonicity is a general increase in muscle tone that can be associated with either elevated contractile activity and/or
passive stiffness in the muscle.5,77–79 FN33
b. Hypotonicity is a general decrease in muscle tone that can be associated with either reduced contractile activity and/or
passive stiffness in the muscle.FN34 As the cause is often unknown, the terms neurogenic hypotonicity and non-neurogenic
hypotonicity are recommended.

FN31
Varying reliability has been found from pelvic floor muscle (PFM) studies assessing pain and tension using digital palpation scales.73–76Patients who present
with alteration in the musculoskeletal structure need to be referred to a Physical Therapist well trained in the treatment of CPPS.
FN32
Muscle tone is evaluated clinically as the resistance provided by a muscle when a pressure/deformation or a stretch is applied to it46,77,78Muscle tone may be
altered in the presence or absence of pain. There is no single accepted or standardized way of measuring muscle tone, and there are no normative values.
FN33
As ‘‘hypertonicity’’ can also be used to describe increased muscle tone of neurogenic origin, the term ‘‘increased tone’’ is preferred when the cause is non-neurogenic.
FN34
As ‘‘hypotonicity’’ can also be used to describe decreased muscle tone of neurogenic origin, the term ‘‘decreased tone’’ is preferred when the cause is non-
neurogenic.

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2. Stiffness: Stiffness is the resistance to deformation.80,81 FN35
3. Compliance: Passive compliance is defined as the reciprocal of muscle stiffness.80,81 FN36
4. Tension: may have a similar meaning to tone and stiffness.FN37
5. Spasm: persistent contraction of striated muscle that cannot be released voluntarily.82 FN38

a. Contracture: is an involuntary tightening of a muscle. Clinically, a muscle cramp and contracture may appear similar,
however contractures are electrically silent.83

6. Cramp: a muscle cramp is a painful involuntary muscle contraction that occurs suddenly and can be temporarily
debilitating.83,84 FN39
7. Fasciculation: A fasciculation is a single, spontaneous, involuntary discharge of an individual motor unit.83 FN40
8. Tender point: tenderness to palpation at soft tissue body sites.46
9. Trigger point (TrP): a tender, taut band of muscle that can be painful spontaneously or when stimulated.85 The taut band is
electrically silent. Local or referred pain may be reproduced.86 FN41

VI Neurological Aspects4
1. Tenderness on palpation corresponding to the nerve distribution.
2. Pain mapping (reproduce pain on palpation).
3. Identify referred pain by palpation.
4. Possible skin changes (color, blistering, temperature).

VII Psychological Aspects

Observation by the provider may reveal:
1. Anxiety and/or depressed mood, and avoidance or reduction of activities which exacerbate pain, or are believed by the
patient to carry a risk of increasing the pain or causing harm.
2. Expression of helplessness and hopelessness (feeling of despair and representing ‘the internal belief that one cannot
manage one’s pain’).18,54

VIII Sexual Aspects (59)

A patient with sexual pain often has one or more other sexual dysfunctions including desire disorder, arousal disorder or
orgasm disorder.
In most cases the physical examination will not identify the specific etiology of sexual dysfunction. However, a focused and
comprehensive pelvic examination in females and males is mandated. In addition, assessment of the secondary sexual
characteristics should be performed.60 FN42 For the specific assessment, see the relevant Domains.

Section 3: Further Evaluation

Pain Evaluation and Measurement (7)
Pain rating(s) are essential in patient evaluation, including; Baseline and ongoing regular evaluation of severity, quality of life,
questions about thoughts, emotions and behavior associated with the pain (questionnaires).
Pain Measurement
1. One of the most commonly used tools is the visual analogue scale (VAS)(85), which is a 10 cm line from ‘‘0’’ no pain to ‘‘10’’
extreme pain.5 FN43

0 1 2 3 4 5 6 7 8 9 10
No pain Extreme pain
Not unpleasant Extremely unpleasant

FN35
Passive elastic stiffness is defined as the ratio of the change in the passive resistance or passive force (DF) to the change in the length displacement (DL) or DF/
DL.81 The term should only be used if stiffness is measured quantitatively such as with instruments like dynamometry or myotonometry.
FN36
It represents the compressibility of a muscle, clinically assessed by pressing a finger into it (palpation) to determine how easily it is indented and how ‘‘springy’’ it is.
FN37
Muscle tension can be increased or decreased due to exogenous factors such as the amount of pressure applied and endogenous factors such as thickness/ cross
sectional area of the muscle itself, fluid present within the muscle (swelling, inflammation), position (e.g., standing vs. sitting) or increased neural activity.
FN38
Occurs at irregular intervals with variable frequency and extent. Spasm over days or weeks may lead to a contracture.
FN39
Pain is intense and localized. It tends to occur when the muscle is in the shortened position and contracting, is generated by the motor unit, and displays a high
firing rate (20–150 Hz).83 Muscle cramp either during or immediately after exercise is commonly referred to as ‘‘exercise- associated muscle cramping.’’84 However,
cramps are not specific to exercise.
FN40
The source generator is the motor unit or its axon, prior to its terminal branches. Fasciculations display an irregular firing pattern of low frequency (0.1–10 Hz).83
Clinically, fasciculations are recognized as individual brief twitches. They may occur at rest or after muscle contraction and may last several minutes.
FN41
An active TrP is said to have a characteristic ‘‘twitch’’ response when stimulated; however, the twitch response to palpation has been shown to be unreliable.
The most reliable sign of a TrP is sensitivity to applied pressure.86
FN42
Blood pressure, heart rate, peripheral pulses, edema, lower extremity strength, and vibratory sensation is almost always helpful.60
FN43
A simple verbal rating scale can also be used, for example, ‘‘none,’’ ‘‘mild,’’ ‘‘moderate,’’ ‘‘severe.’’

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2. Pain Mapping Utilizing a Pain Body Chart87 FN44

Pain evaluation involves additional pain mapping by identifying pain generators through diagnostic procedures.FN45 These
include EMG, Q-tip touch sensitivity testing,88,89 trigger point injections, nerve blocks and imaging.88 FN46

I Lower Urinary Tract

A. QuestionnairesFN47
a. Voiding diary with volume intake and output for 3 days at initial evaluation. Patient sensation at voiding might be
recorded. At follow-up only the number of voids during day and night time is necessary. Morning volume might be
recorded as a help to monitor highest functional capacity.90
b. Basic symptom severity Questionnaires (condition specific):
i. The O’Leary–Sant Symptom Index.91
ii. International Prostate Symptom Score.92

c. Visual Analogue Scale (VAS)87 or a Likert scale for pain during the last 24 hr and over the last month (to fit with the voiding
diary).FN48

B. Laboratory Testing
a. Urine Dipstick (red blood cells, pH, leucocytes, nitrite).
b. Urine Culture.FN49
c. Urine Cytology in high risk patients.
d. Investigations for Ureaplasma and Chlamydia are optional.

FN44
Patients color the pain sites on the body chart.
FN45
As pain is multidimensional, it can be helpful to assess separately pain intensity, pain distress, and interference of pain with activities of daily life.
FN46
Kaufman Q-tip touch sensitivity test. This involves touching all four quadrants of the vulvar and vestibular Skene’s gland ostia to evaluate for vestibulodynia,
using a visual analog scale to document the level of pain and sensitivity the patient is experiencing.89
FN47
Many of the questionnaires have not been studied and validated in patients with CPPS. The main assessment is still a thorough history and a full and accurate
physical examination followed by pain mapping and other studies as indicated.
FN48
Separate scores for the average, mildest and worst pain might be obtained.
FN49
If sterile pyuria, culture for tuberculosis, in high risk patients.

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e. C.T. Urogram for Hematuria.

C. Intravesical Anesthetic Challenge

An Anesthetic Challenge may be useful in pain mapping to identify the bladder and/or the urethra as a pain generator.93 FN50

D. Urodynamic Evaluation (1)

a. Flowmetry and Post-void Residual
b. Filling Cystometry94,95 FN51
c. Pressure-Flow Study

It is recommended to perform filling cystometry and pressure flow study if the flowmetry suggests voiding dysfunction. The
demonstration of pain may identify the bladder and/or urethra as a pain generator.
In males, bladder outlet obstruction might be a differential diagnosis96 and it is recommended to perform flowmetry in all males
and consider pressure-flow studies. In males with a peak flow below 20 ml/second. In females, flowmetry and post void residual
urine volume should be considered, and pressure-flow study is optional.

E. Cystoscopy
Needs to be done for patients with hematuria97 and to identify Hunner lesions.

a. ESSIC standardized the procedure for cystoscopy and hydrodistension.11 FN52

Cystoscopic findings by hydrodistension are important in subclassification of IC/BPS, see for example the ESSIC
classification.11,31,98,99 FN53
i. Glomerulation
During cystoscopy with hydrodistension, glomerulations, with or without waterfall lesions (blood trickling downwards),
may often be observed.100 FN54
ii. Hunner Lesion Figure 1

A Hunner lesion is not an ulcer, but an inflammatory infiltrate.11,101 FN55

i. Morphologic findings in Hunner Lesion

1. Inflammatory infiltrate on examination of biopsy taken with electro-resection or by cold cup biopsy.
2. Lymphocyte-like cells dominate in the infiltrate, but neutrophilic and eosinophilic granulocytes as well as plasma cells and
mast cells are also found.
3. Perineural and perivascular arrangement of lymphocyte-like cell infiltrates
4. Granulation tissue.101–104 FN56

F. Differential Diagnosis (Confusable, treatable diseases):

Criteria for diagnosis are needed as the target disease may be confused with other treatable diseases (confusable diseases)
because of similar features.11
a. Ketamine Cystitis

FN50
A solution of lidocaine and sodium bicarbonate administered intravesically results in reduction of pain. Alkalinized lidocaine instillation has not been validated,
but may be useful.93
FN51
The NIDDK criteria excluded patients with detrusor overactivity at filling cystometry in order not to confuse the picture in clinical trials.94 However, this does
not mean that detrusor overactivity cannot coexist with interstitial cystitis/bladder pain syndrome. In the interstitial cystitis database, approximately 14% of IC/BPS
patients had detrusor overactivity.95
FN52
A rigid cystoscope is preferred to facilitate taking adequate biopsies. Glycine or corresponding filling fluid should be used to allow for coagulation after biopsies. Infusion
height should be approximately 80 cm above the Symphysis Pubis. A dripping chamber is used and the bladder is filled until fluid dribbling stops. If necessary, a digital block is
applied around the urethra to prevent leakage. Pre-distension inspection includes observation for radiating vessels, coagulum or fibrin deposits, white spots, hyperaemia, edema,
cracks, scars or any other mucosal changes. Continuous inspection while filling the bladder is advised. When maximum capacity is reached, the distension is maintained for 1–
3 min. The bladder is emptied and the color of the fluid checked for the degree of bleeding. The total volume drained is the measured maximum bladder capacity. During a second
filling, the bladder is filled to approximately 1/3rd to 2/3rds of the bladder capacity to achieve optimal vision for inspection and biopsies. The bladder should not be filled to
maximum capacity or distended again to avoid further provocation of changes with doubtful reproducibility.33
FN53
The finding of a Hunner lesion is important because effective treatment is available.98,99The presence of Hunner lesions may be the diagnostic finding of the
proposed disease ‘‘Interstitial Cystitis.’’31
FN54
The significance of the presence of glomerulation remains to be determined.100
FN55
A Hunner lesion is a distinct cystoscopic finding and typically presents as a circumscript, reddened mucosal area with small vessels radiating towards a central
scar, with a fibrin deposit or coagulum attached to this area. This site ruptures with increasing bladder distension, with petechial oozing of blood from the lesion and
the mucosal margins in a waterfall manner. A rather typical edema may develop post-distension with varying peripheral extension. Usually, lesions are multiple but
occasionally they may be single. It is not unusual for more lesions to be detected at re-inspection than seen at the initial phase of distension.11
FN56
To a large extent, the detection rate and the findings on distribution of mast cells have been dependent on laboratory routines and staining as well as fixation
techniques. Tryptase staining methods provide a stable result that is not sensitive to laboratory variations.103,104

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Fig. 1. Hunner lesion.

Ketamine Cystitis is a new condition not previously described. Caused by recreational ketamine abuse, ketamine cystitis
includes increased voiding, frequency, dysuria, bladder pain and hematuria.105,106 FN57

II Female Genital

A. Vulva, Vestibule and Clitoris

1. Questionnaires
i. Visual Analog Scale for pain.86
ii. Female Sexual Function Index (FSFI).61
iii. Female Sexual Distress Scale (FSDS).107

2. Laboratory Testing
i. Culture.
ii. Biopsy.

3. Diagnostic Testing
i. Vulvoscopy, with or without biopsy.
ii. Quantitative Sensory Testing (Q-tip touch sensitivity test).72,89,108

B. Intra-abdominal Female Genital

1. Questionnaires
i. Visual Analog Scale(85) for pain.

2. Laboratory Testing
i. Culture.
ii. Complete blood count.

3. Laparoscopy (with or without biopsy)

4. Ultrasound (US)
5. MRI
6. Venography (to rule out Pelvic Congestive Syndrome)109

C. Pelvic Floor Muscle

1. Questionnaires.
i. Visual Analog Scale for pain.86
ii. Pelvic Floor Distress Inventory (PFDI).110

FN57
The molecular mechanism for ketamine-induced cystitis is unknown. The affected bladder exhibits a denudation of the urothelium with inflammatory cell
infiltration. The upper urinary tract is also damaged in patients who use a higher dose and with a longer duration. Attention by both medical organizations and
social workers for this increasing social phenomenon particularly among young people is now urgently needed.105,106

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iii. Prolapse and Incontinence Sexual Questionnaire (PISQ).111

2. Laboratory Testing
i. Wet Mount, Culture.
ii. Biopsy.

3. Imaging References
i. Ultrasound (4D if available for visualization of mesh, where applicable).
ii. MRI (with or without defecography).
iii. Defecography.

III Male Genital

A. Prostate Pain
1. Quantitative assessments.
i. Bladder diary.90,112
ii. CPSI (Chronic Prostatitis Symptom Index).113
iii. Visual Analog Scale for Pain (VAS).86

2. Laboratory Testing
i. Urinalysis (including post prostate massage).
ii. Urine Culture post prostate massage.
iii. Semen Culture.

3. Uroflowmetry, Post voiding residual volume, pressure flow study

4. Cystoscopy
5. Ultrasonography, with or without biopsy.

B. Scrotum, Epididymis, Testicle, Penis

1. Quantitative assessments
i. VAS for Pain.86
2. Ultrasonography

C. Urethra Pain
1. Quantitative assessments
i. Bladder diary.
ii. VAS for Pain.86

2. Laboratory Testing
i. Urinalysis (including post prostate massage, Ureaplasma/Chlamydia as appropriate).

3. Urethroscopy/Urethrography
4. Ultrasonography

D. Sexual Pain (See Domain VIII)

1. Questionnaires
i. VAS for Pain.86
ii. International Index of Erectile Function (IIEF).114

IV Gastro-Intestinal (40)
1. Questionnaires
i. Rome III Criteria Questionnaire.115
ii. Colorectal Rectal Distress Inventory.116

2. Laboratory Testing
i. Culture.

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ii. Stool Evaluation for ova and parasites.
iii. Antibody testing.
iv. Biopsy.

3. Diagnostic Testing
i. Anorectal Manometry (paradoxical contraction of the pelvic floor muscles when instructed to strain during
defecation).
ii. Rigid or flexible endoscopy (Anorectal sigmoidoscopy) with or without biopsy.
iii. Anorectal/Pelvic US, 3D.
iv. Barium Enema.
v. CT Scan, Defecography, MRI defecography.

V Musculoskeletal117
1. Questionnaires
i. McGill Pain Questionnaire.118
ii. Pelvic Floor Distress Inventory (PFDI).110
iii. Female Sexual Function Index (FSFI).61
iv. Female Sexual Distress Scale (FSDS).107

2. Pain Location Drawing (Pain Mapping)

i. Pain Chart body map.87

3. Evaluation of Muscle Tension There is no single tool which is able to measure all components of muscle tone. Some tools
may be able to measure aspects of tone such as contractility, stiffness or elasticity. Instrumented methods may have a role
in the valid and reliable evaluation of muscle tone, for example, surface electromyography, dynamometry, real-time
ultrasound, elastometry, myotonometry.
i. Pressure manometry is the measurement of resting pressure or pressure rise generated during contraction of the
pelvic floor muscles using a pressure device (a manometer) inserted into the urethra, vagina or anus.119,120 FN58
ii. Surface electromyography (sEMG) refers to the bioelectrical activity generated by muscle fibres.121,122 FN59
iii. Dynamometry is the measurement of pelvic floor muscle resting and contractile forces using strain gauges
mounted on a speculum (a dynamometer), which is inserted into the vagina.123
iv. Real-time ultrasound measures pelvic floor muscle morphology and function via a non-invasive (trans-abdominal
or trans-perineal) probe.124 FN60
v. Elastometry measures the elasticity of a tissue.125 FN61

4. Trigger point injection or needling has been used as a diagnostic test to identify pain generators.125 FN62

5. Imaging
i. X-Ray.
ii. Ultrasound.
iii. MRI.

VI Neurological Aspects

A. Neuropathic Pain Questionnaires

1. VAS Pain Score.86
2. Pain DETECT (Validated for CPPS evaluation).129
3. Leeds Assessment for neuropathic symptoms and signs (not validated for chronic pelvic pain).130
4. Douleur Neuropathique 4 Questionnaire.131

FN58
The tool has been used as an outcome measure in intervention studies of pelvic floor pain.119,120 However, the tool has not been tested for reliability in this population.
FN59
Pelvic floor muscle surface electrodes use either flat interface perineal electrodes or intra-vaginal/intra-anal probes to record sEMG either at rest or during a PFM
contraction. Surface EMG is considered to be non-specific to the PFM. Because of the large surface area covered by the electrode, cross-talk from adjacent muscles
often occurs.121,122 It is therefore not considered reliable as a measure.
FN60
Trans-perineal measures of ano-rectal angle and levator plate angle have been tested for reliability in a male pelvic pain population.124Therefore, this tool shows
promise as an instrumented method to evaluate pelvic floor muscle changes in pelvic pain.
FN61
It has recently been applied to measure the passive stiffness of puborectalis in asymptomatic women and shown to be reliable in this pilot study125However, it
requires testing to establish application in a pelvic pain cohort.
FN62
The taut band(s) of sarcomeres within the TrP can be identified by ultrasonography.126 and magnetic resonance elastography.127 A tissue compliance meter
which measures stiffness in the taut band has been shown to confirm the hardness of the discrete band of muscle that harbors the tender region in peripheral
skeletal muscle.128

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B. Quantitative Sensory Testing
1. 1Q-tip touch sensitivity.
2. Sensory pain mapping.72
3. Reflex evaluation.
4. Electromyography.

C. Nerve Blocks
1. May/may not be done under Computed Tomography, Ultrasound or EMG guidance.132,133

D. Imaging
1. Ultrasound
2. Magnetic resonance Imaging (MRI)

VII Psychological Aspects18,54

The chief purpose of psychological assessment is to get a complete picture of the pain syndrome with all affected dimensions:
somatic, affective, cognitive and behavioral, and the individual consequences for the patient. Direct questioning about the
patient’s view of what is wrong or what worries him/her is more helpful than questionnaires.FN63
1. Questionnaires
i. SF-12 or SF-36.134
ii. Brief Pain Inventory.135
iii. Catastrophizing Questionnaire can be considered in certain cases.136

VIII Sexual Aspects

1. Questionnaires.
i. Female Sexual Function Index (FSFI).61
ii. Female Sexual Distress Scale (FSDS).107
iii. International Index of Erectile Function (IIEF).137

2. Laboratory Testing
i. Hormone Panel.
ii. Complete Metabolic Panel.
iii. Culture.

3. Imaging
i. Doppler US to assess blood flow.

It is also particularly important to work up the partner’s potential sexual dysfunction. Early referral to a sexual counsellor is
optimal.

IX Evaluation of Comorbidities
If patients have symptoms and signs of comorbidities, evaluation should be undertaken according to relevant guidance, and
may be appropriate to refer to the relevant specialist.

SUMMARY
This first ICS Standard for Terminology in Chronic Pelvic Pain Syndromes aims to improve understanding of these syndromes
and patient diagnosis. It is hoped that this will help develop the field, through facilitating phenotyping of patients, development of
pertinent animal models and new preclinical development of therapeutic strategies.
Evaluation of patients based on the nine domains should be individualized, taking into consideration the patient’s personal
perception of pain, and also the biopsychosocial aspects of CPPS.
Discussions on nomenclature partly focused on the risk of inadequate patient care if diagnostic terminology is changed without taking
into account the practical impact of its application on the patient’s access to appropriate treatment, reimbursement, and social benefits.
This Standard for Terminology in CPPS will be reviewed in the future as continuing research, such as the Multidisciplinary Approach to
the Study of Chronic Pelvic Pain (MAPP) Research Network, generates new insights.138–140 Working with the guideline bodies, such as the
AUA, East Asian IC Study Group/SICJ, EAU, ESSIC, FGIDS, and IASP, the ultimate aim should be to achieve international consensus.

CONSULTANTS
Ursula Wesselmann, Professor of Anesthesiology and Neurology, University of Alabama, Birmingham, AL, USA. Peter Rosier,
Department of Urology, University Medical Center Utrecht, Utrecht, Netherlands. Fernando Cervero, Anaesthesia Research Unit,

FN63
Early referral to a psychological healthcare provider should be considered. Patients with sexual dysfunction may need sexual counseling.

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McGill University, Montreal, QC, Canada. Alain Watier, Gastroenterology, Sherbrooke, QC, Canada. Kari Bø, Professor of Physical
Therapy, Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.
Any products/companies referred to in this document are not necessarily recommended or endorsed by the ICS.

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Neurourology and Urodynamics 35:137–168 (2016)

An International Urogynecological Association

(IUGA) / International Continence Society (ICS)
Joint Report on the Terminology for Female
Pelvic Organ Prolapse (POP)
Bernard T. Haylen,1,2* Christopher F. Maher,1,2 Matthew D. Barber,2 Se rgio Camargo,2
Vani Dandolu,2 Alex Digesu,2 Howard B. Goldman,2 Martin Huser,2 Alfredo L. Milani,2
Paul A. Moran,1,2 Gabriel N. Schaer,1,2 and Mariëlla I.J. Withagen2
1
Standardization and Terminology Committees IUGA & ICS
2
Joint IUGA / ICS Working Group on Female POP Terminology

Introduction: The terminology for female pelvic floor prolapse (POP) should be defined and organized in a clinically-
based consensus Report. Methods: This Report combines the input of members of two International Organizations, the
International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted at intervals
by external referees. Appropriate core clinical categories and a sub-classification were developed to give a coding to
definitions. An extensive process of fourteen rounds of internal and external review was involved to exhaustively examine
each definition, with decision-making by collective opinion (consensus). Results: A Terminology Report for female POP,
encompassing over 230 separate definitions, has been developed. It is clinically-based with the most common diagnoses
defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the
different specialty groups involved in female pelvic floor dysfunction and POP. Female-specific imaging (ultrasound,
radiology and MRI) and conservative and surgical managements are major additions and appropriate figures have been
included to supplement and clarify the text. Emerging concepts and measurements, in use in the literature and offering
further research potential, but requiring further validation, have been included as an appendix. Interval (5-10 year)
review is anticipated to keep the document updated and as widely acceptable as possible. Conclusion: A consensus-
based Terminology Report for female POP has been produced to aid clinical practice and research. Neurourol. Urodynam.
35:137–168, 2016. # 2016 Wiley Periodicals, Inc., and The International Urogynecological Association

Key words: female; pelvic organ prolapse; standardization report; terminology report

INTRODUCTION
Prolapse (Latin: Prolapsus – ‘‘a slipping forth’’) refers to a falling, slipping or downward displacement of a part or organ. Pelvic
organ refers most commonly to the uterus and/or the different vaginal compartments and their neighboring organs such as
bladder, rectum or bowel. Pelvic organ prolapse (POP) is thus, primarily, a definition of anatomical change. Some such changes
may well be considered within the range of normality for certain women. A diagnosis of POP ideally demands clear clinical
evidence, starting with a woman having symptoms related to the ‘‘downward displacement’’ of a pelvic organ.
There is currently no single document encompassing all elements required for diagnoses in the area of female POP. Such a report
would require a full outline of the terminology for symptoms, signs, clinical assessments, functional investigations for female POP,
the imaging associated with those investigations, the most common diagnoses and terminology for the different conservative and
surgical treatment modalities.

Bernard T. Haylen, University of New South Wales, Sydney. N.S.W. Australia. bernard@haylen.co
Christopher F. Maher, University of Queensland. Brisbane. Australia. chrismaher@urogynaecology.com.au
Matthew D. Barber, Cleveland Clinic, Cleveland. Ohio. U.S.A. barberm2@ccf.org
Sergio FM Camargo, Hospital Presidente Varga, Porto-Alegre-RS. Brazil. sergiocamargo47@gmail.com
Vani Dandolu, University of Nevada, Las Vegas. U.S.A. vdandolu@medicine.nevada.edu
Alex Digesu, St Mary’s Hospital, London. United Kingdom. a.digesu@imperial.ac.uk
Howard B Goldman, Cleveland Clinic, Cleveland. Ohio. U.S.A. goldmah@ccf.org
Martin Huser, Brno University Hospital, Brno. Czech Republic. martin.huser@gmail.com
Alfredo L. Milani, Reinier de Graaf Gasthuis, Delft. Netherlands. fredmilani@me.com
Paul A. Moran, Worcestershire Royal Hospital, Worcester. United Kingdom. moranpa@doctors.org.uk
Gabriel N. Schaer, Kantonsspital, Aarau. Switzerland. Gabriel.Schaer@ksa.ch
Mariëlla I.J.Withagen, University Medical Centre, Utrecht. Netherlands. m.i.j.withagen@umcutrecht.nl
DISCLOSURES: BT Haylen: No disclosures; CF Maher: No disclosures; MD Barber: No disclosures; SFM Camargo: No disclosures; V Dandolu: Research grant–Allegan,
Consultant-Pfizer; A Digesu: Honorarium for lectures or sponsorship to cover travel expenses at Meetings from: Astellas, Pfizer, Allergan, AMS, Medtronic, Uroplasty; HB
Goldman: Consultant – Allergan, Medtronic, Uroplasty; Speaker – Astellas, Allergan, Medtronic, Uroplasty; M Huser: No disclosures; AL Milani: No disclosures; PA
Moran: Speaker & consultant: Astellas and Ethicon Women’s Health and Urology. Consultant: Boston Scientific. GN Schaer: Advisor (in Switzerland) for Astellas,
Novartis, Pfizer; MIJ Withagen: Research Grant 2010–Ethicon Women’s Health & Urology

Correspondence to: Associate Professor B.T. Haylen, Suite 904, St Vincent’s Clinic, 438 Victoria Street, Darlinghurst. 2010. Ph: ## 61 - 2 - 83826983, Fax: ## 6 1- 2 - 83826984.
N.S.W. AUSTRALIA. bernard@haylen.co
Published online 7 January 2016 in Wiley Online Library (wileyonlinelibrary.com).
DOI 10.1002/nau.22922

# 2016 Wiley Periodicals, Inc., and The International Urogynecological Association

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There will be a need to reference considerably the 2010 IUGA-ICS Joint Terminology Report on Female Pelvic Floor Dysfunction1.
An original aim of that report1 had been to provide a general terminology, forming a ‘‘backbone’’ or ‘‘core’’ terminology to which
more specific terminologies can be attached. Reference can also be made to three other published Standardization Reports2–4 and
6 joint IUGA-ICS Female Terminology Reports5–10 subsequent to the 2010 Report1, three published5–7, three8–10 advanced in
development.
In terms of the previous standardization document on female POP4, now 20 years old, there has been much discussion and
debate11–14 on the possible need to update its classification POP-Q, or at least to present it in a refreshed version. The POP Working
Group has opted for the latter, with major upgrades to symptoms, signs, investigations and diagnoses, but a conservative approach
to the classification itself (apart from adding a validated simplified version), due to the longevity of its use and the lack of any
validated, clearly superior alternative classification. Female-specific imaging (ultrasound, radiology and MRI) and conservative and
surgical managements are major additions and appropriate figures have been included to supplement and clarify the text.
Emerging concepts and measurements, in use in the literature and offering further research potential, but requiring further
validation, have been included as an Appendix. This Report acknowledges that POP is often not a diagnosis in isolation but may be
associated with POP-related and unrelated voiding, defecatory and/or sexual dysfunctions and/or other diagnoses of pelvic floor
dysfunction.
This Terminology Report is inherently and appropriately a definitional document, collating the definitions of those terms, i.e.
‘‘words used to express a defined concept in a particular branch of study’’15, here POP. Emphasis has been on comprehensively
including those terms in current use in the relevant peer-reviewed literature. The aim is to assist clinical practice and research.
Some new and revised terms have been included. Explanatory notes on definitions have been referred, where possible, to the
‘‘Footnotes’’ section.
Like all the other joint IUGA-ICS female-specific terminology reports, every effort has been made to ensure this Report is:
(1) User-friendly: It should be able to be understood by all clinical and research users.
(2) Clinically-based: Symptoms, signs and validated assessments/investigations should be presented for use in forming
workable diagnoses for POP and associated dysfunctions. Sections 1-5 will address symptoms, signs, POP quantification,
investigations for associated dysfunctions and current POP imaging modalities that may be used to make those diagnoses. A
number of related radiological investigations including Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT)
have also been incorporated. Section 6 will address POP diagnoses, possible POP-related diagnoses and co-existing diagnoses. The
scope of the Report will exclude more invasive investigations requiring an anesthetic. Sections 7 and 8 will list the terminology for
evidence-based conservative and surgical treatments for POP.
(3) Origin: Where a term’s existing definition (from one of multiple sources used) is deemed appropriate, that definition will be
included and duly referenced. A large number of terms in female pelvic floor prolapse and dysfunction, because of their long-term
use, have now become generic, as apparent by their listing in medical dictionaries.
(4) Able to provide explanations: Where a specific explanation is deemed appropriate to describe a change from earlier
definitions or to qualify the current definition, this will be included as an addendum to this paper (Footnote [FN] 1,2,3. . . .).
Wherever possible, evidence-based medical principles will be followed.
It is suggested that acknowledgement of these standards in written publications related to female POP, be indicated by a
footnote to the section ‘‘Methods and Materials’’ or its equivalent, to read as follows: ‘‘Methods, definitions and units conform to
the standards jointly recommended by the International Urogynecological Association and the International Continence Society
except where specifically noted’’.

SECTION 1: SYMPTOMS:
Symptom: Any morbid phenomenon or departure from the normal in structure, function or sensation, experienced by the
woman and indicative of disease or a health problem16. Symptoms are either volunteered by, or elicited from the woman or may be
described by the woman’s caregiver1–3.

1
: In the era of advanced cellphone camera technology, a woman, at times, will bring photographic evidence of the prolapse at its worst. This can add to other
clinical evidence, particularly if there is a discepancy between symptoms and signs.
2
: The more formal classification of constipation is as follows:
Rome II diagnostic criteria for constipation:

• At least 12 weeks, which need not be consecutive, in the previous 12 months, of two or more of:
(i) Straining in > 1 in 4 defecations.
(ii) Lumpy or hard stools in > 1 in 4 defecations.
(iii) Sensation of incomplete evacuation in > 1 in 4 defecations.
(iv) Sensation of anorectal obstruction/ blockage in > 1 in 4 defecations.
(v) Manual manoeuvres to facilitate > 1 in 4 defecations (e.g: digital evacuation, support of the pelvic floor).
(vi) Less than 3 defecations per week.
• Loose stools are not present and there is insufficient evidence for IBS (irritable bowel syndrome)

3
: A symptomatic-based subdivision of Stage II (see Appendix A) was overlooked at this time in favor of maintaining the current strictly anatomical definition of the
‘‘sign of POP’’.

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Pelvic Organ Prolapse (POP) Symptoms
Prolapse symptoms1: A departure from normal sensation, structure or function, experienced by the woman in reference to the
position of her pelvic organs. Symptoms are generally worse in situations when gravity might make the prolapse worse (e.g. after
long periods of standing or exercise) and better when gravity is not a factor e.g. lying supine. Again symptoms may be more
noticeable at times of abdominal straining e.g. defecation.

A: Vaginal Prolapse Symptoms

(i) Vaginal bulging1: Complaint of a ‘‘bulge’’, lump or ‘‘something coming down’’ or ‘‘falling out’’ through the vaginal introitus.
The woman may state she can either feel the bulge by direct palpation or see it, perhaps aided with a mirror. FN1
(ii) Pelvic pressure1: Complaint of increased heaviness or dragging (pain or discomfort) in the suprapubic area and/or pelvis.
(iii) Bleeding, discharge, infection1: Complaint of abnormal vaginal bleeding, discharge or infection which may be related to
ulceration of the prolapse.
(iv) Splinting / Digitation1: Complaint of the need to digitally replace the prolapse or to otherwise apply manual pressure, e.g. to
the vagina, perineum or perianal area (splinting), or rectally (digitation) to assist voiding or defecation.
(v) Low backache1 (POP-related): Complaint of low, sacral (or ‘‘menstrual-like’’) backache associated temporally with vaginal POP
and relieved when prolapse is reduced.

B: Urinary Tract Prolapse Symptoms

(i) Urethral Prolapse: Complaint of a ‘‘lump’’ at the external urethral meatus.

C: Anorectal prolapse symptoms

(i) Anorectal prolapse: Complaint of a ‘‘bulge’’ or ‘‘something coming down’’ towards or through the anus/rectum. The woman
may state she can either feel the bulge by direct palpation or see it perhaps aided with a mirror. FN1
(ii) Rectal prolapse: Complaint of external protrusion of the rectum.

Effects of Pelvic Organ Prolapse on Bladder, Bowel and Sexual Function.

As demonstrated in Figure 1, higher stage utero-vaginal prolapse will usually cause anatomical distortion to surrounding organs,
bladder and rectum most commonly. This can lead to abnormal function, most commonly difficulty with bladder and bowel
emptying. Commonly, symptoms related to those surrounding organs are the most bothersome leading to the eventual diagnosis
of the POP.

Figure 1. Utero-vaginal prolapse.

D: Potential prolapse-related lower urinary tract symptoms:

(i) Hesitancy1: Complaint of a delay in initiating micturition.
(ii) Slow stream1: Complaint of a urinary stream perceived as slower compared to previous performance (particularly prior to the
development of POP) or in comparison with others.
(iii) Intermittency1: Complaint of urine flow that stops and starts on one or more occasions during voiding.
(iv) Straining to void1: Complaint of the need to make an intensive effort (by abdominal straining, Valsalva or suprapubic
pressure) to either initiate, maintain or improve the urinary stream.

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(v) Spraying (splitting) of urinary stream1: Complaint that the urine stream is a spray or split rather than a single discrete
stream.
(vi) Feeling of incomplete (bladder) emptying1: Complaint that the bladder does not feel empty after micturition.
(vii) Need to immediately re-void1: Complaint that further micturition is necessary soon after passing urine.
(viii) Post-micturition leakage1: Complaint of a further involuntary passage of urine following the completion of micturition.
(ix) Position-dependent micturition1: Complaint of having to take specific positions to be able to micturate spontaneously or to
improve bladder emptying e.g. leaning forwards or backwards on the toilet seat or voiding in the semi-standing position.
(x) Splinting to micturate: as above A (iv).
(xi) Dysuria1: Complaint of burning or other discomfort during micturition. Discomfort may be intrinsic to the lower urinary
tract or external (vulvar dysuria).
(xii) (Urinary) retention1: Complaint of the inability to pass urine despite persistent effort.
(xiii) Increased daytime urinary frequency1: Complaint that micturition occurs more frequently during waking hours than
previously deemed normal by the woman.
(xiv) Urgency1: Complaint of a sudden, compelling desire to pass urine which is difficult to defer.

E: Potential prolapse-related anorectal dysfunction symptoms1,8

(i) Constipation8: Complaint that bowel movements are infrequent and/or incomplete and/or there is a need for frequent
straining or manual assistance to defecate. FN2
(ii) Feeling of incomplete bowel evacuation1,8: Complaint that the rectum does not feel empty after defecation and may be
accompanied by a desire to defecate again.
(iii) Straining to defecate1,8: Complaint of the need to make an intensive effort (by abdominal straining or Valsalva) to either
initiate, maintain or improve defecation.
(v) Sensation of anorectal blockage8: Complaint suggestive of anorectal obstruction.
(vi) Splinting / Digitation1,8: Defined above in A (iv).
(vii) Fecal (rectal) urgency1,8: Complaint of a sudden compelling desire to defecate that is difficult to defer.
(viii) Post-defecatory soiling (NEW): Soiling occurring after defecation.

F: Potential prolapse-related Sexual dysfunction symptoms1,10,17:

(i) Dyspareunia: Complaint of persistent or recurrent painor discomfortassociatedwith attempted or completevaginal penetration.
(ii) Obstructed intercourse: Complaint that vaginal penetration is impeded. Possible causes include narrowing or a bulge.
(iii) Vaginal laxity: Complaint of excessive vaginal looseness.
(iv) Libido – loss or decrease: Complaint of loss or decrease of sexual desire

G: Other Possible Associated Symptoms1

1
(i) Urinary incontinence symptoms : Urinary incontinence (symptom); stress (urinary) incontinence; urgency (urinary)
incontinence; postural (urinary) incontinence; nocturnal enuresis; mixed (urinary) incontinence; continuous (urinary)
incontinence; insensible (urinary) incontinence; coital (urinary) incontinence.
(ii) Bladder storage symptoms1: nocturia; overactive bladder syndrome.
(iii) Bladder sensory symptoms1: Increased bladder sensation; reduced bladder sensation; absent bladder sensation.
(iv) Lower Urinary Tract Infection1: Urinary tract infection (UTI); recurrent urinary tract infections (UTIs); other related history.

H: More common POP-related symptoms: Table I gives a consensus view of the authors of the more common POP-related
symptoms

TABLE I. The symptoms that women with POP would more and most commonly  describe.

Potential prolapse-related symptoms

Vaginal prolapse Bulge sensation /visualization  , pelvic pressure  , low (sacral) backache

Urinary tract Frequency  , recurrent UTI  , incomplete emptying/urinary retention , slow stream

Ano-rectal Incomplete defecation  , digitation/splinting , rectal urgency , post-defecatory soiling

Sexual Dyspareunia , vaginal laxity

Other possible associated symptoms

Urinary incontinence  Stress, urge, postural, nocturnal, coital

Bladder storage Urgency, nocturia,

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SECTION 2: SIGNS
Sign: Any abnormality indicative of disease or a health problem, discoverable on examination of the patient; an objective
indication of disease16 or a health problem.
A: Signs of Pelvic Organ Prolapse: All examinations for POP should be performed with the woman’s bladder empty
(and if possible an empty rectum). An increasing bladder volume has been shown to restrict the degree of descent of the
prolapse18. The choice of the woman’s position during examination, e.g. left lateral (Sims), supine, standing or lithotomy is
that which can best demonstrate POP in that patient and which the woman can confirm as the maximal extent she has
perceived e.g. by use of a mirror or digital palpation. The degree of prolapse may be worse after a lengthy time in the upright
position. FN1
(i) Pelvic organ prolapse (anatomical definition of the sign of POP)1: The descent of one or more of the anterior vaginal wall,
posterior vaginal wall, the uterus (cervix) or the apex of the vagina (vaginal vault or cuff scar after hysterectomy). The presence of
any such sign should be correlated with relevant POP symptoms13,19-21, i.e., patient report of maximal prolapse. More commonly,
this correlation would occur at the level of the hymen or beyond19–21.
(ii) Pelvic organ prolapse – (POPQ) - (staging1,3,4):
Stage 0: No prolapse is demonstrated.
Stage I: Most distal portion of the prolapse is more than 1cm above the level of the hymen.
Stage II: The most distal portion of the prolapse is situated between 1 cm above the hymen and 1cm below the hymen. FN3. See
also Appendix.
Stage III: The most distal portion of the prolapse is more than 1cm beyond the plane of the hymen but everted at least 2cm less
than the total vaginal length.
Stage IV: Complete eversion or eversion at least within 2 cm of the total length of the lower genital tract is demonstrated.
(iii) Uterine/ cervical prolapse: Observation of descent of the uterus or uterine cervix.

Figure 2. Uterine Prolapse.

(iv) Anterior vaginal wall (compartment) prolapse: Observation of descent of the anterior vaginal wall (compartment). Most
commonly this might represent bladder prolapse (cystocele). Higher stage anterior vaginal wall prolapse will generally involve
descent of uterus or vaginal vault (if uterus is absent). Occasionally, there might be an anterior enterocele (hernia of peritoneum
and possibly abdominal contents), most commonly after prior reconstructive surgery.

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Figure 3. Anterior vaginal wall (compartment) prolapse.

(v) Posterior vaginal wall (compartment) prolapse: Observation of descent of the posterior vaginal wall. Commonly, this would
represent rectal protrusion into the vagina (rectocele). Higher stage posterior vaginal wall prolapse after prior hysterectomy will
generally involve some vaginal vault (cuff scar) descent and possible enterocele formation. Enterocele formation can also occur in
the presence of an intact uterus.

Figure 4. Posterior vaginal (compartment) wall prolapse.

(vi) Vaginal vault (cuff scar) prolapse: Observation of descent of the vaginal vault (cuff scar after hysterectomy).

Figure 5. Vaginal vault prolapse.

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B: Clinical Staging4:
Each aspect of POP, uterine (cervical) prolapse, anterior vaginal wall (compartment), posterior vaginal wall (compartment),
vaginal vault (cuff scar) prolapse can and should be subject to a clinical staging.

Figure 6. shows prolapse staging4 – 0, I, II, III, IV. (uterine – by the position of the leading edge of the cervix).

C: Supplementary Physical Examination Techniques

(i) Digital rectal-vaginal examination4: While the patient is straining and the prolapse is maximally developed. The aim is to try
to differentiate between a high rectocele and an enterocele.
(ii) Q-tip (urethral) testing4: Measurement of urethral axial mobility at rest and straining to assess degree of mobility.

D: Clinical Assessment of Associations of POP

(i) Levator Defects / Trauma22: Per-vaginal palpation for levator injury/defect/ ‘‘avulsion’’.
(ii) Uterine retroversion23,24: (Turning backward) The axis of the uterus is directed backwards towards the hollow of the sacrum,
away from its anteverted position overlying the bladder. Cervix is noted in/ towards the anterior fornix with fundus perhaps
palpable in the posterior fornix. FN4

E: Other Possible Signs.

(i) Urinary incontinence signs1: Urinary incontinence; stress (urinary) incontinence; urgency (urinary) incontinence;
extraurethral incontinence; stress incontinence on prolapse reduction (occult or latent stress incontinence)
(ii) Other pelvic examinations/signs1: Vulvar examination; urethral inspection/palpation (urethral mucosal prolapse, urethral
caruncle; urethral diverticulum); vaginal examination; bimanual pelvic examination; pelvic floor muscle function (normal pelvic
floor muscles, overactive pelvic floor muscles, underactive pelvic floor muscles, non-functioning pelvic floor muscles); examination
for levator (puborectalis) injury; perineal examination (perineal elevation, perineal descent); rectal examination (anal sphincter
tone and strength, anal sphincter tear, fecal impaction present/absent, other rectal lesions, anal lesions, other perianal lesions),
vaginal atrophy.
(iii) Other relevant examinations/Signs1: Neurological signs, abdominal signs (bladder fullness/retention; abdominal masses or
distension; scars from previous relevant surgery or trauma; renal tenderness or masses).
(iv) Frequency volume chart / Bladder diary1
(v) Pad testing1

SECTION 3: PROLAPSE QUANTIFICATION

A: Pelvic Organ Prolapse Quantification (POP-Q)4

(i) Fixed Point of Reference. The hymen is the fixed point of reference used throughout the POP-Q system of quantitative prolapse
description.

4
: The axis of the retroverted uterus is parallel to that of the vaginal axis with less impediment to uterine (cervical) descent. In contrast, the anteverted uterus is
perpendicular to the vaginal axis with impediment to descent by the posterior vaginal wall and behind that the rectum.

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(ii) Defined Points. The anatomic position of the six defined points (two on the anterior vaginal wall, two in the superior vagina,
and two on the posterior vaginal wall) for measurement should be centimeters (cm) above or proximal to the hymen (negative
number) or cm below or distal to the hymen (positive number) with the plane of the hymen being defined as zero (O). For example,
a cervix that protruded 3 cm distal to the hymen would be þ 3 cm. All points are measured on maximal straining (except total
vaginal length).
(iii) Anterior Vaginal Wall.
(a) Point Aa. A point located in the midline of the anterior vaginal wall three (3) cm proximal to the external urethral meatus.
By definition, the range of position of Point Aa relative to the hymen is -3 to þ 3 cm.
(b) Point Ba. A point that represents the most distal (i.e., most dependent) position of any part of the upper anterior vaginal wall
from the vaginal cuff or anterior vaginal fornix to Point Aa. By definition, Point Ba is at �3 cm in the absence of prolapse and would
have a positive value equal to the position of the cuff (Point C) in women with total uterine prolapse or post-hysterectomy vaginal
eversion.
(iv) Superior Vagina. These points represent the most proximal locations of the normally positioned lower reproductive tract.
The two superior sites are as follows:
(c) Point C. A point that represents either the most distal (i.e. most dependent) edge of the cervix or the leading edge of the
vaginal cuff (hysterectomy scar) after total hysterectomy.
(d) Point D. A point that represents the location of the posterior fornix in a woman who still has a cervix. It is included as a point of
measurement to differentiate suspensory failure of the uterosacral-cardinal ligament ‘‘complex’’ from cervical elongation. When
the location of Point C is significantly more positive than the location of Point D, this is indicative of cervical elongation which may
be symmetrical or eccentric. Point D is omitted in the absence of the cervix.
(v) Posterior Vaginal Wall.
(e) Point Ap. A point located in the midline of the posterior vaginal wall three (3) cm proximal to the hymen. By definition, the
range of position of Point Ap relative to the hymen is -3 to þ3 cm.
(f) Point Bp. A point that represents the most distal (i.e., most dependent) position of any part of the upper posterior
vaginal wall from the vaginal cuff or posterior vaginal fornix to Point Ap. By definition, Point Bp is at �3 cm in the absence
of prolapse and would have a positive value equal to the position of the cuff in a women with total post-hysterectomy vaginal
eversion.
(vii) Other Landmarks and Measurements.
(g) The genital hiatus (GH) is measured from the middle of the external urethral meatus to the posterior margin of the hymen.
(h) The total vaginal length (TVL) is the length of the vagina (cm) from posterior fornix to hymen when Point C or D is reduced to
its full normal position. (See Figure 40 - Appendix).
(i) The perineal body (PB) is measured from the posterior margin of the hymen to the mid-anal opening.
(viii) Recording Measurements: (NB: Intraoperative measurements with traction can be quite different from measurements
made during Valsalva in clinic, both in regards to cervical location and the vaginal walls). Measurements directly after removing
a vaginal pessary are unreliable and will tend to understage the degree of POP.
The position of Points Aa, Ba, Ap, Bp, C, and (if applicable) D with reference to the hymen should be measured (cm) and
recorded.

Figure 7. The six sites (Aa, Ba, C, D, Bp and Bp), the genital hiatus (gh), perineal body (pb) and total vaginal length (tvl) used cm above or proximal to the hymen
(negative number) or cm below or distal to the hymen (positive number) with the plane of the hymen being defined as zero (0). Alternatively, a three by three
grid can be used to organize concisely the measurements as noted in Figure 8.

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Figure 8. Grid presentation of POP-Q measurements.

B: Simplified POP-Q25,26
This is based on the POP-Q with similar ordinal staging but with only four points measured instead of nine. There is no Stage 0; it
is combined with Stage 1. It is undertaken in the dorsal lithotomy position with patient forcefully bearing down, performing
Valsalva or coughing.
(i) Four points used:
. Anterior vaginal segment: point Ba (estimated around 3cm proximal to hymenal remnants).
. Posterior vaginal segment: point Bp (estimated around 3cm proximal to hymenal remnants).
. Cervix point C
. Apex/posterior fornix: point D (non-hysterectomized); point C (hysterectomized)

Figure 9. Simplified POP-Q.

(ii) Staging:
I, II, III, IV as for POP-Q above.

C: Additional available measurements awaiting further validation

These have been included as an Appendix after the References
(i): Vaginal Anatomical Levels and Lengths.
(ii): Perineal measurements.
(iii): Vaginal measurements.

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SECTION 4: INVESTIGATIONS
Urodynamics1: Functional study of the lower urinary tract.
Clinical sequence of testing1: Urodynamic investigations generally involve a woman attending with a comfortably full bladder
for free (no catheter) uroflowmetry and post void residual urine volume (PVR) measurement prior to filling and voiding (with
catheter) cystometry.
A: Assessment of Impact of Prolapse on Voiding Function
POP can have a negative impact on voiding function, screening for which importantly involves a postvoid residual and ideally
uroflowmetry. Voiding cystometry may clarify the cause of any voiding dysfunction.
(i) Postvoid Residual1–3: Volume of urine left in the bladder at the completion of micturition. Conditions for PVR measurement:
PVR reading is erroneously elevated by delayed measurement due to additional urine production (1-14 mls/min). Ultrasonic
techniques (transvaginal, translabial most accurately) allow immediate27 (within 60 seconds of micturition) measurement and
possible repeat measurement (Figure 10). A short plastic female catheter provides the most effective bladder drainage for PVR
measurement by catheterization.

Figure 10. An image of postvoid residual of 65ml by transvaginal ultrasound, reducing to 4ml with a subsequent attempt at voiding.

(ii) Uroflowmetry1–3: Measurement of urine flow rates during micturition16

. Flow rate: Volume of urine expelled via the urethra per unit time. It is expressed in ml/sec.
. Voided volume (ml): Total volume of urine expelled via the urethra.
. Maximum (urine) flow rate (MUFR - ml/sec) - Qmax: Maximum measured value of the flow rate.
. Flow time (sec): The time over which measurable flow actually occurs.
. Average (urine) flow rate (AUFR- ml/sec) - Qave: Voided volume divided by the flow time.

Figure 11. A schematic representation of urine flow over time.

The dependence of urine flow rates on voided volume28 makes it desirable to reference raw urine flow rate data to established
normative data.

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Figure 12. The Liverpool nomogram29 for the maximum urine flow rate in women (under the 10th centile on repeat measurement can be regarded as
abnormally slow30).

(iii) Pressure- Flow studies1–3;31

Cystometry: Measurement of the pressure/volume relationship of the bladder during filling and/or pressure flow study during
voiding. Higher voiding detrusor pressures and slower urine flow during voiding may point an element of bladder outflow
obstruction1–3,32, though other patterns of pressure-flow data are possible.

Figure 13. Filling and voiding cystometric trace, the latter part showing evidence of an element of bladder outflow obstruction. Normal bladder
capacity, stable detrusor: no phasic activity seen. Voided with low urine flow rate and elevated detrusor pressure. Bladder outflow obstruction is thus
demonstrated.

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B: Assessment of Impact on Prolapse on Defecatory Function
(i) Ultrasound Assessment: See imaging section.
(ii) Radiological Assessment: See imaging section.

C: Other urodynamic investigations for intercurrent diagnoses1–3,31

(i) Filling cystometry: The pressure/volume relationship of the bladder during filling can evaluate the presence of intercurrent
diagnoses (ii-iv).
(ii) Urodynamic stress incontinence1:
Involuntary leakage of urine during filling cystometry, associated with increased intra-abdominal pressure, in the absence of a
detrusor contraction.
(iii) Detrusor Overactivity1:
The occurrence of involuntary detrusor contractions during filling cystometry. These contractions, which may be spontaneous or
provoked, produce a wave form on the cystometrogram, of variable duration and amplitude (Figure 14).
(iv) Bladder Oversensitivity1:
Increased perceived bladder sensation during bladder filling with: an early first desire to void; an early strong desire to void,
which occurs at a low bladder volume; a low maximum cystometric bladder capacity. No abnormal increases in detrusor pressure
are noted.
(v) Detrusor underactivity1FN5 and Acontractile detrusor1FN6
Can also be diagnosed at voiding cystometry.

Figure 14. Cystometric trace showing detrusor overactivity1.

5
: Detrusor underactivity: Detrusor contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or a failure to achieve complete
bladder emptying within a normal time span.
6
: Acontractile detrusor: The detrusor cannot be observed to contract during urodynamic studies resulting in prolonged bladder emptying and/or a failure to achieve
complete bladder emptying within a normal time span. The term ‘‘areflexia’’ has been used where there is a neurological cause but should be replaced by neurogenic
acontractile detrusor.

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SECTION 5: PROLAPSE IMAGING
Imaging may assist the clinical assessment of POP or intercurrent pelvic floor diagnoses. Use of any of the different imaging
modalities is, however, entirely optional.
A: Prolapse-related ultrasound imaging – 2-D
(i) Modalities
Transabdominal, perineal, introital and transvaginal ultrasound1.

� Transabdominal (T-A): curvilinear scanning applied to the abdomen.

� Perineal: curved array probe applied to the perineum. This term incorporates transperineal and translabial ultrasound.
� Introital: sector probe applied to the vaginal introitus.
� Transvaginal (T-V): intravaginal curvilinear, linear array, or sector scanning.

(ii) Clinical applications:

� Bladder neck descent/mobility. The position of the bladder neck at rest and on Valsalva.
� Urethral funnelling: i.e., opening of the proximal third of the urethra during coughing or on Valsalva.
� Post void residual: Several formulas have been described in the literature to measure the bladder volume by ultrasound33–35. An
early formula [(h x d x w) x 0.7] has been demonstrated to give reproducible results with a percentage error of 21%33 (see
Figure 15 for definitions of h,d,w).
� Bladder abnormalities: e.g., tumor, foreign body.
� Urethral abnormality: e.g., diverticulum.
� Intercurrent uterine and/or pelvic abnormality: dependent on probe range.
� Postoperative findings: e.g., bladder neck position and mobility, position of meshes, tapes, or implants.
� Descent of pelvic organs: visualization of descent of the bladder, uterine cervix, and rectum during coughing or on Valsalva.
� Assessment of voluntary pelvic floor muscle contractility.
� Pelvic floor/levator ani muscle defect (‘‘avulsion’’) and hiatal ballooning36.
� Ultrasound measurements of bladder and detrusor wall thickness, and ultrasound estimated bladder weight (UEBW) are
potential noninvasive clinical tools for assessing the lower urinary tract. UEBW is higher in women with overactive bladder and
detrusor overactivity37,38. FN7.

Figures 16 and 17 show examples of 2-D introital ultrasound in patients with POP symptoms.

Figure 15. Ultrasound measurement of the bladder volume from Poston GJ et al. 198333(redrawn).

7
: Women with detrusor overactivity have a median UEBW of 48.0 g (95% CI 46-51), with urodynamic stress incontinence a median UEBW of 30 g (95% CI 29-31) and
those who have associated detrusor overactivity and urodynamic stress incontinence have a median UEBW of 37.3 g (95% CI 33-41) (p<0.001)37,38.

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Figure 16. (above): 56 year old female with stage II cystocele and urodynamic stress incontinence. Left: at rest. Right: during valsalva. B ¼ Bladder,
BB ¼ bladder base, U ¼ urethra, S ¼ symphysis pubis, arrow ¼ bladder neck during Valsalva, V ¼ vagina, R ¼ rectum. Arrow ¼ bladder neck during Valsalva
with bladder neck funnelling as a sign of urethral incompetence.

Figure 17. (above): 72 year old female with stage II rectocele. Measurement of rectocele (RC) width (1) and depth (2) during Valsalva. M ¼ muscularis of rectum.

B: Prolapse-related ultrasound imaging – 3-D

(i) Modalities: Endovaginal, transanal, and translabial/transperineal

� Endovaginal ultrasound imaging may inadvertently compress tissues thus distorting the anatomy.
� Transanal ultrasound approach requires an expensive and dedicated transducer, and it is a more uncomfortable and
embarrassing test for the woman. Its most common clinical indication is the assessment of sphincter integrity following
obstetric trauma.
� Translabial/transperineal approach overcomes the limitations of endovaginal and transrectal techniques providing minimal
pressure on local structures and it is least likely to alter surrounding anatomy.

(ii) Evaluations:
The following pelvic floor abnormalities/ surgical sequelae can be evaluated:

(a) Trauma (injury/damage) of the levator ani muscle (LAM).

(b) Excessive distensibility of the puborectalis muscle and levator hiatus (‘‘ballooning’’).
(c) Pathologies of the anterior vaginal compartment like urethral diverticula.
(d) Bladder tumours or foreign bodies (sling, mesh, bulking agents).
- Polypropylene meshes: highly echogenic and thus easily identified in the coronal and axial plane, unless they are obscured by
vaginal prolapse.
- Periurethral bulking agents, used as a continence procedure, can also be depicted with 3D pelvic floor ultrasound. FN8

8
: Synthetic implant such as macroplastique, are hyperechogenic whereas collagen injections are hypoechoic and can be seen as spherical structures surrounding the
bladder neck.

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Figure 18 shows 3D ultrasound imaging of the pelvic floor anatomy.

Figure 18. (above): 3D ultrasound image of levator ani muscle of an asymptomatic nulliparous woman at rest. 3D ultrasound image of the pelvic floor at
rest showing the anatomy and the reference plane of measurements. Left: sagittal view; PB: pubic bone; U: urethra; V: vagina; ARA: anorectal angle; white line:
plane of minimal hiatal dimensions (plane of all measurements). Right: axial view; PB: pubic bone; U: urethra; V: vagina; R: rectum; PV: pubovisceralis muscle;
black line: antero-posterior diameter of the levator hiatus; white line: transverse diameter of the levator hiatus at the level of pubourethralis, white double-
arrowed line: transverse diameter of the levator hiatus at the level of pubovaginalis.

(iii) 3D ultrasound imaging of the female urethra

3D ultrasound imaging of the rhabdosphincter overcomes the limits of MRI and two-dimensional (2D) ultrasound imaging that
incorrectly measure the urethral sphincter volume using mathematical formulas based upon assumptions that the shape of the
urethra is similar to that of an ellipse. Since the urethral shape is neither elliptical nor spherical, but rather an atypical geometric
shape, equations should not be used39. FN9. Figure 19 shows 3D ultrasound imaging of the urethral sphincter

Figure 19. (above): 3D translabial image of the female urethra. The urethra lumen is shown clearly in the rendered volume image (bottom right). (U, urethra;
UL, urethra lumen; RS, rhabdosphincter).

(iv) 3D ultrasound imaging of the levator ani trauma

The presence of levator ani trauma has been postulated to be associated to an increased risk of pelvic organ prolapse40. This
can be evaluated using a tomographic ultrasound imaging assessment of the levator ani muscles (Figure 20).

9
: The importance of precise structural assessment of the urethral sphincter using multiple axial cross-sectional areas at set distances can assist the evaluation of
women with stress urinary incontinence. It has been suggested that it may predict the severity of incontinence as well as the outcome of continence surgery since a
weak sphincter will have a lower volume compared to a competent/continent urethral sphincter39.

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Figure 20. (above): Tomographic ultrasound imaging assessment of the levator ani muscles Intact LAM.

(v) 3D ultrasound imaging of ballooning of the genital hiatus

The presence of ballooning of the genital hiatus (¼ excessive distensibility of the levator hiatus) on Valsalva manoeuvre has also
been associated to the severity of urogenital prolapse. An area of more than 25 cm2, 30 cm2, 35 cm2 and 40 cm2 has been defined as
mild, moderate, marked and severe ballooning respectively (Figure 21)41.

Figure 21. (above): Ballooning of the genital hiatus on Valsalva manoeuvre – levator defect.

C: Magnetic resonance imaging (MRI) of the pelvic floor

Magnetic resonance imaging (MRI) allows the detection of ligamentous and muscular pelvic floor structures in fine detail.
Although it does not use ionising radiation, it is a high cost technique. Static MRI relies on static sequences and high spatial
resolution images, to delineate the passive and active elements of the pelvic organ support system. Most commonly, images are
acquired in axial, sagittal and coronal planes.
MRI has been proposed to be a useful method for diagnosing and staging POP. Several lines and levels of reference have been
described in the literature. The most commonly used ones are either a line drawn from the inferior margin of the pubis symphysis
to the last coccygeal joint (pubococcygeal line—PCL) or a line extending caudally along the longitudinal axis of the symphysis pubis
in the sagittal plane, noted as midpubic line (MPL)42,43 (Figures 22 and 23).

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Figure 22. (above): Sagittal MRI image of the pelvic floor obtained at rest in a 50-year-old normal volunteer woman. The H line is drawn from the inferior
border of the pubic symphysis to the posterior wall of the rectum at the level of the anorectal junction.

The M line is drawn perpendicularly from the PCL to the most posterior aspect of the H line. (PCL: pubococcygeal line, black arrow: bladder base, white arrow:
vaginal vault,  : anorectal junction, from Colaiacomo MC42 et al. 2009).

Figure 23. (above): Severe uterine prolapse in a 41-year-old woman. Sagittal function MRI image obtained during defaecation shows the uterus moving
downward inside the vagina and the cervix exits the vaginal introitus (white arrow). H and M lines are abnormally elongated. Urethral funnelling without
hypermobility (arrowhead) and severe posterior compartment descent (black arrow) are also noted (from Colaiacomo42 et al. 2009).

Other applications of MRI are the assessment of the LAM morphology (size, thickness volume) and detection of LAM injuries/
defects/ (‘‘avulsion’’) (figure 24)44–46.

Figure 24. (above): Examples of grades of unilateral defects in the pubovisceral portion of the LAM in axial magnetic resonance images at the level of the mid
urethra. The score for each side is indicated on the figure, and the black arrows indicate the location of the missing muscle (A. grade 1 defect; B. grade 2 defect;
and C. grade 3 defect, from DeLancey. Levator Ani Impairment in Prolapse. Obstet Gynecol 2007).

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D: Current possible measurements using MRI in urogynecology
(i) Bladder neck and cervical descent / mobility:

� Position of bladder neck and cervix at rest and on Valsalva

� Pubo-coccygeal line: A line extending from the inferior border of the pubic symphysis to last coccygeal joint (pubococcygeal
line—PCL) Bladder neck or cervical descent > 2 cm below this line with straining indicates weakness of the pelvic floor. If
alternative landmarks are used in scientific papers they should be clearly described.

Figure 25. (above): shows a number of possible measurements using MRI imaging. (a) Axial T2-weighted image of the pelvic floor of a healthy nulliparous
Caucasian woman showing measurement of the anteroposterior diameter of the genital hiatus between the arrows from midurethra to mid-anus at the level
of the lower border of the pubic symphysis. Transverse diameter (width) of the levator hiatus was measured between the stars at the point of maximum
extension of the levator muscles at the level of the urinary bladder and proximal urethra. Reproduced from Am J Obstet Gynecol with permission from the
Publisher. (b) An example of a unilateral levator defect of the pubococcygeus muscle (right image) seen on MRI imaging. Reproduced with kind permission
from Mr. Olubenga Adekanmi; image reviewed by Professor John DeLancey.

E: Computed tomography (CT) of the pelvic floor

Computed tomography (CT) is not routinely recommended for imaging the pelvic floor mainly due to irradiation and poor soft
tissue contrast. However multiplanar spiral CT may offer an accurate visualization of the pelvic floor soft and bony structures by
reconstruction of axial images using 1 mm thick slices without gaps thus increasing the diagnostic accuracy of pelvic floor
anatomical disorders (ie. LAM trauma) (Figures 26 and 27).

Figure 26. (above): Computed tomography (CT) of the LAM. Axial view of CT multiplanar 3-dimensional data volume, with 1 mm slice thickness without gaps,
showing an intact pubovisceral muscle arising from the body of the pubic bone and forming a sling around the rectum (U: urethra, V: vagina, R: rectum, PM:
pubovisceral muscle, PR: puborectalis muscle).

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Figure 27. (above): Computed tomography (CT) of the LAM. Axial view of CT scan of a woman with bilateral injury of the pubovisceral muscle. Measurement
of levator symphysis gap (LSG) is denoted bilaterally (U: urethra, V: vagina, R: rectum, PM: pubovisceral muscle).

F: Associated POP-related Radiology8

Defecography demonstrates normal anatomy of the anorectum as well as disorders of rectal evacuation. With barium paste
inserted rectally prior to defecation, measurement of the anorectal angle is allowed with evidence of the presence, size or emptying
of any rectocele.
Enteroceles, rectal intusssusception and mucosal prolapse might be diagnosed as well as a spastic pelvic floor (anismus).

6: DIAGNOSES
This Report highlights the need to base diagnoses for female pelvic organ prolapse on the correlation between a woman’s
symptoms, signs and any relevant diagnostic investigations.

A: Pelvic Organ Prolapse

Diagnosis by symptoms and clinical examination, assisted at times by any relevant imaging (i.e. clinically evident):

(i) Uterine/ cervical prolapse: Clinically evident descent of the uterus or uterine cervix.
(ii) Anterior vaginal wall (compartment) prolapse: Clinically evident descent of the anterior vaginal wall (compartment).
(iii) Posterior vaginal wall (compartment) prolapse: Clinically evident descent of the posterior vaginal wall (compartment).
(iv) Vaginal vault (cuff scar) prolapse: Clinically evident descent of the vaginal vault (cuff scar after hysterectomy).

Clinical staging (see Figures 6 and 28-30) assists in description.

Figures 28–30: Different types and stages of pelvic organ prolapse.

Figure 28. (above): Stage II Anterior vaginal wall (compartment) prolapse.

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Figure 29. (above): Stage III Uterine prolapse.

Figure 30. (above): Stage IV Vaginal prolapse (complete eversion).

B: Possible prolapse-related diagnoses:

(i) Voiding dysfunction: A diagnosis by symptoms and urodynamic investigations is defined as abnormally slow and/or
incomplete micturition, based on abnormal slow urine flow rates and/or abnormally high post void residuals, ideally on repeated
measurement to confirm abnormality. (Voiding cystometry can be required to determine the cause of the voiding dysfunction). FN10
(ii) Recurrent urinary tract infections (UTI): A diagnosis by clinical history assisted by the results of diagnostic tests involves the
determination of the occurrence of at least three symptomatic and medically diagnosed urinary tract infections (UTI) over the
previous 12 months. One possible POP-related cause is a chronically elevated postvoid residual.
(iii) Defecatory dysfunction: A diagnosis by clinical history assisted, at times, by the results of diagnostic tests involving the
confirmation of abnormal or difficult function in the initiation, passage or completion of defecation.
(iv) Sexual dysfunction: A diagnosis by clinical history (including specific questionnaires) involving the confirmation of
abnormal function and/or difficulty with sexual intercourse.

10
: It is acknowledged this definition may not encompass cases of (i) symptoms of voiding dysfunction without abnormality of voiding parameters; (ii) abnormality
of voiding parameters without symptoms of voiding dysfunction.

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C: Intercurrent diagnoses:
(i) Urodynamic stress incontinence: Involuntary leakage of urine during filling cystometry, associated with increased intra-
abdominal pressure, in the absence of a detrusor contraction. In the circumstances where this diagnosis is only made when the POP
is reduced, the additional term ‘‘occult’’ is appropriate.
(ii) Detrusor overactivity: The occurrence of involuntary detrusor contractions during filling cystometry.
(iii) Bladder oversensitivity: Increased perceived bladder sensation during bladder filling with: an early first desire to void; an
early strong desire to void, which occurs at a low bladder volume; a low maximum cystometric bladder capacity. No abnormal
increases in detrusor pressure are noted.
(iv) Detrusor underactivity1FN5 and Acontractile detrusor1FN6

7: CONSERVATIVE TREATMENTS
Conservative: restricted to non-surgical and non-pharmacological treatments.
A: Lifestyle interventions: Interventions that intentionally change the way a person lives in order to improve health status (e.g.
weight loss and avoiding heavy lifting or coughing, e.g. by ceasing tobacco smoking), to avoid exacerbation of POP by decreasing
intra-abdominal pressure.

B: Devices
Device: An object or instrument that has been invented/created for a particular purpose.
(i) Pessary: A device that is inserted into the vagina to provide structural support to one or more of descending vaginal
compartments, i.e.; the uterus, anterior vaginal wall (and bladder), posterior vaginal wall (and rectum) and/or vaginal apex (with
or without small intestine after a prior hysterectomy)47.
Types of pessary: Vaginal pessaries can be broadly divided into two types: support pessaries (ring, ring with support, Gehrung,
Hodge) and space filling pessaries (doughnut, gellhorn, cube, inflatable pessaries).

Figure 31. Pessaries (clockwise from top left) donut, cube, ring with central support, gellhorn.

Figure 32. Shelf pessary.

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The most frequently used pessaries are listed below, as shown in figure 3147.

a. Ring pessary with or without central support

b. Gellhorn pessary; round solid pessary with a central stem
c. Donut pessary FN11
d. Cuboid pessary FN12
e. Shelf pessary: Similar to a Gellhorn but asymmetric

C: Physical Therapies9
Pelvic physiotherapy: Assessment, prevention and/or treatment of pelvic floor dysfunction, performed by a pelvic
physiotherapist. The therapy aims at reducing POP symptoms and related bother as well as improvement of pelvic floor
function. Pelvic physiotherapy covers many specialized therapies that can be used to train the pelvic floor: physical activity,
cognitive behavioural therapy, bladder training, bowel habit training, muscle training (endurance, power), coordination training,
biofeedback, and electrical muscle stimulation9. The role of continence nurses amongst other health professionals in performing
some of these specialized therapies in acknowledged.
Other therapies: Refer to the terminology document of Bo et al9.

8: SURGICAL TREATMENTS

A: General POP Surgical Terminology

(i) Prosthesis5: A fabricated substitute to assist a damaged body part or to augment or stabilize a hypoplastic structure.
(ii) Mesh5: A (prosthetic) network fabric or structure; open spaces or interstices between the strands of the net. The use of this
term would be for POP surgery with synthetic materials.
(iii) Mesh kit5: A set of articles or equipment utilized for POP surgery containing mesh with a system of trocars designed to
achieve mesh fixation or allow mesh passage to or through specific areas within the pelvis.
(iv) Implant5: A surgically inserted or embedded prosthesis or graft. (Explant: a surgically excised prosthesis or graft).
(v) Tape (Sling)5: A flat strip of synthetic material. The use of this term would be for incontinence surgery with synthetic
materials.
(vi) Graft5: Any tissue or organ for transplantation. This term will be used to refer to biological materials inserted.

Autologous grafts: From patient’s own tissues e.g. rectus sheath or fascia lata. Allografts: From post-mortem tissue banks.
Xenografts: From other species e.g. modified porcine dermis, porcine small intestine and bovine pericardium.

Terminology for grafts has not been separated into the different applications for POP and continence surgery.
(vii) Trocar5: A surgical instrument with either a pyramidal, conical or needle-type cutting or dissecting point.
(viii) Tissue6: A collection of similar cells and the intercellular substances surrounding them.
(ix) Native6: Pertaining to birth - ‘‘in situ autologous‘‘.

B: Specific Surgeries
The following classification of surgical procedure subtypes is proposed when describing specific surgeries. It is acknowledged
that more complex cases may require two or more procedures in addition to other non-POP related surgical interventions. Each
surgical procedure should be described with respect to site specificity and either as primary surgery or further surgery7. All surgical
procedures are primarily divided by surgical approach as follows:

I. Vaginal repairs:

(i) Anterior vaginal wall repair with native tissue.

(ii) Anterior vaginal wall repair with mesh or graft reinforcement.
(iii) Posterior vaginal wall repair with native tissue.
(iv) Posterior vaginal wall repair with mesh or graft reinforcement.
(v) Vaginal vault repair involving uterus.
(vi) Vaginal vault repair (post-hysterectomy).

II. Abdominal repairs:

(i) Abdominal Repair with Mesh or Graft.

(ii) Abdominal Repair without Mesh or Graft.

11
: A more space occupying pessary.
12
: A cuboid pessary does deliver ‘support’ by suction of the vaginal walls.

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III. Obliterative Procedures:

(i) Colpocleisis.
(ii) Total colpectomy.

I: Vaginal Repairs (colporrhaphy): (Greek: kolp o vagina þ raphe suture)

(i) Anterior vaginal wall repair with native tissue: Repair the vagina by excision and suturing of the edges of any defect. Native
tissue repair may be further sub-classified depending on the type of associated fascial repair:

(a): Midline fascial plication:. This represents perhaps the most common procedure currently performed for anterior wall prolapse
[Fig 33 below]. FN13
(b) Site specific repair: Paravaginal – bilateral vaginal reattachment of the lateral edge of damaged fascia to the Arcus Tendineus
Fasciae Pelvis (Alt: White line).
(c) Other site specific repair: Transverse, distal, combined.
(d) Anterior enterocele repair.

Figure 33. (above): Midline native tissue anterior vaginal repair.

(ii) Anterior Vaginal Wall Repair with mesh or graft reinforcement (a structural addition or inclusion used to give additional
strength in function). It should be noted whether the graft is biologic, absorbable synthetic or permanent synthetic.
This may be further sub-classified into:

(a) Mesh or graft placement without additional vault/uterine support with or without concurrent fascial plication.
(b) Mesh or graft placement with additional vault/uterine support. This may be sud-divided into:

� Transobturator mesh kit: Normally involves two needle passes through the obturator membrane bilaterally to retrieve and
secure mesh arms through the area of the Arcus Tendineous Fasciae Pelvis (ATFP) and thus stabilize a central mesh support
to the anterior vaginal wall.

13
: It was first described by Kelly in 1913 and involves dissection under the full thickness of the vaginal epithelium followed by central plication of the pubocervical
fascia over the bulging bladder with excision of the ‘excess’ vaginal wall skin. The Kelly-Kennedy plication suture (Alt: bladder neck buttress) is an extrapolation of
midline fascial plication involving placement of sutures under the proximal urethra and bladder neck to try and treat or prevent stress incontinence.

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� Mesh kit with bilateral fixation to Sacrospinous Ligament [SSL]: Anterior vaginal wall mesh or graft with concurrent vault/
uterine suspension employing either bilateral iliococcygeal fixation or fixation to the SSL.
(iii) Posterior vaginal wall repair with native tissue: Repair the vagina by excision and suturing of the edges of any defect.
Native tissue repair may be further sub-classified depending on the type of associated fascial repair:

(a) Midline fascial plication - This represents perhaps the commonest procedure currently performed for posterior wall prolapse
and involves dissection under the full thickness of the vaginal epithelium followed by central plication of the pre-rectal fascia
over the bulging rectum with excision of the ‘excess’ vaginal wall skin. [Fig 34 below]
(b) Site specific repair: Lateral (Uni- or Bilateral), Transverse (upper and/or lower), Combined
(c) Closure and/or excision of enterocele vaginally with or without concurrent posterior wall repair.

Figure 34. (above): Midline native tissue posterior vaginal repair.

(iv) Posterior Vaginal Wall Repair with mesh or graft reinforcement (a structural addition or inclusion used to give additional
strength in function. It should be noted whether the graft is biologic, absorbable synthetic or permanent synthetic.
This may be further sub-classified into:

(a) Mesh or graft placement without additional vault/uterine support with or without concurrent fascial plication.
(b) Mesh or graft placement with additional vault/uterine support. This may be sub-divided into:

(i) Mesh kit with bilateral mesh fixation to the SSL.

(ii) Mesh suspension kit with ischio-anal needle pass.
(iii) Posterior vaginal wall mesh/graft with concurrent vault/uterine suspension employing either bilateral iliococcygeal
fixation or fixation to the SSL.
(iv) Transperineal mesh/graft insertion.

Concurrent surgery performed in addition to vaginal posterior wall repairs:

(a) Perineal Repair (alternatives; Perineorrhaphy, Perineoplasty).

(b) Levator ani muscle plication.
(c) Repair/closure of enterocoele.
(d) Anal sphincter repair.

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(v): Vaginal Vault Repairs (involving uterus)
(a) Vaginal hysterectomy – removal of the uterus and cervix vaginally.
(b) Vaginal hysterectomy with adjunctive McCall Culdoplasty – Culdoplasty sutures incorporate the uterosacral ligaments into
the posterior vaginal vault to obliterate the cul-de-sac and support and suspend the vaginal apex after vaginal hysterectomy.
(c) (Modified) Manchester Repair (Fothergill operation) – This procedure combines anterior vaginal wall repair with amputation
of the cervix and uterosacral ligament suspension with or without concurrent vaginal posterior wall repair. FN14
(d) Sacrospinous hysteropexy - fixation of the uterus to the SSL. Variations of this technique to include:

(a) Unilateral or bilateral procedure.

(b) Anterior or posterior approach.
(c) Permanent or absorbable suture and number of ‘bites’ taken.
(d) Type of suture placement device employed.
(e) Direct vision or with the use of a specific instrument (tactile feedback).

(e) Laparoscopic assisted vaginal hysterectomy with or without concurrent laparoscopic uterosacral ligament plication.

(vi) Vaginal Vault Repairs (Post-hysterectomy)

(a) Sacrospinous colpopexy – Fixation of the vaginal vault to the SSL. Variations of this technique (as above a-e for sacrospinous
hysteropexy).

Figures 35. Sacrospinous colpopexy.

Figure 36. Suture placement around junction of medial third and lateral two-thirds of ligament assisted by retraction (Miya speculum 7 o’clock; narrow
Deaver 1 o’clock; Yankauer sucker not shown).

14
: Its essential feature is suturing the cut cardinal/uterosacral ligament complex in front of the stump of the cervix hence pulling the cervix upwards and
backwards, maintaining anteversion and creating anterior vaginal wall length.: This procedure can be performed intra- or extra-peritoneally. Concurrent McCall
culdoplasty or vaginal vault suspension techniques may be employed dependant on the extent of prolapse47.

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(b) Intraperitoneal uterosacral ligament (USL) vaginal vault fixation: This is usually associated with posterior wall fascial wall
reconstruction and possible concurrent excision and closure of enterocele.
(c) Extraperitoneal USL vaginal vault fixation: This is usually combined with posterior wall fascial reconstruction with or
without enterocele closure and/or excision.
(d) Mesh suspension kit with ischio-anal needle pass. The graft is fixed to the vault and elevation achieved when the upper graft
arms are retrieved back through the levator ani muscle bilaterally.
(e) Vaginal Trachelectomy for Cervical Stump Prolapse (previous subtotal hysterectomy) The cervical stump is removed in an
identical fashion to the initial steps of a vaginal hysterectomy.

II Abdominal Procedures

(i) Abdominal Procedures with Mesh or Graft FN15

(a) Open / Laparoscopic / Robotic Sacrocolpopexy – Suspension of the vagina utilizing mesh or graft to the anterior longitudinal
ligament usually at the level of the sacral promontory. (Fig 37 below)

Figure 37. Sacrocolpopexy.

(b) Open / Laparoscopic / Robotic Sacrocervicocolpopexy – Suspension of the cervix (and usually vagina) utilizing mesh or graft
to the anterior longitudinal ligament usually at the level of the sacral promontory. This procedure is commonly performed as an
adjunct following subtotal hysterectomy for advanced utero-cervical prolapse.
(c) Open / Laparoscopic / Open Sacrohysteropexy- suspension of the cervix (with or without additional vaginal attachment)
utilizing mesh or graft to the anterior longitudinal ligament usually at the level of the sacral promontory. Sacrohysteropexy is
performed for women who are keen to preserve their uterus.

(ii) Abdominal Procedures without Mesh or Graft

(a) Open / Laparoscopic / Robotic paravaginal repair – Extraperitoneal bilateral reattachment of the lateral edge of damaged
fascia to the Arcus Tendineus Fasciae Pelvis (Alt: White line).
(b) Laparoscopic / Robotic suture hysteropexy – The plicated uterosacral ligaments are resutured to the cervix.
(c) Open / Laparoscopic / Robotic closure of enterocoele sac:

(a) Moschowitz procedure- Concentric purse string suture(s) are placed around the cul-de-sac to include the posterior vaginal wall,
pelvic side-walls and serosa of the sigmoid.
(b) Halban procedure- Obliteration of the cul-de-sac by using successive sutures placed sagittally between the uterosacral
ligaments.
(c) Uterosacral ligament plication (Fig 38 below) – transverse plication of the uterosacral ligaments to obliterate the cul-de-sac.
Successive sutures are placed into the medial portion of one ligament, into the back wall of the vagina and into the medial
border of the opposing ligament.

15
: Variations in technique for all abdominal mesh/graft procedures: (i) Type of mesh or graft used; (ii) Shape of mesh /graft- single piece, ’DIY’ two piece ‘Y’ mesh, Y
mesh kit product; (iii) Points and length of attachment to vagina. (iv) Suture material employed / Metal stapling devices; (v) Peritoneal closure over mesh/graft.

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Figure 38. Uterosacral ligament plication.

(d) Open / Laparoscopic / Robotic Burch Colposuspension – Elevation or attachment of the upper paraurethral tissue adjacent to
the bladder neck region to the iliopectineal ligament bilaterally. Although a recognized treatment for stress incontinence, this
procedure will often correct associated anterior wall prolapse symptoms.

III: Obliterative Procedures

́ o þ kleisis closure) – Operation for obliterating the lumen of the vagina. FN16
(i) Colpocleisis: (Greek: kolp
(ii) Total colpectomy: (Greek: kolp ́ o þ ektome excision): Total excision of the vagina in a woman with no uterus and vaginal
eversion. FN17

C: Measuring Outcome in POP surgeries7

As per IUGA-ICS Report on outcome measures for POP surgery7, every study evaluating POP surgery should report.
(i) Perioperative data: i.e. blood loss, operating time, length of hospital stay, return to normal activities and complications.
(ii) Subjective (patient-reported) outcomes: At its simplest level this can be reported as the presence or absence of vaginal bulge.
Patient satisfaction and quality of life can be measured by validated instruments that cover prolapse, urinary, bowel and sexual
function.
(iii) Objective outcomes: POP-Q measurement generally and should be tabulated with absolute values and percentages to allow
other studies to compare results.
(iv) Secondary outcomes (e.g. lower urinary tract symptoms, stress urinary incontinence or bowel and sexual dysfunction) in
their studies whenever possible.
(v) Surgery type and operated compartment:

(a) Primary surgery: indicates the first procedure required for treating POP in any compartment.
(b) Further surgery: provides a term for any subsequent procedure relating to primary surgery. Further surgery is subdivided into:

� Primary surgery in a different (new) site/compartment.

� Repeat surgery in the same site/compartment for POP symptom recurrence.
� Surgery for complications e.g. mesh exposure, pain, infection or hemorrhage.
� Surgery for non-POP-related conditions usually urinary or fecal incontinence.

16
: This is usually performed in a woman with a uterus who is no longer sexually active. It can be performed in the absence of a uterus in a woman with vaginal
eversion instead of total colpectomy. The Le Fort’s procedure involves denuding the vagina of skin both anteriorly and posteriorly, typically in a rectangular shape,
avoiding the bladder neck and cervix. The cut edges are sewn together to achieve vaginal closure whilst leaving a bilateral epithelium-lined tunnel behind. The
Labhardt procedure involves the removal of a 1 cm horse shoe shape of vaginal epithelium is removed over the posterior fourchette up to just under the urethra. By
closing the incision and building up the perineum, an extremely high posterior repair almost closing the vagina is created.
17
: The vagina is totally denuded of skin, typically in sections, whilst avoiding the bladder neck region. The prolapse is then reduced by a series of successive purse-
string sutures and the epithelium at the entrance closed.

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D: Complications of POP surgeries5,6
Complications related to POP native tissue repair and surgeries using prostheses/graft/mesh have been classified separately
according to joint IUGA/ICS recommendation5,6. The sorting system used in both documents utilizes specific category, time and
site taxonomy together referred as CTS classification system. Classification is aided by on line calculators at either http://www.ics.
org/complication or http://www.ics.org/ntcomplication.

This document has involved 14 rounds of full review, by co-authors, of an initial draft (Version 1) completed on November 30,
2014. Comments for each round of review were collated and debated as necessary in order to form a subsequent version. Live
meetings on the document took place in Washington, Rio, Nice and Montreal.

ACKNOWLEDGEMENTS
The assistance of Prof Steven Swift is gratefully acknowledged for the Simplified POP-Q section and other helpful input. Prof John
DeLancey also contributed helpful input to Section 3 and the Appendix. We thank our invited external reviewers Prof Steven Swift,
Prof Mark Vierhout, Prof Michele Meschia, Prof Doug Tincello and Prof Don Wilson for their constructive contributions. We also
thank those who submitted constructive comments following IUGA and ICS website presentation of Version 12: Dr Kiran Ashok,
Prof Phil Toozs-Hobson, Dr Kamil Svabik. Further helpful comments were received at an open forum at ICS Montreal from Beth
Shelly, Julia Herbert, Kari Bo and Joe Lee. The talents of medical illustrator, Levent Efe were crucial to the development of this
document (levent@leventefe.com.au).
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48. de Boer TA, Milani AL, Kluivers KB, et al. The effectiveness of surgical correction of uterine prolapse: Cervical amputation with uterosacral ligament plication
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APPENDIX - Concepts and available measurements awaiting further validation.

A: Subdivision of Stage II POP-Q:
An optional subdivision of Stage II into IIa (-1 to hymen) and IIb (hymen to þ1) was considered at length. Stage IIA would then be
defined as -1 to 0 (so the hymen, that is 0, is included in stage IIA) and stage IIB (>0 to þ1), meaning the dependent part of prolapse
beyond the hymen but no further than þ1. It was felt that this might reflect a clinical difference between the two subdivisions in terms
of symptoms. That change was not made at this time in part to maintain the current strictly anatomical definition of the ‘‘sign of POP’’.

B: Vaginal Anatomical Levels and Lengths:

(i) Level I: Uterine cervix (if present) and/or upper 2.5cm of vagina. Footnote FN18
(ii) Level II: Mid-vagina from distal end of Level I to hymen. FN19
(iii) Level III (vaginal vestibule): Vaginal entrance (Latin: ‘‘vestibulum’’ ¼ ‘‘a space at the entrance of a canal’’) from hymenal ring
to just below the clitoris anteriorly (anterior vestibule), labia minora laterally and anterior perineum posteriorly (posterior
margin of vestibule) FN20

18
: Refinement of previous classification49 reflecting the average length of non-gravid uterine cervix50 and the average length of the supportive influence of the
distal segment of the uterosacral ligaments on the posterolateral vaginal wall bilaterally51..
19
: Mean length of Level II in women at posterior colporrhaphy found to be 5.0cm52
20
: The outer edge of the vestibule is known as Hart’s line (see white line in Figure 39 with blue line demarcating anterior and posterior vestibule).

Figure 39. Anterior and posterior vestibule.

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(iv) Posterior vestibule: Posterior hymenal ring to anterior perineum (posterior margin of vestibule). FN21
(v) Total vaginal length4: Posterior vaginal vault to hymen (cm), i.e. Levels I and II posteriorly.
(vi) Total posterior vaginal length52–54: Posterior vaginal vault to posterior margin of vestibule (anterior perineum - cm), i.e.
Levels I, II and III posteriorly.
(vii) Anterior vaginal length: Anterior hymenal ring to the anterior vaginal vault (anterior cervicovaginal junction or anterior
cuff post-hysterectomy)55.

Figure 40. Posterior vestibule.

Figure 41. Vaginal Levels (I to III) and Vaginal lengths (Anterior, Total, Total Posterior).
C: Additional available intraoperative measurements.
(i) Perineal measurements:
(a,b) Perineorrhaphy Width (PW) and Depth (PD)54: Width and depth of the excised perineum

21
: Mean length in women at posterior colporrhaphy was found to be 1.8cm52.

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Figure 42. Perineorrhaphy width (PW) and perineorrhaphy depth (PD).

(c) Perineal length (PL)54: Distance from posterior margin of vestibule to anterior anal verge.

Figure 43. Perineal length.

(d) Mid-perineal thickness (MPT)54: Thickness (cm) of the mid-perineum in the midline.

Figure 44. Mid-perineal thickness.

(e) Perineal Gap (PG)52–54: Thinned out medial area (cm) between Moynihan forceps placed bilaterally where the labia minora
meet the perineum.

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Figure 45. Perineal Gap.

(f) Perineorrhaphy Commencement Position (PCP): NEW Where in Level III, the perineorrhaphy is commenced, e.g. hymen, mid-
vestibule, posterior margin of vestibule.

(ii) Posterior vaginal measurements53:

(a) Posterior Vaginal Vault Descent (PVVD52,53: Descent of the posterior vaginal vault towards the perineal gap obtained by
subtracting the inferiorly displaced vaginal vault and the anterior perineum (second figure) from the total posterior vaginal length
(TPVL - first figure – posterior vaginal vault to anterior perineum).
(b) Mid-Vaginal Laxity (MVL) (Undisplaced)52,53: Laxity of the vaginal mucosa (anterior traction) midpoint in the vagina super-
posteriorly and in the midline with the vaginal vault held in an undisplaced position (similar to that after vault fixation)

Figure 47. (right): Distance from vaginal vault (on traction) to anterior
perineum. Posterior vaginal vault descent is the subtraction of this
measurement from the TPVL.
Figure 46. (left): Total posterior vaginal length (TPVL).

(c) Recto-vaginal Fascial Laxity (RVFL)52,53: Laxity of the rectovaginal fascia (anterior traction) midpoint in the vagina super-
posteriorly (mucosa opened) and in the midline with the vaginal vault held in an undisplaced position

Figure 48. (left): Mid-vaginal laxity (vault undisplaced). Figure 49. (right): Recto-vaginal fascial laxity.

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Neurourology and Urodynamics

An International Urogynecological Association (IUGA)/

International Continence Society (ICS) Joint Report on the
Terminology for Female Anorectal Dysfunction
Abdul H. Sultan,1a* Ash Monga,2a,b Joseph Lee,3a,c Anton Emmanuel,4a Christine Norton,5a Giulio Santoro,6a
Tracy Hull,7a Bary Berghmans,8a,b Stuart Brody,9a and Bernard T. Haylen10a,c
1
Urogynaecologist and Obstetrician, Croydon University Hospital, Croydon, United Kingdom
2
Urogynaecologist, Princess Anne Hospital, Southampton, United Kingdom
3
University of Melbourne, Mercy Hospital for Women, Monash Health, Melbourne, Victoria, Australia
4
Gastroenterologist, University College Hospital, London, United Kingdom
5
Kings College London, London, United Kingdom
6
Regional Hospital, Treviso, Italy
7
Cleveland Clinic Foundation, Cleveland, Ohio
8
Clinical epidemiologist Pelvic physiotherapist, Health Scientist, Maastricht University Medical Center, Maastricht University,
Maastricht, The Netherlands
9
Department of General Anthropology, Charles University, Prague, Czech Republic
10
University of New South Wales, Sydney, New South Wales, Australia

Introduction: The terminology for anorectal dysfunction in women has long been in need of a specific clinically-based
Consensus Report. Methods: This Report combines the input of members of the Standardization and Terminology
Committees of two International Organizations, the International Urogynecological Association (IUGA) and the
International Continence Society (ICS), assisted on Committee by experts in their fields to form a Joint IUGA/ICS
Working Group on Female Anorectal Terminology. Appropriate core clinical categories and sub classifications were
developed to give an alphanumeric coding to each definition. An extensive process of twenty rounds of internal and
external review was developed to exhaustively examine each definition, with decision-making by collective opinion
(consensus). Results: A Terminology Report for anorectal dysfunction, encompassing over 130 separate definitions,
has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness
have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved
in female pelvic floor dysfunction. Female-specific anorectal investigations and imaging (ultrasound, radiology
and MRI) has been included whilst appropriate figures have been included to supplement and help clarify the text.
Interval review (5–10 years) is anticipated to keep the document updated and as widely acceptable as possible.
Conclusion: A consensus-based Terminology Report for female anorectal dysfunction terminology has been produced
aimed at being a significant aid to clinical practice and a stimulus for research. Neurourol. Urodynam.
# 2016 Wiley Periodicals, Inc., and The International Urogynecological Association.

Key words: anorectal; fecal incontinence; female sexual dysfunction; female pelvic floor; imaging; terminology

INTRODUCTION
The anatomical configuration of the anorectum is complex. The mechanisms that control continence and allow defecation are
multifactorial and dependent on many factors such as the consistency of stool, bowel transit, rectal compliance and sensitivity,
intact neurological function and integrity of the pelvic floor, and anal sphincters.

This document is being published simultaneously in Neurourology and Urodynamics (NAU) (DOI 10.1002/nau.23055) and the International Urogynecology Journal (IUJ)
(DOI 10.1007/s00192-016-3140-3), the respective journals of the sponsoring organizations, the International Continence Society (ICS) and the International
Urogynecological Association (IUGA).
a
Standardization and Terminology Committees IUGA.
b
ICS.
c
Joint IUGA/ICS Working Group on Female Anorectal Terminology.
Dr. Mickey Karram led the peer-review process as the Associate Editor responsible for the paper.
Potential conflicts of interest: Dr. Sultan has patent on anal sphincter blocks with royalties paid to the Mayday Childbirth Charity fund. He described the Sultan
Classification of third degree tears and runs hands-on workshops on Perineal and Anal Sphincter Trauma (www.perineum.net.; A Monga: reports being Consultant for
Gynecare and AMS and Speaker for Astellas and Pfizer and advisor for Allergan.; Dr. Lee reports personal fees from AMS, personal fees from BSCI, during the conduct of
the study; Dr. Emmanuel served on advisory boards for Coloplast, Shire, Pfizer. Honoraria for talks from these companies as well as Ferring and Astra-Zeneca; Dr. Norton
reported Consultancy for SCA, Coloplast, Shire, Dr Falk, Clinimed; Dr. Santoro has nothing to disclose; Dr. Hull has nothing to disclose; Dr. Berghmans has nothing to
disclose; Dr. Brody has nothing to disclose; Dr. Haylen has nothing to disclose.

Correspondence to: Abdul H. Sultan, MB ChB, MD, FRCOG, Urogynaecology and Pelvic Floor Reconstruction Unit, Croydon University Hospital, London Road, Croydon,
Surrey, CR7 7YE, United Kingdom. E-mail: abdulsultan@NHS.net
Received 13 May 2016; Accepted 23 May 2016
Published online in Wiley Online Library
(wileyonlinelibrary.com).
DOI 10.1002/nau.23055

# 2016 Wiley Periodicals, Inc., and The International Urogynecological Association.

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Historically, anorectal physiological investigations have quite often produced inconsistent results. Until the advent of
imaging techniques such as endoanal ultrasound, the etiology of fecal incontinence was largely attributed to pudendal
neuropathy.1 We now better understand the contribution of vaginal delivery to anal sphincter trauma.2 Imaging has taught us
that training in clinical digital assessment can improve detection and repair of obstetric anal sphincter injuries and thereby
minimize the risk of developing fecal incontinence.3 Obstructive defecation is another common embarrassing problem and
imaging techniques that attempt to capture the defecation process are often inconclusive.4 Artificial contrast material replicating
normal fecal consistency for defecating proctography is not available and magnetic resonance imaging requires an upright
scanner.
When multiple conditions such as fecal incontinence, obstructive defecation, urinary incontinence, neurological diseases,
medical conditions etc. co-exist, management becomes increasingly difficult and multidisciplinary assessment becomes
important.5 As the pelvic organs (bowel, bladder, and vagina) are in close proximity to each other, clinicians need to be
aware of the impact of dysfunction and surgery of one organ may have on the neighboring structures. It is therefore
important for clinicians and pelvic surgeons to have more global knowledge and adopt a holistic approach to pelvic floor
dysfunction.
There is a need for standardized terminology in female anorectal dysfunction to accumulate accurate prevalence data,
perform the appropriate investigations, institute management, and conduct audit and research. Lack of a unified definition of
anal incontinence has resulted in variations in prevalence data from epidemiological data. ‘‘Pseudo incontinence’’ with mucoid
leakage (usually caused by organic colonic disease, dietary sensitivity or fecal impaction) is often mistaken as fecal
incontinence as questionnaires do not quite differentiate them.6 There is indeed the need for a general terminology, forming a
‘‘backbone’’ or ‘‘core’’ terminology to which more specific terminologies can be attached.7
This Terminology Report is inherently and appropriately a definitional document, collating the definitions of those terms,
that is, words used to express a defined concept, in a particular branch of study. Emphasis has been on comprehensively
including those terms in current use in the relevant peer-reviewed literature. The aim is to assist clinical practice and research.
Some new and revised terms have been included. Explanatory notes on definitions have been referred, where possible, to the
‘‘Footnotes section.’’
Similar to a previous report7 the female-specific terminology report should be as follows:
(1) User-friendly: It should be able to be understood by all clinical and research users.
(2) Clinically-based: Symptoms, signs, and validated investigations should be presented for use in forming workable
diagnoses. The first three sections will address symptoms, signs, and assessment tools. The next two sections will describe
anorectal physiological investigations and currently used pelvic imaging modalities routinely used in the office or anorectal
laboratory to make those diagnoses. A number of related radiological investigations as well as magnetic resonance imaging
(MRI) have also been included. The value of electromyography and related nerve conduction, reflex latency, and sensory
investigations will be outlined.
(3) Origin: Where a term’s existing definition (from one of multiple sources used) is deemed appropriate, that definition will be
included and duly referenced. A number of terms in female anorectal function and dysfunction, because of their long-term use,
have now become generic, as apparent by their listing in medical dictionaries.
(4) Able to provide explanations: Where a specific explanation is deemed appropriate to explain a change from earlier
definitions or to qualify the current definition, this will be included as an addendum to this paper (Footnote [FN] 1,2,3 . . . .).
Wherever possible, evidence-based medical principles will be followed.
It is suggested that acknowledgement of these standards in written publications related to female anorectal dysfunction, be
indicated by a footnote to the section ‘‘Methods and Materials’’ or its equivalent, to read as follows: ‘‘Methods, definitions and units
conform to the standards jointly recommended by the International Urogynecological Association and the International
Continence Society, except where specifically noted.’’ It should be noted that the Working Group for this document was formed and
started generation of this document prior to the Rosier statement.8

SECTION 1: SYMPTOMS
Symptom: Any morbid phenomenon or departure from the normal in structure, function, or sensation, experienced by the
woman and indicative of disease9 or a health problem. Symptoms are either volunteered by, or elicited from the individual, or may
be described by the individual’s caregiver.7,10,11

1.1: Anorectal Incontinence Symptoms

7
Anal incontinence (symptom ). Complaint of involuntary loss of feces or flatus.
(i) Fecal incontinence7: Complaint of involuntary loss of feces.
(a) Solid
(b) Liquid
(ii) Flatus Incontinence7: Complaint of involuntary loss of flatus (gas).
(iii) Double incontinence (NEW): Complaint of both anal incontinence and urinary incontinence [FN1].
(iv) Coital fecal (flatal) incontinence (NEW): Fecal (flatal) incontinence occurring with vaginal intercourse (see related definition
‘‘Coital fecal urgency’’) [FN2].

FN1
In regards to definition of various types of urinary incontinence, the interested reader can refer to (Haylen 2010).7
FN2
A history of receptive anal intercourse has been shown to increase the risk of anal incontinence.12

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(v) Passive fecal leakage (NEW): Involuntary soiling of liquid or solid stool without sensation or warning or difficulty wiping
clean [FN3].
(vi) Overflow fecal incontinence (NEW): Seepage of stool due to fecal impaction.

1.2: Anorectal Storage Symptoms

(i) Increased daytime defecation (NEW): Complaint that defecation occurs more frequently during waking hours than previously
deemed normal by the woman.
(ii) Nocturnal defecation (NEW): Complaint of interruption of sleep one or more times because of the need to defecate.
(iii) Fecal (rectal) urgency7: Complaint of a sudden compelling desire to defecate that is difficult to defer.
(a) Fecal urgency warning time: time from first sensation of urgency to voluntary defecation or fecal incontinence.
(iv) Fecal (flatal) urgency incontinence7: Complaint of involuntary loss of feces (gas) associated with (fecal) urgency.
(v) Tenesmus (NEW): A desire to evacuate the bowel, often accompanied by pain, cramping, and straining, in the absence of feces
in the rectum.
(vi) Coital fecal urgency (NEW): Feeling of impending bowel action during vaginal intercourse.

1.3: Anorectal Sensory Symptoms

(i) Diminished rectal sensation7: Complaint of diminished or absent sensation in the rectum.
(ii) Increased rectal sensation (NEW): Complaint of a desire to defecate (during rectal filling) that occurs earlier or more persistent
to that previously experienced.

1.4: Defecatory and Post-Defecatory Symptoms

(i) Constipation7 (Updated): Complaint that bowel movements are infrequent and/or incomplete and/or there is a need for
frequent straining or manual assistance to defecate [FN4].
(a) Slow transit: infrequent bowel motions due to delay in transit of bowel contents to reach rectum.
(b) Obstructed defecation: Complaint of difficulty in evacuation [FN5].
(ii) Feeling of incomplete bowel evacuation7: Complaint that the rectum does not feel empty after defecation and may be
accompanied by a desire to defecate again.
(iii) Straining to defecate7: Complaint of the need to make an intensive effort (by abdominal straining or Valsalva) to either
initiate, maintain, or improve defecation.
(iv) Sensation of blockage (NEW): Complaint suggestive of anorectal obstruction.
(v) Digitation (NEW): Use of fingers in rectum or vagina to manually assist in evacuation of stool contents.
(a) Rectal digitation: Use of fingers in rectum to physically extract stool contents to assist in evacuation.
(b) Vaginal digitation: Use of thumb or fingers in the vaginal to assist in evacuation of stool.
(vi) Splinting (NEW): Support perineum or buttocks manually (usually with thumb or fingers) to assist in evacuation of stool
content.
(vii) Post defecatory soiling (NEW): Soiling occurring after defecation.

FN3
Soiling is a bothersome disorder characterized by continuous or intermittent liquid anal discharge. It should be differentiated from discharge due to fistulae,
proctitis, hemorrhoids, and prolapse. Patients complain about staining of underwear and often wear protection.
 The discharge may cause inflammation of the perineal skin with excoriation, perianal discomfort, burning sensation, and itching,
 It often indicates the presence of an impaired internal sphincter function or a solid fecal mass in the rectum but could also be due to the inability to maintain hygiene due
to hemorrhoids.

FN4
Rome III criteria for functional constipation:
1. Must include two or more of the following:
a. Straining during at least 25% of defecations.
b. Lumpy or hard stools in at least 25% of defecations.
c. Sensation of incomplete evacuation for at least 25% of defecations.
d. Sensation of anorectal obstruction/ blockage for at least 25% of defecations.
e. Manual maneuvers to facilitate at least 25% of defecations (e.g., digitalevacuation, support of the pelvic floor).
f. Fewer than three defecations per week.
2. Loose stools are rarely present without the use of laxatives.
3. Insufficient criteria for irritable bowel syndrome.

Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

FN5
Difficulty evacuating stool, requiring straining efforts at defecation often associated with lumpy or hard stools, sensation of incomplete evacuation, feeling of
anorectal blockage/obstruction or manual assistance to defecate (or inability to relax EAS/dyssynergic defecation).

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1.5: Anorectal Prolapse Symptoms
(i) Anorectal prolapse (updated): Complaint of a ‘‘bulge’’ or ‘‘something coming down’’ towards or through the anus/rectum. The
woman may state she can either feel the bulge by direct palpation or see it aided with a mirror [FN6].

1.6: Anorectal Pain Symptoms (NEW)[FN7]

(i) Pain during straining/defecation: Complaint of pain during defecation or straining to defecate.
(ii) Inflammatory anorectal pain: Complaint of pain characterized by burning or stinging [FN8] (fissure, inflammation, sepsis).
(iii) Non-inflammatory anorectal pain: Complaint of blunted anorectal pain, as opposed to sharp stinging or burning type of
pain (proctalgia fugax, Levator ani syndrome, pudendal neuralgia13) See Section Pain Syndromes.

1.7: Anorectal Sexual Dysfunction Symptoms[FN9]

Symptoms of sexual dysfunction7 . A departure from normal sensation and/or function experienced by a woman during sexual
activity.
Female sexual dysfunction22 . Complaint of dyspareunia or impairment of sexual desire, arousal, or orgasm.
(i) Receptive anal intercourse (NEW): Having a penis penetrating one’s anus [FN10].
(ii) Other anal sexual practices with body parts: Stimulation of the anus and/or rectum with bodily parts other than the penis
(e.g., finger, fist) for sexual purposes by the recipient and/or a partner.
(iii) Other anal sexual practices with non-living objects: Stimulation of the anus and/or rectum with non-living objects
(e.g., dildo) for sexual purposes by the recipient and/or a partner.
(iv) Anodyspareunia (NEW): Complaint of pain or discomfort associated with attempted or complete anal
penetration12[FN11].
(v) Anal laxity (NEW): Complaint of the feeling of a reduction in anal tone [FN12].

1.8: Miscellaneous Anorectal Symptoms

(i) Rectal bleeding/mucus7: Complaint of the loss of blood/mucus per rectum [FN11].
(ii) Perianal itching/pruritus ani (NEW): Complaint of itchy anus [FN13].
(iii) Flaturia (NEW): Complaint of passage of gas per urethra.
(iv) Fecaluria (NEW): Complaint of passage of fecal material per urethra.
(v) Vaginal flatus/feces (NEW): Complaint of passage of flatus or feces per vagina.

SECTION 2: SIGNS
Sign: Any abnormality indicative of disease or health problem, discoverable on examination of the patient: an objective
indication of disease or health problem.7

2.1: Vaginal and Anorectal Inspection23

(i) Excoriation: Perianal excoriation, skin rashes.
(ii) Soiling: Perianal fecal soiling or vaginal fecal soiling.
(iii) Discharge: Perianal or vaginal bloody or mucus discharge.
(iv) Gaping anus: Non-coaptation of anal mucosa at rest.

FN6
Anorectal prolapse can be due to hemorrhoidal, mucosal, rectal prolapse, or rectal intussusception. These definitions are further explained under ‘‘Signs.’’
FN7
This refers to pain localized to the anorectal region, and may include pain, pressure, or discomfort in the region of the rectum, sacrum, and coccyx that may be
associated with pain in the gluteal region and thighs.
FN8
Fissure pain during, and particularly after, defecation is commonly described as passing razor blades or glass shards See FN10.
FN9
Receptive anal intercourse is associated with increased risk of both any female sexual dysfunction,14 as well as with specifically female sexual arousal disorder
with distress15 (‘‘a persistent or recurrent inability to attain [or to maintain until completion of the sexual activity] an adequate wetness and vaginal swelling
response of sexual excitement’’). The association of receptive anal intercourse with sexual dysfunction might be due to physiological and/or psychological processes.
The psychological factors including emotional development problems,16 poorer mood,17 poorer intimate attachment18 as well as general dissatisfaction are associated
with women’s receptive anal intercourse.19 Physiologic factors could include that: (1) mechanical stimulation of the anus and rectum during anal intercourse
increases hemorrhoid risk; (2) women with hemorrhoidectomy have impaired sexual function; and (3) persons with hemorrhoids who have not yet had
hemorrhoidectomy ‘‘are more likely to have abnormal perineal descent with pudendal neuropathy.’’20,21 Thus, pudendal nerve dysfunction could be one mechanism
leading to sexual dysfunction, and this might be the case even in the absence of diagnosed haemorrhoids.13
FN10
A history of receptive anal intercourse has been shown to increase the risk of anal incontinence, rectal bleeding, and anal fissure.12
FN11
Unlike dyspareunia (from coitus), it might be normal to experience pain or discomfort during receptive anal intercourse.
FN12
This may be accompanied by a finding of decreased anal resting tone (in some cases, the result of anal intercourse)—see under Signs. Damage to the internal
anal sphincter is the likely basis for the laxity. Unlike stool passage, receptive anal intercourse is not likely to elicit reflex relaxation of the internal sphincter.
FN13
Pruritus ani has been classified into primary and secondary. The primary form is the classic syndrome of idiopathic pruritus ani. The secondary form implies an
identifiable cause or a specific diagnosis.

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(v) Scars, sinuses, deformities, condylomata, papillomata, hematoma:[FN14].
(vi) Deficient perineum/cloacal-like defect: A spectrum of tissue loss from the perineal body and rectovaginal septum with
variable appearance. There can be a common cavity made up of the anterior vagina and posterior rectal walls or just an extremely
thin septum between the anorectum and vagina.
(vii) Anal fissures: Longitudinal split in the skin of the anal canal, exposing the internal anal sphincter muscle. The majority of
fissures are found in the mid-line posteriorly and there may be a skin tag associated with them.
(viii) Hemorrhoids: Abnormality of the normal cushion of specialized, highly vascular tissue in the anal canal in the submucosal
space. Hemorrhoids can be divided into those originating above the dentate line which are termed internal and those originating
below the dentate line which are termed external. Internal hemorrhoids are graded as follows:
Grade I - bleeding without prolapse.
Grade II - prolapse with spontaneous reduction.
Grade III - prolapse with manual reduction.
Grade IV - incarcerated, irreducible prolapse.
Grade II and Grade III hemorrhoids will become evident on asking the patient to bear down and grade IV hemorrhoids are obvious
at the time of the examination. A proctoscopy is essential in examining for hemorrhoids unless they are completely prolapsed.
(ix) Anorectal prolapse: Full thickness eversion of the lower part of the rectum and anal canal. The exposed mucosa is red with
circumferential folds around the central pit, which is the lumen of the rectum. Look for associated utero-vaginal prolapse, fistulas,
sepsis, and ulcers.
(x) Fistula in ano: An anal fistula is an abnormal connection between the anal canal epithelium (or rarely rectal epithelium) and
the skin epithelium. Patients may complain of pain, swelling, intermittent discharge of blood or pus from the fistula, and recurrent
abscesses formation.
(xi) Rectovaginal fistula: Is a communication from the rectum to the vagina.
(xii) Ano-rectal/vaginal/perineal fistula: Is an abnormal communication from the anal canal to the vagina or perineal
area.

2.2: Vaginal Examination

All examinations for pelvic organ prolapse should be performed with the woman’s bladder empty (and if possible an empty
rectum),7 straining to maximally reveal the prolapse. All compartments should be examined for prolapse but of particular
relevance to ano-rectal dysfunction is posterior vaginal wall prolapse.
(i) Posterior vaginal wall prolapse7: Observation of descent of the posterior vaginal wall. Commonly, this would
represent rectal protrusion into the vagina (rectocele). Higher stage posterior vaginal wall prolapse after prior hysterectomy

Fig. 1. Figure a and b shows prolapse staging—0, I, II, III, and IV (uterine by the position of the leading edge of the cervix).

FN14
With perianal hematomas, the lump may be anywhere around the anal margin and may be multiple. Pilonidal sinuses are usually a small mid-line pit with
epithelialized edges.
FN15
Figure used from Pelvic floor dysfunction document7 (Fig. 1a and b).

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would generally involve some vaginal vault (cuff scar) descent and possible enterocele formation. Posterior vaginal wall
prolapse can be a rectocele, enterocele, or a perineocele. Enterocele formation can also occur in the presence of an intact
uterus.
(ii) Rectocele: Bulge in posterior vaginal wall associated with herniation of anterior wall of the rectum.
(iii) Enterocele: Bulge of upper wall of the vagina associated with herniation of the peritoneal sac and loops of small bowel.
(iv) Perineocele: Bulge in the perineum associated with herniation of the anterior wall of the rectum.

2.3: Anorectal Examination

The patient lies in the left lateral position with hips flexed and ankles away from the examiner. Dorsal lithotomy position could
also be used.
(i) Perianal sensation/reflex: In patients with possible neurogenic pelvic floor dysfunction there should be particular
note of those neurological signs related to S2-4 but these should be complimented by a more general neurological
examination as indicated. Specific to ano-rectal dysfunction, assessment of anal reflex, and perianal sensation should be
performed.
(ii) Digital rectal examination: The gloved finger should be placed in the center of the anus with the finger parallel to the skin
of the perineum in the midline. The finger should then be pressed gently into the anal canal but at the same time pressed
backwards against the skin of the posterior wall of the anal canal and underlying sling of the puborectalis muscle. This
overcomes most of the tone of anal sphincter and allows the finger to straighten and slip into the rectum. This will allow
assessment of:

(a) Resting anal tone, voluntary squeeze of the anal sphincter as well as the levator muscles, sustained squeeze over 5 sec and
involuntary contraction elicited during a cough.
(b) Obvious hemorrhoids can be palpated but grade II and grade III. Hemorrhoids are better assessed by proctoscopy. Painful
examination may be associated with fistula in ano, fissure in ano, infection or pilonidal abscess.
(c) Palpable anal sphincter gap. An assessment can be made of a palpable anal sphincter gap to assess if there has been
previous obstetric or surgical damage. The perineal body can be assessed for deficiency.
(d) Rectal contents. The contents of the rectum can be assessed. The feces may be hard or soft, the rectum may be empty or
collapsed and sometimes ballooned out. This allows assessment of fecal impaction.
(e) Confirmation of presence of rectocele, enterocele, or perineocele. Use of POP-Q for staging of prolapse [See FN15].
(f) Bidigital examination may be carried out with the patient supine in a gynecological examining position. By
inserting the index finger in the vagina and the middle finger in the rectum, the rectovaginal septum and any
intervening small bowel loops can be palpated to differentiate a rectocele from an enterocele, during a Valsalva
maneuver.
(g) Rectal lesions such as carcinoma, intussusception or recto-vaginal fistula. If a mass is felt on a fingertip, the patient should be
asked to strain, and this will often move the mass down to bring it within reach.
(h) An assessment can be made of the rectovesico/recto uterine pouch to look for extra rectal masses.

2.4: Examination of Pelvic Floor Muscle Function7

Pelvic floor muscle function can be qualitatively defined by the tone at rest and the strength of a voluntary or
reflex contraction as strong, normal, weak, or absent or by a validated grading symptom. Voluntary pelvic floor
muscle contraction and relaxation may be assessed by visual inspection, by digital palpation (vaginal or anorectal)
(circumferentially), electromyography, dynamometry, manometry, or ultrasound. Factors to be assessed include muscle
strength (static and dynamic) (graded as strong, normal, weak or absent), voluntary muscle relaxation (graded as
absent, partial, complete, delayed), muscular endurance (ability to sustain maximal or near maximal force), repeatability (the
number of times a contraction to maximal or near maximal force can be performed), duration, co-ordination, and
displacement.24 Assessment can be made of each side of the pelvic floor separately to allow for any unilateral defects and
asymmetry.23 Assessment of displacement (perineal elevation or descent) of the pelvic floor can be made during cough or
Valsalva. Normally, there is some downward movement of the pelvic floor muscles or there is a ventral movement (perineal
elevation, inward (cephalad) and upward movement of vulva, perineum, and anus). Rectal examination observations can
include:
(a) Anal sphincter tone and strength: given the absence of a formal quantitative assessment via the rectal route, assessment of
anal tone and strength on digital examination, can be graded using the same convention used when grading transvaginally—as
strong, normal, weak, or absent or by a validated grading symptom.
(b) Anal sphincter tear: may be recognized as a clear ‘‘gap’’ in the anal sphincter on digital examination.

2.5: Squeeze Pressure

Measurement of squeeze pressure involves the exertion of pressure, compressing the assessor’s finger during digital
palpation or using a mechanical device. The patient is asked to squeeze the PFM as hard as possible (maximum strength), to
sustain the squeeze contraction (endurance), or to repeat squeeze contractions (repetitions). The measurement can be done in
the anorectum using manual muscle testing with digital rectal palpation or pressure manometry in the vagina using manual

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muscle testing with digital vaginal palpation or pressure manometry, or dynamometry. So far, not all quantitative assessments
and scales of pelvic floor squeeze pressure have the same methodological qualities, like validity, reproducibility, and
responsiveness.24–28
Pelvic floor muscle spasm was defined as persistent contraction of striated pelvic floor muscle that cannot be released
voluntarily. If the contraction is painful, this is usually described as a cramp.29 Spasm over days or weeks may lead to a
contracture.
Pelvic floor muscle tenderness: sensation of discomfort with or without pain; discomfort of pelvic floor muscle elicited through
palpation. Tenderness can be scored30 during a digital rectal (or vaginal) examination of levator ani, piriformis and internal
obturator muscles bilaterally, according to each subject’s reactions: 0, no pain; 1, painful discomfort; 2, intense pain; with a
maximum total score of 12.
Although not universally accepted, pelvic floor muscle traction is the use of a pulling force to examine or treat pelvic floor
muscles, postulated to end pelvic muscle spasm or relieve pain.31

2.6: General Examination

Anorectal dysfunction may be associated with systemic disease and intestinal malignancy and a thorough medical examination
should observe for signs relating to conditions such as anaemia, jaundice, lymphadenopathy, etc.

2.7: Neurological Examination

In patients with possible neurogenic pelvic floor dysfunction there should be particular note of those neurological signs related
to S2-4 but these should be complimented by a more general neurological examination as indicated. Specific to ano-rectal
dysfunction, assessment of anal reflex, and perianal sensation should be performed.

2.8: Abdominal Examination

A thorough abdominal examination should evaluate for the following:
(i) Abdominal masses or distension.
(ii) Scars indicating previous relevant surgery or trauma.
(iii) Tenderness.

SECTION 3: ASSESSMENT TOOLS AND QUESTIONNAIRES (NON INVASIVE)

3.1: Pictorial Stool Chart

It is a pictorial chart of stool consistencies. First described (but not published as a pictorial instrument) by Heaton et al.,32,33 the
‘‘Bristol stool chart’’ seems to have widespread face validity and recognition and is useful in conversations with patients about
their stool consistency, despite little validation work. It has not been validated as an outcome measure and a reported change in
category may not represent sufficient degree of precision for use as a trial end point.

3.2: Bowel Diary

It is a recording of bowel actions. Bowel diaries have been widely used in diagnostic and intervention studies. Patient recall is less
accurate than a diary.34,35 Patients tend to underestimate symptom frequency, in one study by over 50%.36 However, there are few
published examples and no consensus on what should be included. Elements that might be included:

� Urgency,
� Fecal incontinence (amount, consistency),
� Flatus incontinence,
� Passive staining/soiling (tends not be discrete episodes),
� Pads (changes, degree of soiling),
� Straining/difficulty/time in the toilet,
� Unsuccessful attempts to defecate,
� Assistive measures (e.g., digital stimulation, manual evacuation, irrigation),
� Laxative or rectal evacuant use,
� Diet and fluids (type and/or timing).

Patients often need careful and detailed instructions on how to complete a diary, and still many are poorly completed. An
incomplete diary is difficult to interpret and is liable to misinterpretation as a low bowel/event frequency.

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3.3: Symptom Scores and Questionnaires
(i) Fecal incontinence (FI)
The International Consultation on Incontinence (ICI) chapter 5B37 has reviewed FI questionnaires and found none with a grade A
recommendation (validity, reliability, and responsiveness established with rigor). The ICI grades B (validity and reliability
established with rigor, or validity, reliability, and responsiveness indicated) and C (early development—further work required) are
noted where available in the text below.
The Cleveland Clinic Score,38 often termed the ‘‘Wexner’’ score, was the first attempt to have a score based on both the frequency
and consistency of FI and effect on lifestyle. In the original version it was physician-completed, although in subsequent literature it
has also been completed by patients (grade C). The St Mark’s score39 was an adaptation of the original Wexner score, adding scores
for urgency and use of anti-diarrheals (grade C). This has been found to correlate reasonably well to patients’ global assessment of
their bowel function.40
The Fecal Incontinence Quality of Life Scale41 (grade B) and Fecal Incontinence Severity Index42 (FISI) (grade B) were developed
using items suggested by experts and then proposed to patients for ranking.
The international consultation on incontinence questionnaire—bowels (ICIQ-B)43 has 23 items developed by literature review,
expert opinion and in-depth qualitative interviews with patients, to include items of greatest importance to both clinicians and
people with symptoms.44 It has been validated up to the point of responsiveness to change, but further work is needed.
(ii) Constipation
There has been no exercise similar to the ICI Chapter 5B37 which has graded constipation questionnaires.
The Patient Assessment of Constipation Quality of Life questionnaire45 (PAC-QOL) and the PAC-SYM46 are the best validated and
most widely used tools for idiopathic constipation.47 The PAC-SYM items were developed from the literature and patient focus
group interviews. The validation process was robust and the instrument has 12 items grouped into three subscales (stool
symptoms, rectal symptoms, and abdominal symptoms), each scored 0–4. It has also been validated for use with constipated older
people in a care home environment47 and opioid-induced constipation.48
The Cleveland Clinic constipation score gives a simple numerical total score49 based on symptoms and physiological findings.
Values allocated to symptoms and findings appear to be arbitrary. Validation has been limited.
Altomare has developed a scoring system specifically for the Obstructed Defecation Syndrome,50 but this has not been formally
validated. Table I shows utility of patient reported outcomes questionnaires for female anorectal dysfunction in clinical or research
settings.

TABLE I. Patient Reported Outcome Questionnaires for Female Anorectal Dysfunction

Conditions Tools Clinical Research

Bowel dysfunction Bristol stool chart R R

Bowel dysfunction Bowel diary R R
Fecal incontinence Cleveland clinic score/ R R
Wexner R R
St Marks score R R
FI QoL O R
FISI O R
ICIQ-B O R
Constipation PAC-QoL R R
PAC-SYM R R
Altomare O R

O, optional; R, recommended.

SECTION 4: ANORECTAL PHYSIOLOGICAL INVESTIGATIONS

Anorectal physiological assessment is a key part of the assessment of some patients with pelvic floor symptoms51,52 providing a
clinically meaningful, quantitative measure of a specific anorectal function. It is only in the context of the patient’s symptoms,
thorough examination and radiological investigations that physiological measurements can be correctly interpreted.

4.1: Investigations to Exclude Organic Disease

(i) Anoscopy or proctoscopy is the inspection of the anal canal to identify anal fissure, fistula, or hemorrhoids as a cause of anal
symptoms.
(ii) Rigid sigmoidoscopy is a bedside test to inspect the rectal mucosa, with no bowel preparation.
(iii) Flexible sigmoidoscopy refers to the inspection of the distal colonic mucosa, typically up to the splenic flexure, with a 60 cm
flexible endoscope following enema preparation. Colonoscopy examines the entire colon following a full oral preparation to clear
the bowel to allow this.

4.2: Anorectal Physiology Tests

Functional assessment tests of fecal incontinence and evacuatory disorders aim to qualify and quantify function, determine the
etiology, guide management, and monitor progress.

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4.2.1 Manometry
Anal manometry is a test to assess the mechanical strength of the anal sphincters.53,54 A range of methods is available, including
water perfused, solid state, and micro-balloon systems. The length of the canal is measured either by station pull-through or
continuous pull-through. Station pull-through involves inserting the catheter to 6 cm from the anal verge, withdrawing the
catheter at 5–10mm intervals and measuring for 1–5 min at each ‘‘station’’ (see Fig. 2). Continuous pull-through involves
withdrawing the catheter at a set speed by hand or by a mechanical puller. As normal values can differ substantially between
laboratories according to the style of catheter used, each unit is encouraged to generate its own normal data.51,52
In patients with fecal incontinence the value of manometry is:
(a) To define functional weakness of one or both sphincter muscles (as a compliment to anal endosonography).
(b) To support findings of other tests and to monitor outcome and predict response to biofeedback training.
(c) In cases where anal endosonography is not available, vector manometry may help identify anatomic defects of the anal
sphincter complex.
In constipated patients the value of manometry is:
(a) To exclude Hirschsprung’s disease.
(b) To identify and predict responses to biofeedback training (pelvic floor dyssynergia ¼ failure to expel a water-filled balloon).
4.2.1.1: Functional anal length
Functional anal canal length is defined as the length of the anal canal over which resting pressure exceeds that of the rectum by
greater than 5 mmHg or, alternatively, as the length of the anal canal over which pressures are greater than half of the maximal
pressure at rest.
4.2.1.2: Maximum resting pressure
The maximum resting pressure is the maximum resting pressure generated in the anal canal at rest. Strictly speaking, it is
defined as the difference between the intrarectal pressure and the highest recorded rectal pressure at rest. However, rectal contents
may affect the accuracy of rectal pressure measurements.The internal anal sphincter (IAS) exhibits continuous tonic activity and is
responsible for 55–85% of the resting anal canal pressure (see Fig. 2). Its contribution to resting tone is variable along the length of
the anal canal with the proximal two thirds being more reliant on IAS tone to maintain adequate resting pressures.55,56 The range
of maximal resting pressure is typically between 60 and 120 cmH2O. The EAS has constant tonic activity contributing to the resting
anal canal pressure.
4.2.1.3: The maximum squeeze pressure
The maximum squeeze pressure is the maximum pressure generated in the anal canal during a voluntary contraction. Although
the EAS contributes to the resting pressure the specific function of the EAS can be assessed during the squeeze and cough
maneuvers. The pressure increment above resting pressures during these maneuvers is a direct representation of EAS function. The
normal range, as stated above, varies according to measurement modality in each laboratory, but is approximately above
60 cmH2O.57,58 Typically, higher values are obtained by automated pull-through rather than station withdrawal methodologies.51
4.2.1.4: Involuntary maximum squeeze pressure
A common maneuver is a maximal cough to measure this involuntary increment, usually reported as a present or absent
response, rather than numerically.
4.2.1.5: Endurance squeeze pressure
The endurance squeeze pressure is the length of time the individual is able to maintain the pressure during a voluntary
contraction. To assess the endurance squeeze pressure, measurements are taken during a 5–10 sec squeeze (normal �5 sec).
Incontinent patients typically have fatigue rate of greater than two-thirds of initial pressure at the end of the sustained squeeze. By
calculating fatigability, the fatigue rate (using linear regression on the mean pressure over one second periods throughout the
endurance squeeze) can be derived.
4.2.1.6: Rectoanal inhibitory reflex
The recto-anal inhibitory reflex (RAIR) a relaxation response in the IAS following rectal distension. A drop of at least 25% of
resting pressure has to occur with subsequent restoration to at least two thirds of resting pressure for it to be deemed present. It is
elicited by rapid insufflation and disinflation of 50 mls of air into a balloon positioned in the distal rectum during anal manometry
at the level of the proximal high pressure zone.52 This reflex is absent in Hirschsprung’s disease: of greater physiological meaning,
this reflex is thought to underlie the sampling response that allows rectal content to be sensed by the anal mucosa, thus ensuring
continence of flatus and stool.59

Fig. 2. Typical station pull through manometry trace on a patient, with explanations.

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4.2.1.7: Balloon expulsion pressure
The balloon expulsion pressure is the anal canal pressure during straining with a filled balloon in the rectum. Balloon expulsion
can be performed on patients with evacuatory difficulty. An inappropriate increase in sphincter pressure on attempted voiding
evacuation is usually reported as a present or absent response, rather than numerically. Such increased pressure is referred to as
‘‘anismus’’ or ‘‘paradoxical sphincter contraction.’’
4.2.1.8: Advanced manometric techniques
4.2.1.8.1: Vector manometry
Vector manometry is a quantitative measure of radial symmetry and volume of the anal sphincter. It involves withdrawing
(commonly using a mechanical puller) a radially arranged multi-channel anorectal manometry catheter through the length of the
anal canal.60,61 The following parameters are identified:
� Radial asymmetry index (RAI) is a quantitative measure of the radial symmetry and can be calculated at any level in the anal
canal but most commonly refers to the level at which the highest resting pressure is generated. The principle is that an
asymmetrical sphincter is more likely to have a sphincter defect.
� The vector volume is the volume of the 3D shape generated and provides a value which reflects the overall length and symmetry
of the sphincter (Fig. 3).
4.2.1.8.2: High resolution manometry
In this technique, a catheter with a large number of pressure sensors spaced less than 0.5 mm apart along the length of the
catheter. This allows complete definition of the intra-anal pressure environment. The resulting data is displayed on a
topographical three dimensional plot to allow easier pattern recognition. It is a measurement with the variables of pressure
(displayed as the color), distance into the anal canal (y-axis) and time (x-axis). Normal ranges are slightly higher than measured
with standard manometry, but the readings agree well with each other.62
4.2.1.8.3: Ambulatory anorectal manometry
Using solid-state catheters, prolonged ano-rectal motor events have been recorded, including in ambulant subjects. The clinical
applicability of these techniques has not been established.63–65
4.2.2: Sensory measurements
4.2.2.1: Assessment of rectal sensation to distension
Rectal sensation to distension is most commonly assessed by manually inflating an intrarectal domestic balloon at a rate of
approximately 5 ml/second.56,66 The following are elicited:
� Volume which elicits the first sensation of balloon expansion (threshold) [typical normal range 12–25 ml],
� Volume to get an urge to defecate (typical normal range 35–65 ml),
� Maximal tolerated volume (typical normal range 120–300 ml).

[normal ranges for the latter two sensations are highly variable due to lack of consensus on measurement technique especially of
the nature and speed of inflation of the balloon]
The pressure required to elicit these sensations can also be measured using an electro-mechanical barostat and may be more
reproducible. The barostat measures the volume and the pressure required to elicit these volumes sensations.67,68 Typically
distension thresholds with a barostat are higher, with larger volumes being required to elicit the same sensation. However, again,
the published ranges vary widely between units: typically distension volumes 1.5 to 3 times are published for thresholds with a
barostat compared to manual balloon inflation.
Distension sensitivity testing is of proven value in:
(a) Patients with fecal incontinence to help with biofeedback training by normalization of the initial sensation sensory
thresholds.
(b) Identifying visceral hypersensitivity, poor rectal compliance, or rectal irritability if maximal tolerated volumes are low.51,52
There is no evidence to support use of the sensory thresholds for diagnosis and biofeedback training of patients with
constipation. Compliance testing has also not proven valuable in identifying candidates for specific therapies.

Fig. 3. Vector volume anal manometry trace. The left hand panel illustrates the shape of the contour curve at a fixed point, and the right hand figure shows the
integrated whole across the length of the sphincter (from proximal to distal). It is evident that the greatest pressure is exerted in the distal canal.

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4.2.2.2: Mucosal electrosensitivity
This is test to measure anal and rectal sensory thresholds. Mucosal electrical stimulation is performed using a probe with two
ring electrodes between which a small electrical potential is applied generating an alternating square wave with a variable
frequency. Normal ranges have been established as anal electrosensation <10 mA, and rectal as <30 mA.69 In general, prolonged
anal electrosensation is suggestive of damage to the sensory fibers of pudendal nerve, and prolonged rectal electrosensation is
suggestive of autonomic neuropathy.
4.2.3: Rectal dynamics
4.2.3.1: Rectal compliance
Rectal compliance is the term that describes the relationship between pressure and volume, reflecting the ability of the rectum to
act as a reservoir and is assessed using a barostat, Inflating the bag within the rectum prior to the recording inflation protocol,
known as conditioning, has been shown to improve the precision of compliance testing.59 Typically, compliance figures between 4
and 11 mmHg/ml are quoted as the normal range.
4.2.3.2: Rectal impedance planimetry
These studies are the preserve of research institutions rather than clinical practice. The rationale is to calculate the diameter or
cross sectional area of an intra rectal bag during a distension sequence. Impedence planimetry measures the cross sectional area
which enables the circumferential wall tension to be calculated.70
4.2.4: Attempted defecation and balloon expulsion
Patients with symptoms of prolapse and elderly patients with a history of constipation who present with passive incontinence
should be thoroughly examined for the presence of a full thickness rectal prolapse. Patients are asked to strain as they would to
pass stools whilst on a toilet or commode and given enough time to reproduce the prolapsing lump before examination.
Expulsion of a water-filled balloon can be used in the assessment of constipated patients. The ability to expel the balloon within
1 min may be a useful tool in demonstrating the absence of pelvic floor dyssynergia.
4.2.5: Neurophysiology
4.2.5.1: Single fiber EMG
A single fiber needle EMG technique is used to measure the muscle fiber density in the external sphincter and puborectalis. A
raised fiber density indicates re-innervation in the muscles, which may occur following partial denervation. Calculating EAS fiber
density is another method of assessing denervation and re-innervation of the EAS. It is used almost exclusively as a research tool.
Conventional EMG can be used to quantify the re-innervation of the EAS by detecting prolongation in the duration of the motor
unit potential.
4.2.5.2: Concentric fiber EMG
Concentric needle EMG can be used to record activity in the external sphincter and puborectalis. The responses of these muscles
to voluntary contraction, coughing, and straining can be displayed. The data are qualitative and compared to appearances in these
muscles at rest. The muscles can also be studied at several sites to define areas of functioning muscle and identify sites of muscle
injury (sphincter mapping) although this is has now been superseded by anal endosonography.
4.2.5.3: Surface EMG
Electrodes placed on the skin of the perineum or inside the vagina or rectum. Surface recordings from the sphincter show
increased activity with body actions and decreased activity in sleep. Needle EMG however is regarded as superior.71 Some centers
use surface EMG as an indicator of anal sphincter activity to provide feedback for patients undergoing behavioral biofeedback
training for fecal incontinence or constipation.
4.2.5.4: Pudendal nerve terminal motor latencies (PNTMLs)
The PNTML is a measurement of the delay between the electrical stimulation of the pudendal nerve and the EMG activity of the
EAS. The pudendal nerve is stimulated as it passes over the ischial spine using a specially designed electrode attached to the index
finger of the assessor in the rectum.71 The surface EMG recording electrode which sits on the base of the assessor’s index finger and
measures external sphincter activity. The test does not reliably reflect the pudendal nerve damage. This may be because PNTMLs
measure the speed of nerve conduction, which involves the fastest nerve fibers that are least susceptible to damage. The latencies
are reported as normal if below 2.2 msec, but are also very operator dependent, with poor reproducibility and hence not
recommended for general clinical use.72

4.3: Clinical Role of Anorectal Physiological Measurements

As can be seen from the above, the reliability, reproducibility, and clinical validity of these tests are unproven, owing to the
variety of methodologies of measurement undertaken. Standardization in each individual laboratory, with normal ranges from
each laboratory, is therefore the required standard. Table II shows the utility of anorectal physiology tests within clinical or
research settings.

TABLE II. Anorectal Physiology Tests for Female Anorectal Dysfunction

Anorectal physiological tests Conditions Clinical Research/optional

Anorectal manometry Anal sphincter function R R

Defecography Extent of rectal intussusception/rectocele O R
Neurophysiological testing Preoperative before sphincteroplasty or SNM; or in O R
PTNML73 Patients with possible pudendal neuralgia
CN-EMG When USS or MRI equivocal

O, optional; R, recommended.

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SECTION 5: IMAGING

5.1: Ultrasonography (2D/3D/4D) of the Posterior Compartment Including Anal Sphincters, Pelvic Floor Muscles, and Prolapse
(Endoanal, Transperineal, Transvaginal)
Ultrasound is increasingly being incorporated as an investigation of posterior compartment disorders7,74 (Table III). An
integrated multi-compartmental pelvic floor ultrasonography with a combination of different modalities has been described to
assess pelvic floor dysfunction for a global and multi-compartmental perspective.75,76
Modalities in current routine clinical use:
(a) Endoanal: intra-anal 3608 sector scanning using rotational mechanical probe or radial electronic probe.
(b) Transperineal: curved array probe applied in the perineum between the mons pubis and the anal margin. This term
incorporates trans-labial ultrasound. Introital ultrasound is usually assumed to imply the placement of transducer with smaller
footprints (such as end-firing endo-vaginal probe) within the introitus.
(c) Transvaginal: intra-vaginal curvilinear, linear array, or 3608sector scanning.
5.1.1: Endoanal ultrasonography (EAUS)
The majority of current systems provide 2D & 3D Imaging which give a 3608 axial view of the anal canal and of the rectal
wall.4,77,78 Endoanal ultrasound can be performed with the patient placed in the dorsal lithotomy, left lateral or prone position.
Irrespective of the position, the probe should be rotated so that the anterior aspect of the anal canal is superior (12 o’clock) and left
lateral is right (3 o’clock) on the screen. The anal canal is divided into three levels of assessment in the axial plane referring to the
following anatomical structures:
• Upper level: the hyperechoic sling of the puborectals muscle (PR) and the complete ring of the internal anal sphincter (IAS) are
visualized (Fig. 4a),
• Middle level: corresponds to the superficial part of the EAS (concentric band of mixed echogenicity), the conjoined longitudinal
layer, the IAS (concentric hypoechoic ring), and the transverse superficial perinei muscles (Fig. 4b),
• Lower level: corresponds to the subcutaneous part of the EAS where the IAS is absent (Fig. 4c).
The acquisition of a three-dimensional data volume (3D ultrasound) and the underlying techniques vary. Acquisition may be
‘‘free-hand’’ (low resolution 3D) or ‘‘automatic computer-controlled’’ (high resolution 3D).79,80
5.1.2: Transperineal Ultrasonography (TPUS)
Conventional convex transducers (frequencies between 3 and 6 MHz and field of view at least 708) provide 2D imaging of the
pelvic floor.81,82 Transperineal ultrasound is performed with the patient placed in the dorsal lithotomy position, with the hips
flexed and abducted. If necessary, the patient can be examined standing, to maximise descent of pelvic organs, especially if the
patient finds it difficult to produce an effective Valsalva maneuver. No rectal or vaginal contrast is used. Perineal ultrasound
provides sagittal, coronal and oblique sectional imaging, with the mid-sagittal plane being the most commonly used as this gives
an overall assessment of all anatomical structures (bladder, urethra, vaginal walls, anal canal, and rectum) between the posterior
surface of the symphysis pubis (SP) and the posterior part of the levator ani (LA) (Fig. 5a and b). The imaging is usually performed at
rest, on maximal Valsalva maneuver and on pelvic floor muscle contra-ction (PFMC). The access to the mid-sagittal plane allows the
following evaluations83:
• Integrity of the perineal body: appearing as a triangular shaped, slightly hyperechoic structure anterior to the anal sphincter,
• Measurement of the anorectal angle (ARA): formed by the longitudinal axis of the anal canal and the posterior rectal wall,
• Dynamic assessment of the posterior compartment. During Valsalva it is possible to visualize descent of an enterocele, to
assess the movement of the anterior rectal wall to detect a rectocele, and to evaluate movement of the PR and ARA to diagnose
pelvic floor dyssynergy (Fig. 5c).
3D TPUS may be performed with volumetric probes (electronic curved array of 4–8 MHz). An advantage of this technique is the
opportunity to obtain tomographic or multi-slice imaging, for example, in the axial plane, in order to assess the entire PR and its
attachment to the pubic rami84 (Fig. 6). It is also possible to measure the diameter and area of the levator hiatus (LH) and determine
the degree of hiatal distension on Valsalva. Four dimensional (4D) imaging indicates real-time acquisition of volume ultrasound
data.

TABLE III. Imaging Modalities for Female Anorectal Dysfunction

Conditions Imaging techniques Levels of evidence Grade of recommendation

Fecal incontinence Endoanal US Level II Grade B

Static MRI Level II Grade B
Defecating proctography Level III Grade C
Pelvic organ prolapse Dynamic MRI Level II Grade B
Transperineal US Level II Grade B
Defecating proctography Level II Grade B
Obstructed defecation Dynamic MRI Level II Grade B
Defecating proctography Level II Grade B
Transperineal US Level III Grade C
Perianal sepsis Static MRI Level II Grade B
Endoanal US Level II Grade B
Fistulography Level III Grade C
Chronic pelvic pain Static MRI Level III Grade C

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Fig. 4. Endoanal ultrasonography. (a) Upper level of the anal canal; (b) Middle level of the anal canal; (c) Lower level of the anal canal. PR, puborectalis; IAS,
internal anal sphincter; EAS, external anal sphincter; LM, longitudinal muscle; SE, sub epithelium.

5.1.3: Transvaginal Ultrasonography (TVUS)

Transvaginal ultrasound is performed with the patient placed in the dorsal lithotomy position. Currently, the transducers used
for pelvic floor 3D TVUS are high multi-frequency (9–16 MHz), 3608 rotational mechanical probe or radial electronic probe (Fig. 7a).
The pelvic floor is divided into four levels of assessment in the axial plane referring to the following anatomical structures85: (not to
be confused with Delancey’s description of vaginal Levels of supports).

Fig. 5. 2D-Transperineal ultrasound. (a) Schematic drawing; (b) Pelvic organs at rest; (c) Pelvic organs descend below the symphysis pubis line after Valsalva
maneuver (cystocele, enterocele, rectocele). PR, puborectalis muscle; A, anal canal; PB, perineal body; V, vagina; U, urethra; P/SP, symphysis pubis.

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Fig. 6. 3D-Transperineal ultrasound. Axial image of the pelvic floor at rest showing the LA attachment to the pubic rami (PR). AC, anal canal; LA, levator ani; B,
bladder; U, urethra; SP, symphysis pubis.

• Level I: at the highest level the bladder base is visualized on the screen at 12 o’clock position and the inferior third of the rectum
at 6 o’clock position,
• Level II: corresponds to the bladder neck, the intramural region of the urethra and to the anorectal junction. At this level the
subdivisions of the LA (pubovaginalis, puboperinealis, puboanalis, puborectalis, and iliococcygeus) may be identified,
• Level III: corresponds to the midurethra and to the upper third of the anal canal. At this level the LA is visualized as a multilayer
hyperechoic sling coursing lateral to the vagina and posteriorly to the anal canal and attaching to the inferior pubic ramus (Fig. 7b).
In the axial plane of minimal hiatal dimensions, identified as the minimal distance between the inferior edge of the SP and the
anterior border of the LA at the ARA, the biometric indices (anteroposterior and transverse diameters, area) of the LH can be
determined (Fig. 7c),86
• Level IV: at the outer level, the perineal muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineii
muscles), the perineal body, the distal urethra and the middle and inferior third of the anal canal are visualized. The anterior-
posterior diameter of the urogenital hiatus (UGH), corresponding to the SP-perineal body distance, can be determined.87
Transvaginal ultrasound may be also performed with electronic probes with linear array, which provide mid-sagittal image of
the posterior compartment.76 The main advantage of this technique is the dynamic assessment of the anorectal region, during
Valsalva and pelvic floor muscle contraction (PFMC).
5.1.4: Clinical applications of ultrasonography of the posterior compartment
5.1.4.1: Fecal incontinence
Anal inspection and digital rectal examination can give information about internal and external anal sphincter function but are
inaccurate for determining external anal sphincter defects <90 degrees and internal sphincter defects. Therefore, a sufficient
diagnostic work-up should comprise at least rectal examination, anal inspection and endoanal ultrasonography.88 EAUS has become
the gold standard for morphological assessment of the anal canal.75 The International Consultation on Incontinence (ICI)89 has
recommended EAUS as the first line imaging investigation for fecal incontinence to differentiate between those with intact anal
sphincters and those with sphincter lesions (defects, scarring, thinning, thickening, and atrophy). Routine use of transperineal,
transvaginal and translabial ultrasonography to image the anal sphincter complex are not recommended,89 although research is
ongoing. The operator should identify if there is a combined or isolated lesion of the IAS and EAS and report the number of defects, as
well as the extent of the defect circumferentially (radial angle in degrees or in hours of the clock) and longitudinally (proximal, distal or
full length).89–91 Using 3D EAUS, two scoring systems have been proposed to define the severity of anal sphincter damage.92,93
EAUS has an important role in detecting undiagnosed anal sphincter injuries following vaginal delivery2 and can be useful in the
management of subsequent pregnancies following OASIS (119). It is also useful to evaluate the results of treatment (anterior
sphincter repair, bulking agent injections).75,89
5.1.4.2: Levator ani injuries
Levator avulsion is the disconnection of the muscle from its insertion on the inferior pubic ramus and the pelvic sidewall,
whereas tears may occur in any part of the muscle. Avulsion is a common consequence of overstretching of the levator ani during
the second stage of labor and it is detectable by 3D TVUS and 3D TPUS imaging as the lateral attachments of the levator ani to the

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Fig. 7. 3D-Endovaginal ultrasound. (a) Schematic drawing; (b) Axial image of the pelvic floor at Level III, showing the LA attachment to the inferior pubic rami
(IPR); and (c) the levator hiatus. AC, anal canal; LA, levator ani; B, bladder; U, urethra; SP, symphysis pubis; OF, obturator foramen; T, transducer; AP,
anteroposterior diameter of the levator hiatus; LL, laterolateral diameter of the levator hiatus.

pubic bone are clearly visualized.94 Defects are usually visualized most clearly on maximal PFMC. Tomographic ultrasound
imaging is particularly useful. Levator ani injuries affect the size of the levator hiatus, with a hiatal enlargement to over 25 cm2 on
Valsalva maneuver defined as ‘‘ballooning,’’ and are related to symptoms and signs of prolapse.
5.1.4.3: Obstructed defecation syndrome (ODS)
The term obstructed defecation syndrome (synonym: ‘‘outlet obstruction’’) encompasses all pelvic floor dysfunctions, which are
responsible for an incomplete evacuation of fecal contents from the rectum, straining at stool and vaginal digitations. During
maximal Valsalva maneuver, dynamic TPUS and TVUS may be used to demonstrate.82,95
• Rectocele: herniation of a depth of over 10 mm of the anterior rectal wall,
• Rectal intussusception: invagination of the rectal wall into the rectal lumen, into the anal canal or exteriorized beyond the
anal canal (rectal prolapse),
• Enterocele: herniation of bowel loops into the vagina. It can be graded as small, when the most distal part descends into the
upper third of the vagina, moderate, when it descends into the middle third of the vagina, or large, when it descends into the lower
third of the vagina,
• Dyssynergic defecation: the ARA becomes narrower, the LH is shortened in the anteroposterior dimension, and the PR muscle
thickens as a result of contraction.
5.1.4.4: Perianal abscesses and fistulas

5.2: MRI for Anal Sphincters and Pelvic Floor (Static, Dynamic, Endocoil) Upright, Supine, Left Lateral Position
5.2.1: Static MRI
Static MRI provides detailed information of the pelvic floor anatomy.96 Current state-of-the art MR imaging of the pelvic floor
includes imaging at a magnetic field strength of 1.5 Tesla (T), using pelvic or phased-array coils and T2-weighted fast-spin echo
(FSE) sequences. The spatial resolution can be enhanced by using endoluminal (endorectal, endovaginal) coils. In combination
with T2-weighted FSE sequences, endoluminal coils provide improved signal-to-noise ratio (SNR) and high resolution images.97
Based on T2-weighted turbo spin-echo sequences, muscles are relative hypointense, ligaments and fascia hypointense while fat
and smooth muscle are hyperintense. The prominent pelvic floor structures of the posterior compartment visualized at MRI are
(Fig. 8):
• Perineal body and superficial perineal muscles,
• Anal sphincters: the IAS is easily recognized as a circular hyperintense structure. It is approximately 2.9 mm thick on
endoluminal MRI. The inter-sphincteric space is seen as a bright line on T2-weighted MRI. The EAS has a thickness of 4.1 mm on
endoluminal imaging,
• Puborectalis muscle and levator ani,
• Superficial perineal muscles,
• Rectum and rectal support.

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Fig. 8. Static MRI. Axial image of the anal canal. U: urethra; V: vagina; SM: submucosa; IS: internal sphincter; LM: longitudinal muscle; ES: external sphincter;
ACL: anococcygeal ligament.

5.2.2: Dynamic MRI

With the development of fast multi-slice sequences MR imaging has gained increasing acceptance for dynamic imaging of pelvic
floor. Because the posterior compartment is traditionally in the focus of interest, dynamic MR imaging of the pelvic floor is often
called ‘‘MR defecography.’’98
Dynamic pelvic imaging may be performed in an open-configuration MR system in the sitting position, or in a closed-
configuration MR-system in the supine position. Both techniques are equally effective in identifying most of the clinically relevant
abnormalities of the pelvic floor.98 For evaluation of the posterior compartment of the pelvic floor, the rectum should be filled with
a contrast agent (ultrasound gel or mashed potatoes, gadolinium-based MR contrast agent) to study the actual act of defecation.
The use of reference lines for image evaluation is helpful.99,100 The most used reference line is the pubococcygeal line (PCL), which
is defined on mid-sagittal images as the line joining the inferior border of the symphysis pubis to the last or second last coccygeal
joint (Fig. 9a). The anorectal junction (ARJ) is defined as the cross point between a line along the posterior wall of the distal part of
the rectum and a line along the central axis of the anal canal. To determine pathologic pelvic floor descent, the measurements are
made on the images, which show maximal organ descent, usually during maximal straining or during evacuation (Fig. 9b). The
anorectal angle (ARA) is defined as the angle between the posterior wall of the distal part of the rectum and the central axis of the
anal canal and can be measured at rest, squeezing and straining. The extent of rectoceles and enteroceles are measured.
The degree of pelvic floor relaxation is measured with two reference lines (Fig. 9a): the H line which represents hiatal widening
and extends from the inferior aspect of the symphysis pubis to the posterior wall of the rectum at the level of the ARJ and the M line
which represents hiatal descent and extends perpendicularly from the PCL to the posterior end of the H line. Lesions of the pelvic
musculofascial support result in widening of the hiatus and descent of the levator plate. Thus, the H and M lines tend to elongate

Fig. 9. Dynamic MRI. (a) Mid-sagittal steady state free precession T2-weighted image obtained at straining shows landmarks used in the HMO-system. The
landmarks are the inferior aspect of the symphysis pubis (A) and the posterior wall of the rectum at the level of the anorectal junction (B). The H line (H)
represents the anteroposterior hiatal width and extends from A to B. The M line (M) represents hiatal descent and extends perpendicularly from the
pubococcygeal line (PCL) to the posterior end of the H line. (b) During Valsalva maneuver, there is a bladder descent below the PCL (small white arrow), with a
perineal descent (black arrow) and a rectocele developing with a posterior vaginal wall prolapse (long white arrow).

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with pelvic floor relaxation, widening the levator plate descent. Abnormal pelvic floor relaxation is present, when the H line
exceeds 6 cm, and when the M line exceeds 2 cm in length.
5.2.3: Clinical applications of MRI of the posterior compartment
5.2.3.1: Fecal incontinence
Endoanal ultrasound and endoanal magnetic resonance imaging (MRI) have been demonstrated to be comparable in the
detection of external sphincter defects.101 External phased array coil MRI can replace endoluminal MRI with comparable results.102
5.2.3.2: Levator ani injuries
Abnormalities of the LA are identified on MRI as present or absent.103 Defect severity is further scored in each muscle from 0 (no
defect) to 3 (complete loss). A summed score for the two sides (0–6) is assigned and grouped as minor (0–3) or major (4–6).
5.2.3.3: Obstructed defecation
During maximal Valsalva maneuver, dynamic MRI may be used to demonstrate:
• Rectocele: measured as the depth of wall protrusion beyond the expected margin of the normal anorectal wall. Based on
sagittal MR-sections through mid of pelvis, rectoceles are graded as small (<2 cm), moderate (from 2 to 4 cm), and large (>4 cm),
• Rectal intussusception: the infolding of the rectal mucosa occurring during defecation. Depending on the location, an
intrarectal intussusception, limited to the rectum, is distinguished from an intra-anal intussusception extending into the anal
canal. The location of the intussusception may be anteriorly, posteriorly, or circumferentially. The intussusception either involves
only the mucosa or the full thickness of the rectal wall,
• Enterocele: defined as a herniation of the peritoneal sac, which contains omental fat (peritoneocele), small bowel (enterocele)
or sigmoid (sigmoidocele), into the rectovaginal or rectovesical space below the PCL. The largest distance between the PCL and the
most inferior point of the enterocele is measured with a perpendicular line. Depending on this distance, small (<3 cm), moderate
(3–6 cm), and large (>6 cm) enteroceles are distinguished,
• Dyssynergic defecation: different structural imaging findings can be seen on dynamic pelvic MRI, including prominent
impression of the puborectal sling, narrow anal canal, prolonged evacuation, a lack of descent of the pelvic floor and thus a failure
to increase the ARA.
In comparison with clinical examination (POP-Q), dynamic MRI has no additional value in the prediction of symptoms with
increasing degree of POP.104
5.2.3.4: Perianal abscesses and fistulas

5.3: Defecating Proctography

Evaluates in real time the morphology of rectum and anal canal in correlation with pelvic bony components both statically and
dynamically by injection of a thick barium paste into the rectum and its subsequent evacuation.105 Contrast administration into
the bladder and vagina provides a more comprehensive assessment of the pelvic organs and has been labelled ‘‘dynamic
cystoproctography.’’104
At rest, the anal canal is closed and rectum assumes its normal upright configuration. The position of the pelvic floor is inferred
by reference to the PCL (inferior margin of pubic symphysis to the sacro-coccygeal junction) (Fig. 10a). Perineal descent is measured
from to this line to the ARJ, and may be up to 1.8 cm at rest. Some pelvic floor descent during evacuation is considered normal, and a
descent of up to 3 cm from the rest position to anal canal opening is acceptable. The ARA is defined as the angle between the anal
canal axis and the posterior rectal wall, and on average is around 908 (Fig. 10b). The puborectalis length (PRL) can be estimated by
measuring the distance between the ARA and symphysis pubis.
A normal emptying phase at the proctogram is described by five elements:
• Increase in the ARA by around 20–30 degrees,
• Obliteration of the puborectalis impression and the PRL should increase by around 3–4 cm,
• Wide opening of the anal canal within a couple of seconds,
• Evacuation of rectal contents proceeding promptly and to completion,
• Lack of significant pelvic floor descent.
After evacuation is complete, the anal canal should close, the ARA recover and the pelvic floor return to its normal baseline
position. Post toilet imaging may be required, particularly in those suspected of retained barium within rectoceles (Fig. 10c).
5.3.1: Clinical applications of defecating proctography
Assuming that posterior wall prolapse and rectocele can be considered the same anatomic entity, clinical examination is not
accurate in diagnosing anatomical defects of posterior vaginal wall and enteroceles compared to defecography as reference
standard. Clinical examination overestimates the presence of the posterior wall defects (large false positive rates) but misses
enterocele in patients with primary POP (large false negative rates).106,107 The major function of proctography is not merely to
document evacuatory abnormalities, but also to classify those abnormalities into those potentially surgically relevant, those likely
to benefit from behavioral biofeedback therapy alone, or indeed those which are incidental.108
5.3.1.1: Pelvic floor descent
Pelvic floor descent, defined as the distance moved by the ARJ or ARA at rest to the point of anal canal opening, is considered
abnormal if it exceeds 3 cm.105
5.3.1.2: Intussusception and prolapse
Intussusception refers to infolding of the rectal wall into the rectal lumen. It may be described as intra-rectal, intra-anal or
external to form a complete rectal prolapse.
5.3.1.3: Rectocele
Rectocele diagnosis on evacuation proctography is defined as any anterior rectal bulge (Fig. 10c). The depth of a rectocele is
measured from the anterior border of the anal canal to the anterior border of the rectocele. A distance of <2 cm is classified as small,
2–4 cm as moderate and >4 cm as large. Of more relevance however is barium trapping at the end of evacuation (defined as
retention of >10% of the area, and this itself is related the size of the rectocele.

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Fig. 10. Defecating proctography. (a) Schematic drawing; (b) Measurement of the anorectal angle at rest (ARA); (c) Image during Valsalva manouver, showing
the displacement of the anterior rectal wall (rectocele) with posterior vaginal wall prolapse (black arrows). PCL, pubococcygeal line; UB, urinary bladder; U,
uterus; ARJ, anorectal junction; R, rectocele.

5.3.1.4: Enterocele
An enterocele is diagnosed when small bowel loops enter the peritoneal space between the rectum and vagina. Diagnosis of an
enterocele on proctography is only really possible if oral contrast has been administered before the examination.105 Herniation of
the sigmoid into the rectogenital space (sigmoidocele) is significantly less common than an enterocele.
5.3.1.5: Dyssynergic defecation
Various proctographic abnormalities have been described including prominent puborectal impression, a narrow anal canal, and
acute anorectal angulation. However these observations may be found in normal controls and are in themselves unreliable
distinguishing features.

5.4: Contrast Enema

Contrast enema is used to identify colon pathology (benign and malignant lesions, diverticular disease, inflammatory
conditions, congenital anomalies, intrinsic and extrinsic abnormalities).
5.4.1: Single-contrast barium enema
Using an appropriate catheter, a barium-water mixture or a water-soluble solution of diatrizoate sodium (Gastrografin) is
inserted into the colon with the patient in the prone position until the column of barium reaches the splenic flexure.
5.4.2: Double-contrast or air-contrast barium enema
This procedure has become the routine study for evaluation of the bowel.108 With the double-contrast examination, the colon is
coated with a thin layer of contrast material and the bowel is distended with air so that the entire mucosal circumference is
visualized.

5.5: Colonic Transit Studies (Radio-Opaque Oral Markers, Pill Transit, Nuclear Medicine Scintigraphy)
Slow transit constipation can be distinguished by colonic transit studies.109,110
5.5.1: Radiological transit (shapes) study
Segmental and total colonic transit time is assessed with the use of radio-opaque markers and sequential abdominal X-rays.
There are different protocols. Most frequently used, utilizes a capsule containing 24 markers of 1  4.5 mm. Patient takes one
capsule on day 0 by mouth and X-ray is performed on day 5 (Fig. 11). Patients who expel at least 80% markers on day 5 have normal
colonic transit. Patients who retain 6 or more markers may have follow-up abdominal X-rays within several days. If remaining
markers are scattered about the colon, the condition is slow transit or colonic inertia. If the remaining markers are accumulated in
the rectum or rectosigmoid, this suggests functional outlet obstruction.

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Fig. 11. Radiologic transit study. On day 5, the remaining markers are more than 80%, suggesting functional outlet obstruction.

5.5.2: Nuclear transit study

Colon scintigraphy is performed at 6, 24, and 48 hr in ventral and dorsal projection after oral administration of methacrylate-
coated capsule of non-resorbable 111 Indium-labeled polystyrene (111ln-DTPA) micropellets.109 The geometric center, as the sum
of products of colon segment activity and colon segment number (1 ¼ ascending colon, 2 ¼ transverse colon, 3 ¼ descending colon,
4 ¼ rectosigmoid, and 5 ¼ evacuated feces) dividing by the total counts is used to determine the velocity of colonic transit. Meals
normally reach the cecum at 6 hr and are evacuated in 30 to 58 hr. Retention of radioactivity in the proximal colon at 48 hr,
indicates slow colonic transit while retention in the rectum indicates anorectal dysfunction. Table III shows utility of various
imaging modalities for female anorectal dysfunction.

6: DIAGNOSIS
6: DIAGNOSIS (most common) [defined as prevalence >10%]
Diagnosis is based on symptoms, signs, examination, and any relevant diagnostic investigations

6.1: Local (Fissures, Hemorrhoids)

Fissure: Is a break in the lining of the anal canal
Hemorrhoids: Abnormality of the normal cushion of specialized, highly vascular tissue in the anal canal in the submucosal space.

6.2: Fecal Incontinence

Fecal incontinence: involuntary loss of solid or liquid stool and could be due to:
6.2.1: Anal sphincter disruption is due to discontinuity of the external anal sphincter, internal anal sphincter or both.
6.2.2: Hypocontractile/acontractile sphincter is due to neuropathy or atrophy.
6.2.3: Combined anal sphincter disruption and hypocontractile/acontractile sphincter.
6.2.4: Rectal overactivity due to exaggerated smooth muscle contraction of the rectum could also be associated with
hypersensitivity.110,111
6.2.5: Overflow incontinence seepage of stool due to fecal impaction.

6.3 Obstructed Defecation Syndrome

Obstructed defecation: incomplete evacuation of fecal contents from rectum due to physical blockage of the fecal stream during
defecation attempts. It includes symptoms such as straining to defecate, sensation of blockage, digitation, and splinting.
Constipation due to slow transit, irritable bowel syndrome, Hirschsprung’s disease, megarectum, anismus are not within the remit
of this standardization document. Associated features of obstructed defecation are:
6.3.1: Rectocele: Bulge in posterior vaginal wall associated with herniation of anterior wall of the rectum (See FN16).
6.3.2: Enterocele/sigmoidocele: Bulge of upper wall of vagina associated with herniation of peritoneal sac and small bowel
(enterocele) or sigmoid colon (sigmoidocele).
6.3.3: Intussusception: Full thickness invagination of the upper rectum without extrusion through the anus leading to
interruption of flow of the fecal stream.

FN16
A transverse defect rectocele occurs simply by a detachment of the perineal body from the rectovaginal fascia. The hammock of rectovaginal fascia supporting the
rectum remains intact but separates from the perineal body. A midline vertical defect is created by a midline separation of the rectovaginal fascia, and a separation of the
rectovaginal fascia can occur from it’s lateral attachments. Rectoceles are more commonly situated in the mid to distal aspect of the posterior vaginal wall.

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Fig. 12. (adapted from ref. [125]). Algorithm: fecal incontinence. IAS, internal anal sphincter; EAS, external anal sphincter; SNM, sacral neuromodulation;
MACE, malone antegrade continence enema.

Fig. 13. (adapted from ref. [125]). Algorithm: constipation. IBS-C, irritable bowel constipation predominant; IRA, ileorectal anastomosis; J, hypnotherapy;
behavioural psychotherapy; CBT, psychiatrist management; CBT, cognitive behavioural therapy; I, investigations; M, management; T, treatment.

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6.3.4: Internal mucosal prolapse: Mucosal prolapse of the anterior, posterior, or circumferential mucosal layer.
6.3.5: External rectal prolapse: Full thickness rectal prolapse outside the anal canal
6.4: Sepsis
6.4.1: Abscess
Infection in a (non Crohn’s) anal gland, located at the base of the dentate line, that initially forms an abscess, which can be
located in one of the potential spaces surrounding the anus and rectum.
6.4.2: Ano-rectal/vaginal/perineal fistula
Rectovaginal fistula is a communication from the rectum to the vagina and rarely the perineal area. An anovaginal/perineal
fistula is an abnormal communication from the anal canal to the vagina or perineal area.
6.5: Pain Syndromes
6.5.1: Levator ani syndrome
Episodic rectal pain caused by spasm of the levator ani muscle. Proctalgia fugax (fleeting pain in the rectum) and coccydynia
(pain in the coccygeal region) are variants of levator ani syndrome (See FN17).
6.5.2: Proctalgia fugax
Definition: Proctalgia fugax (or Levator syndrome) is a severe, episodic, rectal and sacrococcygeal pain.112 It can be caused by
cramp of the pubococcygeus or levator ani muscles (See FN18).
6.5.3: Pudendal neuralgia
Pudendal Neuralgia (PN) is a painful condition that is caused by inflammation of the pudendal nerve involving it’s
dermatome.115 It can affect both men and women (See FN19).

FN17
Symptoms of levator ani syndrome are painful rectal spasm, typically unrelated to defecation, usually lasting >20 min. The pain may be brief and intense or a
vague ache high in the rectum. It may occur spontaneously or with sitting and can waken the patient from sleep and occurs more often on the left. The pain may
feel as if it would be relieved by the passage of gas or a bowel movement. In severe cases, the pain can persist for many hours and recur frequently. During clinical
evaluation: a dull ache to the left 5 cm above the anus or higher in the rectum and a feeling of constant rectal pressure or burning. Physical examination can exclude
other painful rectal conditions (e.g., thrombosed hemorrhoids, fissures, abscesses, scarring from previous surgery). Physical examination is often normal, although
tenderness or tightness of the levator muscle, usually on the left, may be present. Occasionally the cause can be low back disorders. Coccydynia (coccygodynia) is
complaint of pain and point tenderness of the coccyx (this is NOT anorectal pain).
FN18
Proctalgia fugax most often occurs in the middle of the night and lasts for seconds to 20 min. During an episode, which sometimes occurs after orgasm, the
patient feels spasm-like, sometimes excruciating pain in the anus, often misinterpreted as a need to defecate. Because of the high incidence of internal anal sphincter
thickening with the disorder, it is thought to be a disorder of the internal sphincter or that it is a neuralgia of pudendal nerves. It tends to occur infrequently (once a
month or less). Like all ordinary muscle cramps, it is a severe, deep rooted pain. Defecation can worsen the spasm, but may relieve it,113 or provide a measure of
comfort. The pain might subside by itself as the spasm disappears on its own, or may persist or recur during the same night. Patients with proctalgia fugax are
usually asymptomatic during the anorectal examination, leaving no signs or findings to support the condition, which is based on symptoms by history taking,
diagnostic criteria, described above, and the exclusion of underlying organic disease (anorectal or endopelvic) with proctalgia.114
FN19
The condition is also known as pudendal neuropathy, pudendal nerve entrapment, cyclist’s syndrome, pudendal canal syndrome, or Alcock’s syndrome. The
Nantes criteria13 includes:
1. Pain in the anatomical region of pudendal nerve innervation.
2. Pain that is worse with sitting.
3. No waking at night with pain.
4. No sensory deficit on examination.
5. Relief of symptoms with a pudendal block.

Primary symptoms of PN include:

a) Pelvic pain with sitting that may be less intense in the morning and increase throughout the day. Symptoms may decrease when standing or lying down. The pain can
be perineal, rectal or in the clitoral/penile area; it can be unilateral or bilateral.
b) Sexual dysfunction. In women, dysfunction manifests as pain or decreased sensation in the genitals, perineum or rectum. Pain may occur with or without touch. It may
be difficult or impossible for the woman to achieve orgasm.
c) Difficulty with urination/defecation. Patients may experience urinary hesitancy, urgency and/or frequency. Post-void discomfort is not uncommon. Patients may feel
that they have to ‘‘strain’’ to have a bowel movement and the movement may be painful and/or result in pelvic pain after. Constipation is also common among patients
with PN. In severe cases, complete or partial urinary and/or fecal incontinence may result.
d) Sensation of a foreign object being within the body. Some patients will feel as though there is a foreign object sitting inside the vagina or the rectum.

It is important to note PN is largely a ‘‘rule out’’ condition. In other words, because its symptoms can be indicative of another problem, extensive testing by
physical examination, assessment by touch, pinprick, bimanual pelvic palpation with attention to the pelvic floor muscles, in particular the levator and
obturator muscles, tenderness of the bladder and sacrospinous ligaments are required to ensure that symptoms are not related to another condition.
Maximum tenderness, or a trigger point can be produced by applying pressure to the ischial spine. Palpation of this area can reproduce pain and symptoms as a
positive Tinel’s sign.115
As PN is a diagnosis of exclusion, other conditions that should be excluded include coccygodynia, piriformis syndrome, interstitial cystitis, vulvodynia, vestibulitis,
chronic pelvic pain syndrome, proctalgia, anorectal neuralgia, pelvic contracture syndrome/pelvic congestion, proctalgia fugax, or levator ani syndrome.
In addition to eliminating other diagnoses, it is important to determine if the PN is caused by a true entrapment or other compression/tension dysfunctions. In
almost all cases, pelvic floor dysfunction accompanies PN. Electrodiagnostic studies will help the practitioner determine if the symptoms are caused by a true
nerve entrapment or by muscular problems and neural irritation.

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Fig. 14. Classification of perineal trauma.119

Fig. 15. Classification of 3rd and 4th degree tears (with permission from Springer116).

6.6: Obstetric Anal Sphincter Injuries (OASIS)

OASIS are reported to occur in 0.5–14% of vaginal deliveries (2.9–19% of primiparous vaginal deliveries).116 It has previously been
shown in a prospective study that about one third of OASIS can be diagnosed 8 weeks after delivery by endoanal ultrasound alone.
As these were not identified clinically, the injuries were believed to be ‘‘occult.’’2 However, it has subsequently been proven that
such injuries are not necessarily occult but in fact undiagnosed due to lack of expertise of midwives and doctors.3
Training in diagnosis and management of perineal trauma has been shown to be suboptimal117 and dedicated hands-on courses
have shown significant improvements in diagnosis and classification of OASIS.118 Sultan therefore proposed a more descriptive
classification of OASIS (Figs. 12 and 13)119 that has now been accepted internationally to support consistency in reporting.120–122 To
avoid underestimation of the injury, if there is uncertainty regarding the full extent of the injury it should be classified as the
greater degree, for example, if one is unsure as to whether an injury is a Grade 3a or 3b it should be classified as 3b (Figs. 14 and 15).
This classification also has clinical relevance as it ensures increased vigilance for internal sphincter injuries that are best repaired
soon after delivery123 as persistent internal sphincter defects are associated with fecal incontinence.124 Examination techniques to
improve detection of these injuries and avoiding pitfalls in diagnosis have been described in detail.116

ACKNOWLEDGMENTS
We gratefully acknowledge contributions from Dr Helen Frawley, Beth Shelley following ICS (V29 Jan 2015) IUGA website
presentation of Version 30 (Aug15, Dr Alexis Schizas and Kari Bo at ICS Montreal (V33 8Oct15).

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88. Dobben AC, Terra MP, Deutekom M, et al. Anal inspection and digital rectal examination compared to anorectal physiology tests and endoanal ultrasonography in
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90. Sultan AH, Kamm MA, Nicholls RJ, et al. Prospective study of the extent of internal anal sphincter division during lateral sphincterotomy. Dis Colon Rectum
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91. Richter HE, Fielding JR, Bradley CS, et al. Endoanal ultrasound findings and fecal incontinence symptoms in women with and without recognized anal sphincter tears.
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92. Starck M, Bohe M, Fortling B, et al. Endosonography of the anal sphincter in women of different ages and parity. Ultrasound Obstet Gynecol 2005;25:169–76.
93. Norderval S, Markskog A, Rossaak K, et al. Correlation between anal sphincter defects and anal incontinence following obstetric sphincter tears: Assessment using
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94. Dietz HP, Moegni F, Shek KL. Diagnosis of levator avulsion injury: A comparison of three methods. Ultrasound Obstet Gynecol 2012;40:693–8.
95. Dietz HP, Steensma AB. Posterior compartment prolapse on two-dimensional and three-dimensional pelvic floor ultrasound: The distinction between true rectocele,
perineal hypermobility and enterocele. Ultrasound Obstet Gynecol 2005;26:73–7.
96. Stoker J. Anorectal and pelvic floor anatomy. Best Pract Res Clin Gastroenterol 2009;23:463–75.
97. Tan E, Anstee A, Koh DM, et al. Diagnostic precision of endoanal MRI in the detection of anal sphincter pathology: A meta-analysis. Int J Colorectal Dis 2008;23:641–51.
98. Mortele KJ, Fairhurst J. Dynamic MR defecography of the posterior compartment: Indications, techniques and MRI features. Eur J Radiol 2007;61:462–72.
99. Lakeman MM, Zijta FM, Peringa J, et al. Dynamic magnetic resonance imaging to quantify pelvic organ prolapse: Reliability of assessment and correlation with
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100. Bolog N, Weishaupt D. Dynamic MR imaging of outlet obstruction. Rom J Gastroenterol 2005;14:293–302.
101. Dobben AC, Terra MP, Slors JF, et al. External anal sphincter defects in patients with fecal incontinence: Comparison of endoanal MR imaging and endoanal US.
Radiology 2007;242:463–71.
102. Terra MP, Beets-Tan RG, van Der Hulst VP, et al. Anal sphincter defects in patients with fecal incontinence: Endoanal versus external phased-array MR imaging.
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103. DeLancey JO, Sorensen HC, Lewicky-Gaupp C, et al. Comparison of the puborectal muscle on MRI in women with POP and levator ani defects with those with normal
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104. Broekhuis SR, F€ utterer JJ, Hendriks JC, et al. Symptoms of pelvic floor dysfunction are poorly correlated with findings on clinical examination and dynamic MR
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105. Brennan D, Williams G, Kruskal J. Practical performance of defecography for the evaluation of constipation and incontinence. Semin Ultrasound CT MR
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106. Maglinte DD, Hale DS, Sandrasegaran K. Comparison between dynamic cystocolpoproctography and dynamic pelvic floor MRI: Pros and cons: Which is the
‘‘functional’’ examination for anorectal and pelvic floor dysfunction? Abdom Imaging 2013;38:952–73.
107. Groenendijk AG, Birnie E, de Blok S, et al. Clinical-decision taking in primary pelvic organ prolapse; the effects of diagnostic tests on treatment selection in comparison
with a consensus meeting. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:711–9.
108. Rollandi GA, Biscaldi E, DeCicco E. Double contrast barium enema: Technique, indications, results and limitations of a conventional imaging methodology in the
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109. Ghoshal UC, Sengar V, Srivastava D. Colonic transit study technique and interpretation: Can these be uniform globally in different populations with non-uniform
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Received: 12 May 2016

| Accepted: 13 May 2016

DOI 10.1002/nau.23124

REVIEW ARTICLE

International Continence Society Good Urodynamic Practices

and Terms 2016: Urodynamics, uroflowmetry, cystometry, and
pressure-flow study

Peter F.W.M Rosier1* | Werner Schaefer2 | Gunnar Lose3 |

Howard B. Goldman4 | Michael Guralnick5 | Sharon Eustice6 |
Tamara Dickinson7 | Hashim Hashim8
1 Department of Urology, University Medical Center

Utrecht, Utrecht, The Netherlands AIMS: The working group initiated by the ICS Standardisation Steering Committee
2 Department of Medicine (Geriatrics), University of has updated the International Continence Society Standard “Good Urodynamic
Pittsburgh, Pittsburgh, Pennsylvania Practice” published in 2002.
3 University of Copenhagen Herlev Hospital, Herlev,
METHODS: On the basis of the manuscript: “ICS standard to develop evidence-
Denmark
based standards,” a new ICS Standard was developed in the period from
4 Glickman Urologic and Kidney Institute Cleveland
December 2013 to December 2015. In July, a draft was posted on the ICS website
Clinic, Lerner College of Medicine, Cleveland, Ohio
5 Medical College of Wisconsin, Milwaukee,
for membership comments and discussed at the ICS 2015 annual meeting. The input
Wisconsin
of ICS membership was included in the final draft before ICS approval and
6 Peninsula Community Health, Cornwall, UK
subsequent peer review (for this journal).
7 UT Southwestern Medical Center, Dallas, Texas RESULTS: This evidence-based ICS-GUP2016 has newly or more precisely
8 Bristol Urological Institute, Bristol, UK
defined more than 30 terms and provides standards for the practice, quality control,
*Correspondence
interpretation, and reporting of urodynamics; cystometry and pressure-flow
Peter F.W.M Rosier, MD, PhD, Department of analysis. Furthermore, the working group has included recommendations for
Urology, University Medical Centre Utrecht, pre-testing information and for patient information and preparation. On the basis of
C04.236, Heidelberglaan 100 PoBox 85500,
3508GA Utrecht, The Netherlands
earlier ICS standardisations and updating according to available evidence, the
Email: p.f.w.m.rosier@umcutrecht.nl practice of uroflowmetry, cystometry, and pressure-flow studies are further
detailed.
CONCLUSION: ICS-GUP2016 updates and adds on to ICS-GUP2002 to improve
urodynamic testing and reporting both for individual care and scientific purposes.

KEYWORDS
clinical practice standard and quality, cystometry, incontinence, lower urinary tract dysfunction,
pressure-flow study, urodynamic, uroflowmetry

1 | INTRODUCTION urodynamic practice and urodynamic quality control and the

revised ICS standard on urodynamic equipment.2 Following
The ICS Standardisation Steering Committee has initiated a the traditional ICS Standardisation style, while including the
working group (WG) to update the International Continence new method and structure,3 changes of current standards are
Society's Good Urodynamic Practice 20021 (GUP2002) with recommended and arguments provided for making these
the aim of including new evidence and information on changes.
This report provides evidence-based specific recom-
Dr. Roger Dmochowski led the peer-review process as the Associate Editor mendations for routine clinical urodynamic testing, and
responsible for the paper includes expert consensus where evidence is lacking.

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| ROSIER ET AL.

Conclusions and recommendations are highlighted in the 2.4 | Recommendation

text and can be used for summary and express reading. We
For the purpose of uniformity, particularly in research we
define “ICS standard” as: “Best practice, based on evidence,
recommend and define the following as ICS standard
with the use of standard terms and standard techniques,
terms:
evaluated and reported clinically or scientifically, in a
Urodynamics: The general term to describe all the
complete and validated manner.” In individual cases and/or
measurements that assess the function and dysfunction of the
in research settings, the decision may be made not to adhere
LUT by any appropriate method. Urodynamics allows direct
to this standard, but any deviation from the standard should
assessment of LUT function by the measurement of relevant
be specified.
physiological parameters. (GUP2002 not changed).
The ICS standard is particularly intended for evaluation of
Invasive urodynamics: Any test that is invasive, as it
the function of the lower urinary tract (LUT) of adult persons
involves insertion of one or more catheters or any other
without relevant neurological abnormalities and with intact
transducers into the bladder and/or other body cavities, or
“normal” anatomy of the LUT. Many of the recommendations
insertion of probes or needles, for example for EMG
in this document may, however, also be considered relevant,
measurement.
generalizable, or applicable for patients with neurological
Non-invasive urodynamics: All urodynamics done
abnormalities, for Video-urodynamics or for urodynamics in
without the insertion of catheters: for example, uroflowmetry,
research settings and/or also for patients with neobladders,
PVR, penile compression-release test, penile cuff, urethral
augmented bladders, or diversions. The recommendations may
connector, condom catheter, or sonography.
also be helpful for performing urodynamics in children.4
Ambulatory urodynamics: See the applicable ICS
Standard.7 (Not further discussed in this standard.)
ICS standard urodynamics protocol (NEW): a patient
2 | DEFINITIONS OF TERMS FOR undergoing collection of a clinical history (should include (a)
URODYNAMIC TESTS valid symptom and bother score(s) and medication list),
relevant clinical examination, (3 days) bladder diary,
representative uroflowmetry with post-void residual (PVR)
2.1 | Introduction and evidence base and a complete ICS standard urodynamic test (see below), is
Over the years, a variety of terms have been developed for the referred to as having had the “ICS standard urodynamics
group of diagnostic tests that evaluate LUT function. The WG protocol (ICS-SUP).”
has constructed a table with terms and has provided their ICS standard urodynamic test (NEW): Uroflowmetry
frequencies of use, both in PubMed (searching in title and and PVR plus transurethral cystometry and pressure-flow
abstract) and in Google (Table S1). Uroflowmetry, Post Void study (see below): all tests are performed in the patient's
Residual (PVR), Cystometry, Pressure-flow study, Electro- preferred or most usual position: comfortably seated and/
myography (EMG), Urethral Pressure Profile, and Video or standing, if physically possible. The patient(s) is
urodynamics are the terms most frequently used in the reported as having had an ICS standard urodynamic test
scientific literature. The ICS Standardisation of Terminology (ICS-SUT).
of LUT Function (ST2002)5 (re-) introduced or used many of ICS supplementary urodynamic tests: ICS-SUT may
these terms, and the AUA-SUFU has also provided be supplemented with EMG, with imaging, with continuous
definitions of some terms.6 urethral pressure(s) and/or with urethral pressure profile
measurement. Cystometry may be done via a suprapubic
2.2 | Conclusions catheter (specify supplements).

Many terms have been introduced in earlier standardizations, Recommendation: The WG suggests all ICS-SUT-
without providing a precise definition. data as a minimum, and preferably complete ICS-SUP
A significant variety of synonyms are used for urody- data should be specifically reported or summarized for
namic tests and studies in the scientific literature as well as in the total cohort of patients in all research reports that
lay texts and we conclude that the use of currently existing contain (invasive) urodynamic results.
terms is not yet without variation in scientific literature. Furthermore, the WG suggests referring to the current
manuscript when research is reported as “. . . according
2.3 | Discussion to ICS Standard Good Urodynamic Practices (ICS-
GUP2016),” when complete ICS-SUT or SUP data are
Variations in the application of terms may bias communica-
reported.
tion, in science and also in communication with patients. The
following terms are not really new and many were introduced Uroflowmetry: A test that produces the [Citation from
earlier, sometimes long ago. GUP2002]: “. . . flow rate of the external urinary stream as

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ROSIER ET AL.
| 3

volume per unit time in millilitres per second (mL/s).” 3 | PATIENT INFORMATION AND
ICS uroflowmetry minimally reports the maximum flow PREPARATION OF THE PATIENT
rate and the volume voided and PVR. (GUP2002, not FOR INVASIVE URODYNAMICS
changed.) Other characteristics such as flow pattern
(specify) and other parameters may be added but should
be specified.
3.1 | Introduction and evidence base
Post-void residual volume (PVR): (GUP 2002) The Although evidence indicates that urodynamics is generally
remaining intravesical fluid volume determined directly well tolerated, studies have examined pain and embarrass-
after completion of the voiding. The technique (eg, ment, using a variety of questionnaire methods. Younger
ultrasound or catheter) used to measure the volume should patients have been identified as a group that may
be specified. experience more pain and apprehension 9 associated with
Voided percentage (Void%): The numerical descrip- depression, anxiety and/or bladder pain syndrome.10
tion of the voiding efficacy or efficiency which is the Effectiveness of patient information leaflets requires
proportion of bladder content emptied. Calculation: comprehensibility and communicative effectiveness.11–13
[(volume voided/volume voided + PVR) × 100]. The WG However, reports analysing existing information conclude
suggests—solely for the purpose of standardization—that that this is of poor quality. Studies to develop a detailed
the term voided percentage with the abbreviation Void% is explanatory leaflet, which were used in a double-blind
preferred. The relevance of the parameter is not discussed randomized controlled trial to conclude that “leaflet” or
here. “no leaflet” intervention had a disappointing satisfaction
Cystometry: Continuous fluid filling of the bladder outcome.14,15 Poor understanding of the test has been
via a transurethral (or other route, eg, suprapubic or associated with lack of satisfaction with care and with, for
mitrofanoff) catheter, at least with intravesical and example, the perception that the investigation in itself is
abdominal pressure measurement and display of detru- therapeutic.16
sor pressure, including cough (stress) testing. Cystom-
etry ends with “permission to void” or with incontinence 3.2 | Conclusions
of the total bladder content. The fluid type and
temperature, filling method and rate, catheter sizes, Some evidence exists that information leaflets about
pressure recording technique, and patient position urodynamic investigations are too difficult for patients to
should all be specified. understand.
Cysto-urethrometry: A cystometry is done with Young adults and patients with a bladder pain syndrome
continuous urethral pressure measurement (specify may have a relatively negative experience with urodynamic
technique). investigation.
Pressure-flow study: The intravesical and abdominal Conflicting evidence exists about which precise informa-
pressures are measured, from the moment of “permission to tion is helpful to give to patients before urodynamic testing to
void,” while uroflowmetry is performed with a transurethral reduce distress.
(or suprapubic) catheter in place. The position of the patient,
the catheter sizes, and the pressure and flow recording 3.3 | Discussion
technique should be specified. Effective communication is an expectation in modern
Pelvic muscle electromyography (EMG): Pelvic mus- healthcare, so that patients become actively engaged in the
cle activity is judged with surface electrodes. ICS Standard: test and their care delivery. The WG has discussed that a
two skin electrodes on the perineal surface with an leaflet with a minimum set of items would facilitate informed
appropriate reference (=Pelvic muscle EMG). Other type, decision making. The WG is convinced that good information
for example, vaginal probe: “vaginal EMG,” “anal EMG” or before and during the test increases a patient's acceptance and
“needle EMG,” etc. and/or number and position of electrodes confidence, and will reduce confusion.
should be specified.
Urethral pressure profile: See ICS Standardisation of
3.4 | Recommendation
urethral pressure measurement.8
Urodynamics may be combined with imaging (specify). The WG suggests, although in the absence of good evidence,
Invasive urodynamics performed with contrast fluid as the that an explanatory leaflet about urodynamic investigation
filling medium is Video urodynamics: X-ray (image with sufficient information, which uses clear, unambiguous
amplifier) pictures or cine-loops are made at relevant wording will be appreciated by the majority of patients.
moments. The contrast medium and report patient radiation The WG suggests that a leaflet should include the items
dose should be specified. Video urodynamics is not further listed here below. The WG recommends that a leaflet that
discussed in this document. includes these items in an understandable manner for the

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| ROSIER ET AL.

patient is referred to as the (NEW) ICS Standard Information standards for implementation is of importance.22 Simple
Leaflet for Urodynamics. dissemination is not usually very effective and, as an
example, for example, “blended” or “continuous quality
improvement,” strategies may be required.23

4.4 | Recommendations
The WG recommends that departments develop urodynamic
practice protocols on the basis of the ICS-GUP standards and
facilitate specific training in, and evaluation of, urodynamic
practice.
We recommend that centers should—ideally coordinated
and together on a nationwide level—decide on individual
accreditation and recertification (eg, required minimum
number of tests) as well as the level of authority and
autonomy to perform urodynamic tests.

5 | CLINICAL PRACTICE
PRE-TESTING INFORMATION

5.1 | Introduction and evidence base

All guidelines on urinary incontinence recommend a clinical
4 | URODYNAMIC PRACTICE history, and validated symptom and/or bother scores are
PROTOCOLS recommended in the majority of these.24–28 Urinalysis and
physical examination as the first step in the evaluation of a
4.1 | Introduction and evidence base patient with urinary incontinence are considered routine. The
GUP2002 has in this regard mentioned non-invasive
In an area where a minimum standard for urodynamic testing urodynamics, frequency/voiding chart (FVC), or bladder
workload exists,17 it was concluded on the basis of a postal diary (BD) uroflowmetry and PVR) for all patients with LUT
survey that training had insufficient effect, and that practice symptoms (LUTS). FVC and BD are mentioned in ST2002
significantly varied.18 When 100 consecutive graphs from all
and defined after that publication.29 The test should be
men who underwent cystometry in one center were reviewed, requested with the goal of answering a specific question
“significant defects [in the pressures] were not uncommon”; (GUP2002). In order to formulate this question prior to
furthermore, ±10% of the transurethral catheters was reported
urodynamics, as mentioned here above, a complete history, a
to have been “falling out during voiding.”19 Disappointingly, list of medications taken must available as well as the results
although willingness to change practice was observed, actual of the physical exam. Observation of the patient's gait,
changes did not occur despite the distribution of a standard evaluation of sacral sensation and reflexes and identification
protocol for some of the elements of urodynamic testing.20 of other neuro-urological findings are important. An
abdominal exam and evaluation of the extremities for
4.2 | Conclusions oedema are also helpful. In women, a systematic pelvic
Published evidence to support implementation of practice exam should include evaluation for prolapse,29 vaginal wall
standards is scarce and the conclusion on the basis of simple masses, atrophy, pelvic muscle quality, and the ability to
implementation strategies toward the achievability of voluntarily contract them (as is standardized30), urinary
practice improvement is not very encouraging. leakage with strain, and any other details. In men, genital
exam and a digital rectal prostate examination with an
estimation of size is necessary. Prostate pain or abnormalities
4.3 | Discussion
and degree of anal tone should be noted.
Implementation of standardized practice is a complex process A (3-day) FVC or BD provides information that may
that requires changing routine habits and beliefs while obviate cystometry (eg, when excessive fluid intake is
keeping an eye on context, for example, acceptability, recognized) or may help to ensure and evaluate whether the
adoption, appropriateness, feasibility, fidelity, and costs.21 cystometry, especially cystometric capacity, is representative
Furthermore, the quality of the practice guidelines or of the patient's typical situation (“typical voided volumes”;

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from GUP2002). Non-invasive urodynamic testing, that is, variety of primary outcomes related to different voiding
uroflowmetry plus PVR in men and women, should precede positions (see Table S2). The results do not allow a very
invasive urodynamics. This information gathering process strong recommendation to be made, partly because test-retest
serves as the foundation for determining treatment as well as variation inherently plays a role.47 On the basis of these
formulating questions that can be answered with (invasive) results and also on the basis of expert experience and
urodynamics. A urinalysis to screen for infection or plausibility, the WG concludes as follows.
haematuria should be available.
When planning urodynamic tests, the physician 6.2 | Conclusions
should specifically instruct the patient whether or not
to change any conservative measures or change or take The WG concludes that it is useful, considering the
medication before or after the test according to ((local) representativeness of the test-result, for patients to be allowed
standards and/or guidelines and) the individual situation to undergo uroflowmetry in their own preferred position.
of the patient.
6.3 | Discussion
5.2 | Conclusion Uroflowmetry and therefore flow rate, voided volume, and
PVR are inherently sensitive to patient cooperation and
We conclude that clinical practice guidelines and expert
emotion, and should only be clinically interpreted if the
“first principles” agree that prior to invasive urodynamics, voiding has been representative with regard to both voided
history, physical examination, and urinalysis should be volume and the patient's opinion (eg, uroflowmetry may be
completed.
abnormal if voiding was postponed for too long before the
The usefulness of a FVC-BD to help anticipate test). Furthermore, the interpretation can only be relevant if
cystometric capacity and appropriate fill rate has never the test was done in a technically reliable manner, based on
been formally investigated. It is, however, the WG's
the examiner's opinion.
conclusion that the FVC-BD voided volumes should be
considered relevant to evaluate the representativeness of the
cystometry, as was recommended in GUP2002. 6.4 | Recommendations
The WG recommends permitting patients to undergo
5.3 | Recommendation uroflowmetry in their preferred position and to strive for
minimum physical discomfort and anxiety for the patient, as
The WG advises that apart from the clinical information well as ensuring personal dignity.
(history, medication, and clinical examination), the infor- The WG recommends checking if the voiding is
mation from the (3-day) FVC or BD, and the uroflowmetry representative, based on the patient's report and also on the
and PVR are utilized while performing invasive association with the patient's FVC or BD volumes.
urodynamics. The position of the patient during voiding studies should
The WG advises specific instructions to the patient
be reported.
with regard to the continuation of usual LUT management The WG recommends considering repetition of the
(eg, medication) if the patient is on treatment, and— uroflowmetry if the result has not been representative for
persisting or new onset—symptoms require urodynamic
the patient or if the result indicates abnormality. Particularly,
analysis. if the voided volume and/or flow rate are unexpectedly low or
the PVR is (much) larger than expected or explainable in both
women and in men.
6 | PRACTICE OF UROFLOWMETRY

6.1 | Introduction and evidence base

7 | PRACTICE OF CYSTOMETRY
GUP2002 presents uroflowmetry as a first line screening for
most patients with LUTS and has provided practice
7.1 | Introduction and evidence base
recommendations. ICI consultations and clinical practice
guidelines have reconfirmed uroflowmetry as the first line GUP2002 has specified catheters, pressures, pressures
test.5,7,28 Data quality control is relevant and important31 and reference and quality checks for cystometry (and also for
ICS has updated equipment performance requirements.2 pressure-flow study). The WG has not found evidence that
Apart from technical quality, the clinical situation is relevant. supports changes in these specifications. The WG has
Some papers concerning position during voiding of men32–39 however studied and further specified six items in relation
or women40–46 have been published since GUP2002, with a to the practice of filling cystometry. For each item we report

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conclusions on the basis of the evidence and provide without specific evidence, but similar to practice in children's
recommendations below. cystometry, that a filling rate in mL/min of roughly 10% of the
largest voided volume (reported on a FVC or −BD; and PVR
7.2 | What determines filling rate? should be taken into account here) at a constant rate is a
practical means to implement the above cited GUP2002
The rate at which the bladder is filled during cystometry recommendation to use the person's typical voided volumes.
affects the results of the cystometry.48,49 ST2002 has defined This would, in a sensible manner, narrow the currently
two different ranges of filling rate: maximum physiological existing non-physiological fill rate-range and may also
filling rate as estimated by body weight in kilogram divided prevent too fast filling or filling to very unusual volumes.
by four, thus typically in the range of 20–30 mL/min. The The WG suggests standardizing the filling in a fixed rate for
commonly applied filling rate in practice is often higher and, the purpose of comparability in clinical cohort (management)
and this is (ST2002-) referred to as non-physiological filling research protocols where cystometric capacity, sensation, or
rate. Neither ST2002 nor GUP2002 are however specific in compliance are outcome parameters.
the rate to select however GUP2002 has stated that the The end of filling should relate to a “strong but not
[citation] “typical voided volumes should be used for the uncomfortable need to void.” The largest voided volume on
control of subsequent invasive studies.” the FVC-BD may be an indicator for this volume, however
The actual volumes in the bladder during cystometry may with as yet unknown specificity, and PVR should be taken
differ from the recorded filling volumes due to diuresis, which into account. “Strong desire to void” (SDV) should be
can add significantly volume, for example, up to 25% to the indicated on the urodynamic graph. Permission to void is
cystometry volume.50,51 Cystometric capacity is most given when the pump is stopped (ST2002) and end of filling
reliably determined by calculation of voided volume (mL) should be regarded as the beginning of the voiding phase. A
plus PVR (mL) immediately after pressure-flow study specific marker on the urodynamics graph to indicate
(ST2002). The WG has been unable to find evidence that permission to void must be used however, if there is a delay
stopping or slowing down the filling rate, for example, when between halting the pump and permission to void.
urgency is perceived and/or when detrusor overactivity (DO)
is observed, is of any relevance. GUP2002 has suggested that 7.2.3 | Recommendations
the investigator should stop filling and observe the pressure,
The WG recommends that the person doing the cystometry
when reduced compliance is thought to be a consequence of
knows the FVC-BD results as well as the results of uroflowmetry
filling rate above physiological filling rate.
and PVR, prior to performing invasive urodynamics.
The WG suggests that the ICS maximum physiological filling
7.2.1 | Conclusions
rate is standard and suggests that “non physiological filling rate” is
Current ST2002 cystometry (pump-) non-physiological standardized on the basis of the individual patient's typical voided
filling rate is frequently applied, but a recommended more volumes (including estimation of the PVR volume) to prevent too
specific value or range is lacking. fast filling and/or too large volumes.
Filling rate, especially when very fast or to volumes that The WG recommends use of the maximum physiological
are very much larger than the person's usual (maximum) rate when comparability is relevant (eg, this may be required in
volumes, may influence the results or the representativeness prospective research cohorts, before and after intervention).
of the cystometry. Evidence that filling rate should be Parameters during cystometry depending on bladder
changed during the cystometry is lacking. volumes should be corrected for diuresis if relevant for
Diuresis, occurring during cystometry, adds volume that clinical management or for scientific purposes.
is not recorded by the urodynamics system with automated The WG recommends that “permission to void” should
filling volume recording, but that is relevant for interpretation always be marked on the urodynamic graph to indicate the
of the results. beginning of the pressure-flow study. Stopping the fill pump
Correction of filled volume for diuresis in retrospect is a more or less automatic marker, but when there is a delay
should be considered with regard to reporting of filling between stopping the filling and this permission, a specific
sensation parameters, compliance and cystometric capacity marker should be used to allow correct interpretation of the
(=pressure-flow voided volume plus PVR; and assuming the graphs after the test.
diuresis to be constant).

7.2.2 | Discussion 7.3 | How is the patient instructed to report

sensations?
A balance between a filling rate that is slow enough to mimic
a representative bladder filling and fast enough to complete Prior to filling cystometry, patients are typically informed
the cystometry in an efficient fashion is a pragmatic approach (written and verbal) that they will be asked to report the
to achieving a representative result. The WG considered, sensations they experience during the test. The ST2002

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recommends that three sensation parameters be recorded 7.3.3 | Recommendations

during cystometry: first sensation of filling (FSF), first desire The WG recommends marking FSF, FDV, and SDV, during
to void (FDV) and SDV. In addition, the patient may report cystometry as recommended by ST2002, on the basis of
sensation(s) that are considered to represent “urgency” explicit verbal instructions and communication before and
(ST2002) which can be marked specifically. These sensory during the test specified in this GUP, and reporting the
parameters have been confirmed as applicable, consistent, results.
and reproducible in healthy persons and in patients with
overactive bladder (OAB) syndrome.52–54,57,58 There is,
however, conflicting data regarding the reliability and/or 7.4 | Fluid-filled external transducers and
representativeness of bladder sensation reporting during catheter system
cystometry.55–57,59,60 The use of a visual analogue scale
Current ICS standard cystometry and pressure-flow study
(VAS) to grade the level of sensation has been shown to
requires fluid-filled catheters with external pressure trans-
correlate well with some of the standard sensation param-
ducers to be leveled at the height of the upper edge of
eters.61 Similarly, a keypad, allowing patients to indicate
symphysis pubis. (GUP2002, ST2002). The urodynamic
differing levels of sensation, had a good and reproducible
pressure is therefore the excess pressure above atmospheric
association with filling volume.62
pressure at the hydrostatic level of the upper edge of the
7.3.1 | Conclusions symphysis pubis. Some studies that have compared fluid-
filled catheters with microtip sensor catheters or air-filled
The ST2002 expert-based recommendation for the
catheters have shown that the results of the cystometry using
assessment of sensations during cystometry is reasonable these alternative systems are not interchangeable with the
and applicable as is demonstrated in various study current ICS standard.63–65
reports.

7.3.2 | Discussion 7.4.1 | Conclusions

The WG has decided not to change the ICS standard in favor ICS standard urodynamic intravesical pressure (pves),
of the use of VAS. However, despite introduction of standard abdominal pressure (pabd) or other urodynamic pressure is
terms in 2002, few studies published have reported the excess pressure above atmosphere at the hydrostatic level
cystometry filling sensations and the WG feels the need to of the upper edge of the symphysis pubis. This is valid for all
reintroduce these and to add practice recommendations. It pressures recorded with fluid-filled lines.
should be noted that the WG has not evaluated the relevance The WG concludes that comparisons of micro-tip
of the filling sensation parameters. catheter systems (multicenter group averages) or air-filled
catheters in vitro or in vivo (pairwise averages of two
FSF should, at the beginning of the cystometry, be
separated from the (urethral) sensations caused by the measurements) with ICS standard fluid-filled systems
catheterization. The explanation to the patient may be that demonstrated that both systems give different results. The
reports of these studies have concluded that systems are not
FSF is “Tell me the moment when you perceive that your
bladder is not empty anymore”; FDV is (if little or no chronic interchangeable.
PVR exists) usually roughly associated with FVC-BD
“typical voided” volumes and can be asked as “Tell me 7.4.2 | Discussion
when you have the sensation that normally tells you to go to Fluid-filled external pressure systems referenced to the
the toilet, without any hurry, at the next convenient moment.” symphysis pubis are fundamentally different from the
SDV is “. . . the moment that you, without any pain or any micro-tip or air-filled catheter systems, as the latter record
fear of losing urine, will not postpone the voiding; you will pressure without a clear reference level. The use of ICS
visit the nearest restroom also, for example, while shopping.” standard urodynamic pressures allows pressure related data
SDV may however occur suddenly and include the fear to be comparable between patients and centers. Systemati-
of leaking (or actual urine loss) in specific patients and cally obtained clinical evidence for the clinical reliability of
patients should report this also. Correlating the results of micro-tip or air-filled catheter systems is scarce. Every
cystometry volume and sensations with FVC-BD may urodynamic laboratory should be familiar with the potential
provide background information regarding day-to-day sen- artefacts of the specific system used for pressure measure-
sory findings and bladder volumes and may also limit the risk ment, and take the possibility of system- differences of up
of overfilling. to 10 cm H2O into account.66 The WG considers that the
Fear of leakage, pain, or other signs or symptoms during availability of alternative systems has consequences for
the test should be specifically marked on the urodynamic multi-center studies. Also the WG has considered gener-
graph. alizability of pressure values published in studies using

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other than fluid-filled external pressure systems is Women (right picture): Catheter is taped to the inner
undecided. side of the labia or (similar in men and women) adjacent
ICS guidelines on equipment performance provide to the anus.
minimum system requirements for pressure responses and
calibration.2,66 Centers that utilize other pressure systems
should provide reference values for their data.

7.4.3 | Recommendations
ICS standard cystometry is performed with a fluid-filled
system with external transducers at the reference level of the
upper edge of the symphysis pubis.
Urodynamic laboratories should ensure that the equip- 7.5.2 | Recommendation
ment, including the catheters and transducers, meet the
ICS standard invasive urodynamics is done with the thinnest
requirements as explained in the ICS guideline on equipment
possible double lumen catheter. However, on the basis of the
performance.2,66
lack of evidence for inferiority of two catheter techniques,
Urodynamic laboratories should check the performance
this alternative is considered acceptable.
of their system at regular intervals and calibrate according to
The WG recommends finding evidence with specific
manufacturer recommendation, and as advised in the ICS
studies to direct practice standardization and harmonization
guideline on equipment performance.66
for the catheters used for invasive urodynamics.
The WG recommends fixation of the catheters as adjacent
7.5 | Transurethral catheter as possible to the anus and the urethral meatus with tape,
ICS standard invasive urodynamics is done with the thinnest without blocking the urinary meatus.
possible (6–7F) transurethral double or triple lumen catheter
or a suprapubic catheter on the basis of ST2002 and 7.6 | Abdominal pressure catheter placement:
GUP2002. rectal versus vaginal
7.5.1 | Discussion Flaccid filled balloon which may be punctured or slowly
perfused open end catheters in the rectal ampulla are used to
The ICS recommendation, reiterated here above, is based on
measure abdominal (“perivesical”) pressure (GUP2002). The
expert opinion and consensus. GUP2002 notes that the use of
WG has discussed that “slowly perfused open end” should not
two separate catheters is “less convenient.” However, many
be used because rectal filling may cause a sensation of need to
studies since 2002 report the use of separate filling and
defecate and may influence the result of urodynamics, though
pressure catheters and the removal of the filling catheter for
there is no research evidence on this topic.
stress provocation and/or for the pressure-flow study.
In a prospective, randomized trial comparing open
Reported practice includes the range from 5 to 8F for the
(without balloon) vaginal versus open rectal abdominal
pressure recording catheter and usually ±10F for the filling
pressure 6F catheters in women undergoing external sensor,
catheter. The WG has no arguments for discarding the use of
fluid fill cystometry, the authors noted no differences in
double catheter systems at present but has again (after
discomfort or patient acceptability, however it was reported
GUP2002) discussed the need to re-catheterize if the test
that women declined randomization on the basis of a
needs to be repeated and also the necessity to interfere with
preference for a vaginal catheter. Set-up time, catheter events
the patient at the moment of SDV, just before the voiding.
affecting signal quality (including during provocation), or
However, the excess cost of the double or triple lumen
alteration in patients with vaginal prolapse were also not
catheter is a disadvantage. No head to head comparisons have
different. The report states that despite quality control
been performed and no new evidence has been published on
measures (catheter repositioning and flushing of air bubbles,
the spectrum of advantages and disadvantages of two catheter
checking signal quality during and at end of study) only 13%
technique versus the recommendations in GUP2002.
of graphs all had optimum quality and a significant number
Publications applying results of invasive urodynamics
of catheters was lost during the tests.67
sometimes report a high rate of expelled catheters and it is the
WG's opinion that advice on catheter fixation, applicable for
7.6.1 | Conclusions
both intravesical (shown here for double lumen) and rectal
catheters, will reduce that problem: Although limited evidence suggests that women may prefer
vaginal reference catheter placement, the WG concludes that
Men (left picture): Catheter is taped in the length of the this is insufficient to demonstrate that this is a reliable
penis over the catheter, without obstructing the meatus. alternative to rectal catheterization.

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7.6.2 | Discussion 7.7.2 | Discussion

After bowel resection with anal closure, the stoma may need The sitting or standing position is the most representative for
to be considered as the route to measure abdominal pressure, daily life situations and is probably the least uncomfortable
especially in men. There is no specific evidence, but the and/or embarrassing for the patient. Furthermore, in the
position of the catheter-tip is usually above the bladder in a sitting position the intra-rectal as well as the intravesical
stoma, and bowel activity may much more likely cause catheter are at similar levels in the pelvic cavity (and similar
artefacts in those cases, hampering measurement of absolute to the transducer) which makes reliable (better balanced)
abdominal pressures and detrusor subtraction pressure, and pressure and subtraction more likely. Seated or standing
therefore, the interpretation. (men) cystometry also allows a smooth transition from
The WG considered that full (pre) filling or overfilling cystometry to pressure-flow study when SDV is reached,
of rectal catheters with a balloon, as widely used, is a causing little movement artefact.
significant source of abdominal pressure measurement
error. The catheter and balloon should be filled with water 7.7.3 | Recommendations
in a way that all air is replaced and without causing any ICS standard cystometry is done in the vertical position
excess pressure inside the balloon. Rectal balloon (standing or normally seated) whenever physically possible.
catheters should not be re-filled after insertion and A pressure-flow study is done comfortably seated (women,
therefore should be punctured to prevent over-filling and some men) or standing if that is preferred position (men).
measurement error.
7.8 | Reliability and need for repeat
7.6.3 | Recommendations
cystometry for confirmation
Rectal placement of a fully fluid-filled open, or punctured
balloon catheter, to measure abdominal pressure should be In a prospective study of invasive urodynamics in healthy,
considered the ICS standard. asymptomatic female volunteers, poor reproducibility of
The WG recommends that vaginal or stoma placement sensory volume markers (FSF and FDV) as well as Qmax and
of the abdominal pressure catheter is used alternatively only if pdetQmax between two cystometries done at the same session
rectal catheter placement is impossible. was reported.70 Similarly, poor reproducibility of urody-
namic results at short-term follow-up (1–5 months) was
7.7 | Patient positioning for cystometry and noted.71 In another prospective study of immediate repeat
cystometry in patients with neurogenic LUT dysfunction, the
pressure-flow
authors noted wide 95% limits of agreement for differences in
It was noted on the basis of a literature review that DO was same session test parameters (maximum cystometric capac-
detected with a consistently higher rate in the upright position ity, compliance, storage pdet.max, DLPP, Qmax, voiding pdet.
72
compared to supine position. DO would have been missed in max, pdetQmax). However, the study reported excellent
76% of cases of cystometry was done in the supine position and reproducibility in the detection of DO. The authors suggested
60% would have been missed if the study was done supine that one single urodynamic study may be inadequate to form
compared to seated. Having the patient stand after being filled the basis for clinical decisions in patients with spinal cord
increased the chance of detecting DO by 21%.68 In a prospective injury.73
study, urodynamic stress incontinence was detected in 55% if In a later single-center study in women with symptoms
the women were sitting but only 2% if supine, while DO was and signs of urinary incontinence (without neurological
detected in 55% when seated but only in 9% when supine.69 abnormalities), the reproducibility of immediate repeat
Combined diagnosis (DO plus USI) was observed seated in cystometry plus pressure-flow analysis was overall good to
18%, and zero when supine. Volumes at the time of reporting— excellent, with intra-class correlations of around 0.75 and few
ICS-standard—filling sensations and cystometric capacity differences in urodynamic diagnosis between the first and
were lower for seated cystometry.2 Position during cystometry second run. Nevertheless, these authors suggested that
may also be relevant for the need to change the position for the repetition of urodynamic tests is justified to ensure diagnosis.
optimal pressure-flow study (see below). In elderly men, the immediate or longer interval test retest
variation is less with regard to pressure-flow analysis.
7.7.1 | Conclusions However, it is not reported whether differences in cystometry
values have been observed.74–78
The detection of DO, the detection of urodynamic stress
incontinence, and bladder volumes at reported bladder filling
sensation are influenced by the position of the patient. Sitting 7.8.1 | Conclusions
or standing position appears to have a higher sensitivity for Predominantly, single-center evidence suggests that imme-
detecting these abnormalities. diate or longer term test- retest variation is sometimes large

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for specific parameters (like sensation) but less with regard to patient considers the micturition completed. Note that
pressure-flow variables, especially in elderly men. pressure-flow analysis is only validated for voluntarily
There is no convincing evidence that the clinical initiated micturitions and not for incontinence.
diagnosis on the basis of the first cystometry is often changed The WG considered that the relevance of instruction,
on repetition of the test. There is no definite evidence that position and privacy for the patient while performing
immediate repetition of an adequately performed urodynamic pressure-flow study is equal to uroflowmetry and we refer
test “for confirmation” is required. to both the paragraphs here above for the practice of
uroflowmetry and/or cystometry for the practice of pressure-
7.8.2 | Discussion flow study.
The WG considered that large test-retest variations may also
reflect inadequately standardized methods of testing. Test
8.2 | Discussion
retest data is scarce which was the reason to also include
studies with patients with neurological abnormalities in the There is an inevitable delay between the fluid stream leaving
WG's summary of the evidence. Measurement errors are a the bladder and hitting the flowmeter which should be taken
significant source of test-retest variation, but are seldom into account when a pressure-flow study is analysed (ST1997;
reported. The WG considers it prudent to repeat a technically GUP2002).2 The delay between urethral meatus and
adequate test when observations are not explainable in flowmeter should be reduced by placing the flowmeter as
relation to the patient's symptoms and signs, and especially close to the meatus as possible for every voiding position.
when the urodynamic question is insufficiently answered and Reducing the meatus to flowmeter distance may also result in
consequences for management are significant. Furthermore, more relaxed voiding because the patient may experience less
the WG considers that some observations may be situational concern about spattering.
(eg, the inability to void during a test) and may not always be
soluble. 8.3 | Recommendation
7.8.3 | Recommendations The WG recommends, especially for the purpose of pressure-
flow analysis, a shortest possible meatus-to-flowmeter
The WG does not recommend routine immediate repetition of
distance, adjusted to the voiding position, but recommends
invasive urodynamics “for confirmation” if the test was
correcting for delay between pressure and flow.
technically adequate, has been considered representative, and
has answered the clinical question.
The WG recommends immediate repetition of the test 8.4 | Discussion and suggested terms
when doubt exists as to whether the test has answered the
Presentation of pressure-flow studies should be with a plot of
clinical question.
the flow (-delay corrected) rate (mL/s) on the X-axis and the
The WG recommends repetition of a urodynamic test
(delay corrected) synchronous detrusor pressure (cm H2O) on
when technical errors and artefacts have been observed at
the Y-axis in addition to the time-based graphs (ST 1997).
immediate post-test analysis.
ST1997 introduced “urethral function” and “urethral
resistance (relation)” without precisely defining these as
(new or standard) terms. The “(passive) urethral resistance
8 | PRACTICE OF PRESSURE-FLOW relation” as a means of quantifying bladder outflow
STUDIES AND AN UPDATE OF obstruction (in male patients with prostatic enlargement)
TERMS was defined before ST1997.81,82 New ICS terms are desirable
to acknowledge the relevance of the anatomical structures
adjacent to the anatomically defined urethra per se, to
8.1 | Introduction
describe outflow conditions during micturition (with or
An ICS subcommittee (ST1997) on standardization of without further specifying anatomy) and the WG suggests
terminology for pressure-flow studies revised and ex- introducing a specific (ICS)standard to further detail terms
panded diverse sections of the earlier ICS terminol- and practice for pressure-flow study analysis.
ogy.79,80 ST1997 identified and defined five relevant The terms bladder outlet obstruction and bladder
parameters with the preferred abbreviations to depict outflow obstruction are already frequently used. The WG
pressure-flow studies. introduces (NEW) Bladder Outflow Obstruction (BOO)
For urodynamic practice: the “pressure-flow study” (as (“outflow” to recognize what is measured) with the
defined above) begins immediately after permission to void definition: a (specified) cut-off of bladder outflow resistance
(ST2002) and ends when the detrusor pressure has returned to based on the pressure flow relation (ratio) that is considered
the baseline value and/or the flow rate to zero and/or the clinically relevant (the WG does not define cut-off values

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but advises that the term should be preferred for both 8.5 | Recommendations
genders and all ages).
The WG has suggested some terms with the aim of improving
ST1997 also stated that the urethral function during
communication with regard to pressure-flow analysis.
voiding can be overactive, without further definition or
However, the WG strongly recommends an updated ICS
specification. There is a lack of terminology with regard to
standard for pressure-flow analysis to ensure optimal ICS
specific diagnosis of voiding dysfunction, also here the
standardization of quantitative analysis (and standardization
here above mentioned specific new ICS standard is
of diagnosis) of bladder outflow function as well as of
needed.
detrusor voiding contraction diagnosis and/or detrusor
The WG suggests already now: (NEW) Normal voiding
contractility analysis for all patient groups.
function: flow rate (and pressure-rise) are within normal
limits, begin more or less directly after permission to void and
ends with an empty bladder.
Bladder outflow physical properties may vary during one 9 | TECHNICAL AND CLINICAL
course of voiding and the WG suggests that new terms are
QUALITY CONTROL DURING
introduced when analysis methods and cut-off values or
pattern descriptions are provided to describe (as introduced in
INVASIVE URODYNAMICS
ST1997) “overactive urethral function during voiding.” We
conclude that no commonly agreed parameter or pattern 9.1 | Introduction and evidence base
description exists to clinically quantify or qualify “(over-) Quality control and standardization are an important part of
active urethral function” (if) outflow properties vary during a urodynamics. Without training and standardization of
voiding. equipment, and adherence to quality control and standards
“Underactive detrusor” and “acontractile detrusor” are of urodynamic practice has been shown to be difficult.17 The
defined in ST1997 and ST2002 as different from “normal consequence is a large inter-site variability.18 One national
detrusor” during micturition. GUP 2002 has also introduced board has argued that maintaining expertize requires
that contraction during micturition may vary, or may be performing at least 30 urodynamic tests a year per
variable. Within this context, the WG discussed that voiding urodynamicist and 200 tests in a department.19,20
may be influenced by mental state and, although evidence is A number of recommendations for control during
lacking in the neuro–gyneco–urological literature, anxiety in urodynamics has been provided in the GUP2002 and a
the test situation for the patient may plausibly influence number are renewed or added, in the recently published “ICS
initiation of the voiding reflex83–85 and consequently affect guidelines on urodynamic equipment performance.”2 Fur-
detrusor function. The WG suggests (NEW) “Situational thermore, an overview of common features errors and
inability to void” and “Situational inability to void as artefacts has been published.66,86
usual” when in the opinion of the person performing the test, The WG has found no new evidence necessitating re-
in communication with the patient, the attempted voiding has discussion of equipment requirements, labelling and scaling
been not representative. of traces in the graph and refers to earlier documents in this
The WG here introduces the term “detrusor voiding regard.1,2,5,79
contraction” for any analysis of combined pressure and Typical signal patterns, such as straining, rectal
flow (± other variables) that qualifies or quantifies the contractions, coughing and DO are important in quality
actual observed voiding. Following on to this: “detrusor control and everyone who performs or evaluates urody-
contractility” is now suggested for any method that aims namic tests should be able to recognize these during the
to quantify “intrinsic” detrusor muscle properties (eg, test.66,87,96–100 In diverse retrospective single and multicen-
potential-maximum-force or velocity) by any method. ter evaluations, it was demonstrated that the expert
We refer to, for example, stop-flow or interrupted- recognition and identification of specific patterns occurring
voiding tests and mathematical (extrapolation) or graph- in the urodynamic traces has required adaption or correction
ical analysis methods of pressure, flow and/or other of the—initial—diagnoses.19,87–100
parameters, such as, for example, the bladder working
function.
Acknowledging the GUP2002, we suggest that the
9.2 | Conclusions
terms “unsustained contraction” (when waxing and Expert evidence confirms that prevention, recognition and
waning) or “fading contraction” may be used when management of errors and recognition of artefacts are
analysis methods and cut-off values or pattern descriptions important elements of urodynamic quality control. System-
are provided. We also acknowledge that no parameters to atic urodynamic quality management, including plausibility
clinically demarcate normal, stable, or sustained detrusor analysis, is relevant before, during and after the test as well as
contraction are available as yet. while reporting the results of the test.

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9.3 | Discussion The WG has listed terms here that are considered to be of
use during the test and its evaluation. Many of the terms have
The WG considers that regular calibration of pressure
been used in earlier ICS standardization documents, but
measurement systems should be documented in each
usually not with precise definitions. While many terms refer
urodynamic laboratory and that, in general, new technologies
to preventable or correctable problems, these features
need to prove their usefulness as well as accuracy compared
including artefacts should nevertheless also be recognized
to existing standards before clinical application.
during evaluation after the test. The WG has opted for terms
that are as descriptive as possible and is convinced that better
definition and description of these errors and artefacts is a tool
9.4 | Recommendations to improve practice. The features, patterns or events terms
The WG recommends that everyone performing or evaluating mentioned here should also be used in the ICS standard
urodynamics should be able to recognize usual pressure urodynamics report (see below).
patterns and be able to perform continuous quality control Initial resting pressure (NEW) is the pves and the pabd
during the test. pressure at the beginning of the cystometry. To prevent
The WG recommends that training and a process of reading measurements from a kinked catheter in an empty
continuous knowledge maintenance as the basis for perform- bladder with the catheter holes blocked with (insertion)
ing urodynamic tests should be established. gel and/or pushed against the bladder surface, the WG
recommends (GUP2002) gentle flushing of both catheter
Terms related to the cystometry observations and channels and/or filling 20–30 mL of the bladder, before the
evaluation. initial resting intravesical pressures are considered to be
Adequate set-up of the system and continuous quality “established.” Initial resting pressures should be within the
monitoring are mandatory and all patterns and features physiological limits specified in previous manuscripts96,97
occurring during the test should be recognized. Typical and GUP2002.
patterns may lead to recognition of pathophysiology or Dead signal (NEW): A signal that is not showing small
explain the perceived dysfunction. However, when an error pressure fluctuations and is not adequately responding on
or an artefact is observed during the test,59 the person straining, patient movements, or coughing is reported as a
performing the test should act accordingly and prevent dead signal.
continuation in case of an error. The WG explains here Previously (GUP2002): “In principle, a good pdet signal
for clarity that artefacts are, like rectal activity, in analogy requires only that pves and pabd show the same fine structure
with, for example, scattering on ultrasound imaging, more and quality of signals before filling, during filling, and after
or less unavoidable. Errors are usually preventable or voiding.”
correctable. Pressure drift (NEW): Continuous slow fall or rise in
Recommended terms to describe most common pressure, that is physiologically inexplicable.
features, artefacts, and errors during invasive Poor pressure transmission (NEW): Poor pressure
urodynamics: A fluid-filled pressure measuring system transmission has occurred when the cough/effort pressure
shows patient movement and external manipulation of the peak signals on pves and pabd are not nearly equal.
catheter. This causes signals or signal patterns that should Note: The WG does not define a new limit for not “nearly
be recognized during the test and at (re-) evaluation of equal.”
graphs. Prevention of fluid leaks and air bubbles in the Expelled catheter (NEW): When a catheter is expelled,
pressure tubing system is needed (GUP2002). This already this is observed as a sudden drop in either pves or pabd, usually
starts before beginning the test while setting up the below zero.
equipment. However, the effects of fluid leaks and air in Earlier ICS description: “If a sudden drop or increase
the system on the pressures should be recognized at the occurs in either pves or pabd signal, the usual cause is
beginning of the test and during the test also and should be movement, blockage, or disconnection of a catheter.”
corrected (GUP2002). Furthermore, they should also be Expelled catheter is usually simply visible during the
recognized and reported during post-test analysis, if test and should provoke correction or repetition of the
recognition and correction during the procedure has failed, test. However, this term should also be used in post-test
to prevent mis-diagnosis.66 evaluation.
Urodynamic laboratories should apply standard practice Catheter flush (NEW): When one of the catheters is
and therefore be aware of all potential features, errors, and flushed during the test a steep pressure rise is observed in that
artefacts that may occur when measuring with the fluid- pressure line for one or two seconds followed by an
filled system. Whoever is performing tests should be able to immediate fall to resting pressure.
recognize artefacts and prevent, recognize, and correct A catheter flush is not always necessary after a
errors. carefully performed set-up but is suggested in GUP2002.

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Flushing of the catheter measuring channel may be (with or without leakage) occurs immediately following the
considered necessary to wash away entrapped air, or the cough pressure peak.
gel used during insertion or urethral mucus, from the No precise definition of cough associated detrusor
measuring hole. The rectal catheter can only be flushed activity is available. “Cough induced DO” is sometimes
when an open or a punctured balloon catheter is used, and reported, although the precise (patho-)physiology and/or
flushing should definitely not be done if a closed balloon is relevance remain speculative.
used (which is not ICS standard). A catheter flush should Position change (NEW): A change in patient position,
be marked accordingly, but flushes are normally unneces- either active or passive (eg, tilting), is visible on the
sary after the cystometry has continued after the first cystometry trace by a lasting change of equal magnitude in
milliliter of filling. both pves and pabd.
Tube knock (NEW): Tube knock is observable as high Note: A position change should be (is readily) noted
frequency, short duration spikes visible in pves, pabd, or both, during the test. Position change should be followed by
and with spikes also usually visible in pdet. readjustment of the external pressure sensors height to the
Pump vibrations (NEW): Pump vibrations are visible standard so that the pves and pabd-values are similar to the
as stable frequency oscillations of small but constant pressure values before the position change. A position
amplitude if the filling tube touches the pressure connecting change should not affect pdet. The position change pattern
tube (when a two catheter system is used) and the pump is should be recognized during post-test evaluation of the
switched on (switching of the pump can ascertain the cystometry.
situation). Rectal contractions (NEW): Rectal contractions are
Cough pressure peak (NEW): A cough pressure peak is temporary phasic increases in pabd without synchronous
recognizable during post-test evaluation as a phasic positive change in pves resulting in negative deflections of pdet.
pressure change observed in pves and in pabd. Previously (GUP-2002), “Rectal contractions are usu-
Urodynamic stress test (NEW): The term urodynamic ally of low amplitude and may or may not be felt by the
stress test is used for any physical effort of the person patient.”
tested, to elevate abdominal pressure during cystometry, Dropped pabd at void (NEW): A drop in pabd during
with the aim of examining (urodynamic) stress urinary voiding is reported during the voiding time, pabd decreases
incontinence. below the previous resting pressure (as a consequence of
ICS has defined urodynamic stress incontinence. Evi- pelvic (and abdominal) muscle relaxation).
dence is lacking (or conflicting) with regard to the preferred Note: The WG considers that this phenomenon will
technique of urodynamic stress testing. affect the pressure-flow analysis result, because it affects
Note: The provocation method, the pressure measuring pdet. This observation should be differentiated from
catheter(size) and method, the leak detection method as well expelled catheter (that usually results in a much larger
as the absolute or relative (percentage of cystometric pressure drop).
capacity) intravesical volume(s) while testing should be Straining (NEW): Straining is observable as a
reported. temporary increase in both pves and pabd pressure.
Leak point pressure (NEW): The leak point pressure Straining may be associated with (patient-active) position
(LPP) is the pressure (spontaneous or provoked) that has change (such as repositioning from leaning backwards to
caused fluid to be expelled from the bladder at the moment upright).
that it is visible outside the urethra (may also be used for Note: A short abdominal strain peak may in
extra-urethral urine loss or stoma). This may refer to retrospect be indistinguishable from a position change
Abdominal, Cough or Valsalva LPP or Detrusor or a cough.
LPP.5,6,28,29 Provocation and pressure recording site (“type After-contraction (NEW): An after-contraction, is a
of LPP”) should be reported. continued or new detrusor pressure rise immediately after
Diverse methods of LPP measurement have been flow ended. It is important to note if this occurs with the
published with a variety of combinations of provocation or complete emptying of the bladder.
pressure recording site/type and/or technique. Detrusor LPP Note: Cough checking of (intravesical) catheter
and Valsalva LPP were defined in ST2002. However, no ICS position is always required after pressure-flow. To
(or commonly agreed) standard technique or protocol is separate the after-contraction pattern from expelled
available and a variety of terms and techniques are used catheter or catheter tip (with measuring hole) bending in
(counts in PubMed (April 2015): Cough LPP: 21; Valsalva the outlet when the bladder empties, this cough check is
LPP: 226; Detrusor LPP: 64; Abdominal LPP: 98; specifically important when a pves increment after voiding
Overactivity LPP: 0). is observed.
Cough associated detrusor overactivity (NEW): Previously published description: a pressure increase
Cough associated DO is reported when the onset of the DO after flow ceases at the end of micturition.

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10 | THE URODYNAMIC GRAPHS development of an ICS standard urodynamics report

AND THE URODYNAMICS REPORT template.

10.1 | Introduction and evidence base

A standard urodynamics protocol contains diverse elements.
Results of clinical analysis and evaluations are documented
when a (ICS Standard) Urodynamic Test is ordered. An ICS-
SUT should be followed by a urodynamics report. The WG
has not found evidence with regard to the standardization of
such a report and no evidence regarding the elements that it
should contain.
ICS (ST2002) has acknowledged urodynamic observa-
tions, but has not been specific in the definition of the type of
observations relevant for diagnosis or for urodynamic
conditions or the elements of urodynamic testing to be
reported. Furthermore, the ST2002 has only mentioned (or
standardized) a few of the possible observations, out of the
many that can be the result of a complete ICS-SUT.
Contemporary urodynamic equipment is able to provide lists
test data and/or graphs, but here too no standard exists for
these.
11 | CONCLUSION
GUP2002 has standardized the layout of the urodynamic
The ICS Standardisation WG has updated the International
graph. The WG presents elements for qualitative reporting of
Continence Society's Good Urodynamic Practice standard.
the results of a ICS-SUT to ensure a descriptive and objective
This evidence-based ICS GUP2016 has defined terms and
urodynamic diagnosis or establishment of a urodynamic
standards for the practice of urodynamics labs in general
condition.
as well as for the (individual) practice of quality control
during and after cystometry, and pressure-flow analysis.
10.2 | Discussion Furthermore, the WG has included recommendations for
pretesting information and for patient information and
While it will not be possible to cover all possibilities in one
preparation as well as recommendations for the urody-
standard urodynamics report, the report may be customized,
namics report. On the basis of earlier ICS standardisations
for example, relevant to the final diagnosis the urodynamic
and the available evidence, the practice of uroflowmetry,
evidence has to be reported. However, when a test is done, all
cystometry and pressure-flow study have been further
results and observations should be systematically reported. It
detailed. The WG expresses the hope that implementation
is good clinical practice to integrate the urodynamics report
of this update of Good Urodynamic Practices will help to
with what is known about the patient from history and other
increase the quality of both individual clinical and
examinations and tests.
research urodynamics.
On the basis of expert experience and consensus, the WG
lists qualitative elements to be included in the urodynamics
report of an ICS SUT without standardizing the numerical
values. 12 | POTENTIAL CONFLICTS OF
INTEREST
10.3 | Recommendations Dr. Rosier reports grants from Astellas, grants from
The WG recommends that, in addition to the GUP2002 Laborie/MMS/Tdoc, grants from ONO-Pharma, outside
standard urodynamic graph, a [cited form ST1997] “plot of the submitted work; Dr. Guralnick reports personal fees
detrusor pressure against flow rate during voiding” should from Astellas, other from InControl Medical, LLC, outside
be provided, according to the example in this ICS standard the submitted work; Dr. Lose reports grants from Coloplast,
(ST1997).79 For the “ICS standard urodynamic test,” the other from Astellas, other from Contura, outside the
WG recommends both (NEW) an “ICS standard urody- submitted work; Dr. Eustice has nothing to disclose; Dr.
namic (time-based) graph” as well as (NEW) an “ICS Hashim has nothing to disclose; Dr. Goldman has nothing
standard pressure-flow plot” to be required elements in the to disclose; Ms. Dickinson has nothing to disclose; Dr.
ICS standard urodynamics report. The WG recommends Schaefer has nothing to disclose.

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59. Van Meel TD, Wyndaele JJ. Reproducibility of urodynamic
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| 17

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71. Gupta A, Defreitas G, Lemack GE. The reproducibility of in a representative male sample. Psychother Psychosom.
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up. Neurourol Urodyn. 2004;23:311–316. relative pressure. Neurourol Urodyn. 2009;28:468.
72. Broekhuis SR, Kluivers KB, Hendriks JC, Massolt ET, Groen 87. Hogan S, Jarvis P, Gammie A, Abrams P. Quality control in
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toms of urinary incontinence. Neurourol Urodyn. 2010;
88. Kraus SR, Dmochowski R, Albo ME, Xu L, Klise SR, Roehrborn
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CG. Urodynamic standardization in a large-scale, multicenter
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74. Rosier PF, de la Rosette JJ, Koldewijn EL, Debruyne FM, 89. Schaefer W. Humpty Dumpty − still alive. Quality control
Wijkstra H. Variability of pressure-flow analysis parameters in in urodynamics: analysis of an International Multi-Center Study.
repeated cystometry in patients with benign prostatic hyperplasia. Letter to the Editor. Neurourol Urodyn. 2010;29:797–798.
J Urol. 1995;153:1520–1525. 90. Lenherr SM, Clemens JQ. Urodynamics: with a focus on
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la Rosette JJ. Variability of clinical and pressure-flow study 91. Liao L, Schaefer W. Qualitative quality control during urody-
variables after 6 months of watchful waiting in patients with lower namic studies with TSPs for cystometry in men with lower urinary
urinary tract symptoms and benign prostatic enlargement. J Urol. tract symptoms suggestive of benign prostatic hyperplasia. Int
1996;156:1026–1034. Urol Nephrol. 2014;46:1073–1079.
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FM, de La Rosette JJ. Variability of pressure-flow studies in pressure-flow data with computer-based urodynamic systems
men with lower urinary tract symptoms. Neurourol Urodyn. from men with benign prostatic hyperplasia. Asian J Androl.
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urodynamic parameters with position change in children? 2007;9:771–780.
Analysis of a rospectively enrolled cohort. J Urol. 2007;178: 100. Liao L, Schaefer W. Urodynamic quality control, II: Recognition
2567–2570. of typical signal pattern and its role in real-time qualitative quality
94. Nager CW, Albo ME, Fitzgerald MP, et al. Urinary Incontinence control. Chin J Urol. 2006;27:300–303.
Treatment Network. Reference urodynamic values for stress
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incontinent women. Neurourol Urodyn. 2007;26:333–340.
U. Positional changes in voiding dynamics of children with
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102. Rane A, Iyer J. Posture and micturition: does it really matter how a
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pressures. Neurourol Urodyn. 2012;31:535–540.
Rane A. Comparison of Intra-abdominal and Intravesical
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control. Chin J Urol. 2006;27:296–299. Townsville Australia. Presented in IUGA 2010. 2007.
98. Liao L, Schaefer W. Development of urodynamic standards for quality Available at: http://www.ics.org/Abstracts/Publish/105/Scientific
control. In: Ivanov O, ed. Applications and Experiences of Quality Programme.pdf
Control. Rijeka Croatia: InTech; 2011:75–137. ISBN: 978-953-307- 104. Moore KH, Richmond D, Sutherst JR, Imrie AH, Hutton JL.
236-4. Crouching over the toilet seat: prevalence among British
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pressure-flow data with computer-based urodynamic systems Obstet Gynaecol. 1991;98:569–572.

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Neurourology and Urodynamics 21:261^274 (2002)

Good Urodynamic Practices: Uro£owmetry, Filling

Cystometry, and Pressure-Flow Studies
Werner Sch�fer,* Paul Abrams, Limin Liao, Anders Mattiasson, Francesco Pesce,
Anders Spangberg, Arthur M. Sterling, Norman R. Zinner,
and Philip van Kerrebroeck
International Continence Society O⁄ce, Southme Hospital, Bristol, BSIO 5NB,
United Kingdom
This is the ¢rst report of the International Continence Society (ICS) on the development of com-
prehensive guidelines for Good Urodynamic Practice for the measurement, quality control, and
documentation of urodynamic investigations in both clinical and research environments. This
report focuses on the most common urodynamics examinations; uro£owmetry, pressure recording
during ¢lling cystometry, and combined pressure^£ow studies. The basic aspects of good uro-
dynamic practice are discussed and a strategy for urodynamic measurement, equipment set-up and
con¢guration, signal testing, plausibility controls, pattern recognition, and artifact correction are
proposed. The problems of data analysis are mentioned only when they are relevant in the judgment
of data quality. In general, recommendations are made for one speci¢c technique. This does not
imply that this technique is the only one possible. Rather, it means that this technique is well-estab-
lished, and gives good results when used with the suggested standards of good urodynamic practice.
Neurourol. Urodynam.21:261^274,2002.  2002 Wiley-Liss, Inc.

Key words: urodynamics; standardisation; uro£owmetry; cystometry; pressure-£ow studies

INTRODUCTION is expected that the necessary technological developments in

automation will follow.
A Good Urodynamic Practice comprises three main
Urodynamics allows direct assessment of lower urinary
elements:
tract (LUT) function by the measurement of relevant physio-
^ A clear indication for and appropriate selection of, logical parameters. The ¢rst step is to formulate the ‘urody-
relevant test measurements and procedures namic question or questions’ from a careful history, physical
^ Precise measurement with data quality control and examination, and standard urological investigations. The
complete documentation patient’s recordings of micturitions and symptoms on a fre-
^ Accurate analysis and critical reporting of results quency volume chart, and repeated free uro£owmetry with
determination of post-void residual volume provide important
The aim of clinical urodynamics is to reproduce symptoms
whilst making precise measurements in order to identify
the underlying causes for the symptoms, and to quantify the
related pathophysiological processes. By doing so, it should be
possible to establish objectively the presence of a dysfunction
and understand its clinical implications. Thus, we may either
con¢rm a diagnosis or give a new, speci¢cally urodynamic, Urodynamic techniques were performed according to the ‘Good Urody-
diagnosis. The quantitative measurement may be supple- namic Practice’ recommended by the International Continence Society.
mented by imaging (videourodynamics).
This report is from the Standardization Committee of the International
Urodynamic measurements cannot yet be completely auto- Continence Society.
mated, except for the most simple urodynamic procedure,
uro£owmetry. This is not an inherent problem of the measure- *Correspondence to: Werner Sch�fer, International Continence Society
ment itself, but is due to the current limitations of urodynamic O⁄ce, Southme Hospital, Bristol, BSIO 5NB, United Kingdom.
equipment and the lack of a consensus on the precise method E-mail: Vicky@icso⁄ce.org.
of measurement, signal processing, quanti¢cation, documen- DOI 10.1002/nau.10066
tation, and interpretation. With the publication of this ICS
Standardisation document on good urodynamic practice, it Published online inWiley InterScience (www.interscience.wiley.com).
 2002 Wiley-Liss, Inc.

Good Urodynamic Practices: Uro£owmetry, Filling Cystometry, and Pressure-Flow Studies

188

262 Sch�fer et al.

noninvasive, objective information that helps to de¢ne the spe-

ci¢c ‘urodynamic question’or questions, prior to invasive uro-
dynamics such as ¢lling cystometry and pressure-£ow studies.
Recommendations for good urodynamic practice are bullet
pointed, inset, and printed in bold.

RECORDING MICTURITIONS
AND SYMPTOMS
A Micturition Time Chart records the time of each micturi-
tion. The usefulness of such a record is signi¢cantly enhanced
when the voided volumes are recorded in a Frequency Volume
Chart. The Bladder Diary adds to this the relevant symptoms
and events such as urgency, pain, incontinence episodes, and
pad usage. Recording for a minimum of 2 days is recom-
mended. From the recordings, the average voided volume,
voiding frequency, and if, the patient’s time in bed is recorded,
day/night urine production and nocturia can be determined. Fig. 1. Typical normal flow (top), constrictive flow (bottom, dotted
line), compressive flow curve (bottom).
This information provides objective veri¢cation of the pati-
ent’s symptoms, and furthermore, key values for plausibility
control of subsequent urodynamic studies, for example, in urethral lumen on the intraurethral pressure at the £ow rate
order to prevent over-¢lling of the patient’s bladder. controlling zone (FRCZ). Typically, below the minimum ure-
thral opening pressure (pmuo), the urethral lumen is closed.
The lumen then opens widely with little additional pressure
UROFLOWMETRY
increase.With normal detrusor contractility and low intraure-
Uro£owmetry is noninvasive and relatively inexpensive. thral pressure, the normal £ow curve is arc-shaped with a high
Therefore, it is an indispensable, ¢rst-line screening test for maximum £owrate. (Fig. 1, top).
most patients with suspected LUT dysfunction. Objective A normal £ow curve is a smooth curve without any rapid
and quantitative information, which helps one to understand changes in amplitude, because the shape of the £ow curve is
both storage and voiding symptoms are provided by this sim- determined by the kinetics of the detrusor contraction, which
ple urodynamic measurement. arising from smooth muscle, does not show rapid variations.
Adequate privacy should be provided and patients should A decreased detrusor power and/or a constant increased
be asked to void when they feel a ‘‘normal’’ desire to void. urethral pressure will both result in a lower £owrate and a
Patients should be asked if their voiding was representative smooth £at £ow curve. A constrictive obstruction (e.g., ure-
of their usual voiding and their view should be documented. thral stricture), with reduced lumen size results in a plateau-
Automated data analysis must be veri¢ed by inspection of the like £ow curve. (Fig. 1, broken line).
£ow curve, artifacts must be excluded, and veri¢cation must A compressive obstruction with increased urethral opening
be documented. The results from uro£owmetry should be pressure (e.g., benign prostatic obstruction) shows a £attened
compared with the data from the patient’s own recording on asymmetric £ow curve with a slowly declining end part. (Fig. 1,
a frequency/volume chart. Sonographic estimation of post- bottom).
void residual volume completes the noninvasive assessment The same pattern may also originate from a weak detrusor
of voiding function. in aging males and females. Fluctuations in detrusor contr-
actility or abdominal straining, as well as variable outlet
conditions, (e.g., intermittent sphincter activity) will lead to
Normal Uro£ow
complex £ow rate patterns.
Normal voiding occurs when the bladder outlet relaxes Rapid changes in £owrate may have physiological or physi-
(is passive) and the detrusor contracts (is active). An easily dis- cal causes that owe to either changes in outlet resistance,
tensible bladder outlet with a normal detrusor contraction for example, sphincter/pelvic £oor contraction or relaxation,
results in a smooth arc-shaped £ow rate curve with high ampli- mechanical compression of the urethral lumen, or interfer-
tude. Any other shapes, such as curves that are £at, asymmetric, ence at the meatus, or to changes in driving energy, for exam-
orhave multiplepeaks (£uctuating and/or intermittent), indicate ple, abdominal straining. These intracorporeal causes lead to
abnormal voiding, but are not speci¢c for it’s cause. true £owrate changes. Rapid changes in £owrate may also be
It is assumed that it is normal for the mechanical properties artifacts, when the £owrate signal is extracorporeally modi-
of a relaxed outlet to be constant, and that the properties can ¢ed through interference between the stream and the collect-
be de¢ned by the dependency of the cross-sectional area of the ing funnel, the £owmeter, movement of the stream across the

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1. ICS Standardisations
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Good Urodynamic Practice Guidelines 263

surface of the funnel, or patient movements. (see £ow-curves ferent for free uro£owmetry compared to combined pressure/
in Figs. 3^8). £ow recordings.
In free uro£owmetry, the shape of the £ow curve may sug-
gest speci¢c types of abnormality, but reliable, speci¢c, and
Accuracy of Uro£owmeters
detailed information about the cause for abnormal voiding
Uro£owmetry measures the £ow rate of the external urin- cannot be derived from a £ow curve alone. Only when uro-
ary stream as volume per unit time in milliliters per second, £owmetry is combined with intravesical and abdominal
(ml/s). The ICS Technical Report [Rowon et al., 1984] made pressure recordings does it become possible, from the pres-
technical recommendations with respect to uro£owmetry, sure^£ow relationship, to analyze separately the contribu-
but did not compare di¡erent £owmeters by speci¢c testing. tions of detrusor contractility and bladder outlet function to
There are, however, di¡erences in the accuracy and precision the overall voiding pattern. (Figs. 3^8)
of the £ow rate signals that depend on the type of £owmeter, Urine £ow rate measurement is a¡ected by a number of
on internal signal processing, and on the proper use and cali- important factors.
bration of the £owmeter. The desired and actual accuracy of
uro£owmetry should be assessed in relation to the potential
Detrusor Contractility
information that could be obtained from the urinary stream
compared to the information actually abstracted for clinical As the voiding function re£ects the interaction between the
and research purposes. Some relevant aspects of the physiolo- relaxed outlet and the contracting detrusor, variation of both
gical and physical information contained in the urinary will a¡ect the £ow. For steady out£ow conditions, all varia-
stream are outlined here. tions in £owrate are related to changes in detrusor activity
The desired clinical accuracy may di¡er from the technical alone. The detrusor contraction strength varies neurogeni-
accuracy of a £ow meter. The ICS Technical report recom- cally and myogenically, and can cause signi¢cant variability
mended the following standards: a range of 0^50 ml/s for in urine £ow rate measurements. (Fig. 5).
Qmax, and 0^1,000 ml for voided volume, maximum time con-
stant of 0.75 s; an accuracy of  5% relative to full scale,
Bladder Out£ow Resistance
although a calibration curve representing the percentage error
over the entire range of measurement should be made available. If detrusor, contractility is constant, then changes in
However, technical speci¢cations from the manufacturers out£ow resistance will lead to changes in £ow rate, for ex-
are rare and often not in accordance with ICS recommenda- ample, in patients with detrusor^sphincter dyssynergia
tions: this situation should be recti¢ed. (Figs. 3, 7, 8).
Furthermore, as most £owmeters are mass £ow meters
(e.g., a weight transducer or rotating disk), variations in the
Bladder Volume
speci¢c gravity of the £uid will have a direct in£uence on the
measured £ow rate. For example, urine of high concentration As the bladder volume increases and the detrusor muscle
may increase apparent £ow rate by 3%. With X-ray medium, ¢bers become more stretched, there is an increase in the
the £ow rate may be overestimated by as much as 10%. These potential bladder power and work associated with a contrac-
e¡ects should be corrected by calibration software. tion. This is most pronounced in the range from empty up to
Thus, since the overall accuracy of £ow rate signals will not 150^250 ml bladder ¢lling volume. It appears that at volumes
be better than  5%, it would not be meaningful to report a higher than 400^500 ml, the detrusor may become over-
maximum £ow rate to a resolution better than a full milliliter stretched and contractility may decrease again. Therefore,
per second (ml/s). Under carefully controlled research condi- Qmax is physiologically dependent on the bladder volume.
tions, a better resolution may be possible by £owmeter cali- This dependency will vary between individuals and with the
bration and instrument selection. However, such improvements type and degree of pathology, for example, in constrictive
in resolution may not be required for routine clinical applica- obstruction, Qmax is almost independent of volume, and in
tions. The dynamic properties of most £owmeters will be compressive obstruction, the dependency becomes weaker
good enough for free uro£owmetry. When pressure £ow data with increasingly obstructed outlet conditions and lower £ow
are analyzed, however, the limitation in signal dynamics rate.
should be taken into account because they will be di¡erent
for pressure than for £ow. Flow signals have a much slower
Technical Considerations
response, and are less accurate than pressure signals.
The £ow rate signal is in£uenced by the technique of mea-
surement and by signal processing. The external urinary
Problems in Urine Flow Rate Measurement
stream should reach the £owmeter unaltered and with mini-
The problems in measurement, as well as the information mal delay. However, any funnel or collecting device, as well
that can be abstracted from the £ow rate signal are rather dif- as the £owmeter, will inevitably introduce modi¢cations to

Good Urodynamic Practices: Uro£owmetry, Filling Cystometry, and Pressure-Flow Studies

190

264 Sch�fer et al.

the £ow rate recording. Physically, the external urinary stream If a maximum £ow value is determined electronically by
breaks into drops not far from the meatus. This ¢ne structure simple signal peak detection without the recommended elec-
of the stream has a high frequency, which can be assessed tronic smoothing, it should be labeled di¡erently, Qmax.raw.
by drop spectrometry, and contains interesting information. Such raw data has meaning only if a detailed speci¢cation of
For standard uro£owmetry, however, such high frequencies the type of £owmeter used is given.
should be eliminated by signal processing. The interpretation of any dynamic variation (signal pat-
For free uro£owmetry, all intracorporeal modulations of terns) in free £ow will rely on personal experience, can be only
the £ow rate are physiological artifacts and should be mini- descriptive, and in general will remain speculative.
mized, for example by asking the patient to relax and not to For the documentation of the results of uro£owmetry, the
strain. Nevertheless, certain dynamic patterns of intracorpor- following recommendations are made:
eal modulations can provide information about functional
� Maximum (smoothed) urine £ow rate should be rounded
obstruction, for example, typical patterns of the detrusor^
to the nearest whole number (a recording of 10.25 ml/s
sphincter dyssynergia, or abnormal straining. This informa-
would be recorded as 10 ml/s);
tion may be lost by excessive ¢ltering or during analog to digi-
� Voided volume and post void residual volume should be
tal A/D conversion with a ¢lter speed of less than 10 Hz. The
rounded to the nearest 10 ml (a recording of a voided
precise interpretation of dynamic variations in the £ow rate
volume of 342 ml would be recorded as 340 ml);
signal is only possible when the £ow rate is viewed together
� The maximum £ow rate should always be documented
with the simultaneously recorded pressure signals. Thus, only
together with voided volume and post void residual volume
in combined pressure^£ow recordings can the details of the
using a standard format: VOID: Maximum Flow Rate/
£ow signal be fully understood.
VolumeVoided/Post Void Residual Volume.
For the determination of the ‘true’ maximum £ow rate
value, particularly during free £ow, such high frequency signal For example, the automatically detected £ows, Qmax.raw,
variations are more likely to be misleading, and consequently are 16.6 and 21.3 ml/s with voided volumes 86 and 182 ml,
they should be suppressed electronically. respectively. The smoothed Qmax values are 8 and 17 ml/s and
should be reported with voided volumes of 90 and 180, res-
pectively, and the estimated residuals as VOID1 ¼8/90/0 and
Recommendations for Uro£owmetry
VOID2 ¼ 17/180/20 (see Figs. 2, 5, 6).
In order to facilitate the recording of urine £ow rate and The adoption of these standards will aid the interpretation
pattern recognition of £ow curves, it is recommended that gra- of uro£owmetry results. If data are not available, then a
phical scaling should be standardized as follows: hyphen should be used, for example, if only the voided volume
is known, VOID:�/340/�or if the voided volume was miss-
� one millimeter should equal 1 s on the x-axis and 1 ml/s and
ing, VOID: 10/�/90.
10 ml voided volume on the y-axis.
� If a £ow/volume nomogram is used, this should be stated
With respect to the technical accuracy of uro£owmeters,
and referenced.
it is meaningful for routine clinical measurements to read
£owrate values only to the nearest full ml/s and volumes to Uro£owmetry data from other than free £ow, for example,
the nearest 10 ml. measured in combination with intravesical pressure should be
In order to make electronically-read Qmax values more reli- reported with an additional descriptive index, p, i.e., Qmax.p,
able, comparable, and clinically useful, we recommend inter- for pressure^£ow recording.
nal electronic smoothing of the £ow rate curve. It is
recommended that:
INVASIVE URODYNAMICS: FILLING
� a sliding average over 2 s should be used to remove positive CYSTOMETRY, PRESSURE^FLOW
and negative spike artifacts. STUDY OF VOIDING

If curves are smoothed by hand, the same concept should

be applied. That is, when reading Qmax graphically, the line Introduction
should be smoothed by eye into a continuous curve so that Invasive urodynamic procedures should not be performed
in eachperiod of 2 s,there are norapid changes.Such a smoothed, without clear indications and the formulation of speci¢c uro-
clinically-meaningful maximum free £ow Qmax will be di¡erent dynamic question(s). This process will usually be aided by the
(lower) from the peak value in the £ow rate recording of electro- a priori completion of a frequency volume chart and free uro-
nic instruments currently available. (see Figs. 2, 5, 6, 8). £owmetry. There are certain key recommendations, which
It is recommended that: will lead to the performance of a successful urodynamic study.
� only £ow rate values, which have been ‘smoothed’, either � A good urodynamic investigation should be performed
electronically or manually, should be reported. interactively with the patient. It should be established by

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Good Urodynamic Practice Guidelines 265

Fig. 2. Exclusion of artifactual spikes in the flow curve, Qmax.raw, and determination of a clinically
relevant maximum flow rate, Qmax, by manual smoothing. The results from uroflowmetry should be
reported in the standard format: Qmax/Vvoid/Vres.

discussion with the patient that the patient’s symptoms namics [van Waalwijk et al., 2000]. This makes a consensus on
have been reproduced during the test; quality even more important, because only when such criteria
 There should be continuous and careful observation of the are precisely de¢ned can they be implemented in an ‘‘auto-
signals as they are collected, and the continuous assessment mated intelligent’’ambulatory system.
of the qualitative and quantitative plausibility of all signals; Quality control relies on pattern recognition and a knowl-
 Artifacts should be avoided, and any artifacts that occur edge of normal values as well as prior identi¢cation of useful
should be corrected immediately. It is always di⁄cult and information obtained from noninvasive urodynamics and all
is often impossible to correct artifacts during a retrospec- other sources relevant for the urodynamic question. Thus,
tive analysis. Furthermore, it is more time consuming than before invasive urodynamics, a frequency volume chart
if the signals are continuously observed and tested at regu- should be completed and multiple free £ows should be evalu-
lar intervals and artifacts recognized during the uro- ated. Useful information obtained from noninvasive testing
dynamic study and corrected. includes typical voided volumes and post-void residual
volumes as well as the expected values for Qmax. This informa-
At present, ambulatory urodynamic monitoring has to tion should be used for the control of subsequent invasive stu-
rely on retrospective quality control and artifact corrections. dies. Only by good preparation can it be assured that (a) the
However, in principle, the same quality criteria apply for proper answers to the urodynamic questions will be obtained
ambulatory urodynamic monitoring as for standard urody- before the study is terminated and (b) necessary modi¢ca-

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266 Sch�fer et al.

Fig. 3. Full recording of filling and voiding. Starting with initial values for pves, pabd of 32 cmH2O in the
typical range for a standing patient with zero pdet; testing signal quality with a vigorous cough
atbeginning, and regularly repeated (here less strong) coughs. Additionally, the pressure recordings
show the typical pattern of a talking patient, while the pdet trace is unaffected; a weak contraction at
first desire FD; another vigorous cough before voiding; beginning of flow shows dyssynergic sphincter
activity as proven by decrease in flow with increase in pdet.

tions, additions, or repetitions of measurements will have and procedures, (c) an understanding of how to assure quality
been performed in order to derive the necessary information. control of urodynamic signals, and (d) the ability to analyze
The e¡ective practice of urodynamics requires: (a) a theore- critically the results of the measurements. Because urody-
tical understanding of the underlying physics of the measure- namics deals largely with mechanical measurements such as
ment, (b) practical experience with urodynamic equipment pressure and volume and their related changes in time, and

Fig. 4. Good recording quality until cystometric capacity CC is reached; at second cough before
voding the intravesical signal is lost (no response in pves, negative spike in pdet). Dead pves  signal
during voiding, which is ‘‘live’’ again only at second cough after voiding. Thus, pressure–flow study is
lost. Careful observation of signals would have made it possible to interrupt the study immediately
when signal failed and correct this problem before voiding starts.

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Fig. 5. Variable flowrate due to varying detrusor contraction strength. VOID: 7/250/70.

because many analytical models use mechanical concepts quality and plausibility control should be used: (a) on a physical
such as resistance to £ow or contraction power, it is essential and technical level, (b) on a biomechanical level, and (c) on a
that the nature of these measurements and concepts, in parti- pathophysiological clinical level. A common problem in urody-
cular for pressure and £owrate, are understood. Therefore, in namics is that clinicians often proceed immediately to a clinical
addition to a comprehensive understanding of anatomy and interpretation, i.e., to level c without a critical analysis of the
physiology, some basic knowledge of biomechanics and phy- potential pathophysiological information content, without con-
sics is required. sidering the plausibility of the signals (level a), without consid-
The quality control of urodynamic measurements must be ering the biomechanical context of the measurements (level b),
approached on a holistic basis. Di¡erent types and levels of data and without taking into account the physical properties of the

Fig. 6. The first part of the traces shows typical bi-phasic movement artifacts. The two coughs before
voiding prove good recording quality. The typical picture of a unobstructed voiding: a weak detrusor
contraction with pdet of 40 cmH2O and a Qmax of 9 ml/s is supported by vigorous straining, which
causes some variability in flow (VOID: 9/380/100).

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Fig. 7. A good recording showing the typical pattern of increasing detrusor overactivity and a
dyssynergic event during voiding.

parameters, technical limitations, and accuracy of the signals. Measurement of Urine Flow Rate During
Therefore, it is recommended that: Pressure^Flow Studies

� Invasive urodynamics should not be performed without The usefulness of the concept of a FRCZ for data analysis
precise indications and well-de¢ned ‘urodynamic ques- requires that the recorded pressure and £ow rate signal be syn-
tions’ that are to be answered by the results of the urody- chronized with respect to the FRCZ [Gri⁄ths et al. 1997].
namic study. Normally, no measurable time delay will exist between

Fig. 8. High quality recordings allow detailed interpretation. The typical pattern of rectal activity
becomes clearly visible in pdet. The flow artifacts can identified as dyssynergic events and manually
corrected from Qmax.raw ¼ 11.2 ml/s to Qmax ¼ 9 ml/s.

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the intravesical pressure signal and the actual £ow at the The reference height is the level at which the transducers
FRCZ. However, a signi¢cant delay is to be expected for the must be placed so that all urodynamic pressures have the same
typical urodynamic £ow rate recorded extracorporeally. This hydrostatic component. It is often argued that it does not make
delay will vary with anatomy, pathology, £ow rate, and the a di¡erence for the most relevant parameter, pdet, if the same
set-up for measurement. Our understanding of the actual error is introduce to pves and pabd, as they tend to cancel each
dynamics of £ow rate changes is limited, and the relatively other out. This is not an acceptable argument. The hydrostatic
slow response of most £ow meters may not be su⁄cient pressure is real and important, and inevitably plays a role
to match the dynamics of the much-faster pressure signal. in any intracorporeal pressure recording. Many important
The actual time di¡erence may be from 0.5 to 2 s; the time aspects of quality and plausibility control, such as typical rest-
delay between urethral closure and the end of any £ow record- ing value ranges at di¡erent patient position, are based on the
ing may be much longer, particularly in prostatic obstruction proper recording of pressures, and will not apply if pressures
and terminal dribbling than between the opening of the are not recorded according to ICS standards. Also, it is only
urethra and the start of a £ow rate signal.Therefore, we recom- meaningful to subtract one pressure from the other, for exam-
mend the use of more descriptive terminology for synchroniz- ple (pves �pabd ¼ pdet), when both are recorded to the same
ing pressure and £ow values, such as pdet.Qbeg for the pressure reference level.
at which £ow begins instead of pdet.open, and pdet.Qend when
Pressure Transducers
£ow ends instead of pdet.close. The time delay correction
needs to be considered when analyzing pressure £ow studies Urodynamic techniques were developed using external
[Gri⁄ths et al. 1997]. pressure transducers connected to the patient with £uid-¢lled
In average, the maximum £ow rate Qmax recorded during lines, allowing easier compliance with the standards of correct
PF studies, (Qmax.p), is lower than during free £ow (Qmax). zero and reference height. Catheter mounted pressure trans-
This, however, is not due simply to a mechanical increase of ducers, so-called microtip transducer catheters have become
out£ow resistance by the intraurethral catheter, because such popular due to their apparent higher accuracy, better dynamic
a di¡erence is also found in suprapubic PF studies. A di¡er- resolution, and their apparent independence from hydrostatic
ence has also been reported between Qmax.p during con- pressure. A catheter mounted pressure transducer is an ad-
ventional and ambulatory urodynamics. This indicates more vantage for dynamic recordings of urethral pressures during
complex causes, possible psychogenic, but also physiologic, coughing (stress pro¢les) as well as for ambulatory urody-
for example, that a di¡erence in detrusor contraction strength namics in mobile patients. Here only the application of cathe-
may be involved, and that the fast ¢lling rate used in clinical ter mountedpressure transducers for intravesical and abdominal
studies may lead to reduced contractility. This could also pressure recordings will be discussed as urethral pressures are
explain the di¡erence in results between conventional and dealt with in a separate report [Lose et al., 2002].
ambulatory studies. All aspects of urodynamic pressure recording outlined in
the preceeding section are valid and independent of trans-
ducer type. It is impossible to de¢ne the precise position of
Measurement of Intravesical and Abdominal Pressure
an intravesical and a rectal catheter mounted pressure trans-
� It is recommended that there is strict adherence to the ICS ducers at to place them at any common level, and impossible
standardization of zero pressure and reference height. Only to position them at the standard level of the upper boarder of
then can pressure recordings be compared between patients the symphysis pubis. It has become popular to circumvent this
and centers. problem by setting the catheter mounted pressure transducers
to zero pressure when inside the body at the start of pressure
Zero pressure and reference height are concepts which
recording. This, however, means that both the standard zero
are often confused in urodynamics. For example, by use of
pressure as well the reference level are ignored, so that such
the misleading term ‘‘zero reference height’’. As both are
recorded pressure cannot be compared between patients or
independent features of pressure, they must be considered
centers. The fact is, the initial intravesical and abdominal
separately, and both must follow recommended ICS
resting pressures are real, are di¡erent between patients, and
methodology.
depend signi¢cantly on patient’s position. Thus, there are sig-
� Zero pressure is the surrounding atmospheric pressure. ni¢cant potential errors; by ignoring the correct atmospheric
zero pressure, an error of up to 50 cmH2O, and as the refer-
Zero pressure is the value recorded when a transducer is
ence height of the catheter mounted pressure transducers is
open to the environment when disconnected from any tubes
usually undetermined, another potential error of 10 cmH2O
or catheters, or when the open end of a connected, £uid-¢lled
is possible for a full bladder can occur. In addition, when a
tube is at the same vertical level as the transducer. Only then
study starts with zero abdominal pressure then the commonly
can a‘‘set zero’’or ‘‘balance’’ be performed.
observed abdominal pressure decrease at pelvic £oor relaxa-
� The reference height is de¢ned as the upper edge of the tion during voiding will evidently result in negative abdom-
symphysis pubis. inal pressure values, and thus in pdet being higher than pves.

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270 Sch�fer et al.

The same problems of apparent independence from the or £ow data. There are, however, data suggesting that results
existing hydrostatic pressure also applies to air-¢lled catheters from a single study may be misleading. A double lumen cathe-
and/or connection tubings. Due to the absence of a water col- ter facilitates a second ¢ll/void study to establish reproducibil-
umn between the balloon-covered opening on the catheter ity. Re-introduction of the separate ¢lling tube for a repeated
and the external transducer, the reference height in an air- study is more invasive and complicated.
¢lled system will refer to the position of the sensing balloon
� The use of a rectal balloon catheter is recommended for the
on the catheter and not to the external transducer.
measurement of abdominal pressure, pabd.
� It is recommended that for intravesical and abdominal pres- Although there are various methods for the successful
sure recording external transducers connected to £uid- recording of abdominal pressures, a £accid, air-free balloon
¢lled tubings and catheters be used. If microtip or air-¢lled in the rectal ampulla gives a suitable signal for pabd to deter-
catheters are used, any deviation from standard zero and mine a meaningful pdet when pves is measured synchronously
reference level should be minimized and taken into account (pdet ¼ pves �pabd). In females, vaginal recording may be more
at the time of data analysis. acceptable and provides comparable results. The recording of
pabd allows the measurement of any abdominal (i.e., perivesi-
cal) pressure component during changes in intravesical pres-
Urodynamic Catheters
sure.The role of the balloon is to maintain a small £uid volume
Comparison between patients and urodynamic studies per- at the catheter opening and to avoid fecal blockage, which can
formed in di¡erent centers would be facilitated by the use of prevent or impair pressure transmission to the transducer.
standard catheters. It is recommended that: Additionally, as the rectal ampulla and the vagina are not
homogeneously £uid ¢lled spaces, the balloon prevents pres-
� For the measurement of intravesical pressure and for blad-
sure artifacts arising from contact between the catheter open-
der ¢lling, the standard catheter for routine urodynamics is
ing and the wall tissue. The balloon serves this function best
a transurethral double-lumen catheter.
when it is ¢lled only to 10^20% of its unstretched capacity.
Only in small children and patients with severe constrictive Over¢lling and elastic distention of the balloon is the most
obstruction (stricture) does suprapubic pressure recording common mistake in abdominal pressure recording. The resul-
have clear advantages. Intraurethral catheters should be as tant high balloon (not abdominal) pressure will produce a
thin as possible, limited only by the practicality of insertion misleading pressure reading. Such an arti¢cially-elevated bal-
and by internal lumen sizes, which should be su⁄ciently large loon distention pressure can be avoided by making a small
to avoid excessive damping of pressure transmission and to hole in the balloon, although this is unnecessary if the balloon
achieve the desired ¢lling rate with standard pumps. A 6-Fr is ¢lled properly as described above. It is also possible to
double lumen catheter is the smallest practical size at present. record reliable abdominal pressure with a very slowly per-
The major advantage of a double lumen catheter is that fused (<2 ml/min) open ended catheter. However, excessive
the ¢ll/void sequence can be repeated without the need for £uid volume in the rectal ampulla may cause problems.
re-catheterization. Note that the use of a 6-Fr double lumen
catheter can limit the infusion rate during cystometry to
Equipment: Minimum Requirements for Filling Cystometry
20^30 ml/min, as a typical roller pump may not manage to
and Pressure^Flow Studies of Voiding
transport a higher perfusion rate through such a small lumen.
This can result in a incorrect ¢lling volume being indicated by The ICS has not yet speci¢ed de¢nite technical standards in
the machine, when the ¢lling volume is calculated from the respect of minimum requirements for ¢lling cystometry and
pump setting. For example, with a ¢lling rate set at 60 ml/ pressure £ow studies beyond the ICS Technical Equipment
min and an actually achieved ¢lling rate of 30 ml/min, the Report [Rowan et al. 1997] and the appendix to the ICS docu-
machine will show double the ¢lling volume. Thus after void- ment on pressure £ow [Gri⁄ths et al., 1997], where an data
ing, a high calculated residual will occur. With some equip- exchange software standard is recommended. Some further
ment, higher ¢lling rates are possible; it is essential that any aspects will be discussed in more detail here.
system should be critically tested to (a) measure the maximum
¢lling rate that can be achieved by a particular catheter Equipment Recommendations
attached to an individual pump and (b) correct or calibrate
The minimum recommended requirements for a urody-
the indicated infused volume.
namic system are:
The use of two separate tubes for ¢lling and recording is
less convenient. Removing the larger ¢lling tube for voiding � three measurement channels, two for pressure and one for
may appear to be an advantage because only a single small £ow;
tube is left in the urethra. However, there are no data to sug- � a display (on printer and/or monitor) and secure storage of
gest that, for example, in a compressive obstruction such as three pressures (pabd, pves, pdet,) and £ow (Q) as tracings
BPO, a 6-F catheter has detrimental in£uence on the pressure against time;

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 infused volume and voided volume may be shown graphi- For a print-out, maximum full scale de£ections of
cally or numerically; 200 cmH2O, 50 ml/s, and 1,000 ml are su⁄cient for pressure,
 on-line display of pressures and £ow, with adequate scale £ow and volume, respectively. In most cases, half the maxi-
and resolution; scales must be clearly given on all axes; no mum full scale will be su⁄cient to show all relevant parts of
information should be lost electronically when tracings go curves. Line resolution should be better than 0.10 mm.
o¡-scale on display; During interventions, for example, interruption of bladder
 possibilities to record standard information about sensa- ¢lling or manipulation of catheters, the continuation of both
tion and additional comments (event recording). measurement and recording must always be possible.
On-line recording of comments should be possible, to com-
Meaningful plausibility assessment and quality control is plete the documentation.
possible only when the measured and derived signals are dis-
played continuously as curves over time, without delay (in real
time), as the examination proceeds. Each displayed curve and Calibration of Equipment
number should be labeled according to ICS standards with The need to calibrate pressure transducers, £owmeters, and
clear scaling of amplitudes and the time axis. The following pumps cannot be stated; simply ‘‘yes’’ if there is a need or ‘‘no’’
sequential position of tracings is suggested: pabd at the top, there is not. The speci¢cation of the manufacturer should be
then pves, pdet and Q (see Figs. 3^8 ). It is least important when studied. Two aspects must be considered: the intended accu-
pabd goes o¡-scale and is cut o¡ (Fig. 6). Additional parameters racy of the system and the investigator’s experience with the
such as EMG, bladder ¢lling, and voided volumes can be dis- system. If a new system is installed or new transducers are
played either as curves or digitally as numbers. being used, it is recommended that regular calibration be car-
The following minimum technical speci¢cations are ried out. If experience with daily calibration shows that the
recommended: potential error is small (e.g., <2 cmH2O), then it will be su⁄-
cient to calibrate once a month. However, calibration should
 Minimum accuracy should be  1 cmH2O for pressure not be ignored and good urodynamic equipment makes it
and  5% full scale for £ow and volume; technically possible to perform a calibration. Calibration
 Ranges of 0^250 cmH2O, 0^25(50) ml/s, and 1,000 ml for should not be confused with simple ‘zero balancing’, which is
pressure, £ow, and volume, respectively; only one part of a calibration. In addition to setting the zero, it
 The software must ensure that no information for pressures must possible to check and adjust the amplitudes of all mea-
up to 250 cmH2O and for £ow rates up to 50 ml/s is lost surement channels, i.e., to calibrate all signals.
internally even when not displayed and that o¡-scale values Calibration of a £owmeter can be achieved by pouring a
are clearly identi¢ed; precisely measured volume at a constant £ow into the £ow-
 An analog/digital (A/D) frequency of 10 Hz per channel as meter, typically 400 ml in 20^30 s (at 15^20 ml/s) and check-
the lower limit for pressure and £ow; ing the recorded volume. Special constant-£owrate bottles are
 A higher frequency (minimum 20 kHz) is necessary for available for £ow calibration. Similarly, one can test a pump by
recording EMG; measuring the time to deliver a known volume, for example,
 Calibration of all measurements should be possible. 100 ml into a measuring cylinder. It is recommended that
The scalings should be kept unchanged as much as possible, pump calibration be performed with the ¢lling catheter con-
because urodynamic data quality control is based on pattern nected. Such a pump calibration can only be as good as the
recognition, and the recognition of patterns depend on scal- cylinder used, which needs to have good resolution and be
ing. Therefore, it is recommended that: accurate. Some measuring beakers that are usually available
in clinics are not accurate.
 During recording and for analysis, minimum scaling for
pressure be of 50 cmH2O per cm, for £ow 10 ml/s per cm, Pressure Signal Quality Control: Qualitative
and for the time axis 1 min/cm or 5 s/mm during ¢lling and and Quantitative Plausibility
2 s/mm during voiding.
It is very important to observe and to test signals carefully
To enable a retrospective judgment of the curves, urody- and to correct any problems before starting the urodynamic
namic measurements should be documented as curves over study. If the signals are perfect at the beginning of the study,
time with comments and explanations. It is usually insuf- they usually remain so without the need for major interven-
¢cient to document urodynamic measurements by a few tion. If the signals are not perfect, remedial action must be
numerical values alone. The same amplitude of scaling should taken. If a quality problem does not disappear at once, when
be used for all documentation, although the time axis may be ¢lling commences, it will usually deteriorate further during
compressed. Only if there is no relevant information to be lost the study.
by reducing resolution, for example, during ¢lling, the time Conscientious observation of the patient and of the signals,
scale can be compressed. in particular pdet, during all parts of the study, together with

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272 Sch�fer et al.

continuous signal testing, are the keys to high quality urody- a nonphysiological cause, such as catheter movement, should
namics. The ¢rst aim is to avoid artifacts and the second to be considered.
correct the source of all artifacts immediately when they If a sudden drop or increase occurs in either the pves or pabd
occur. signal, the usual cause is the movement, blockage (Fig. 4), or
The following three criteria form the minimum recommen- disconnection of a catheter. When the patient changes posi-
dations for ensuring quality control of pressure recordings: tion, sudden changes in resting values occur and are seen
equally in both pressure signals. If pves (without change in
 Resting values for abdominal, intravesical, and detrusor
pabd) increases slowly�as typical for a low compliance blad-
pressure are in a typical range (see below);
der�it is important to test for any other possible cause for a
 The abdominal and intravesical pressure signals are‘live’, with
slow pressure increase. One cause could be a problem with the
minor variations caused by breathing or talking being similar
intravesical catheter measurement, for example, the hole for
for both signals; these variations should not appear in pdet;
the pressure conducting lumen is slowly moving into the blad-
 Coughs are used (every I min. or, for example, 50 ml ¢lled
der neck region. This should be assessed by asking the patient
volume) to ensure that the abdominal and intravesical pres-
to cough, if there is no other apparent artifact. Furthermore, it
sure signals respond equally. Coughs immediately before
is recommended that bladder ¢lling is stopped, if the ¢lling
voiding and immediately after voiding should be included.
rate was above a physiological limit of 10 ml/min. If the value
When standards are followed, i.e., with the transducer zeros of pves drops after ¢lling is stopped, it is likely that ‘low com-
set to atmospheric pressure, and the transducers placed at the pliance’ was, at least in part, related to fast ¢lling.
level of the upper edge of the symphysis, a typical range for There are several common problems that must be solved
initial resting pressures values for pves and pabd is (Sch�fer, before the study is started or when observed during a study:
unpublished communications): Problem: Initial resting pdet is negative, for example,
5 cmH2O Possible explanations:
^ supine 5^20 cmH2O.
^ sitting 15^40 cmH2O.  because pabd is too high
^ standing 30^50 cmH2O.
Solution: If pves is in the typical range, and both pressures are
Usually both recorded pressures are almost identical, so ‘live’, open the valve in the abdominal line and drain 1 or 2
that the initial pdet is zero, or close to zero, 0^6 cmH2O in drops from the rectal balloon ¢lling volume. This will
80% of cases and in rare cases up to 10 cmH2O [Liao et al., usually cause pabd to fall to a proper value. If not, gently re-
1999]. position the rectal balloon and/or make a small hole in the
All initial pressure values should be veri¢ed and patients’ balloon.
position should be documented on the urodynamics trace.
 because pves is too low
All negative pressure values, except when caused by rectal
activity, should be corrected immediately. It should always be Solution: This may be due to air bubbles trapped in the cathe-
kept in mind that pabd is recorded not to know the actual rec- ter, the catheter not being in the bladder, or the catheter
tal pressure, but to eliminate the impact of (abdominal) pres- being blocked/kinked. Gently £ush through the pves line
sure changes on pves. The principal aim is to determine the (max.10 ml). It is very important to £ush slowly while obser-
detrusor pressure, pdet, which is the pressure in the bladder ving the pressure signal because pressures above 300 cmH2O
without the in£uence of abdominal pressure. Therefore, pdet may damage the transducer. If this does not solve the pro-
cannot be negative. blem, add some more volume to the bladder via the ¢lling
By talking to the patient during the study, the proper lumen. If resistance to ¢lling is high and it does not drain
dynamic response in the pressure signals can be observed easily when opened, it will be necessary to check catheter
and is ‘‘automatically’’documented (see Figs. 3, 4, 8). position, and to re-position the catheter, if necessary.
Problem: Initial pdet too high, for example,15 cmH 2O
Problem Solving Possible explanations:
If either detrusor or rectal contractions occur, the recorded The key problem here is indicated by the measurement of
pressures in pves and in pabd will be di¡erent. Such changes can 15 cmH2O. The situation is di¡erent from the clear state-
be identi¢ed and interpreted with su⁄cient accuracy and ment that ‘pdet cannot be negative’, as we do not have a de¢-
reliability only when the patient is observed and the relation nite upper limit for the normal maximum ‘resting’ value for
between signal changes and patient sensation/activity are pdet . Thus, we can only follow the present guidelines that in
checked for plausibility and documented. Any pressure most tests, in an empty bladder pdet is between 0^5 cmH 2O,
change caused by smooth muscle contractions will show a and in some 90% it is between 0^10 cmH2O. For any higher
‘‘smooth’’ pattern, (Figs. 5, 7, 8) i.e., there should be no rapid value, stringent plausibility checking must be applied. If the
(‘‘stepwise’’) changes (Fig. 4). If pressures increase or decrease patient has no detrusor overactivity, a pdet of 15 cmH2O is
step-wise, or with a constant slope over a long period of time, unlikely to be valid and there may be a signal problem. First

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check, if pabd and pves are in the expected ranges. For exam- A typical physiological artifact that can be easily recog-
ple, if in a standing patient, initial pves is 30 cmH2O and nized is a rectal contraction. Rectal contractions are usually
pabd is15 cmH2O, then by experience the value of pabd is too of low amplitude and may or may not be felt by the patient
low (because pabd is too low). If in a supine patient pabd is10 (Fig. 8). The value of pabd shows a phasic rise with no change
cmH 2O and pves is 25 cmH 2O, then the value of pves is too in the pdet signal�a potentially confusing fall in pdet results
high (because pves is too high). Check the zero balance and from the electronic subtraction, but this is, of course, an arte-
proper signal response to coughing for both signals. fact. Usually rectal contractions are relevant only because they
 because pabd is too low may be misinterpreted as detrusor overactivity (Fig. 8): they
Solution to pabd being too low: Very slowly £ush the rectal have no relevance to voiding.
balloon with1 or 2 ml. Biphasic spikes as a response to cough tests are another
 because pves is too high. example of artifacts that are easy to correct. However, any
Solution to pves being too high: This problem can be related other artifacts such as a signal which is nonresponding (dead),
to a misplaced catheter, a kink in the catheter, or contact has stepwise changes in pressure, or has negative pressures,
with the bladder wall in an empty bladder, which occludes often cannot be corrected or can be corrected only with a lot
the eyehole(s) of the catheter. Proceed according to the solu- of speculation about the underlying causes of the problem.
tion for pves being too high, in the ¢rst example above. Studies with such artefacts, should be repeated see the next
section).
If no signal problem can be identi¢ed, the clinical study may
Retrospective corrections require the same strategies for
be started, but the pdet signal deserves particular attention. If
plausibility control as during recording, but then they are
compliance is normal and the bladder normal at ¢lling, then
much more di⁄cult and less successful to perform.
it is very important to record and check, for some period after
A few common artifacts (e.g., rectal activity, biphasic spikes
the micturition, the post-voiding resting value of pdet . Only if
at cough tests, or insu⁄cient pabd response during straining)
an elevated pdet is perfectly reproducible for repeated ¢lling
can be accepted during the study as they can be corrected
and voiding studies can it be accepted. However, it is most
retrospectively. Usually, this is easier to do manually than
likely that a high resting pdet will not be reproducible and will
through a computerized system.
be corrected by the measures described above.
In summary, if any resting value or cough response does not ¢t
Urodynamic Computer Software
the usual values or patterns, it should be corrected before blad-
der ¢lling is started. If this is not possible, the signals must be Computer applications should allow the easy use of even
observed even more carefully and every e¡ort made to reveal the most complicated analytical algorithms. However, most
the potential source of error or artifact during the study. of the software o¡ered by the urodynamic equipment industry
is neither original nor validated. The software may, in fact, not
do what the original developer(s) of the algorithm intended.
Therefore, it is recommended that:
Retrospective Artifact Correction
In principle, a good pdet signal requires only that pves and  When analytical urodynamic software is used to perform
pabd show the same ¢ne structure and quality of signals before data analysis according to any published concept, the
¢lling, during ¢lling, and after a voiding. (Figs. 3, 4, 7, 8) Both source of the software should be speci¢ed. It should also
pves and pabd must have the same zero and reference level. The be clearly stated if the software has been validated, i.e.,
most common mistake is to set (balance) the initial pressure proven to provide results consistent with the algorithms
values of pves and pabd to zero with the catheters connected to to which the analyses are attributed.
the patient instead of setting zero to atmospheric pressure.
This results in incorrect pves and pabd. If this is done, uro-
dynamic studies cannot be compared between centers and STRATEGY FOR REPETITION OF
between patients. Although it may seem convenient and easy URODYNAMIC TESTS
to start with a value of pdet as zero, this practice will lead to  It is recommended that a urodynamic test should be
problems later in the test. As soon as pelvic £oor relaxation repeated if the initial test suggests an abnormality, leaves
occurs, which is particularly common during voiding, the the cause of troublesome lower urinary tract symptoms
value of pabd, if starting at zero, becomes negative.With a nega- unresolved, or if there are technical problems preventing
tive pabd, pdet will be higher than pves, a conceptually meaning- proper analysis.
less result. Furthermore, it will then be impossible to correct a
negative pabd. Cough tests at regular intervals, particularly It may not be necessary, however, to repeat a study, which
before voiding and after voiding, document the dynamic beyond any doubt, con¢rms the expected pathology, for exam-
response of the pressure channels and are fundamentally ple, detrusor overactivity which correlates with the patient’s
important. symptoms. However, if the study is inconclusive, then the

Good Urodynamic Practices: Uro£owmetry, Filling Cystometry, and Pressure-Flow Studies

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International Continence Society Guidelines on Urodynamic Equipment Performance

274 Sch�fer et al.

consequences of not ¢nding a clear answer to the urodynamic CONCLUSIONS

question(s) should be considered. If an invasive therapy is
This is the ¢rst report of the ICS Standardization commit-
planned, the urodynamics should be repeated. Therefore, it is
tee of Good Urodynamic Practice. The authors are well aware
necessary to analyze the signals during the study and docu-
that this is just a ¢rst step and many more will have to follow.
ment the study immediately upon its conclusion. Only then
Only the essential aspects are considered, but if these basic
is it possible to be sure that the urodynamic study is of a qual-
standards are followed, the quality of urodynamic studies will
ity that answers the urodynamic question and provides an
be signi¢cantly improved.
understanding about the patient’s clinical problem. Therefore,
it is recommended that:
ACKNOWLEDGMENTS
 The urodynamic ¢ndings and the interpretation of the The Standardisation Committee is grateful for the exten-
results should be documented immediately after the sive editing performed by Vicky Rees, ICS Administrator.
study is ¢nished, i.e., before the patient has left the urody- The committee is also grateful for the detailed comments
namic laboratory. Doing so allows for a second test if received from Linda Cardozo, Paul Dudgeon, Guus Kramer,
required. Joseph Macaluso, GerryTimm, and AlanWein.

The analysis of a good study is easy and straight-forward. REFERENCES

Indeed, an easy analysis actually is the key criterion for good
urodynamics. A good study is one that is easy to read and one Gri⁄ths DJ, H˛fner K, van Mastrigt R, Rollema HJ, Spangberg A,
Gleason DM. 1997. Standardization of terminology of lower urinary
from which a any experienced urodynamicist will abstract the tract function: pressure-£ow studies of voiding, urethral resistance, and
same results and come to the same conclusions. For computer- urethral obstruction. Neurourol Urodyn 16:1^18.
ized analyses, high data quality is even more important than Liao L, Kirshner-Hermanns R, Sch�fer W. 1999. Urodynamic quality control:
for manual graphical data analysis. E¡orts to achieve urody- quantitative plausibility control with typical value ranges. Neurourol
namic data of high quality during the study will produce great Urodyn 18(abstract 99a):365^366.
Lose G, Gri⁄ths DJ, Hosker G, Kulseng-Hansen S, Perucchini D, Sch�fer W,
bene¢ts at the time of data analysis.The future development of Thind P,Versi E. 2002. Standardisation of urethral pressure measurement:
urodynamic equipment and software should force investiga- Report of the sub-committee of the International Continence Society.
tors to conduct proper on-line data quality control. Analysis Neurourol Urodyn 21:258^60.
of ambulatory studies will remain problematic, as it is less easy Rowan D, James DE, Kramer AEJL, Sterling AM, Suhel PF. 1987. Urody-
to conduct on-line assessment of quality, and analysis is time namic equipment: technical aspects. J Med Eng Tech 11:57^64.
van Waalwijk E, Anders K, Khullar V, Kulseng-Hanssen S, Pesce F,
consuming. Hence, it will be necessary to ask the patient to Robertson A, Rosario D, Sch�fer W. 2000. Standardisation of ambulatory
return, on another occasion, should the investigation require urodynamic monitoring: Report of the standardisation sub-committee of
repeating, for whatever reason. the International Continence Society. Neurourol Urodyn 19:113^125.

ICS Standards 2019

1. ICS Standardisations
 201

Neurourology and Urodynamics

International Continence Society Guidelines on

Urodynamic Equipment Performance
Andrew Gammie,1* Becky Clarkson,2 Chris Constantinou,3 Margot Damaser,4 Michael Drinnan,5
Geert Geleijnse,6 Derek Griffiths,2 Peter Rosier,7 Werner Scha
€fer,2 Ron Van Mastrigt,6
(The International Continence Society Urodynamic Equipment Working Group)
1
Bristol Urological Institute, Southmead Hospital, Bristol, United Kingdom
2
Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, USA
3
Department of Urology, Stanford University School of Medicine, Stanford, USA
4
Department of Biomedical Engineering, Cleveland Clinic, Cleveland, USA
5
Department of Medical Physics, Freeman Hospital, Newcastle upon Tyne, United Kingdom
6
Department of Urology, Erasmus Medical Centre, Rotterdam, The Netherlands
7
Department of Urology, University Medical Centre, Utrecht, The Netherlands

These guidelines provide benchmarks for the performance of urodynamic equipment, and have been developed by the
International Continence Society to assist purchasing decisions, design requirements, and performance checks. The
guidelines suggest ranges of specification for uroflowmetry, volume, pressure, and EMG measurement, along with
recommendations for user interfaces and performance tests. Factors affecting measurement relating to the different
technologies used are also described. Summary tables of essential and desirable features are included for ease of
reference. It is emphasized that these guidelines can only contribute to good urodynamics if equipment is used properly, in
accordance with good practice. Neurourol. Urodynam. # 2014 Wiley Periodicals, Inc.

Key words: urodynamics; specification; standardization

INTRODUCTION workshop during the ICS meeting in Barcelona, Spain in

August 2013.
The International Continence Society (ICS) published a report
The guideline contains the following sections, which include
on urodynamic equipment in 1987.1 Since then, technology has
clinical requirements, measurement technologies and calibra-
changed dramatically, particularly in the application of
tion techniques for each parameter. There are also tables for
computers to urodynamics. There is now the possibility that
system requirements (features necessary for valid urodynamic
measurement accuracy may exceed clinical need, while new
measurements) and recommendations (features supportive of
technologies being introduced to the market need benchmarks
good practice).
for assessment of their utility.
This article, developed under the auspices of the ICS
Standardization Steering Committee, aims to:  Uroflowmetry and voided volume.
 Infused volume.
 Pressure measurement (with special considerations of each
 Summarize clinical performance requirements for urody-
parameter measured).
namic equipment.
 EMG.
 Relate these to specification and feature requirements.
 User interface (recording, display and analysis).
 Develop technical specification ranges or limits from these
 Standardized performance tests.
requirements.
 Comment on different measurement technologies with
respect to limitations and artefacts. The ICS emphasizes that these guidelines can only contribute
 Propose a set of tests/requirements for assessment of to good urodynamics if equipment is used properly. For that
systems. reason, they should not be assumed to be sufficient in isolation,

The readership is intended to be purchasers (to check features

are actually necessary), designers (to state what is clinically
Conflict of interest: Mr Gammie – trial sponsor: T-Doc; research grant: MMS,
required) and users (to check that equipment is actually Laborie, Mediwatch, Albyn, Andromeda, Digitimer. Dr Clarkson – none. Prof
performing). Included, therefore, are technical details, summa- Constantinou - none. Dr Damaser – consultant and research grants: T-Doc. Dr
ry lists and some basic descriptions. Drinnan – royalties: Mediplus. Dr Geleijnse – none. Dr Griffiths – consultant:
This document was developed according to the published Laborie, Ethicon. director: Griffiths Gonsulting Dr Rosier – consultant: MMS,
Andromeda, T-Doc, Wellspect. Prof Sch€ afer – none. Prof van Mastrigt – none.
methodology of the International Continence Society Stan- Christopher Chapple led the peer-review process as the Associate Editor
dardization Steering Committee.2 The group commissioned for responsible for the paper.
this report developed an outline of proposed content and 
Correspondence to: International Continence Society, 19 Portland Square, Bristol
revised this in the light of a workshop held at the ICS Annual BS2 8SJ, United Kingdom.
Received 27 November 2013; Accepted 28 November 2013
Scientific Meeting in Glasgow, UK in August 2011. The Published online in Wiley Online Library
subsequent text was reviewed by manufacturers of urody- (wileyonlinelibrary.com).
namic equipment before a final draft was discussed at a DOI 10.1002/nau.22546

# 2014 Wiley Periodicals, Inc.

International Continence Society Guidelines on Urodynamic Equipment Performance

202

2 Gammie et al.
but only alongside training and practice carried out according TABLE II. Desirable Features of Uroflowmetry Equipment
to the ICS Good Urodynamic Practices document.3
The basic requirement of a standard urodynamic system is Documentation should state the minimum recordable volume change or
that it is able to measure at least two simultaneous pressures flow rate
and, in real time, calculate detrusor pressure, defined as the Equipment should allow the user to set the expected density of voided fluid
simultaneous difference between intravesical and abdominal Equipment with load cells should not be damaged by loads less than 5 kg
pressures. Furthermore a standard urodynamic system is Equipment should allow the user to reset the volume recorded to zero
usually capable of measuring the flow rate of the voided between voids during a test
Documentation should clearly state what filtering or integration is used in
volume and regulating the rate of fluid infusion. In practice
signal processing
there are a number of other measurements, depending on the
Equipment should display the delay value used when synchronizing urine
clinical demands and the urodynamic investigation being flow with pressure signals, preferably allowing modification of the value
carried out, including urethral pressure or electromyography An adjustable height urine collection funnel is recommended
(EMG). Simultaneous recording of pressure measurements with In order to reduce flow artefacts, good delivery of the urine stream to the
imaging can be required. Other measurements, such as bladder meter is recommended
wall thickness, detrusor perfusion, and sound recording are also
being researched. This document, however, is limited to
equipment performance for the measurement and recording
of flow, volume, pressure and EMG only. TABLE III. Essential Requirements for Filling Volume Measurement
When new urodynamic equipment appears on the market, it
Parameter Guideline value
is recommended that its function is tested with specific
equipment in specialized centers. Such tests are described in
the section Recommendations for Standardized Performance Accuracy The greater of 1–5% of true value
or 1 ml/min
Tests. All urodynamic equipment should be calibrated and its
Range 0–1,000 ml
performance should be tested with procedures that can be Range of rate of infusion 0–100 ml/min, adjustable during
carried out by simple means that are readily available. These filling
tests are described in the relevant sections below. When in use, Sample rate of volume measurement 2 Hz
correct calibration of the equipment should be verified
regularly.
Registering minimum flow. It is important that a flowmeter
UROFLOWMETRY AND VOIDED VOLUME (see Tables I and II)
registers clinically relevant low flow rates, for instance in the
case of severe bladder outlet obstruction or terminal dribble.
Not registering low flow rates may fail to trigger the autostart
Clinical Requirements or terminate the reading prematurely resulting in inaccurate
volume measurement and an incomplete clinical picture
Accuracy. The accuracy of flow measurement must be (especially in the case of uroflowmetry carried out alone).
sufficient to capture physiological variation. We suggest Flowmeters would be expected to measure at least down to the
equipment should be twice as accurate as test-retest variation lowest level of accuracy, that is, a flow of 1 ml/sec. It is not
in individual subjects as a minimum. Studies which have essential that flowmeters should measure slower urine loss
measured test-retest variation have found differences of 1.4– than this, for example as may occur during leakage, but the
3.3 ml/sec.6,7 Accuracy should therefore be approximately minimum recordable volume change or flow rate should be
1 ml/sec for flow measurement over the clinically important documented.
range. In voided volume there should be a resolution of 2 ml or
Frequency response. Flow is the result of relatively slow
less in order to register leakage, while  3% error from true value
detrusor muscle contractions. The risetime constant of isomet-
is acceptable (range taken from market survey carried out by
ric contractions of strips of bladder muscle is in the order of
authors). This accuracy value must incorporate all variations due
2 sec9 and that of isovolumetric bladder contractions in
to hysteresis, linearity and temperature between 10 and 408C.
patients is comparable.10 Therefore the upper limit of the
Range. The range of flow measurement necessary is 0–50 ml/ bandwidth of a flow measurement system (to 3 dB) need not
sec, with a volume range of 0–1,000 ml.1 Accuracy should be be higher than 0.1 Hz and a sampling rate of 0.2 Hz should be
maintained over this range. The expected clinical range for adequate to record urine flow rate. However, a higher sampling
voiding time is between 14 and 54 sec,8 while gaps between rate would be desirable to allow the more common artefacts to
flows in the same void can occur. Equipment documentation be represented and recognized3 and a measurement bandwidth
should thus state after what time interval it automatically from zero to between 1 and 5 Hz is recommended.
stops recording and should allow for flows at least 120 sec long.

Measurement Technologies
TABLE I. Essential Requirements for Uroflowmetry
Flow and voided volume information are interdependent, as
Parameter Guideline value one is normally calculated from the other. Currently, load cell

Accuracy for flow rate 1 ml/sec

TABLE IV. Desirable Features of Filling Volume Measurement
Accuracy for voided volume The greater of 3% of
true value or 2 ml
Range for flow rate 0–50 ml/sec Equipment should allow the user to calibrate infusion rate and/or filled
Range for voided volume 0–1,000 ml volume
Maximum duration of flow recordable 120 sec Equipment should alert the user to infusion tube or pump blockage
Minimum flow recordable 1 ml/sec Systems measuring filled volume using a load cell should allow the user to
Bandwidth of flow measurement 0 to between 1 and 5 Hz set fluid density and to set filled volume when changing containers

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ICS Guidelines on Urodynamic Equipment Performance 3

(gravimetric) or rotating disc technologies are commonly used. constructed constant flow bottle to verify the flow rate
The dipstick method of measuring flow uses a capacitive reading.13
technique to measure urine depth in the collecting vessel.1 If frequent recalibration is necessary, the flow transducer
However, although technically validated, no reports about its might need to be replaced. The effort and time involved for
use and reliability in clinical practice have been published. Drop regular verification should be balanced with the risk that all the
spectrometry,11 which determines flow by counting the rate of flow rate values measured since the previous verification test
drops of urine leaving the meatus, was technically too are incorrect. Verifying calibration may also be necessary after
demanding and clinically unreliable.5 We therefore describe calibration, since in some equipment the process of calibration
only the load cell and the spinning disc methods. can alter the zero reading. In these cases it may be necessary to
The load cell flowmeter. Load cell (or gravimetric) flow meter repeat the calibration cycle several times in a series of
technology is used by the majority of commercial flow successive and increasingly accurate approximations.
meters,12 and measures the weight of the fluid during voiding.
Knowing the density of the fluid enables volume to be Uroflow and Voided Volume Artefacts
calculated, while flow is rate of change of volume. The
weighing scale should be in a horizontal position for reliable Liquid density error (load cell and spinning disk). The volume
measurement, which is a potential problem when the flow rate is calculated by assuming the density of urine is
equipment is fixed to a urodynamic chair or videourodynamic approximately 1 g/ml. If using a denser contrast medium or if
unit. In practice, a load cell is more vulnerable to errors in its the patient is particularly dehydrated, the indicated flow rate
zero point than its sensitivity, and damage normally manifests will be proportionally high. A prompt or display of liquid
as a fixed offset in voided volume. For this reason, and because density setting, and the capacity for the user to change this, is
it is not always convenient to empty the flowmeter between recommended.
voids, a ‘‘Set zero volume’’ function should be available. Momentum artefact (load cell). The stream of urine has
Equipment should use load cells that will not be damaged by momentum that is registered as a force by a load cell. This is
loads less than 5 kg. indicated as an abrupt change in volume and a brief surge at the
The spinning disk flowmeter. In a spinning disk or momen- start of flow. The size of the effect will depend on the amount
tum-flux flowmeter, the urine stream falls on a rapidly and velocity of urine hitting the load cell, the resultant
spinning disk and the flow rate is measured by the power movement of liquid in the jug, and the filtering in the
needed to keep the rotation speed constant. The spinning disk electronics. Momentum artefact can be reduced, for example
flowmeter thus measures mass flow; as with the load cell, the by fitting a baffle and by a funnel spout that reaches into the
density of the fluid is required in order to calculate volume flow. jug. These slow the urine flow at the impact with the load cell,
Volume voided is calculated by integration of the flow rate. The but cause a time delay in the flowmeter.
design of these flowmeters must allow effective cleaning. Low flow (spinning disk). In spinning disk flowmeters, flow is
measured and integrated to give volume. Integration is
Flow Signal Conditioning and Processing sensitive to small input offsets that are equivalent to a low
but constant flow into the device. These small input offsets
Urine flow is not continuous; by the time the stream reaches must be identified and rejected. The corollary is that the signal
the meter, it has broken into a series of droplets. Therefore a produced by very low urine flow rates can be missed, and this
stage of low-pass filtering typically with a cut-off frequency of can be a clinically important effect, masking a long, dribbling
1 Hz is added (market survey carried out by authors). flow. See the section Registering minimum flow for
Equipment documentation should therefore clearly state recommendations.
what filtering or integration is used, and guide the user as to Time delay (all designs). There is inevitably a delay between a
the effects of this filtering on the display of flow parameters. change in bladder pressure and the corresponding change in
flow rate being detected. This is caused by mechanical delays
Calibration of Flowmeters due to urethral compliance and due to the urine flowing down
into the flow sensor, particularly when the collection funnel is
Calibration. Empty the flowmeter. Set volume to zero and dry. The low-pass filter in the flow meter electronics will
fluid density to one on the recording device. Pour a known introduce a further delay. A total delay of 0.4–0.6 sec has been
volume of water, of the order of 300 ml, into the flowmeter at an shown to be normal.14 This delay is of no importance for plain
approximately constant flow rate of 15 ml/sec. For a spinning uroflowmetry, but is relevant when synchronous pressure
disk flowmeter, pour it at the funnel wall, not directly on measurements are made during voiding cystometry. Systems
the disk. Set the recording device to register the known should display the delay value to the user, and possibly allow
volume. On a load cell flowmeter the process can equally well modification.
be carried out using a known weight instead of a known
volume of water.
FILLED (INFUSED) VOLUME (see Tables III and IV)
Verifying calibration. The calibration of the flow measure-
ment system should be verified regularly, for example, once This section clearly does not apply to ambulatory urody-
every 10 urodynamic measurements. This may be done by namic equipment, where natural filling occurs during the test.
applying the appropriate calibration procedure as described
above, but rather than setting the recording device to the Clinical Requirements
known volume, the volume reading is verified. If the reading is
more than 20 ml different from the poured volume, recalibra- Accuracy. Measurement of infused volume should be accurate
tion of the system is recommended. to within 5%.3 Accuracy of greater than 1% is unlikely to be
An alternative, easy method to verify calibration is to pour clinically useful. However, for very low filling rates, for instance
the urine that is collected in the flowmeter into a measuring in children or in urethral pressure profiles, accuracy to only
beaker and check the volume. Another method uses an easily 1 ml/min will be required. These accuracy values must

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4 Gammie et al.

incorporate all variations due to hysteresis, linearity and Urodynamics systems should therefore have some means to
temperature between 10 and 408C. correct this artefact.
Range. Typically, even for repeated cystometry, the filled It is known that filling with cooled fluid can promote detrusor
volume is unlikely to be more than 1,000 ml, so the measurable contraction.17 Equipment may therefore allow warming of the
volume should be between 0 and 1,000 ml. The equipment infused fluid to body temperature, though there is no
should enable the disregarding of the weight of the bag or conclusive evidence that this significantly affects the results
bottle used for fluid. For filling rate, the ICS defines the of the cystometry. Historically, CO2 gas has been used in place
maximum physiological filling rate as body weight in kilogram of saline to fill the bladder. Simultaneous pressure measure-
divided by four, expressed as ml/min. This is routinely exceeded ments are possible but it is not possible to measure flow rate or
in clinical practice, and much lower rates are used in children. voided volume when using CO2 gas infusion.
Nevertheless it is rare that more than 100 ml/min be infused,
and faster rates will in any case be limited by catheter diameter.
MEASUREMENT OF PRESSURE (see Tables V and VI)
The filling rate is often reduced during the test if the
patient shows signs of detrusor overactivity, so the rate Pressure in urodynamic studies is conventionally measured
must be adjustable during filling. The required range is in centimeters of water (cmH2O), a unit based on the pressure
therefore 0–100 ml/min. exerted by a column of water of measured height. A unit of
Frequency response. If 100 ml/min is the maximum required cmH2O is equivalent to 98.07 Pascals (Pa), the standard unit of
filling rate, then for 5% volume accuracy a sample should be pressure.
recorded faster than every 3 sec. Considering other factors Since pressure signals are sensed, transmitted, and recorded
affecting accuracy, a frequency response of up to 1 Hz will in different forms, when quoting specifications for pressure
therefore be acceptable. measurement, values should be quoted for the entire system,
that is, transducers, catheters and processing together. The type
of catheter should be specified, for example, ‘‘measured using
Measurement Technologies 7Fr water-filled double lumen catheter’’ and ideally also the
Infused fluid is normally saline or contrast medium and the internal diameter of the pressure measurement lumen.
volume is either estimated by counting pump head revolutions
or deduced from the decrease in bag weight. The section User Clinical Requirements
Interface, Analysis and Post-Processing discusses how software
might correct for residual volume and diuresis to estimate Accuracy. The accuracy of pressure measurement must be
actual bladder volume. sufficient to capture physiological variation. We suggest
Infusion pump. The infusion pump is normally of the equipment should be twice as accurate as test–retest variation
peristaltic type where a series of rollers compress a flexible in individual subjects. Studies which have measured this have
tube to drive the saline. This is susceptible to errors due in found mean differences of 2.8 cmH2O7 and 10 cmH2O6. This
particular to variations in tube cross-section and downstream suggests systems should be accurate to between 1.5 and
resistance. Equipment should therefore allow checking and 5 cmH2O for pdet, and thus between 1 and 2.5 cmH2O for pves
calibration of infusion rate, often simply done by running the and pabd (rounding to the nearest 0.5 cmH2O). These accuracy
pumped fluid into a flowmeter. Many peristaltic pumps will values must incorporate all variations due to hysteresis,
turn even when the downstream tube is completely blocked, so linearity, and temperature between 10 and 408C, even in
equipment should register this error and alert the user. Because catheter-mounted transducers that are calibrated at room
of this potential for error, load cell measurement of infused temperature then used at body temperature.
volume is advised. Range. An acceptable range for pressure measurement would
Load cell. A load-cell arrangement measures actual infused be 0–250 cmH2O.3 In addition it is useful for water-filled
volume by weighing the infusion bag. As with the flowmeter, catheters to allow a certain amount, say 30 cmH2O, of negative
contrast medium is denser than saline and will lead to over- pressure to be registered while the patient is temporarily lower
indication of the filled volume if its density is not taken into than the level of the transducers. Certain events, such as
account. Fluid density settings must therefore apply to both flushing catheters, may apply a pressure significantly higher
voided and filled volumes alike. In the case of voided volume, than the working range (called an overload pressure) to the
the effect of mixing contrast with saline or urine should be transducer. Larger diameter syringes are safer in this regard, as
considered. Calibration is achieved by measuring known they are less likely to generate high overload pressures. It is
weights or volumes of fluid. suggested that the application of pressures up to 5,000 cmH2O
Where a load cell is used, there is a very obvious artefact must not damage the transducer or alter the calibration in the
generated when an empty fluid container is swapped for a full working range by more than 1%.
one. In terms of the unprocessed signal, the filled volume will Frequency response. Most clinically relevant pressure signal
increase by a few tens of ml as the container is removed, then changes in urodynamics occur below 3 Hz frequency, including
return to approximately zero when the new bag is fitted. the majority of the power spectrum of a cough.18 Even though a

TABLE V. Essential Requirements for Pressure Measurement

Parameter Guideline value

Accuracy The greater of 3 % of true value or 1 cmH2O

Range 30–250 cmH2O (water-filled systems) 0–250 cmH2O (other systems)
Bandwidth of pressure measurement (whole system) 0 to 3 Hz, equal on both channels
Required feature when water filled catheters are used and patient positions Equipment must allow reference levels to be reset
are changed during the test

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ICS Guidelines on Urodynamic Equipment Performance 5

TABLE VI. Desirable Features of Pressure Measurement Equipment therefore display clearly the pressure values at the start of the
test so this artefact can be taken into account.
Equipment should allow users to compare easily current pressure values Air-filled catheter and external transducer. This arrangement
with starting (baseline) pressures is similar to the water-filled system with an external
The point in time at which baseline pressures are recorded should be able to transducer, except that the catheter is filled with air, and a
be set by the user small balloon covers the opening at the end. The low density of
Equipment should allow the user to see abdominal, intravesical and air can be neglected, and the pressure is transmitted directly
detrusor pressures concurrently
from the balloon at the catheter tip to the transducer. Therefore
Equipment should record when calibration has been carried out to enable
later checks on performance and use
functionally, it is more similar to the catheter-tip transducer,
suffering from the same uncertainty in positioning the catheter
tip in the bladder or rectum. Again, therefore, it is important
that the equipment allows the user to register the pressure
cough has frequency components up to 14 Hz,19 registering the readings at the start of the test.
equal transmission of this signal by both pressure lines is There is little or no artefact due to knocking the line, but at
clinically more important than measuring its precise maxi- the expense of a slowed frequency response. Air-filled catheters
mum pressure value. To adequately register the presence of a behave like an overdamped system, which can result in a
cough signal, therefore, the bandwidth of the whole system delayed and diminished pressure response to rapidly changing
(including catheters) should be at least 3 Hz. A higher pressures.20
bandwidth, however, may allow the more common artefacts
to be represented and recognized.
Pressure Signal Conditioning and Processing

Pressure Measurement Technologies Signal conditioning would normally consist of two phases:
low-pass filtering to remove high frequency artefacts, then
In urodynamics, the pressures to be measured are in internal subtraction of pabd from pves to give pdet. The two processes are
cavities with limited access: the bladder, vagina, rectum or linear and can be applied in either order. However, the separate
stoma, or urethra. Therefore the transducer will be associated pabd and pves traces are of interest, and therefore it is beneficial
with a catheter and tubing to gain access to the measurement to filter them separately, that is, filtering before subtraction,
site. Three different transducer arrangements are in common which requires that the filters in the two channels be similar in
use, all of which require the setting of zero pressure (by frequency response.
convention to atmospheric pressure) and calibration. Only with Abdominal pressure signals such as a cough contain
external transducers and water-filled catheters, however, can components at frequencies in excess of 10 Hz, and indeed there
the reference height be consistently known, and thus pves and are some investigations, such as a cough urethral pressure
pabd repeatably and comparably measured. profile, in which a faster frequency response is required. In this
Water-filled catheter and external transducer. This is recom- case, a higher sampling rate of approximately 100 Hz would be
mended by the ICS.3 A water-filled catheter or balloon is passed required if clinical precision demands this. Note that the entire
to the measurement site, with pressure transmitted along that system must also support the higher measurement bandwidth
catheter and connecting tubing to a transducer that is external when required, which may exclude some arrangements.
to the patient. Even when set up correctly, a water-filled system
is sensitive to being tapped or jostled, but responds reasonably
Calibration of Pressure Transducers
well to fast changes in pressure.20
With a continuous column of liquid along the catheter, the During calibration two different pressures are set by
pressure at the transducer is the same as that in the body at the exposing the catheter tip or sensor to two different well
vertical level of the transducer, regardless of where the catheter defined pressures. The calibration becomes more accurate
tip is. By convention the transducer is leveled to the pubic when the pressure difference between the two pressures is
symphysis, an anatomical landmark for the bladder, and the larger (a pressure difference of at least 50 cmH2O is recom-
zero point set to atmospheric pressure. The patient can move mended). It may be necessary to go into some manufacturer-
between supine, standing and sitting during the course of a designed calibration routines or use one of the calibration
test. Urodynamics equipment using water-filled measurement devices available from some manufacturers. It is hoped that
should therefore have the facility to move the transducers publication of this document will induce manufacturers to
vertically in order to bring the transducers level with the implement adequate means for calibration and include means
symphysis pubis, if the patient is required to change position for recording when calibration has been carried out. Calibration
during the test. Alternatively, some other method of resetting routines should be available for all measurement channels.
the reference level is required. Verifying calibration. The calibration of pressure measure-
Catheter-tip transducers. With catheter-tip transducers, the ment systems should be verified regularly, for example, once
transducer is mounted in the tip of the catheter which is passed every 10 urodynamic measurements for non-disposable trans-
to the site of measurement. The pressure signal is converted to a ducers. This may be done by applying the appropriate
voltage which is then amplified. A high measurement calibration procedure as described in this section, but rather
bandwidth (fast response) can be achieved with little or no than setting zero level and the pressure reading at a defined
movement artefact using catheter-tip transducers. However height/depth, the pressure readings with the catheter at these
the transducer needs to be small, which makes it relatively levels are verified. If the pressure readings are more than
difficult and expensive to manufacture. 2 cmH2O different from the applied pressures, recalibration of
The position of the catheter tip will affect the measurement. the system is necessary. If frequent recalibration is necessary
At the top of the bladder or rectum, the measured pressure will the transducer or catheter might need to be replaced. The effort
be typically 10 cmH2O lower than at the bottom; there is no and time involved for regular verification should be balanced
easy way to correct for this positioning error. Systems should with the risk that all the pressure values measured since the

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Calibration of air-filled catheters. Mount the catheter on a

tripod (Fig. 3). Place the catheter balloon in a container and fill to
at least 50 cm above the catheter balloon. Set zero on the
recording device. Fill the balloon with air (repeatedly charging
and discharging the balloon without properly emptying will
result in a pressure rise inside the balloon and compromise the
pressure measurement). Note the height of the water level
above the balloon and set that level at the recording device.
(Note that lowering the holder and catheter into a prefilled
container will raise the water level, so measure the height with
the holder and catheter submerged).
Fig. 1. Calibration of water-filled catheter by filling the line.

Pressure Artefacts
previous verification test are incorrect. Verifying calibration Since there is redundancy in having two pressure channels,
may also be necessary after calibration since in some most artefacts in urodynamic pressure measurements can be
equipment the process of calibration can alter the zero reading. recognized and dealt with through proper quality control.
In these cases it may be necessary to repeat the calibration cycle Reference level errors. Catheter-tip transducers and air-filled
several times in a series of successive approximations. transducers will have an error due to their unknown and
Calibration of water-filled catheters with external transducers. changing height within the bladder, which is difficult to correct.
The external transducer is connected to the recording device. The same errors can occur in abdominal pressure measure-
Open both three-way valves to the outside air to make sure that ments, resulting in potentially greater error when subtracting
the transducer with air-filled dome cover is exposed to to obtain detrusor pressure. The trace display should therefore
atmospheric pressure, and set the zero level at the recording allow easy comparison of current pressure values with starting
device. Open the valves to the syringe and the line, and (referred to as ‘‘baseline’’) values, in order to allow the operator
completely fill the system with bubble-free water until the to compensate for initial pressure offset. It is not recommended
water level in the line is a defined level above the transducer, at that this offset be set to zero in software at the start of the test,
least 50 cm (Fig. 1). Set that level at the recording device. as this process changes one pressure reading from its real value.
Alternatively, a water-filled pressure measuring system may Air bubbles. Air bubbles introduce two issues with water-
be calibrated by keeping the amount of water in the line filled catheters. First, the non-uniform density of fluids in the
constant and moving the line up and down (Fig. 2). With the catheter will introduce an offset to pressure measurements. The
water level at the level of the transducer, set the recording size of the offset depends on the difference in height between
device to zero. Raise the line so that the water level is at a the two ends of the bubble, which changes as the catheter is
defined level, at least 50 cm above the transducer, and set that moved and as the measured pressure changes. Second, water is
level at the recording device. incompressible and pressure changes are transmitted without
The transducer may also be calibrated by putting the line in a flow of water. Air bubbles are compressible; a change in
water-filled container, noting that the pressure measured pressure requires flow to compress or expand the air bubble.
reflects the height difference between the water level in the The bubble becomes a low pass filter that dampens the
container and the transducer (not the end of the catheter). frequency response of the catheter. Note that this problem does
Calibration of catheter-tip transducers. Mount the catheter on not affect air-filled catheters to the same degree, because the
a tripod (Fig. 3). Set zero on the recording device, while holding opposition to flow offered by air is very low. Equipment should
the catheter tip in the air. Place the catheter tip in a container, allow the operator to compare easily the size of pressure
and fill to at least 50 cm above the catheter tip. Note the height changes on all traces, in order for instance to test for the
of the water level above the sensor and set that level at the presence of air bubbles using a cough.
recording device. (Note that lowering the holder and catheter
into a prefilled container will raise the water level, so measure
the height with the holder and catheter submerged).

Fig. 2. Calibration of water-filled line by moving the line. Fig. 3. Calibration of catheter-tip and air-filled transducers.

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Dislodged catheter. A dislodged catheter that has moved from making measurements using a solid-state catheter-tip trans-
the measured body cavity can be identified by good quality ducer coated in an aqueous lubricating gel.23 In the Brown
control, since the measurement in the affected catheter will and Wickham method,24 a water-filled catheter is passed
stop responding to coughs. If the catheter has moved per urethram then withdrawn using a catheter puller, typically
significantly, the measurement may also show a dramatic at 2–5 mm/sec. Meanwhile, continuous pressure measure-
offset from its baseline value. Again therefore, the trace display ments are made. Since the distal urethra is dry, the line
should allow comparison with baseline values during the test. must be perfused with saline, typically at 2–5 ml/min.
Incomplete pressure transmission. At the start of filling, it is Equipment that supports urethral pressure measurement
sometimes the case that intravesical pressure is not recorded should enable perfusion and withdrawal rates within these
correctly, possibly due to the sensor touching the wall of an ranges. As systems perform differently at different rates and
empty bladder. Equipment should therefore allow users to fill with different catheters, centers should maintain a consistent
the bladder a small amount before baseline values for pressure and clearly defined protocol when making urethral pressure
are recorded, rather than automatically assigning baseline measurements.
values at the start of filling.
Incomplete cough cancellation. With water-filled catheters, it EMG (see Table VII)
is usual that the bladder line is of smaller diameter than the
Electromyography (EMG) measurements can contribute to
abdominal line. In these circumstances the characteristics of
the interpretation of urodynamics studies in that they
the two lines will be different, with the abdominal line usually
document the relationship between pressure and/or flow as
having the faster frequency response. Therefore the complete
well as the activity of the pelvic floor and striated sphincter.
cancellation of a cough in the detrusor trace may be difficult and
Consequently EMG measurements, particularly when associated
any automatic processing should treat a symmetric biphasic
with the investigation of neuropathic disorders of the lower
wave on the detrusor trace as being of acceptable quality.
urinary tract, can be of critical importance. In the past, needle
Artefacts with separate lines. With separate filling and electrodes have been used to investigate individual muscle action
measurement catheters, there will be a positive pressure offset potentials, usually inserted in the anal sphincter providing a
in pves if the measuring catheter is not disengaged from its record of motor unit activity of the group of muscles. While not
insertion position in the filling catheter hole (‘‘piggy-back’’) exactly reflective of pelvic floor muscle activity, needle or wire
before filling commences, or if filling flow faces directly onto electrodes remain the current gold standard of documenting
the measurement point. This artefact disappears if the infusion skeletal muscle activity. However needle electrodes are invasive,
pump is stopped. technically difficult to insert and are not pleasant for the patient.
Single Lumen Artefact. If both filling and pressure measure- Therefore in centers that use it, EMG measurement is limited to
ment are done through the same lumen of a catheter, the surface electrodes measuring the activation of the pelvic floor
positive pressure from the filling pump will add an offset to the muscles.
value measured, and if a roller pump is used this offset is All skeletal EMG signals have a relatively high bandwidth,
variable and confusing. Pressure measurements should there- typically from 10 Hz up to 1 kHz. The EMG amplitude from
fore be made only when the pump is not running. Alternatively, surface electrodes is comparatively low, nominally from 10 to
if continuous measurements are required, calibration may be 100 mV, and depends greatly on skin cleaning, electrode
done when the pump is running, or users compensate by placement and patient morphology in terms of the amount
subtracting the offset, but only when the pump is running. This of fat between electrode and muscle to be monitored. Given the
artefact disappears if the infusion pump is stopped. small signal amplitude, the amplifier properties are important.
Dual-lumen artefact (pump). Dual-lumen water-filled cathe- In particular, it should have a high input impedance in excess
ters are susceptible to a filling artefact in which the pressure of 100 MOhms, and common-mode rejection ratio (CMRR)
generated by the infusion pump affects the pressure in the parallel in excess of 80 dB.1 A notch filter at mains frequency is
measuring lumen, particularly at high filling rates. The effect is due recommended.
to peristalsis from the pump interacting with the compliance of In most cases, the high bandwidth of the EMG is addressed by
the thin catheter wall, and is manifested as a rhythmic signal from using a rectify-integrate (iEMG) or a root-mean-square circuit
the pump rollers superimposed on the pves signal. This artefact too that gives a low-bandwidth estimate of the EMG amplitude or
disappears if the infusion pump is stopped. envelope. When displayed graphically this gives a line trace
where in some cases, subtle or slow changes can be missed and
Abdominal Pressure Special Considerations filtering can lose the phase relationship with the pressure or
flow signals. In fact, the original EMG can be deliberately under-
Catheters in the rectum, vagina, or an abdominal stoma give
sampled at typically 100 Hz, which loses some information
an approximation to the pressure surrounding the bladder. In
content, but nevertheless gives a distinctive EMG appearance
particular, the use of rectal transducers in urodynamics makes
when displayed at the timescale of urodynamic traces.
the assumption that they give a good measure of resting
abdominal pressure.22 However, the rectal transducer will
often measure rectal contractions. These will be manifested as
positive waves on abdominal pressure and thus negative-going
TABLE VII. Essential Requirements of EMG Measurement Equipment
waves on resting detrusor pressure that may sometimes appear
(Where Fitted)
to be substantially below zero. Equipment should therefore allow
the user to see all pressure traces concurrently and negative pdet Parameter Guideline value
readings should be displayed and not clipped to zero.
Minimum impedance 100 MOhms
Urethral Pressure—Special Considerations Minimum CMRR 80 dB
Required feature EMG processing and display variable to suit
In some circumstances, it may be requested to quantify the
clinical need
pressure along the length of a dry urethra. Some authors report

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USER INTERFACE (see Table VIII) Analysis and Post-Processing
Automated analysis is an optional extra which, if included,
Operation should not be affected by artefacts (e.g., Qmax caused by
knocking the flow meter, pmax from cough). If summary
Equipment should be designed such that operation is
statistics and automated analysis are provided, the user should
ergonomic and safe. Surfaces likely to come into contact with
have the ability to check the values for feasibility and change
clinical materials should be easy to clean, while the physical
the relevant ones if necessary. This implies that software
layout should be stable and allow easy access. The equipment
should not filter or remove artefacts, but should be able to
design should be such that technicians at the user’s institution
ignore them for analysis. Results of validation of any
can carry out electrical safety checks without causing damage
automated analyses should be available.26 Established nomo-
to the equipment.
grams and calculated parameters may also be provided. A
Recording facility to estimate bladder volume using post-void residual,
infused and voided volumes may be a useful tool, though
Data should be recorded and stored in such a way that the inaccuracies in these measurements, along with any urethral
study can be displayed in the same way at a later date, infusion, diuresis, and leakage will confound calculation.27
preferably on other equipment as well. Electronic marking of
events is important for analysis of studies at a later date, as
artefacts and real events can easily get confused if they are not RECOMMENDATIONS FOR STANDARDIZED PERFORMANCE TESTS
permanently annotated on the original soft copy. The position Testing of new technologies for pressure and flow rate
of event markers should be adjustable after the test has measurement should be done by a specialized center prior to
finished, and the meaning of any abbreviations used for their introduction to the market to ensure that they have sufficient
labels should be clear. The ability to enter further diagnostic accuracy, linearity, minimal hysteresis and temperature
information such as post void residual volume and the results dependence, and an appropriate frequency response, as well
of related diagnostic tests may be useful in order to display all as consistent performance throughout the lifetime of the
related information to clinicians. The ability to export in plain system. These tests should be performed using all components
data format (.txt or .csv) should be available. Also required is the of the system as they will be utilized clinically since, for
ability to integrate with popular electronic medical software example catheter size and length can affect the frequency
and to export in the ICS standard format (.ics).25 For data response of a pressure measurement system. Potential users
protection purposes, the system should store data securely, or should utilize the results of these tests to determine if a new
allow the user’s institution network to do so. Backing up of data technology would provide sufficiently accurate measurements
onto remote systems or media and connection to the hospital for their needs prior to purchase.
data network should be facilitated. Data recovery in the event A single study can be utilized to test linearity and hysteresis
of power failure would be an advantage. by production of a linear increase in pressure or flow rate
followed by a linear decrease in pressure or flow rate. For
Display
pressure, this can be accomplished using a fluid-filled pressure
The ICS suggests that urodynamic tests should be displayed chamber in which the pressure can be tightly controlled. For
on a 1 mm ¼ 5 sec scale for filling and 1 mm ¼ 2 sec for voiding.3 flow rate, this can be accomplished using a controllable flow
This allows resolution of short scale events, easy visual pump.
comparison of multiple studies and prevents misinterpretation Frequency response can be determined by changing pressure
of traces due to scaling issues. Line thicknesses on screens and or flow rate in a controllable manner such that different
on printouts should allow the clear visualization of clinically frequencies are tested. Two such standard tests for measuring
important details, and these thicknesses should not represent the frequency response of a pressure measuring system are the
values greater than the accuracies recommended above. A pop test and the frequency ramp test.20 For the pop test, a piece
variable on-screen scale allows both visual summary of the of latex, similar to a balloon, is tightly stretched over the top of
whole test, as well as close inspection of detailed features, but an air-filled chamber in which pressure sensing catheters are
default scales and layout should conform to ICS recommenda- placed. The chamber is then pressurized to a standard pressure
tions.3 The system must allow for simultaneous display of all and the latex bulges out in response. The latex is then popped
pressure traces. For those integrating fluoroscopy, temporal with a pin or needle, dropping the pressure in the chamber to
synchronization or embedding of the image are necessary zero (equal to barometric pressure in the room) nearly
features. For ambulatory equipment, the option of a real time instantaneously. This test is therefore sometimes called a
display of pressure is helpful, in order to check the setting up of step test because of the sudden drop to zero pressure. This test
transducers. enables measurement of the response of a pressure sensing

TABLE VIII. Essential Requirements of User Interfaces

Parameter Guideline

Access and cleaning Equipment laid out ergonomically

Display Should allow for later review with line thicknesses representing smaller values than recommended measurement accuracy
Data export Text/spreadsheet format, ICS format and electronic patient record interface
Data storage Backup facility and option for network connection required Secure data storage should be made possible
Image capture and display Simultaneous recording and playback with pressure traces required, if images are used
Display scales Clearly displayed and adjustable
Event marking Required
Automated analyses Relevant parameters should be controlled by user, not fixed

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above benchmarking tests could determine the appropriate
lifetime of a new technology, regardless of how lifetime is
ultimately defined. Change of less than 1% throughout the
lifetime of a system would be expected, after periodic
recalibration has been undertaken.

SUMMARY
The review contained in this article allows clinical require-
ments for a standard urodynamics system to lead to technical
recommendations. Equipment can be over-specified (e.g., more
accuracy than is required) or under-specified (unable to achieve
necessary performance). It is hoped that this document will be
helpful to purchasers, users and manufacturers in avoiding
these errors. Purchasers can use the lists of required features to
check the suitability of equipment for urodynamics. Users can
perform the tests described to check ongoing performance and
calibration. Manufacturers can be guided by this technical
summary of clinical need when introducing new designs or
techniques. The document may also encourage the establish-
Fig. 4. Simple test for flow meter signal response. The rise time to 63% of final ment of standard tests for urodynamic equipment, leading to
value should be less than 0.16 sec. both procurer and operator assurance, and also patient benefit.

ACKNOWLEDGMENT
system to a sudden change in pressure. For the frequency ramp
test the pressure in the pressure chamber is rapidly changed The Standardization Steering Committee member responsi-
and a range of relevant sinusoidal frequencies are examined. ble for overseeing adherence to the required development
Zero to 20 Hz is sufficient to assess urodynamic pressure protocol was Marcus Drake.
measurement systems. Sophisticated software is required to
characterize the pressure measurement system from the
resultant data, but if done well, an accurate determination REFERENCES
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2. Rosier PF, de Ridder D, Meijlink J, et al. Developing evidence-based standards
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4. Parsons BA, Bright E, Shaban AM, et al. The role of invasive and non-invasive
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change through the working range of flow rate frequencies,
11. Zinner NR, Ritter RC, Sterling AM, et al. Drop spectrometer: A non-obstructive,
that is, 0–5 Hz as stated earlier. non-interfering instrument for analyzing hydrodynamic properties of
Temperature dependence can be tested by performing the human urination. J Urol 1969;101:914–8.
linearity and hysteresis test and the frequency response test at 12. Evaluation Report: Urodynamics Systems CEP09038. Centre for Evidence-
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Received: 18 December 2017

DOI: 10.1002/nau.23508
| Accepted: 18 December 2017

TERMINOLOGY

An International Urogynecological Association

(IUGA)/International Continence Society (ICS) joint report
on the terminology for the assessment of sexual health of
women with pelvic floor dysfunction

Rebecca G. Rogers MD1 | Rachel N. Pauls MD2 | Ranee Thakar MD3 |

Melanie Morin PhD4 | Annette Kuhn MD5 | Eckhard Petri Dd, PhD6 |
Brigitte Fatton MD7 | Kristene Whitmore MD8 | Sheryl Kinsberg PhD9 |
Joseph Lee MBChB, FRANZCOG10

1 Dell Medical School, University of Texas, Austin, Texas

2 TriHealth Good Samaritan Hospital, Cincinnati, Ohio
3 Croydon University Hospital Croydon, London, United Kingdom
4 Universite de Sherbrooke, Montreal, Quebec, Canada
5 University Teaching Hospital Berne (Inselspital), Bern, Switzerland
6 University of Greifswald, Schwerin, Germany
7 University Hospital Nîmes, Nimes, Languedoc-Roussillon, France
8 Drexel University College of Medicine, Philadelphia, Pennsylvania
9 Case Western Reserve University, Cleveland, Ohio
10 University of New South Wales, St Vincents Hospital, Sydney, New South Wales, Australia

Correspondence
Aims: The terminology in current use for sexual function and dysfunction in women
Rebecca G. Rogers, Department of
Women's Health, 1301 W 38th Street, with pelvic floor disorders lacks uniformity, which leads to uncertainty, confusion,
Suit705, Dell Medical School, University and unintended ambiguity. The terminology for the sexual health of women with
of Texas, Austin, TX 78705.
pelvic floor dysfunction needs to be collated in a clinically-based consensus report.
Email: rebecca.rogers@austin.utexas.edu
Methods: This report combines the input of members of the Standardization and
Terminology Committees of two International Organizations, the International
Urogynecological Association (IUGA), and the International Continence Society
(ICS), assisted at intervals by many external referees. Internal and external review was
developed to exhaustively examine each definition, with decision-making by
collective opinion (consensus). Importantly, this report is not meant to replace, but
rather complement current terminology used in other fields for female sexual health
and to clarify terms specific to women with pelvic floor dysfunction.

Eckhard Petri and Joseph Lee belongs to Standardization and Terminology Committees IUGA.

Kristene Whitmore belongs to Standardization and Terminology Committees ICS.

Rebecca G. Rogers, Rachel N. Pauls, RaneeThakar, Melanie Morin, Annette Kuhn, Eckhard Petri, Brigitte Fatton, Kristene Whitmore, Sheryl Kinsberg,
and Joseph Lee belongs to Joint IUGA/ICS Working Group on Female Anorectal Terminology.
Dr. Roger Dmochowski led the peer-review process as the Associate Editor responsible for the paper.

Neurourology and Urodynamics. 2018;1–21. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | 1

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the assessment of sexual
health of women with pelvic floor dysfunction
212

2
| ROGERS ET AL.

Results: A clinically based terminology report for sexual health in women with pelvic
floor dysfunction encompassing over 100 separate definitions, has been developed.
Key aims have been to make the terminology interpretable by practitioners, trainees,
and researchers in female pelvic floor dysfunction. Interval review (5-10 years) is
anticipated to keep the document updated and as widely acceptable as possible.
Conclusion: A consensus-based terminology report for female sexual health in
women with pelvic floor dysfunction has been produced aimed at being a significant
aid to clinical practice and a stimulus for research.

KEYWORDS
female pelvic floor dysfunction, female sexual health, terminology

1 | INTRODUCTION This report contains;

The terminology in current use for sexual function and 1. Definitions of sexual function relevant to the treatment of
dysfunction in women with pelvic floor disorders lacks pelvic floor dysfunction and terminology developed to
uniformity, which leads to uncertainty, confusion, and designate the anatomic location of the symptom.
unintended ambiguity. Comprehensive and precise descrip- 2. Terminology currently accepted as standard outside the
tion will aid this situation, leading to more accurate reporting. field of urogynecology will be referenced, as these terms
For example, many definitions are used to describe will allow urogynecologists to communicate effectively
dyspareunia; few are specific as to the location or etiology with other practitioners providing care to women with
of the pain. Women may be treated for sexual complaints sexual dysfunction and pelvic floor disorders.
from a large array of providers including physicians, 3. Assessment of sexual dysfunction of women with pelvic
psychologists, psychiatrists, or sex therapists. While other floor disorders including the history and physical exam
fields have standardized terminology regarding diagnoses of necessary to assess women reporting sexual difficulties
sexual dysfunction in women without pelvic floor dysfunc- which may or may not be related to their pelvic floor
tion, these diagnoses and descriptions do not include dysfunction including physical exam, imaging, nerve
descriptions of conditions commonly encountered by the testing, as well as descriptions of how sexual dysfunction
urogynecologist or others who treat women with pelvic floor is related to other pelvic floor disorders, such as urinary
disorders, such as coital incontinence. More standardized and anal incontinence and pelvic organ prolapse.
terminology would aid inter-disciplinary communication and 4. Management of sexual dysfunction in women with pelvic
understanding, as well as educate our providers on floor disorders is described including conservative,
standardized terminology used in other fields. surgical, and pharmacological management. Management
Existing published reports document the importance of of sexual dysfunction may be provided by different
including the assessment of sexual function. For example, disciplines working in this field. Terminology related to
while Haylen et al1 offers definitions of symptoms, that the different types of therapy will be specified and
document does not comment on how to further evaluate distinguished. In addition, surgical and non-surgical
sexual function or incorporate it into the assessment of management strategies are defined and described.
women with pelvic floor dysfunction. Assessment of how 5. The working group consisted of stakeholders in sexual
pelvic floor dysfunction treatment affects sexual health function including urogynecologists, sex therapists and
and how to measure changes in sexual health are important physiotherapists and the document was vetted through the
to the practice of urogynecology. Ideally, terminology wider membership of IUGA and ICS. The working group
should be consistent between practitioners who treat includes optimal methods of reporting sexual function
women with sexual dysfunction and those who treat research in women with pelvic floor dysfunction. Currently
pelvic floor disorders. Terminology presented in this no single document collates all elements required for
document will align with current terminology documents diagnoses in the area of female sexual function in women
and a literature terms analysis will be included in the with pelvic floor dysfunction in a comprehensive way. This
process. report includes a full outline of the terminology for all

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symptoms, signs, ordered clinical assessments, the imaging 2.1 | Normal sexual function and models of
associated with those investigations, the most common sexual response
diagnoses, and terminology for different conservative and
“Normal” sexual function can be determined using a variety
surgical treatment modalities.
of standards and is therefore difficult to define. Multiple
models have been developed to describe normal or healthy
Like all the other joint IUGA-ICS female-specific
sexual function. In 1966, Masters and Johnson proposed a
terminology reports, every effort has been made to ensure
linear model of sexual response based on their observations of
this Report is:
the physiologic changes that occurred in men and women in a
laboratory setting. Their model consisted of four stages:
1. User-friendly: Able to be understood by all clinical and
excitement, plateau, orgasm, and resolution. Subsequently,
research users.
Kaplan and Lief independently modified this model to include
2. Clinically-based: Symptoms, signs, and validated assess-
the concept of desire as an essential component of the sexual
ments/investigations are presented for use in forming
response. Basson introduced an intimacy-based circular
workable diagnoses for sexual health and associated
model to help explain the multifactorial nature of women's
dysfunctions.
sexual response and that desire is responsive as well as
3. Origin: Where a term's existing definition (from one of
spontaneous. This model further allows for the overlap
multiple sources used) is deemed appropriate, that
between desire and arousal and is ultimately the basis for the
definition is included and duly referenced.
DSM 5 combined disorder, Female Sexual Interest, and
4. Able to provide explanations: Where a specific explana-
Arousal Disorder (FSIAD).
tion is deemed appropriate to explain a change from earlier
definitions or to qualify the current definition, this will be
included as an addendum to this paper (Footnote a,b,c. . .). 2.1.1 | Screening and diagnosis
Wherever possible, evidence-based medical principles
Sexual concerns should be addressed routinely. Many women
have been followed. This Terminology Report is inher-
are hesitant to initiate discussions but still want their provider
ently and appropriately a definitional document, collating
to open the dialogue about sexual problems. When a provider
definitions of terms. Emphasis has been on comprehen-
opens this dialogue, he/she acknowledges and prioritizes the
sively including those terms in current use in the relevant
role that sexual health plays in overall wellbeing. A variety of
peer-reviewed literature. Our aim is to assist clinical
questionnaires can be used to help identify women who suffer
practice, medical education, and research. Some new and
from sexual problems. These questionnaires are a useful
revised terms have been included. Explanatory notes on
adjunct to the patient history and physical examination in the
definitions have been referred, where possible, to the
diagnosis of sexual disorders.
“Footnotes” section.
Once a sexual problem has been brought up and/or
identified, it is important that it is adequately assessed.
Acknowledgement of these standards in written publica-
Though time is limited in the clinical setting, it is important to
tions related to female pelvic floor dysfunction, should be
ask questions that help determine the true nature of problem.
indicated by a footnote to the section “Methods and
When the patient presents with low desire, a detailed
Materials” or its equivalent, to read as follows: “Methods,
description of her problem, including the onset, duration,
definitions and units conform to the standards jointly
and severity of her symptoms, should be obtained. Her level
recommended by the International Continence Society and
of distress should be determined. Open-ended questions allow
the International Urogynecological Association, except
the patient to provide information essential for accurate
where specifically noted.”
diagnosis and the development of an appropriate treatment
plan. If there is not enough time to have a complete
2 | OVERVIEW OF SEXUAL discussion, a return visit should be scheduled to specifically
FUNCTION AND DYSFUNCTION focus on her sexual concerns.

Over 40% of women will experience a sexual problem over

2.1.2 | History and physical exam
the course of their lifetime. A sexual complaint meets the
criteria for a diagnosis when it results in personal distress or A comprehensive medical and psychosocial history, prefera-
interpersonal difficulties. With regard to sexual complaints bly of both partners, is essential.3
that reach the level of a diagnosable sexual disorder, recent A completed medical history can identify conditions that
epidemiologic surveys place the prevalence of diagnosable contribute to her symptoms. The gynecologic history is also a
sexual disorders at approximately 8-12%.2 vital component in the diagnosis. Components of the sexual

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history should include direct questions about sexual behavior, women without.12,14 An estimated 16% to 25% of women
safe sex practices, and whether or not there is a history of with chronic pelvic pain experience dyspareunia often leading
sexual abuse. Sexual history taking should always be to sexual avoidance.15 High pelvic floor muscle tone and
conducted in a culturally sensitive manner, taking account sexual dysfunction are related.16 In women with PFDs there is
of the individual's background and lifestyle, and status of the a positive association between pelvic floor strength and
partner relationship. A history of current medications should sexual activity and function.17
be taken. It should be noted in what way the additional pelvic Resolution of symptoms after successful treatment of
floor symptoms interfere with sexual function. Medications PFDs often improves sexual function and/or women's
as antihypertensive agents (alpha blockers, beta blockers, wellbeing as measured on pelvic floor condition specific
calcium channel blockers, antidiuretics) chemotherapeutics, measures. After surgery for stress urinary incontinence (SUI)
drugs that act on the central nerve system and anti-androgens sexual function was unchanged in 55.5% of women, improved
may interfere with sexual function.4 A history and physical in 31.9% and deteriorated in 13.1%.18 The resolution of coital
examination with special attention to atrophy, infections, scar incontinence is closely correlated to patient's degree of sexual
tissue, and neoplasms should be performed. Motor and satisfaction and preoperative coital incontinence has been
sensory neurological function should be assessed. Clinical suggested as a prognostic factor for improvement of sexual
signs of urinary and fecal incontinence should be noted and function after surgery.19 Most women who undergo surgery
provocation tests such as a cough stress test performed. For for POP report unchanged sexual function.20
women with pelvic neurological disease a detailed neurologi-
cal genital exam is necessary, clarify light touch, pressure,
3 | SYMPTOMS OF SEXUAL
pain, temperature sensation, anal and vaginal tone, voluntary
FUNCTION SPECIFIC TO PELVIC
contraction of vagina and anus as well as anal and
FLOOR DYSFUNCTION
bulbocavernosal reflexes.5 Basic laboratory testing should
be performed such as serum chemistry, complete blood count,
3.1 | Symptom
and lipid profiles to identify vascular risk factor as
hypercholesterolemia, diabetes, and renal failure.4 Any morbid phenomenon or departure from the normal in
structure, function, or sensation, experienced by the woman
and indicative of disease or a health problem. Symptoms are
2.2 | Pelvic floor disorders and sexual
either volunteered by, or elicited from the individual, or may
dysfunction
be described by the individual's caregiver.1 Sexual symptoms
The effects of pelvic floor disorders (PFDs) including urinary may occur in combination with other pelvic floor symptoms
(UI) and anal incontinence (AI) and pelvic organ prolapse such as urinary, fecal, or combined incontinence or pelvic
(POP) on sexual function remain debatable with some studies organ prolapse (POP) or pelvic pain.
showing no and others a negative impact.6–8 This variability
can be attributed partly to the fact that the populations studied,
3.2 | Vaginal symptoms
as well as the methodology and the type of questionnaires
used, are different between the studies. These discordant 1. Obstructed intercourse: Vaginal intercourse that is difficult
findings can also be attributed to the complexity of human or not possible due to obstruction by genital prolapse or
sexual function which is subject to a host of influences. shortened vagina or pathological conditions such as lichen
Despite conflicting published data, in general most PFDs are planus or lichen sclerosis.
thought to negatively affect sexual health. Pelvic floor 2. Vaginal laxity: Feeling of vaginal looseness.1
symptoms have been shown to be associated with low sexual 3. Anorgasmia: Complaint of lack of orgasm; the persistent
arousal, and infrequent orgasm and dyspareunia.7 Up to 45% or recurrent difficulty, delay in or absence of attaining
of the women with UI and/or lower urinary tract symptoms orgasm following sufficient sexual stimulation and
(LUTS) complain of sexual dysfunction with 34% reporting arousal, which causes personal distress.3
hypoactive sexual desire, 23% sexual arousal disorder, 11% 4. Vaginal dryness (NEW): Complaint of reduced vaginal
orgasmic deficiency, and 44% sexual pain disorders lubrication or lack of adequate moisture in the vagina.
(dyspareunia or non coital genital pain).9 Sexual function is
related to women's self-perceived body image and degree of
bother from pelvic organ prolapse (POP).10 Genital body 3.3 | Lower urinary tract sexual dysfunction
image and sexual health are related in women with stage 2 or symptoms
greater POP11–13 particularly in the domains of sexual desire
and satisfaction. Women with anal incontinence (AI) have 1. Coital urinary incontinence: urinary incontinence occur-
similar rates of sexual activity but poorer sexual function than ring during or after vaginal intercoursea

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2. Orgasmic urinary incontinence (NEW): urinary inconti- 6. Vaginal dryness: Complaint of reduced vaginal lubrica-
nence at orgasm tion or lack of adequate moisture in the vagina.g
3. Penetration urinary incontinence (NEW): urinary inconti- 7. Hypertonic pelvic floor muscle: A general increase in
nence at penetration (penile, manual, or sexual device) muscle tone that can be associated with either elevated
4. Coital urinary urgency (NEW): Feeling of urgency to void contractile activity and/or passive stiffness in the
during vaginal intercourse. muscle.4,35,h
5. Post coital LUT symptoms (NEW): Such as worsened 8. Non coital sexual pain (NEW): pain induced by non coital
urinary frequency or urgency, dysuria, suprapubic stimulation.i
tenderness. 9. Post coital pain (NEW): pain after intercourse such as
6. Receptive urethral intercourse (NEW): Having a penis vaginal burning sensation or pelvic pain.
penetrating one's urethra (urethral coitus).b 10. Vulvodynia: vulvar pain of at least 3 months’ duration,
without clear identifiable cause, which may have
potential associated factors.37
3.4 | Anorectal sexual dysfunction symptoms28
1. Coital fecal (flatal) incontinence: Fecal (flatal) inconti-
3.7 | Specific postoperative sexual dysfunction
nence occurring with vaginal intercourse (see related
symptoms
definition “Coital fecal urgency”).
2. Coital Fecal Urgency: Feeling of impending bowel action 1 De novo sexual dysfunction symptoms (NEW): new onset
during vaginal intercourse. sexual dysfunction symptoms (not previously reported
3. Anodyspareunia: Complaint of pain or discomfort associ- before surgery)
ated with attempted or complete anal penetration.28 2 De novo dyspareunia (NEW): dyspareunia first reported
4. Anal laxity: Complaint of the feeling of a reduction in anal after surgery or other interventions
tone. 3 Shortened vagina (NEW): perception of a short vagina
expressed by the woman or her partner
4 Tight vagina (NEW):
3.5 | Prolapse specific symptoms - Introital narrowing: vagina entry is difficult or impossible
(penis or sexual device)
1. Abstinence due to pelvic organ prolapse: Non engagement - Vaginal narrowing: decreased vaginal calibre.
in sexual activity due to prolapse or associated symptoms.c 5 Scarred vagina (NEW): perception by the partner of a
2. Vaginal wind (Flatus): Passage of air from vagina (usually “stiff” vagina or a foreign body (stitches, mesh exposure,
accompanied by sound). mesh shrinkage) in the vagina
3. Vaginal laxity: Feeling of vaginal looseness.d 6 Hispareunia: male partner pain with intercourse after
4. Obstructed intercourse: vaginal intercourse is difficult or female reconstructive surgery.j
not possible due to obstruction by genital prolapse or
shortened vagina or pathological conditions such as lichen
planus or lichen sclerosis.
3.8 | Other symptoms
1. Decreased libido or sexual desire (NEW): Absent or
3.6 | Pain symptoms diminished feelings of sexual interest or desire, absent
sexual thoughts or fantasies, and a lack of responsive
1. Dyspareunia: Complaint of persistent or recurrent pain or desire.1,3 Motivations (here defined as reasons/incentives)
discomfort associated with attempted or complete vaginal for attempting to become sexually aroused are scarce or
penetration.1,e absent. The lack of interest is considered to be beyond the
2. Superficial (Introital) dyspareunia: Complaint of pain or normative lessening with lifecycle and relationship
discomfort on vaginal entry or at the vaginal introitus. duration.
3. Deep dyspareunia: complaint of pain or discomfort on 2. Decreased arousal (NEW): Persistent or recurrent inability
deeper penetration (mid or upper vagina) to achieve or maintain sexual excitement. This may be
4. Vaginismus (NEW): recurrent or persistent spasm of expressed as lack of excitement, lack of lubrication, lack of
vaginal musculature that interferes with vaginal vaginal and clitoral engorgement, or lack of expression of
penetration.f other somatic responses.1,3,k
5. Dyspareunia with penile vaginal movement: pain that is 3. Anorgasmia or difficulty in achieving orgasm (NEW):
caused by and is dependent on penile movement. Lack of orgasm, markedly diminished intensity of

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orgasmic sensations or marked delay of orgasm from any 3. Urethral: Prolapse, caruncle, diverticulum.
kind of stimulation.1,3 4. Vulval agglutination: Labial lips fused.m

4 | SIGNS 4.3 | Vaginal examination

1. Vaginal agglutination: defined as condition where the
4.1 | Sign
walls of the vagina are fused together above the hymen.
Any abnormality indicative of disease or health problem, 2. Vulvo-vaginal hypoesthesia: Reduced vulvo-vaginal sen-
discoverable on examination of the patient: an objective sitivity to touch, pressure, vibration, or
indication of disease or health problem.1 Not all observed temperature.4,34,35,n
changes are associated with pathology from the point of 3. Vulvo-vaginal hyperaesthesia: Increased vulvo-vaginal
view of the patient, and not all require intervention. The sensitivity to touch, pressure, vibration, or temperature
genital examination is often informative and in women with 4. Pudendal neuralgia: elicited or described by the patient as
sexual dysfunction can often be therapeutic. A focused burning vaginal and vulva pain (anywhere between the
genital examination is highly recommended in presence of anus and the clitoris) with tenderness over the course of the
dyspareunia, vaginismus, neurological disease, genital pudendal nerve.1,o
arousal disorders, history of pelvic trauma, acquired or
lifelong orgasmic disorder.4,1 The internal examinations are
generally best performed with the woman's bladder empty.1 4.4 | Examination of pelvic floor muscles1,p
Examination should be performed and described including
vaginal length, calibre and mobility, presence of scarring 1. Muscle tone: In normally innervated skeletal muscle, tone is
and/or pain and estrogenization, and whether or not there is created by “active” (contractile) and “passive” (viscoelas-
vaginal or labial agglutination. The location of any vaginal tic) components clinically determined by resistance of the
pain should be noted. Pelvic organ prolapse should be tissue against stretching or passive movement.47,48
evaluated at it may influence sexual function by both 2. Normal pelvic floor muscles: Pelvic floor muscles which
affecting body image and vaginal symptoms during sexual can voluntarily and involuntarily contract and relax.
activity.39 If the patient has had an operation in which a 3. Overactive pelvic floor muscles: Pelvic floor muscles
synthetic mesh is utilized then mesh may be felt in the which do not relax, or may even contract when relaxation
vagina which may or may not be associated with is functionally needed, for example, during micturition or
symptoms.40Bimanual examination should be performed defecation.
to make observations for any pelvic mass or unusual 4. Underactive pelvic floor muscles: Pelvic floor muscles
tenderness by vaginal examination together with suprapubic which cannot voluntarily contract when this is appropriate.
palpation. Examination of the pelvic floor muscles may 5. Non-functioning pelvic floor muscles: Pelvic floor
elicit signs pertaining to female sexual dysfunction. If muscles where there is no voluntary action palpable.
dyspareunia, vaginismus, or history of pelvic trauma are 6. Pelvic floor muscle spasm or pelvic floor myalgia:
present, completing internal exams is difficult and may be defined as the presence of contracted, painful muscles on
impossible. Assessing for presence of vulvar pain via a palpation and elevated resting pressures by vaginal
gentle, introital palpation, or performing a “Q-tip touch test” manometry.49 This persistent contraction of striated
of the introitus is recommended prior to any internal muscle cannot be released voluntarily. If the contraction
examination. is painful, this is usually described as a cramp. Pelvic
floor myalgia (a symptom) may be present with or
without a change in PFM tone (a sign).
4.2 | Perineal/vulval/urethral inspection and/or 7. Pelvic floor muscle tenderness: occurrence of the
examination sensation of pain or painful discomfort of the pelvic
1. Vulval gaping: non-coaptation of vulva at rest, commonly floor muscles elicited through palpation.
associated with increased size of genital hiatus. 8. Hypertonicity: A general increase in muscle tone that can
2. Deficient perineum/cloacal-like defect: A spectrum of be associated with either elevated contractile activity and/
tissue loss from the perineal body and rectovaginal septum or passive stiffness in the muscle.47,48,50 As the cause is
with variable appearance. There can be a common cavity often unknown the terms neurogenic hypertonicity and
made up of the anterior vagina and posterior rectal walls or non-neurogenic hypertonicity are recommended.
just an extremely thin septum between the anorectum and 9. Hypotonicity: A general decrease in muscle tone that can
vagina.28 be associated with either reduced contractile activity and/

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or passive stiffness in the muscle. As the cause is often research setting, and many do not accurately reflect patient
unknown the terms neurogenic hypotonicity and non- rating of improvement. Therefore, measurement of sexual
neurogenic hypotonicity are recommended.48 activity and function is largely limited to self-report and the
10. Muscle strength: Force-generating capacity of a mus- use of sexual diaries or event logs, clinician-administered
cle.48,51 It is generally expressed as maximal voluntary interviews, or questionnaires. The US Food and Drug
contraction measurements and as the one- repetition Administration drafted guidelines in 2016 which support
maximum (1RM) for dynamic measurements.52,53 the use of event logs and diaries as the primary measures for
11. Muscle endurance: The ability to sustain near maximal or the evaluation of the efficacy of interventions. Further, they
maximal force, assessed by the time one is able to maintain a specified that diaries and event log should record “Sexually
maximal static or isometric contraction, or ability to Satisfying Events (SSE)” and that the number of SSE's may
repeatedly develop near maximal or maximal force deter- be used as a primary endpoint in efficacy trials. Unfortu-
mined by assessing the maximum number of repetitions one nately, these measures do not correlate well with patient
can perform at a given percentage of 1 RM.48,54 report of improvement using other validated sexual function
and quality of life measures.56 Personal interviews are time
consuming and have wide variation in application making the
4.5 | Urogenital aging (NEW): genitourinary reliability of findings suspect.
syndrome of menopause—(GSM)q,r The FDA also recommended the use of patient reported
outcomes for evaluation of sexual function. Most clinicians
1. Pallor/erythema: Pale or erythematous genital mucosa and researchers feel that questionnaires are the most accurate
2. Loss of vaginal rugae: Vaginal rugae flush with the skin in measuring sexual function. Sexual function questionnaires
3. Tissue fragility/fissures: Genital mucosa that is easily include measures which were developed to include concepts
broken or damaged important to women with pelvic floor dysfunction and those
4. Vaginal petechiae: A petechia, plural petechiae, is a small that were developed to address sexual health in women
(1-2 mm) red or purple spot on the skin, caused by a minor without pelvic floor dysfunction. In general, pelvic floor
bleed (from broken capillary blood vessels) condition specific measures are more likely to be responsive
5. Urethral mucosal prolapse: Urethral epithelium turned to change than measures that are not condition specific,
outside the lumen although both have been used in the evaluation of women
6. Loss of hymenal remnants: Absence of hymenal remnants with pelvic floor dysfunction. In addition, some question-
7. Prominence of urethral meatus vaginal canal shortening naires contain individual items or domains relevant to sexual
and narrowing: Introital retraction function, such as the King's Health Questionnaire, which has
8. Vaginal dryness: Complaint of reduced vaginal lubrication a domain specific to sexual function.
or lack of adequate moisture in the vagina. Increasingly, other measures, including those that evalu-
ate body image, also impact sexual function and are
associated with pelvic floor dysfunction. Measurement of
4.6 | General examination these confounders may be important in order to assess the
Identify chronic systemic diseases and their treatments (eg, impact of pelvic floor dysfunction on sexual health.
Diabetes, Multiple Sclerosis, Depression, Hypertension, lichen
sclerosis) which can be associated with sexual dysfunction. 5.1 | Sexual diaries
A daily log of sexual thoughts, activities; supported by the US
4.7 | Neurological examination FDA as a primary outcome measure for the efficacy of
For women with neurological disease affecting the pelvic interventions to evaluate sexual function.
nerves clarify light touch, pressure, pain, temperature
sensation, and vaginal tone, voluntary tightening of the 5.2 | Event logs
anus and vagina, anal and bulbocavernosal reflexes.55
Record individual sexual events or activities. Each event is
classified as a “sexually satisfying event (SSE)” or not. Event logs
5 | INVESTIGATIONS QOL; record individual events rather than activities on a daily basis.
MEASUREMENT OF SEXUAL
FUNCTION/HEALTH
5.3 | Sexually satisfying event
While some physiologic measures of sexual activity and This termed is coined by the US FDA, and is defined by the
function exist, most are not readily available in the clinical or individual completing the questionnaire. The FDA stated that

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TABLE 1 Sexual function questionnaires

Number ICI* Condition-
Instrument Description of items Grade specific
ICIQ-FLUTSsex (BFLUTS) (International Female sexual matters associated with urinary 4 A Yes
Consultation on Continence Questionnaire- symptoms and related bother
Female Lower Urinary Tract Symptoms
Sex)57
GRISS (The Golombok-Rust Inventory of Anorgasmia, vaginismus, impotence, and premature 28 A No
Sexual Satisfaction)58 ejaculation, avoidance, dissatisfaction and non-
sensuality, infrequency and no communication
about sex
ICIQ-VS (International Consultation of Assess effects of vaginal symptoms of sexual 14 B Yes
Incontinence Questionnaire -Vaginal quality of life
Symptoms)59
PISQ (Pelvic Organ Prolapse Urinary Evaluates sexual function in women with 31 B Yes
Incontinence Sexual Questionnaire)60 incontinence and prolapse
PISQ-12 (short form version of the PISQ-31)61 Evaluates sexual function in women with 12 Not Yes
incontinence and prolapse rated
PISQ IR (IUGA- revised version of the PISQ)8 Evaluates sexual function in women with 33 Not Yes
incontinence and prolapse includes evaluation of rated
women with anal incontinence as well as women
who do not report sexual activity
FSFI (Female Sexual Function Index)62 Assesses multiple dimensions of sexual function 19 A No
SFQ (Sexual Function Questionnaire)63 Assess the impact of OAB on sexual health function 31 C Yes
in the male and female population
SQOL-F (Sexual Quality Of Life-Female)64 Assess the impact of female sexual dysfunction of 18 B Yes
quality of life

*International Consultation on Incontinence.

the term “satisfying” and what activities will be classified as a the vascular, neurologic, musculoskeletal, and hormonal
sexual encounter should be defined but did not supply a systems. The clinical utility of these investigations in the
definition. routine assessment of female sexual health needs further
validation. In many instances, these investigations are utilized
in the research setting. Supplemental Table S1 reviews the
5.4 | Questionnaires
validity and reliability testing of physiologic investigations.
Psychometric properties of some tools are reported in
Table 1.64
6.1 | Vascular assessment
1. Pelvic Floor Condition specific sexual function measures: Sexual arousal results in increased blood flow allowing
A validated sexual function measure which is developed to genital engorgement, protrusion of the clitoris and augmented
include concepts relevant women with pelvic floor vaginal lubrication through secretion from the uterus and
dysfunction. Bartholin's glands and transudation of plasma from engorged
2. Generic sexual function measures: A validated measure vessels in the vaginal walls. Several instruments are available
that was developed to evaluate sexual function but does not to measure blood flow during sexual stimulation.65,66
contain items relevant to pelvic floor dysfunction such as Inadequate vasculogenic response may be related to
coital incontinence or vaginal looseness. psychological factors as well as vascular compromise due
to atherosclerosis, hormonal influence, trauma, or surgery.
6 | INVESTIGATIONS;
MEASUREMENT OF PHYSIOLOGIC 1. Vaginal photoplethysmography: A tampon shape intra-
CHANGES vaginal probe equipped with an incandescent light that
projects toward the vaginal walls is inserted; the amount of
Physical investigations aim to evaluate different causes of light that reflects back to the photosensitive cell provides a
sexual dysfunction and include investigations that focus on measure of vaginal engorgement which can be expressed as

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vaginal blood volume or vaginal pulse amplitude depending arousal.84–86 Different approaches can be used to evaluate
on the mode of recording.67,68 Likewise, labial and clitoral motor and sensory neurological function.
photoplethysmography can also be evaluated.69,70
2. Vaginal and clitoral duplex Doppler ultrasound: The 1. Functional magnetic resonance imaging: Investigation of
anatomical integrity of clitoral structures and the changes neural activation in anatomically localized cerebral
in clitoral and labial diameter associated with sexual regions evaluated through monitoring subtle changes in
stimulation can be evaluated in B mode.71 Movement of regional cerebral blood flow that occur with activation of
the blood relative to the transducer can be expressed as the neurons. These patterns of activation and deactivation
measurement of velocity, resistance, and pulsatility.72 are used to examine the cerebral and cognitive response to
Blood flow in arteries irrigating the clitoris and the vagina sexual stimulation.77
are more commonly assessed during sexual 2. Quantitative sensory testing: Assessment of the sensitivity
stimulation.71,73,74 by applying different stimuli (light touch, pressure,
3. Laser Doppler imaging of genital blood flow: An temperature, or vibration) using an ascending or descend-
imager positioned close to the vulva allows the ing method in order to evaluate the detection threshold.
assessment of skin/mucosae microcirculation at a depth These methods can be used to evaluate different vulvo-
of up to 2-3 mm.75 This method has been used to assess vaginal sites including the clitoris, labia minora, and
response to sexual stimulation and correlated with majora as well as vaginal and anal margins.84,87,88
subjective arousal.75 It has also led to a better 3. Reflex examination: Evaluating sacral arc integrity, the
understanding of microvascular differences in women bulbocavernous reflex can be elicited by squeezing the
with provoked vestibulodynia compared to asymptom- clitoris and assessing the contraction of the anal
atic controls.76 sphincter.89 The external anal reflex is tested by repetitive
4. Magnetic resonance of imaging of the genito-pelvic pricking delivered to perianal skin and observing anal
area: Evaluation of the increase in clitoral structure sphincter contraction.89 Latencies can also be evaluated by
volume related to tissue engorgement occurring during stimulating the nerve and evaluating muscle response
arousal.76 through a needle electrode.90
5. Measurements of labial and vaginal oxygenation: A heated
electrode and oxygen monitor are used to evaluate the
arterial partial pressure of oxygen (PO2) transcutane- 6.3 | Pelvic floor muscle assessment
ously.78,79 The temperature of the electrode is kept at a
constant elevated temperature by an electric current. Assessment of pelvic floor muscle (PFM) function involves
Increase in blood flow under the electrode results in more evaluating the tone, strength, endurance, coordination, reflex
effective temperature dissipation (heat loss) with the result activation during rises in intra-abdominal pressure as well as
that more current is needed to maintain the electrode at its the capacity to properly relax this musculature. These muscles
prefixed temperature. The changes in current provide an are involved in sexual function as PFM contraction occurs
indirect measurement of blood flow during sexual during arousal and intensifies with orgasm and PFM tone is
stimuli.79,80 The electrode also monitors oxygen diffusion related to vaginal sensation.91–93 Superficial PFMs such as the
across the skin.78,79 bulbospongiosus and ischiocavernous are also involved in
6. Labial thermistor: Temperature measurement evaluated erection of the clitoris by blocking the venous escape of blood
with a small metal clip attached to the labia minora and from the dorsal vein.94 Thus, reduction in PFM strength and
equipped with a sensitive thermistor.80,81 endurance has been related to lower sexual function.95,96
7. Thermography or thermal imaging of the genital area: Likewise, PFM hypotonicity may be related to vaginal
Evaluation of genital temperature using a camera detecting hypoesthesia, anorgasmia, and urinary incontinence during
infrared radiation from the skin during sexual stimula- intercourse9 while hypertonicity may lead to dyspareunia.97,98
tion.82 This method has been correlated with subjective
arousal.83 1. Pelvic floor manometry: measurement of resting pressure
or pressure rise generated during contraction of the PFMs
using a manometer connected to a sensor which is inserted
into the urethra, vagina, or rectum. Pelvic floor manomet-
6.2 | Neurologic assessment
ric tools measuring pressure in either mmHg, hPa, or
Related to intact sensation, neurological innervation is cmH2O can be used to assess resting pressure, maximal
important for arousal and orgasm. Peripheral neuropathy or squeeze pressure (strength), and endurance.99 Details
central nervous system disorders (eg, diabetic neuropathy, about recommendations to ensure validity of pressure
spinal cord injury) may lead to anorgasmia and decreased measurements are provided elsewhere.99

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2. Pelvic floor dynamometry: measurement of PFM resting 6.4 | Hormonal assessment

and contractile forces using strain gauges mounted on a
Hormones such as estrogen, progestin, and androgen influence
speculum (a dynamometer), which is inserted into the
sexual function and imbalance may lead to various symptoms
vagina.100–102 Dynamometry measures force in Newton
including decreased libido, lack of arousal, vaginal dryness, and
(N). Several parameters such as tone, strength, endurance,
dyspareunia.106,107107 Depending on the underlying suspected
speed of contraction, and coordination can be evalu-
conditions associated with sexual dysfunction, hormonal inves-
ated.100–102
tigations such as estradiol (or FSH if symptoms of deficiency),
3. Pelvic floor electromyography (EMG): the recording of
serum testosterone, dehydroepiandrosterone acetate sulphate
electrical potentials generated by the depolarization of
(DHEAS), free testosterone, dihydrotestosterone, prolactin, and
PFM fibers. Intra-muscular EMG consists in the insertion
thyroid function testing may be considered.108 Moreover, the
of a wire or needle electrode into the muscle to record
evaluation of vaginal pH and vaginal maturation index (ie,
motor unit action potentials while surface EMG requires
percentage of parabasal cells, intermediate cells, and superficial
electrodes placed on the skin of the perineum or inside the
cells) can be helpful in women with vulvovaginal atrophy as it has
urethra, vaginal, or rectum. EMG amplitude at rest and
been shown to be correlated with patient's symptomatology.109
contraction can be recorded.
4. Pelvic floor ultrasound imaging: evaluation of PFM
morphology at rest, during maximal contraction and 7 | COMMON DIAGNOSES
Valsalva. Several parameters pertaining to assess the
bladder neck and anorectal positioning and hiatus The Diagnostic and Statistical Manual of Mental Disorders
dimensions can be measured.103–105 fifth edition (DSM-5), the International Classification of

TABLE 2 Sexual dysfunction diagnoses

Diagnosis Description
DSM—5 Diagnoses (American Psychiatric Association)
Female Sexual Interest/Arousal disorder Lack of, or significantly reduced, sexual interest/arousal as manifested by 3 of the
following:
1. Absent/reduced interest in sexual activity
2. Absent/reduced sexual/erotic thoughts or fantasies
3. No/reduced initiation of sexual activity and unreceptive to partner's attempts to
initiate
4. Absent/reduced sexual excitement/pleasure during sexual activity in almost all or all
(75-100%) sexual encounters
5. Absent/reduced sexual interest/arousal in response to any internal or external sexual/
erotic cues (written, verbal, visual)
6. Absent/reduced genital or non-genital sensations during sexual activity in almost all
or all
(75-100%) sexual encounters
Genito-Pelvic Pain/Penetration disorder Persistent or recurrent difficulties with 1 or more of the following:
1. Vaginal penetration during intercourse
2. Marked vulvovaginal or pelvic pain during intercourse or penetration attempts
3. Marked fear or anxiety about vulvovaginal or pelvic pain in anticipation of, during,
or as a result of vaginal penetration
4. Marked tensing or tightening of the pelvic floor muscles during attempted vaginal
penetration.
Female orgasmic disorder Presence of either of the following on all or almost all (75-100%) occasions of sexual
activity:
1. Marked delay in, marked infrequency of, or absence of orgasm.
2. Markedly reduced intensity of orgasmic sensations
Joint terminology from the International Society for the Study of Women's Sexual Health and the North American Menopause Society
Genitourinary Syndrome of Menopause The genitourinary signs and symptoms of menopause that arise from decreasing level of
estrogens and other steroids. This includes burning and irritation of reproductive
organs and structures, dryness, pain with intercourse and urinary urgency, dysuria and
recurrent infections.

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Diseases 10th edition (ICD-10), and the Joint Terminology signs and symptoms need be present, but the symptoms must
from the fourth International Consultation of Sexual Medi- be bothersome and not better accounted for by another
cine (ICSM) all have proposed diagnoses for sexual disorders diagnosis.113
in women. Many of the diagnoses from the various societies
overlap; we have chosen the diagnoses from the DSM 5, as
8 | TERMS FOR CONSERVATIVE
well as the diagnosis of genitourinary syndrome of meno-
TREATMENTS
pause as these diagnoses seem most relevant to the population
of women with pelvic floor dysfunction, as shown in Table 2.
8.1 | Lifestyle modification
The DSM 5 has combined disorders that overlap in
presentation and reduced the number of disorders from six to Alterations of certain behaviors may improve sexual function.
three. Hypoactive sexual desire disorder (HSDD) and female These include weight loss, appropriate sleep, adequate
sexual arousal disorders (FSAD) have been combined into physical fitness, and management of mood disorders.114–118
one disorder, now called Female Sexual Interest/Arousal Vulvovaginal pain may be treated by dietary changes and
Disorder (FSIAD), based on data suggesting that sexual perineal hygiene (avoiding irritant soaps, detergents, and
response is not always a linear, uniform process, and that the douches), although data are conflicting.119 Dietary modifi-
distinction between certain phases, particularly desire and cations may be disorder specific including low oxalate diet as
arousal, may be artificial. Although this revised classification reduction in dietary levels of oxalate may improve symptoms
has not been validated clinically and is controversial, it is the of vulvodynia,120 or a bladder friendly diet with reductions in
new adopted standardization. One reason offered for the new acidic foods and bladder irritants may treat bladder pain and
diagnostic name and criteria were clinical and experimental associated sexual pain.121,122
observations that sexual arousal and desire disorders typically
co-occur in women and that women may therefore experience
8.2 | Bibliotherapy
difficulties in both.110,111
The DSM-IV categories of vaginismus and dyspareunia Use of selected books and videos to aid in treatment and
have been combined to create “genito-pelvic pain/penetration reduce stress. Shown to improve sexual desire.123,124
disorder” (GPPPD). Female Orgasmic Disorder remains its
own diagnosis. The DSM 5 has also changed the relevant
specifiers of these disorders with the goal of increasing 8.3 | Topical therapies
objectivity and precision and to avoid over-diagnosis of Lubricants and moisturizers-Application of vaginal lubricant
transient sexual difficulties. In particular, all diagnoses now during sexual activity or vaginal moisturizers as maintenance
require a minimum duration of approximately 6 months and may assist with atrophic symptoms and dyspareunia.125–127
are further specified by severity. Examples of some lubricants are described below, although
Genitourinary syndrome of menopause (GSM) is a new no one lubricant or moisturizer has been adequately studied to
term introduced by the International Society of Sexual recommend it over others. Additionally, not all products are
Medicine to describe a variety of symptoms which may be available in all countries.
associated with sexual health. Although not validated, this
diagnosis was introduced in an effort to improve communi-  Essential arousal oil: Feminine massage oil applied to
cation between providers and patients regarding symptoms vulva prior to activity. Some evidence to support efficacy
which may be difficult to discuss. While not a sexual in treatment of sexual dysfunction, including arousal and
dysfunction diagnosis, given the age of women who typically orgasm, compared with placebo.128,129
develop pelvic floor dysfunction, symptoms associated with  Vulvar soothing cream: Non-hormonal cream containing
GSM may be relevant to the assessment of the sexual health of cutaneous lysate, to be applied twice daily. Study shows
women with pelvic floor dysfunction. improvement in vulvar pain with use compared to
For each of the DSM-5 diagnoses, providers should placebo.130,131
indicate whether or not the condition is lifelong or acquired,  Prostaglandin E1 analogue, may help increase genital
generalized of situational, and rate the severity as mild, vasodilation. Ongoing trials to determine efficacy in
moderate or severe in terms of the distress it causes. All of the arousal or orgasmic dysfunction.131–133
diagnoses, except for the pain diagnoses, need to meet the
criterion that it has been present for 6 months, causes
significant distress, and are not a consequence of non-sexual
8.4 | Psychological intervention
mental disorder, severe relationship distress and are not solely
or primarily attributable to a medication or underlying Counseling and therapy are widely practiced treatments for
illness.112 For genitourinary syndrome of menopause, not all female sexual dysfunction.114,134 Even when a sexual

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problem's etiology and treatment is primarily urogenital, once  Vaginal vibrators, external and internal: May be associated
a problem has developed there are typically psychological, with improved sexual function, data controversial.143,144
sexual, relationship, and body image consequences and it may Possibility that use of vibrators for self-stimulation may
be tremendously validating and helpful for these women to be negatively impact sexual function with partner related
referred to counselors or therapists with expertise in sexual activity.145
problems. Psychological interventions include cognitive  Vaginal exercising devices: Pelvic muscle strengthening
behavioral therapy (CBT), sex therapy, and mindfulness tools in form of balls, inserts or biofeedback monitors.
training. While there is insufficient evidence with regard to May improve pelvic floor muscle tone and coordination
controlled trials studying the efficacy of psychological by improving ability to contract and relax. Studies are
treatment in women with sexual dysfunction, the available lacking assessing their use without concurrent physical
evidence suggests significant improvements in sexual therapy.
function after intervention with traditional sex therapy and/  Fractional CO2 laser treatment: Use of thermoablative
or cognitive behavioral therapy. laser to vaginal mucosa may improve microscopic
Specific techniques include: structure of epithelium.146–148 This results in increased
thickness, vascularity, and connective tissue remodeling,
 Sex therapy: Traditional treatment approach with aim to which can improve climacteric symptoms. Although long
improve individual or couple's sexual experiences and term data are lacking, some studies have shown
reduce anxiety related to sexual activity.114 significant improvements in subject symptoms of vaginal
 Cognitive-behavioral therapy: Incorporates sex therapy dryness, burning, itching, and dyspareunia as well as
components but with larger emphasis on modification of quality of life.147,149,150
thought patterns that may interfere with sexual
pleasure.114
8.5.1 | Alternative treatments
 Mindfulness: An ancient eastern practice with Buddhist
roots. The practice of “relaxed wakefulness,” and “being  Acupuncture: Ancient Chinese practice that involves
in the moment,” has been found to be an effective insertion of small needles into various points in the body in
component of psychological treatments for sexual an effort to heal pain or treat disease. It may help with stress
dysfunction.135–137 reduction, pelvic pain, and sexual dysfunction.122,151,152

8.5.2 | Physical therapy

8.5 | Non-pharmacologic treatments
Manual therapy: Techniques that include stretching, my-
 Clitoral suction device: Non-pharmacological treatment, ofascial release, pressure, proprioceptive neuromuscular
this is a battery-operated hand held device, designed to be facilitation, and massage applied externally on the perineum
placed over the clitoris. It provides a gentle adjustable and internally to increase flexibility, release muscle tensions
vacuum suction with low-level vibratory sensation. and trigger points in the pelvic floor muscles. It was found to
Intended to be used three or more times a week for be effective to improve sexual function in women with pelvic
approximately 5 min at a time, this therapy has been shown floor disorders in recent meta-analysis and systematic
to increase blood flow to the clitoral area as well as to the review.17,153,154 These therapies have also been found helpful
vagina and pelvis.117 Small non-blinded studies have in women with genito-pelvic pain.155
shown it may significantly improve arousal, orgasm, and
overall satisfaction in patients with sexual arousal  Pelvic muscle exercises with or without biofeedback: May
disorder.137,138 improve sexual function in women with pelvic floor
 Vaginal dilators: Vaginal forms or inserts, dilators are disorders154 or pain.122
medical devices of progressively increasing lengths or girths  Dry needling: Placement of needles without injection in
designed to reduce vaginal adhesions after pelvic malig- myofascial trigger points.156
nancy treatments or in treatment of vulvar/vaginal  Trigger point injections
pain.139,140 Can be useful for perineal pain or introital i. Anesthetic: Injection of local anesthetics, often Lido-
narrowing following pelvic reconstructive repairs, however, caine, directed by trigger point palpation, can be
routine use after surgery not supported.141 Dilators can also external or transvaginal.156–158
be used for pelvic floor muscle stretching (ie, Thiele ii. Botox: Injection of Botulinum toxin type A, a potent
massage) and was found helpful in women with interstitial muscle relaxant, into refractory myofascial trigger
cystitis and high-tone pelvic floor dysfunctions.142 points to reduce pelvic pain.122,156,157

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8.6 | Prescription treatments two types of HASDD subjects: low sensitivity to sexual cues,
or prone to sexual inhibition. Tailoring on demand therapeu-
8.6.1 | Hormonal tics to different underlying etiologies may be useful to treat
common symptoms in women with lack of sexual interest and
 Estrogen: Available via prescription for both systemic use
provide the appropriate therapy. Testosterone is supplied as a
(oral or transdermal preparations); or locally use (creams,
short acting agent 4 h prior to sexual event to lessen the side
rings, or tablets). May assist with overall well-being, sexual
effect/risk profile.168–171
desire, arousal, and dyspareunia.117,127,159 Role for topical
use in treatment of post-surgical atrophy or mesh
 Apomorphine: Nonselective dopamine agonist that may
extrusion.160
enhance response to stimuli.133,172
 Ospemifene: Selective estrogen receptor modulator for
 Antidepressants and Neuropathics: Include tricyclic anti-
treatment of moderate to severe dyspareunia related to
depressants, and anticonvulsants, may be useful in treating
vulvar and vaginal atrophy, in postmenopausal women.161–
163 sexual pain, and vulvar pain.120,122
Acts as an estrogen agonist/antagonist with tissue
 Bupropion: Mild dopamine and norepinephrine reuptake
selective effects in the endometrium
inhibitor and acetylcholine receptor antagonist, it may
 Testosterone: Not approved for use in women in the USA
improve desire and decrease distress or modulate Selective
or UK, may be available in other countries. Variety of
Serotonin Reuptake Inhibitor (SSRI) induced FSD.173
preparations including transdermal, oral, or pellet admin-
istration. Long term safety unknown, studies suggest
Supplemental Table S2 presents studies evaluating the
improvements in satisfying sexual events, sexual desire,
effect of various treatments on sexual dysfunction.
pleasure, arousal, orgasm, and decreased distress.114,127,133
 Tibolone: Synthetic steroid with estrogenic, progestogenic,
and androgenic properties. It is not currently available in 9 | SURGERY
the USA. Studies have suggested a positive effect on sexual
function with use.159 9.1 | The effect of pelvic reconstructive
 Prasterone: dehydroepiandrosterone suppository available surgery for prolapse and incontinence on
as a vaginal insert. It has been shown to be efficacious when sexual health
compared to placebo in decreasing vulvovaginal
Women with pelvic floor dysfunction commonly report
atrophy.164
impaired sexual function, which may be associated with the
underlying pelvic floor disorder. Treatment of the
8.6.2 | Non hormonal underlying disorders may or may not impact sexual
function.13 While both urinary incontinence and pelvic
 Bremelanotide; formerly PT-141- Melanocortin agonist, organ prolapse affect sexual function, prolapse is more
initially developed as a sunless tanning agent, utilizes a likely than urinary incontinence to result in sexual
subcutaneous drug delivery system. Treatment signifi- inactivity. Prolapse is also more likely to be perceived
cantly increased sexual arousal, sexual desire, and number by women as affecting sexual relations and overall sexual
of sexually satisfying events with associated decreased satisfaction. This perception is independent of diagnosis or
distress in premenopausal women with FSD.165 therapy for urinary incontinence or prolapse.29,174,175 Very
 Serotonin receptor agonist/antagonist; Flibanserin-5-hy- little is known about the impact of fecal incontinence on
droxytryptamine (HT)1A receptor agonist and 5-HT2A sexual function.14 The effect of pelvic reconstructive
receptor antagonist, initially developed as antidepressant. surgery on sexual function has increased but there is
Challenges in FDA applications, due to possible long term need for more focused research.30,176 Overall, randomized
risks. Studies show improved sexual desire, satisfying trials are lacking, varied outcome measures are used among
sexual events, and reduced distress.166,167 studies.18 There is a lack of reporting per DSM-IV/DSM 5
 Dual control model in differential drug treatments for categories and a lack of long-term follow-up. Level of
hypoactive sexual desire disorder and female sexual Evidence (LOE) is poor in many studies, and sexual
arousal disorder: dysfunction is usually reported as a secondary outcome
i. Testosterone in conjunction with phosphodiesterase measure. While any surgery can impact sexual function
type 5 inhibitor (PDE-5) postoperatively, most commonly performed pelvic floor
ii. Testosterone in conjunction with a 5-HT1A agonist surgeries were not designed with the intent to improve
sexual function. In general, successful surgical treatment of
May be able to target physiologic and subjective measures incontinence or prolapse may improve sexual symptoms
of sexual functioning in a more specific manner. Premise of associated with the underlying disorder. For example,

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coital incontinence improves after sling surgery, but important, assessments limited to descriptions of sexual pain
whether it impacts other aspects of sexual function such are not an adequate assessment of sexual health, and absence
as orgasm, desire, or arousal is unclear.18 Surgery for of pain should not be inferred to indicate that sexual function
prolapse may improve underlying symptoms of laxity or is intact or changed.
embarrassment from bulge, which in turn may improve At a minimum, sexual activity status should be assessed.
sexual function, but does not seem to have a direct impact Assessment of sexual activity status should be self-defined
on other aspects of sexual function. A small but significant and not limited to women who engage in sexual intercourse.
number of patients will develop pain or other sexual In addition, it is important to not assume the gender of the
disorders following surgery. These pain disorders spring woman's partner. When reporting level of sexual activity,
from a variety of causes including those caused by the use authors should report numbers of all patients who are sexually
of grafts. Prediction of who will develop these pain active (or inactive), with and without pain, pre- and post
disorders is challenging. A recent paper which evaluated intervention.
the effect of vaginal surgery on sexual function reported In addition to sexual activity status, its associated level of
that women overall reported improved function, decrease in bother should be documented. Use of validated patient reported
dyspareunia rates, and that de novo dyspareunia rates were outcome questionnaires to further assess the quality of sexual
low at 5% at 12 months and 10% at 24 months.177 function should also be considered. These and other self-
Nonetheless, assessment of sexual activity and partner reported outcomes including sexually satisfying events and
status and function prior to and following surgical sexual diaries are described in Section 4, in this document.
treatment is essential in the evaluation of surgical Assessment of the impact of pelvic floor disorder treatment on
outcomes. Because of the negative impact of pain on women's sexual partners should also be considered. Con-
sexual function, assessment of sexual pain prior to and ditions, among others, that commonly impact sexual function
following procedures should also be undertaken. include hormonal status, body image, underlying medical
conditions, and history of sexual abuse. Researchers may want
to consider inclusion of these outcomes.
9.2 | Female genital cosmetic surgery
A number of surgeries have been developed that aim to improve
11 | LIMITATIONS
sexual function by altering the appearance and/or the function of
female genital tract. Evidence supporting the efficacy and safety
This document includes a broad overview of terms important
of these procedures is lacking. In addition, standardized
in the diagnosis and treatment of women with pelvic floor
definitions of these procedures may help foster high quality
disorders. We have not included an in-depth description of all
research, standardization of technique, and outcome measure-
sexual disorders as this is beyond the scope of this document.
ment in this field, but is currently lacking, and beyond the scope
Some disorders such as the persistent vulvar pain and
of this document. These procedures include, but are not limited
vulvodynia are described elsewhere and we have tried to
to, labioplasty, vaginoplasty, laser vaginoplasty, perineoplasty,
reference these documents as appropriate.37 Not all manage-
laser rejuvenation, clitoral de-hooding, labia majora augmenta-
ment strategies presented are supported by robust evidence as
tion, G spot amplification, laser treatment of vulvovaginal
to their efficacy; we have tried to include the data that
atrophy, and platelet risk plasma treatments.
supports interventions as it is available. In addition, there are
ongoing debates regarding terms and diagnoses. For example,
10 | CONSIDERATIONS FOR subsequent to the publication of the DSM-5, the International
REPORTING IN RESEARCH Consultation on Sexual Medicine (ICSM) in 2015,180 and the
International Society for Study of Women's Sexual Health
Sexual health should be included as an outcome for reporting (ISSWSH)181 published consensus papers on the nomencla-
research related to pelvic floor dysfunction; this is particularly ture for female sexual dysfunctions. Based on the available
important in the case of surgical interventions as adverse or evidence regarding clinical presentation, risk factors, and
advantageous sexual function outcomes would likely impact treatment response, both organizations recommended main-
patient's choice and satisfaction with interventions. The taining desire and arousal as distinct and separate clinical
IUGA ICS Joint Report on terminology39 for reporting entities.
outcomes of surgical procedures for POP described in detail
items to be considered when reporting outcomes for prolapse
ACKNOWLEDGMENTS
surgical intervention.18 De novo painful intercourse follow-
ing prolapse surgery should be classified as described in these This document has involved 14 rounds of full review, by co-
documents. While pain and its impact on sexual function is authors, of an initial draft, with the collation of comments.

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The co-authors acknowledge the input to an earlier version of SUI, whereas orgasmic incontinence might be associated with both
this document by Dr. E Lukacz, Dr. V Handa, Dr S Jha, and detrusor overactivity and SUI.23,24 Nevertheless, among women with
Professor Bernard Haylen. The authors further acknowledge OAB, orgasmic incontinence is more common than penetration
incontinence. Coital incontinence on penetration can be cured by
the contributions of members of ICS SSC (2017). The authors
surgery in 80% of women with urodynamically proven SUI. Similarly,
would also like to acknowledge the helpful comments
orgasmic incontinence can respond to treatment with anticholinergics in
provided by Elisabetta Constantini, Beth Shelley, Helena 59% of women with detrusor overactivity.25,26
Frawley, together with the substantial review by ISSWSH. b
Rare condition mostly described in women who have genital
abnormalities such as micro perforate hymen.27
COMPLIANCE WITH ETHICAL c
A third of sexually active women with POP complain that their
STANDARDS prolapse interferes with sexual function.29,30 However, it has been
shown that women with POP have comparable rate of sexual activity to
similarly aged individuals without POP.31,32
Disclaimer: Any products/companies referred to in this
d
document are not necessarily recommended or endorsed by A recent survey of IUGA members noted that 57% of responders
considered vaginal laxity a bothersome condition that impacts
the ICS or IUGA.
relationship happiness and patient's sexual functioning. The most
frequently cited (52.6%) location responsible from laxity was the
CONFLICTS OF INTEREST introitus and the majority of respondents (87%) thought both muscle
and tissue changes were responsible.33
RG Rogers, Royalties from UPTODATE; R Pauls, no e
Dyspareunia rates reported in the literature range from 14 % to 18%.34
disclosures; R Thakar, Vice President of the International f
There is often (phobic) avoidance and anticipation/fear/experience of
Urogynecological Association, Honorariums from Astellas pain, along with variable involuntary pelvic muscle contraction.
and Pfizer for lectures; M Morin, no disclosures; A Kuhn, no Patients with vaginismus could present with severe fear avoidance
disclosures; E Petri, no disclosures; B Fatton, consultant for without vulvar pain or fear avoidance with vulvar pain. Structural or
Astellas, Allergan, Boston Scientific; K Whitmore: Clinical other physical abnormalities must be ruled out/addressed.35 There is
Research, Coloplast, Allergan; S Kingsberg, Paid consultant controversy of whether or not this term should be retained; the
Diagnostic and statistical manual of mental disorders 2013 proposed to
to: Apricus, Emotional Brain, Sprout, Teva, SST, Pfizer,
replace dyspareunia and vaginismus with the term “Genito-Pelvic Pain/
Shionogi, Novo Nordisk, Viveve, Palatin, Metagenenics;
Penetration Disorder (GPPPD).”36
Stock options, Viveve; J Lee, Research Grant from AMS/ g
Decreased vaginal lubrication is often involved in pain with sexual
BSCI for investigator led clinical trials.
activity among postmenopausal women, women with hypo-estrogenic
states for other reasons or after pelvic surgery and may result in
AUTHORS' CONTRIBUTIONS persistent or recurrent vaginal burning sensation with intercourse
(penile or any device).4
RR, JL, RNP, RT, MM, AK, EP, BF, KW, SK contributed in h
A non-relaxing pelvic floor that is mainly associated with dyspareunia.
conception and writing of manuscript. See 4.4.8
i
In certain disorders such as genital herpes, vestibulitis, endometriosis,
or bladder pain syndrome, pain may also occur after non coital
ENDNOTES
stimulation.4
a
Coital incontinence is defined as a complaint of involuntary leakage of j
The term “Hispareunia” has been first suggested by Brubaker in one
urine during or after coitus. Coital incontinence seems to be an editorial to describe partner dyspareunia after sling insertion.38
aggravating factor that women generally describe as humiliating.1 The k
It has been suggested that a distinction could be made between women
prevalence of urinary incontinence during intercourse has been evaluated with sexual arousal concerns that are psychological or subjective in
to range from 2% to 56%, depending on the study population (for eg, the nature (ie, absence of or markedly diminished feelings of sexual
general population or a cohort of women with incontinence), the arousal while vaginal lubrication or other signs of physical response
definition used (any leakage, weekly, on penetration, during orgasm, still occur), those that are genital (impaired genital sexual arousal—
only severe leakage) and the evaluation method used (questionnaire, reduction of the physical response), and those that include complaints
interviews). In a literature review reported in 2002 that covered English- of both decreased subjective and genital arousal.1,4
language papers from 1980 to 2001, Shaw21 reported a 2-10% prevalence l
A normal examination is highly informative to the women and can be of
of coital incontinence in randomly selected community samples. The
reassurance value.4
physio pathological mechanisms involved have been widely debated,22
m
with bladder overactivity conventionally being implicated in orgasmic Other conditions that may influence sexual function are fissures,
incontinence and SUI in penetration incontinence. In the past 5 years, vulval excoriation, skin rashes, cysts, and other tumors, atrophic
studies however, have underlined the role of the urethral sphincter in changes or lichen sclerosis, scars, sinuses, deformities, condylomata,
coital incontinence, which is thought to be crucial even in women with papillomata, hematoma.
detrusor overactivity and orgasmic incontinence.23 The penetration form n
Increased blood flow in the vaginal walls associated with arousal
of coital incontinence is largely associated with urodynamics findings of increases the force in the vaginal walls, which drives transudation of

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NaCl+-rich plasma through the vaginal epithelium, coalescing into the 2. Shifren JL, Monz BU, Russo PA, Segretti A, Johannes CB. Sexual
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p
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defined as hypotonic, normal, and hypertonic,41 or assessed using management. Fertil Steril. 2007;88:1273–1284.
Reissing's 7 point scale from −3 to +3.42 Squeeze pressure or strength 5. Basson R, Althof S, Davis S, et al. Summary of the
during voluntary and reflex contraction can also be graded as strong, recommendations on sexual dysfunctions in women. J Sex Med.
normal, weak, absent, or alternatively by using a validated grading 2004;1:24–34.
system such as Brink's scale or the PERFECT scheme.42–44 These 6. Fashokun TB, Harvie HS, Schimpf MO, et al. Sexual activity and
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142. Idama TO, Pring DW. Vaginal dilator therapy- an outpatient under electromyographic guidance for women with refractory high-
gynaecological option in the management of dyspareunia. J Obstet tone pelvic floor dysfunction: a 6 month prospective pilot study.
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143. Herbenick D, Reece M, Sanders S, Dodge B, Ghassemi A, 159. Modelska K, Cummings S. Female sexual dysfunction in
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ultrastructural modifications of postmenopausal atrophic vaginal 163. Constantine G, Graham S, Portman DJ, Rosen RC, Kingsberg SA.
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M. Efficacy and safety of flibanserin in postmenopausal women Gynecol. 2016;127:1071–1079.
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health of women with pelvic floor dysfunction
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Received: 11 July 2016

| Accepted: 2 August 2016

DOI 10.1002/nau.23107

SPECIAL CONTRIBUTION

An International Urogynecological Association (IUGA)/

International Continence Society (ICS) joint report on the
terminology for the conservative and nonpharmacological
management of female pelvic floor dysfunction

Kari Bo1 | Helena C. Frawley2 | Bernard T. Haylen3 | Yoram Abramov4 |

Fernando G. Almeida5 | Bary Berghmans6 | Maria Bortolini5 |
Chantale Dumoulin7 | Mario Gomes8 | Doreen McClurg9 | Jane Meijlink10 |
Elizabeth Shelly11 | Emanuel Trabuco12 | Carolina Walker13 | Amanda Wells14
1 Department of Sports Medicine, Norwegian School

of Sport Sciences, PO Box 4014, Ullevål Stadion, Introduction and hypothesis There has been an increasing need for the terminology
0806, Oslo, Norway on the conservative management of female pelvic floor dysfunction to be collated in
2 Cabrini Health, La Trobe University, Melbourne,
a clinically based consensus report.
Australia
Methods This Report combines the input of members and elected nominees of the
3 University of New South Wales, Sydney, NSW,
Standardization and Terminology Committees of two International Organizations,
Australia
4 Technion
the International Urogynecological Association (IUGA) and the International
University, Haifa, Israel
5 Federal
Continence Society (ICS), assisted at intervals by many external referees. An
University, São Paolo, Brazil
6 Maastricht University Medical Centre, Maastricht,
extensive process of nine rounds of internal and external review was developed to
Netherlands exhaustively examine each definition, with decision-making by collective opinion
7 University of Montreal, Montreal, QC, Canada
(consensus). Before opening up for comments on the webpages of ICS and IUGA,
8 Centro Hospitalar Porto, Oporto, Portugal
five experts from physiotherapy, neurology, urology, urogynecology, and nursing
9 Glasgow Caledonian University, Glasgow, UK were invited to comment on the paper.
10 Naarden, Netherlands
Results A Terminology Report on the conservative management of female pelvic
11 Moline, IL, USA
floor dysfunction, encompassing over 200 separate definitions, has been developed. It
12 Mayo Clinic, Minnesota, USA is clinically based, with the most common symptoms, signs, assessments, diagnoses,
13 Hospital Universitario Quirón, Madrid, Spain
and treatments defined. Clarity and ease of use have been key aims to make it
14 University of Exeter, Exeter, UK
interpretable by practitioners and trainees in all the different specialty groups involved
Correspondence
in female pelvic floor dysfunction. Ongoing review is not only anticipated, but will be
Kari Bo, Department of Sports Medicine, Norwegian required to keep the document updated and as widely acceptable as possible.
School of Sport Sciences, PO Box 4014, Ullevål Conclusion A consensus-based terminology report for the conservative manage-
Stadion, 0806, Oslo, Norway
Email: Kari.bo@nih.no
ment of female pelvic floor dysfunction has been produced, aimed at being a
significant aid to clinical practice and a stimulus for research.

KEYWORDS
consensus, conservative management, female, pelvic floor dysfunction, terminology

This document is being published simultaneously in Neurourology and Urodynamics (NAU) and the International Urogynecology Journal (IUJ), the respective journals of the
sponsoring organizations, the International Continence Society (ICS) and the International Urogynecological Association (IUGA). IUJ DOI: 10.1007/s00192-016-3123-4
Standardization and Terminology Committees of the IUGA* and ICS#: Bernard T. Haylen*, Jane Meijlink#, Elizabeth Shelly#
Joint IUGA/ICS Working Group on the Conservative Management of Pelvic Floor Dysfunction: Kari Bo, Helena Frawley, Bernard Haylen, Yoram Abramov, Fernando
Almeida, Bary Berghmans, Maria Bortolini, Chantale Dumoulin, Mario Gomes, Doreen McClurg, Jane Meijlink, Elizabeth Shelly, Emanuel Trabuco, Carolina Walker, and
Amanda Wells

Neurourol Urodynam 2016; 9999: 1–24 wileyonlinelibrary.com/journal/nau © 2016 Wiley Periodicals, Inc., and The International Urogynecological Association | 1

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INTRODUCTION Pelvic floor dysfunction: following on from Messelink

et al.'s report from the Pelvic Floor Clinical Assessment
There is currently no single document addressing the conserva- Group of the ICS,2 this report will focus on the terminology of
tive management of female pelvic floor dysfunction in a the management of pelvic floor function and dysfunction,
comprehensive way. The report is based on, and follows on including bladder and bowel dysfunction, pelvic organ
from, the terminology proposed by the International Continence prolapse (POP), sexual dysfunction, and pelvic pain.4
Society (ICS) Standardization of Terminology of Lower Urinary Terminology regarding pelvic pain and anorectal dysfunction
Tract Function,1 the Standardization of Terminology of Pelvic related to PFM dysfunction aligns with the current working
Floor Muscle Function and Dysfunction: Report from the Pelvic groups on chronic pelvic pain and anorectal dysfunction.
Floor Clinical Assessment group of the International Continence Terminology includes symptoms, signs, and investigations
Society,2 and the International Urogynecological Association (expanding on Messelink et al.'s paper2; diagnoses of
(IUGA)/International Continence Society (ICS) Joint Report on PFM-related conditions (avoiding duplication with Haylen
the Terminology for Female Pelvic Floor Dysfunction.3 et al.3); prevention and treatment (including new therapies,
The terminology in current use related to conservative e.g., exercise and adjunctive therapies, including equipment,
management generally lacks uniformity, often because different and lifestyle modifications not covered by Messelink et al.2 or
disciplines use their own terminology. The range of terms in use Haylen et al.3
can lead to uncertainty, confusion, and unintended ambiguity. It Additional descriptions related to the terms used in this
hampers the ability to build a body of literature concerning manuscript are:
conservative interventions, e.g., the terms “behavioral therapy,” Clinicians/practitioners: conservative management of
“lifestyle intervention,” “conservative treatment,” “nonsurgical PFD may be provided by clinicians or practitioners of
treatment,” “physiotherapy,” “biofeedback,” and “pelvic floor different disciplines, commonly physiotherapists/physical
muscle exercise” are often used interchangeably and, at times, therapists, nurses, midwifes, and medical doctors. However,
incorrectly, to describe both the same and different interven- other professions, e.g., fitness instructors and personal
tions. A more standardized terminology would aid interdisci- trainers, may also play a role in education, health promotion,
plinary communication and understanding. and prevention of PFD. Terminology related to the accepted
Existing published reports address some of the aspects of names of professions and the different types of therapies must
this topic, but there are some areas of terminology currently be specified and distinguished (e.g., “physiotherapy” as a
lacking standardization, e.g., Messelink et al.2 and Haylen management provided by a registered physiotherapist, as
et al.3 refer to evaluation and diagnostic terminology, but not distinct from “conservative therapy” and “exercises”/“bio-
to treatment terminology. feedback,” which may be provided by any clinician).
There is a need for a more extensive description of the The emphasis in this document will be on management
management of the pelvic floor and pelvic floor muscle commonly undertaken by clinicians practicing conservative
(PFM) dysfunction than is currently provided in existing management.
terminology reports. With the development of the evidence Multidisciplinary approach: relating to, or involving, two
base for conservative therapies in the management of pelvic or more disciplines that are usually considered distinct,5 e.g.,
floor dysfunction (PFD), especially treatment of conditions physical therapy, urology, gynecology
such as incontinence and pelvic organ prolapse (POP), Gender: with the increasing specificity and complexity
terminology linked with these managements has evolved, of female diagnosis and management it can be argued that a
but with regional and discipline variations. A consensus on gender-specific report is needed. However, many of the
currently accepted terminology is required. Elements in the terms defined in this report are not gender-specific and are
title of the document need to be defined: the same for males, e.g., PFM training and electrical
Conservative: restricted to nonsurgical and nonpharma- stimulation. This report does not preclude an additional
cological approaches. future report on male pelvic floor dysfunction
Management: includes the following aspects:

a) Assessment: including history and physical examination

and investigations
METHODOLOGY
b) Diagnosis
c) Prevention All working group members were asked to provide terms
d) Treatment of pelvic floor dysfunction that they knew existed in the area. After the first
“brainstorming activity,” all terms were listed and grouped
Pelvic floor: structures located within the bony pelvis, i.e., according to introduction, symptoms, signs, examination
urogenital and anorectal viscera, PFM and their connective methods, investigations, diagnosis, prevention, and treat-
tissues, and nerves and blood vessels. ment. All members were given the text to which to add

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) joint report on the terminology for the conservative and
nonpharmacological management of female pelvic floor dysfunction
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BO ET AL.
| 3

more terms. Additional searching for omitted terms in Lower urinary tract pain and/or other pelvic painendnote 2

existing terminology papers of the ICS and IUGA,

Cochrane reviews, and the 2013 ICI document6 was 1. Pain (in general): “an unpleasant sensory and emotional
undertaken. Existing definitions of established terms from experience associated with actual or potential tissue
general medicine,7,8 physiotherapy,5 and exercise science damage, or described in terms of such damage”.11
were used where available. Only in situations where there 2. Tenderness: sensation of discomfort with or without pain;
was no existing terminology were new definitions intro- discomfort elicited through palpation, indicates unusual
duced. We have not referred to or described the sensitivity to pressure or touch.12
responsiveness, reliability, and validity of the measurement 3. Acute pain: pain related to acute trauma, infection or other
methods of symptoms, signs, and evaluations, nor have we well-defined disease processes or conditions.
acknowledged the evidence for the treatment efficacy of any 4. Chronic pain: persistent or continuous/recurrent pain for at
of the therapies defined. least 6 months. If non-acute and central sensitization pain
Agreement on the definitions was reached by consensus.
mechanisms are well documented, then the pain may be
Wherever possible, evidence-based principles were followed. regarded as chronic, irrespective of the time period.13,14
However, this was a challenge in conservative management,
5. Myalgia: muscle pain. Pelvic floor myalgia (a symptom)
as there are many suggested therapies that do not have proven
may be present with or without a change in PFM tone
effectiveness.9,10 Discussion meetings with representatives
(a sign).endnote 3
of the IUGA and ICS were held at the following annual
meetings: IUGA Brisbane 2012, ICS Beijing 2012, IUGA 6. Myofascial pain: pain caused by the presence of trigger
Dublin 2013, ICS Barcelona 2013, IUGA-AUGS Wash- points within muscles or their fascia.15, endnote 4
ington DC 2014, and IUGA Nice 2015.
It is recommended that acknowledgment of these Signs
standards in written publications related to the conservative
management of female pelvic floor dysfunction is stated as Sign: any abnormality indicative of disease or a health
follows: “Methods, definitions, and units conform to the problem, discoverable on examination of the patient; an
standards jointly recommended by the IUGA/ICS Joint objective indication of disease or a health problem.1
Report on the Terminology for the Conservative and
Nonpharmacological Management of Female Pelvic Floor Existing (defined) signs
Dysfunction, except where specifically noted.”
1. Urinary incontinence signs:3
a) UI3
b) Stress (urinary) incontinence3
ASSESSMENT
c) Urgency (urinary) incontinence3
Symptoms d) Extraurethral incontinence3
e) Stress incontinence on prolapse reduction (occult or
Symptom: any morbid phenomenon or departure from the
latent stress incontinenc3
normal in structure, function or sensation, experienced by
the woman and indicative of disease or a health problem. 2. Pelvic organ prolapse signs:3
Symptoms are either volunteered by, or elicited from the a) Uterine/cervical prolapse3
individual, or may be described by the individual's b) Vaginal vault (cuff scar) prolapse3
caregiver.3
c) Anterior vaginal wall prolapse3

Existing (defined) symptoms d) Posterior vaginal wall prolapse3

3. Other pelvic examinations/signs3:
1. Urinary incontinence (UI) symptoms3
a) Vulval abnormalities3
2. Bladder storage symptoms3
b) Urethral mucosal prolapse3
3. Sensory symptoms3
c) Urethral caruncle3
4. Voiding and postmicturition symptoms3
d) Urethral diverticulum3
5. POP symptoms3
e) Total vaginal length (TVL): the distance from the
6. Symptoms of sexual dysfunction3 posterior fornix to the hymen.16
7. Symptoms of anorectal dysfunction3, endnote 1
f) Valsalva maneuver: the action of attempting to exhale
8. Lower urinary tract infection UTI 3
with the nostrils and mouth, or glottis closed.7 Valsalva

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| BO ET AL.

is usually performed with digital closure of the nose, as dorsal perineal movement in response to increased intra-
when trying to equalize pressure in an airplane. abdominal pressure in the absence of incontinence or POP.
Straining/bearing down may have a similar meaning 3. Muscle tone: state of the muscle, usually defined by its
to Valsalva; however, in practice, straining/bearing resting tension, clinically determined by resistance to
down may be interpreted as meaning pushing down- passive movement.19–21 Muscle tone has two compo-
ward and trying to relax the pelvic floor, as when nents: the contractile component, created by the low-
defecating.
frequency activation of a small number of motor units,
g) Bimanual pelvic examination3 and the viscoelastic component, which is independent of
h) Perineal elevation: inward (ventrocephalad) movement neural activity and reflects the passive physical properties
of the vulva, perineum, and anus during, for example, of the elastic tension of the muscle fiber elements and the
PFM contraction. osmotic pressure of the cells.19, endnote 6
i) Perineal descent: excessive dorsocaudal movement of a) Hypertonicity: an increase in muscle tone related to
the vulva, perineum, and anus, for example, during the contractile or viscoelastic components that can be
coughing, Valsalva or straining.3,17 associated with either elevated contractile activity
j) Trophic: promoting cellular growth, differentiation, and/or passive stiffness in the muscle.20,22 The terms
and survival.8 This is the normal status of an organ, neurogenic hypertonicity and non-neurogenic hyper-
tissue or cell with regard to nutrition, size, number, tonicity are recommended to describe the diagnosis
form, and function. A trophic urogenital tract is usually and inform management.
well-estrogenized. b) Hypotonicity: a decrease in muscle tone related to the
k) Atrophic: decrease from previous normal size of the contractile or viscoelastic components that can be
body or a part, cell, organ, or tissue. An organ or body associated with either reduced contractile activity and/
part's cells may be reduced in number, size or both. or passive stiffness in the muscle. The terms
Atrophy of some cells and organs is normal at certain neurogenic hypotonicity and non-neurogenic hypoto-
points in the life cycle. Other causes include malnutri- nicity are recommended to describe the diagnosis and
tion, disease, disuse, injury, and hormone over- or inform management.endnote 7
underproduction.8, endnote 5 4. Stiffness: resistance to deformation.23 Passive elastic
4. Anal signs18 stiffness is defined as the ratio of the change in the passive
resistance or passive force (ΔF) to the change in the
5. Abdominal signs
length displacement (ΔL) or ΔF/ΔL.24 The term should
a) Bladder fullness/retention: abdominal palpation or only be used if stiffness is measured quantitatively, such
suprapubic percussion may indicate a full bladder; as with the use of instruments such as dynamometry or
however, in overweight patients this may not be easily myotonometry.
detected.
5. Tension: may have a similar meaning to tone and
b) Pelvic bone irregularities: indication of a previous stiffness. Muscle tension can be increased or decreased
fracture or sacral agenesis. because of exogenous factors such as the amount of
6. Neurological signs: abnormalities of the nervous system pressure applied and endogenous factors such as
detected by physical examination that reflect an underlying thickness/cross-sectional area of the muscle itself, fluid
neurological disease or injury. Examples of abnormal present within the muscle (swelling, inflammation),
signs may include altered sensation, muscle tone or position (e.g., standing versus sitting) or increased neural
reflexes. If present, the patient should be referred for a full activity.
neurological examination. 6. Spasm: persistent contraction of striated muscle that
cannot be released voluntarily. If the contraction is
painful, this is usually described as a cramp. Spasms
Pelvic floor muscle function signs
occur at irregular intervals with variable frequency
1. Normal PFM: have a level of constant resting tone and extent,25 and over days or weeks may lead to a
(except just before and during voiding and defecation), contracture.
symmetry, and the ability to voluntarily and involuntarily 7. Contracture: an involuntary shortening of a muscle.
contract and relax. Clinically, a muscle cramp and contracture may appear
2. Normal PFM contractile function: a constriction and similar; however, contractures are electrically silent.26
inward (ventrocephalad) movement of the pelvic open- 8. Cramp: a painful involuntary muscle contraction that
ings. Normal, well-functioning pelvic floor muscles may occurs suddenly and can be temporarily debilitating. Pain
demonstrate some (controlled or limited) downward is intense and localized. It tends to occur when the muscle

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) joint report on the terminology for the conservative and
nonpharmacological management of female pelvic floor dysfunction
236

BO ET AL.
| 5

is in the shortened position and contracting, is develop near maximal or maximal force determined
generated by motor units, and displays a high firing by assessing the maximum number of repetitions
rate (20–150 Hz).26, endnote 8 the patient can perform at a given percentage of
9. Fasciculation: a single, spontaneous, involuntary dis- 1RM.35
charge of an individual motor unit. The source generator d) Muscle power: the explosive aspect of strength;
is the motor unit or its axon, before its terminal branches. the product of strength and speed of movement
Fasciculations display an irregular firing pattern of low (force × distance/time).35
frequency (0.1–10 Hz).5,26 Clinically, fasciculations are e) Co-ordination: property of movement characterized by
recognized as individual brief twitches. They may occur the smooth and harmonious action of groups of muscles
at rest or after muscle contraction and may last several working together to produce a desired motion.5
minutes. f) Motor control: the ability of the nervous system to
10. Tender point: tenderness to palpation at soft-tissue body control or direct the muscles in purposeful movements
sites.19 and postural adjustment by selective allocation of
muscle tension across appropriate joint segments.5,36
11. Trigger point (TrP): a tender, taut band of muscle that can
be painful spontaneously or when stimulated.27 The taut g) Submaximal contraction: all contractions without
band is electrically silent.endnote 9 maximal effort, expressed as a percentage of 1RM.
12. Pelvic floor muscle dyssynergia2: incoordination of the h) Synergistic contraction: the combination of several
PFM and another muscle group during a functional muscle actions that serve to optimally achieve a motor
activity, for example, the pelvic floor muscles may not task.37
relax appropriately during micturition or defecation. i) Co-contraction: contraction of two or more muscles at
13. Nonfunctioning PFM (modified from Messelink et al.) : 2 the same time. Co-contraction of muscles can be
a situation in which there is no PFM action measurable synergistic (e.g., resulting in an augmentation of
either on instruction to contract (inability) or as the motor activity) or it could be counterproductive to
absence of an automatic response to an increase in intra- normal function (e.g., contraction of antagonistic
abdominal pressure. This condition can be tbased on any muscles resulting in abnormal movement or training
pelvic floor symptom and on the sign of a noncontracting other muscles instead of the targeted ones, e.g.,
or nonrelaxing pelvic floor. training of gluteal muscles instead of the PFM).
14. Pelvic floor muscle injury (PFMI): on clinical palpation, j) Antagonistic contraction: contraction of muscle/
PFMI is diagnosed when one or more of the following is muscle groups with the opposite action to the desired
present: action (activity that hinders the targeted muscle/
muscle group from contracting).
a) A discontinuity of the puborectalis muscle at its
attachment to the inferior pubic ramus28 16. Other:
b) A distance of >3.5 finger widths between the two a) Hypertrophy: the increase in size (volume) of the
sides of puborectalis muscle insertion29,30 muscle fibers.37
c) A gap in the continuity of the pubovisceral muscle b) Atrophy: the decrease in size of muscle fibers as a
between the pubic rami and the anorectum31 result of inactivity, illness or aging.38
15. Muscle action characteristics: c) Bulk: the absolute volume of a muscle measured using
imaging techniques such as anatomical magnetic
a) Maximal voluntary contraction (MVC): the attempt to
resonance imaging and ultrasound.39
recruit as many fibers in a muscle as possible for the
purpose of developing force.32 MVC of the pelvic d) Anatomic cross-sectional area: for an individual
floor can be assessed by vaginal palpation, manom- muscle, the largest cross-sectional area along the
eters, and dynamometers.endnote 10 length of that muscle and 90° on the muscle length.7
b) Muscle strength: force-generating capacity of a e) Physiological cross-sectional area: the total area of
muscle.5 It is generally expressed as maximal cross-section perpendicular to the muscle fibers.7
voluntary contraction measurements and as the one- f) Flexibility: the ability of a muscle to lengthen and allow
repetition maximum (1RM) for dynamic measure- one joint (or more than one joint in a series) to move
ments.32–34 through a range of motion. Loss of flexibility is defined
c) Local muscle endurance: the ability to sustain near as a decrease in the ability of a muscle to deform.40
maximal or maximal force, assessed by the time a g) Proprioception: sensory information from receptors of
patient is able to maintain a maximal static or muscles, joints, capsules, and ligaments that provides
isometric contraction, or the ability to repeatedly information related to posture and movement.41

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h) Exteroception: sensory information from receptors b) Undetected puborectalis-to-ipsilateral sidewall at-

in the skin registering touch, vibration, heat, and tachment on at least one slice (partial avulsion)43
cold.41 c) A levator–urethra gap (LUG) of greater than 2.5 cm44
2. PFM position in the pelvis: can be measured in the
sagittal plane in relation to defined landmarks, and may
INVESTIGATIONS AND IMAGING be related to PFM dysfunction (elevated or descended
pelvic floor).
All methods and devices used for assessments (e.g., 3. Hiatal dimension: is the cross-sectional area of the pelvic
palpation, manometers, dynamometers, EMG, urodynamics, floor/levator hiatus, including anteroposterior and trans-
ultrasound, and magnetic resonance imaging [MRI]) must be verse distances (Fig. 1).
described in detail, and their responsiveness (ability to detect
small changes), reliability and validity should be reported.42
Radiological imaging

Existing (defined) investigations Videocystourethrography (VCU); intravenous urography

(IVCU); micturating cystography (MCU); defecography;
Urodynamics
colpocystodefecography.
Urodynamics is the functional study of the lower urinary
Magnetic resonance imaging
tract3:
1. PFM injury: can represent a full spectrum, from disruption
1. Uroflowmetry3
3
of a single fascicle, to complete disruption of the muscle
2. Post-void residual (PVR) urine volume origin. At present, there is no universally accepted system
3. Cystometry3 for the diagnosis and evaluation of the extent of the injury.
4. Pressure flow study3 Essentially, abnormalities are judged to have occurred
5. Assessment of urethral function3
a) Urethral pressure measurement3
b) Abdominal leak point pressure (ALPP)3

Frequency–volume chart

The frequency–volume chart (FVC) records the time of

each micturition and the volume voided for at least 24 h,
although 2 or 3 days of recording (not necessarily
consecutive) generally provide more useful clinical data.3

1. Bladder diary: in addition to the FVC, a bladder diary

includes fluid intake, pad usage, number incontinence
episodes, and the degree of incontinence.3

Pad testing

Quantification of the amount of urine lost over the

duration of testing, by measuring the increase in weight of the
perineal pads used (weighed pre- and post-testing).3

Ultrasound imaging

1. PFMI: PFMI is diagnosed on ultrasound when at least one

of the following is present: FIG. 1 Levator hiatal dimensions measured using transperineal ultra-
sound (reproduced with permission from Ingeborg Hoff Braekken). LHap
a) Undetected puborectalis-to-ipsilateral sidewall attach- levator hiatus antero-posterior, LHrl levator hiatus right-left, LHarea
ment on any of the three central slices (full avulsion) levator hiatus area, SP symphysis pubis, t pubovisceral muscle thickness

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when the morphology of the pubococcygeal portion of the Manometer

levator ani muscle deviates from what is seen in normal
A manometer is a device for measuring pressure.
nulliparous women.45 Several groups have studied and
defined levator damage on MRI when one or more of the
Pelvic floor manometry
following is present: absence of pubococcygeal muscle
fibers in at least one 4-mm section, or two or more adjacent
Measurement of resting pressure or pressure rise
2-mm sections in both the axial and the coronal planes.46
generated during contraction of the PFM using a manometer
The degree of injury can be assessed based on the amount
connected to a sensor, which is inserted into the urethra,
of muscle involved in the injury, with reasonable
vagina or rectum. Pelvic floor manometric tools measure
repeatability among different examiners in a single
pressure in mmHg, hPa or cmH2O.42, endnote 11 Conversion of
group.47 More than half the expected muscle bulk is
data to the international standard unit of measurement (hPa) is
associated with the presence of POP.48
recommended (Figs. 3, 4).
2. PFM position in the pelvis: location of the PFM in the
sagittal plane in relation to defined landmarks. They may 1. Perineometer: the first PFM vaginal pressure device
be elevated or descended. connected to a manometer developed by Kegel.49, endnote 12

Palpation Dynamometer
The process of using fingers/hands as part of assessment, to A dynamometer is an instrument that measures power or
gather information about the tissues. Digital palpation of the force.8
PFM is described by Messelink et al. (Fig. 2) 2.
Pelvic floor dynamometry

Measurement of PFM resting and contractile forces using

strain gauges mounted on a speculum (a dynamometer),
which is inserted into the vagina.50 Dynamometry measures
force in Newton units (N = 1 kg × m/s2) (Figs. 5, 6).endnote 13

Electromyography
Electromyography (EMG) is the recording of electrical
potentials generated by the depolarization of muscle fibers.

Electromyographic diagnosis

Electromyographic diagnosis is made by evaluating

the state of the muscle (muscle pathology) by recording
and analyzing the electrical activity generated by the
muscle.36, endnote 14

FIG. 2 Digital palpation of the pelvic floor muscles (reproduced with

permission from subjects in the photo and photographer Andreas Birger
Johansen) FIG. 3 Peritron manometer (reproduced with permission from Laborie)

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FIG. 4 Graphical illustration of pelvic floor muscle manometry readings

(reproduced with permission from illustrator Ingeborg Hoff Braekken).
MVC maximum voluntary contraction, 1/2/3 repetition 1/2/3
F I G . 6 Montreal, Canada, pelvic floor dynamometer (reproduced with
permission from Chantale Dumoulin)
1. Intramuscular EMG: insertion of a wire or needle
electrode into the muscle to record motor unit action
potentials.endnote 15 b) Visual analog scale (VAS), a 10-cm line with the same
2. Surface electromyography: electrodes placed on the skin labels at the ends
of the perineum or inside the urethra, vaginal or rectum c) A simple verbal rating scale can be used, e.g., “none,”
(Fig. 7).endnote 16 “mild,” “moderate,” “severe.”endnote 17
2. Pain mapping: identifying pain generators through
Pain assessment diagnostic procedures such as questionnaires, digital
Pain evaluation palpation, EMG, quantitative sensory threshold measure-
ment, trigger point injections, nerve blocks, and imaging.
Pain evaluation consists of baseline and ongoing regular a) Questionnaires: several pain questionnaires can be used
evaluation of severity, quality of life, thoughts, emotions, and in the evaluation of musculoskeletal pain in the pelvis;
behavior associated with the pain (via direct consultation or the choice will be determined by which is most
questionnaires) and investigations to identify well-defined/ appropriate to the presenting pelvic floor dysfunction:
confusable/non-pain syndromes. McGill Pain Questionnaire,53 Pelvic Floor Distress
Inventory (PFDI),54 Female Sexual Function Index,55
1. Pain measurement: pain can only be measured subjec- Female Sexual Distress Scale,56 Pelvic Pain and
tively. Patient-reported outcome measures include: Urgency/Frequency Questionnaire.57
a) Numerical rating scale (NRS), from 0 (no pain) to 10 b) Pain chart/body map: a simple line drawing of an
(extreme pain), with half-points marked.51,52 outline of the front and back (or relevant body part) of
the human body, onto which the patient sketches or
ticks or marks areas of bodily pain to demonstrate the
site and extent of perceived pain.58
c) Pain checklist: a list of anatomical locations from
which the patient selects sites that are relevant to
his/her complaint.

FIG. 5 Ann Arbor, USA, dynamometer speculum. Note that the bills of
the speculum are covered by a condom when in use (reproduced with FIG. 7 Verity Medical NeuroTrac Myoplus Pro surface electromyogra-
permission from J.A. Ashton-Miller, R. Zielinski, J.O. DeLancey, J.M. phy biofeedback apparatus (also incorporating electrical stimulation
Miller) (reproduced with permission from Quintet, Norway)

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d) Measurement of muscle tone: there is no single tool that and with symptoms suggestive of lower urinary tract,
is able to measure all components of muscle tone. Some sexual, bowel or gynecological dysfunction.14
tools may be able to measure aspects of tone such 2. Chronic PFM pain syndrome: the occurrence of persistent
as contractility, stiffness or elasticity. Instrumented or recurrent, episodic, pain in the PFM, in the absence of a
methods may play a role in the valid and reliable proven or well-defined local pathological condition. It is
evaluation of muscle tone, e.g., surface electromyog- often associated with negative cognitive, behavioral,
raphy (sEMG), wire and concentric electromyography, sexual or emotional consequences, and with symptoms
dynamometry, real-time ultrasound, elastometry, suggestive of lower urinary tract, sexual, bowel or
myotonometry. gynecological dysfunction.14, endnote 18
e) TrP injection or needling: a diagnostic test to confirm if
the identified TrP is a pain generator. The technique is
the same as that used in TrP treatment. Female sexual dysfunction
f) Imaging: tissue-specific evaluation to identify if Any departure from normal sensation and/or function
morphological trauma or deficit is present, which expressed by a woman during sexual activity.3
may relate to the presenting pain. Types of imaging
may include X-ray, ultrasound, and MRI. 1. Dyspareunia3
2. Obstructed intercourse3
3. Vaginal laxity3

DIAGNOSES

Diagnosis: the act or process of identifying or determining the TREATMENTS

nature and cause of a disease or injury through evaluation of
patient history, examination, review of laboratory data, and General terms
the opinion derived from such an evaluation.59
Behavioral
A diagnosis of female PFD is based on the information
obtained from the patient's symptoms, signs, and any relevant
The way someone behaves, especially toward other people,
diagnostic investigations. For the terminology of the six most
and behavioral science is the study of human behavior.60
common PFD diagnoses—urodynamic stress urinary incon-
tinence, detrusor overactivity (DO), POP, voiding dysfunc- 1. Behavior therapy: a type of psychotherapy that attempts to
tion, bladder oversensitivity, and recurrent UTI—the reader modify observable maladjusted patterns of behavior by
is directed to Haylen et al.3 substituting a new response or set of responses to a given
stimulus. The treatment techniques involve the methods,
Additional anorectal diagnosis concepts, and procedures derived from experimental
psychology; they include assertiveness training, aversion
1. Local (fissures, hemorrhoids)18 therapy, contingency management, flooding, modeling,
operant conditioning, and systematic desensitization. It is
2. Fecal incontinence18
also called behavior modification.12, endnote 19
3. Obstructed defecation syndrome18
2. Cognitive therapy: any of the various methods of treating
4. Rectocele18 mental and emotional disorders that help a person to
5. Enterocele/sigmoidocele18 change their attitudes, perceptions, and patterns of
6. Intussusception18 thinking, from rational to realistic thoughts about the
7. Internal mucosal prolapse18 self and situations. The technique is often used in
association with behavior therapy principles.12
8. Abscess/fistula18
3. Cognitive behavior therapy (CBT): Cognitive techniques
are often used in association with behavior therapy
Pain syndromes
principles; this is called cognitive behavior therapy (CBT).

1. Chronic pelvic pain syndrome (CPPS): persistent pain

perceived in structures related to the pelvis, in the absence Physiotherapy
of proven infection or other obvious local pathology that
may account for the pain. It is often associated with negative Physiotherapy involves “using knowledge and skills
cognitive, behavioral, sexual or emotional consequences, unique to physiotherapists” and “is the service only provided

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by, or under the direction and supervision of, a physiothera- function in patients/clients with chronic and irreversible
pist”.61, endnote 20 diseases).5

Adherence Lifestyle
Adherence is the extent to which a client/patient's Lifestyle modification
behavior corresponds to the agreed treatment protocol and/
or regime as recommended by their healthcare provider.62 It Lifestyle modification is the application of interventions
does not refer to the intervention itself; rather, the patient's in the management of lifestyle-related health problems, e.g.,
commitment to undertaking the behavioral change to adhere change to a healthy diet and regular participation in physical
to the intervention.endnote 21 activity and smoking cessation. The following lifestyle
modifications may be applied to treat pelvic floor dysfunc-
Compliance tions, either in combination with other therapies or as “stand-
alone” treatments.
Compliance is the extent to which a client/patient's 1. Fluid consumption/restriction: fluid consumption is the
behavior matches, or complies with, their healthcare provider's intake of fluid over 24 h. Fluid restriction is the limitation
recommended treatment protocol and/or regime.63, endnote 22
of fluid to a prescribed amount over a period of 24 h. These
measures are often undertaken as part of a bladder training
Combination therapy (also known as polytherapy, process.
multimodal therapy or combined modality 2. Dietary modification: an alteration or adjustment of food to
therapy) treat bowel disorders (e.g., constipation and fecal
Combination therapy is the use of more than one intervention incontinence) or urinary disorders (e.g., incontinence or
concurrently to treat a single condition with one or multiple urgency), for example, increasing fiber to treat constipa-
symptoms, for example, a combination of medication with tion. The specifics of the dietary changes should be
PFM training (PFMT). described.
3. Elimination diet: a form of dietary modification. A diet
1. Adjunctive therapies: any treatment or modality used designed to detect what ingredient in the food causes
to augment or assist the main treatment. In conservative symptoms in the patient, food items to which the patient
treatments, adjunctive therapies often refer to equip- may be sensitive are withdrawn separately and success-
ment or a secondary therapy used to supplement the fully from the diet until the item that causes the symptoms
effect of the primary therapy, e.g., biofeedback-assisted is discovered. This is used frequently in patients with fecal
PFMT or neuromuscular electrical stimulation to incontinence, urinary urgency and urinary urgency
augment PFMT. incontinence (bladder diet).64,65
4. Physical activity: any body movement produced by the
skeletal muscles that results in a substantial increase above
Prevention
resting energy expenditure. Physical activity can be done
at work, as transportation, as household and other chores,
Prevention is the act of preventing or decreasing the risk
and as leisure time/sport and fitness activities.66, endnote 23
of disease or disability. Activities that are directed toward
slowing or stopping the occurrence of both mental and
physical illness and disease, minimizing the effects of a Counseling
disease or impairment on disability, or reducing the severity
or duration of an illness.5 Counseling is the provision of professional assistance and
guidance in resolving personal or psychological problems,7
1. Primary prevention: prevention of the development of
and may be part of any clinician's management.
disease in a susceptible or potentially susceptible popula-
tion through such specific measures as general health 1. Patient education: providing patients with knowledge and
promotion efforts.5 understanding of their condition, thereby empowering
2. Secondary prevention: efforts to decrease the duration of them to play an active role in its management (Fig. 8).67
illness, reduce the severity of diseases, and limit the 2. Motivational interviewing: a directive, client-centered
sequelae through early diagnosis and prompt intervention.5 counseling style for eliciting behavior change by helping
3. Tertiary prevention: efforts to limit the degree of clients to explore and resolve ambivalence. Compared
disability and promote rehabilitation and restoration of with nondirective counseling, it is more focused and

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restore patient confidence in controlling bladder function

(modified from Moore et al.71).endnote 24

Timed voiding

Timed voiding is a passive toileting assistance program,

initiated and maintained by caregivers for patients who
cannot participate in independent toileting. It is a fixed
voiding schedule.71

Habit training
Habit training consists of a toileting schedule matched to
FIG. 8 Patient education of pelvic floor muscle function (reproduced
the individual's voiding patterns based on their voiding
with permission from Women's and Men's Health Physiotherapy) diary. The toileting schedule is assigned to fit a time interval
that is shorter than the person's normal voiding pattern and
precedes the time period when incontinent episodes are
goal-directed. The examination and resolution of ambiva- expected.71
lence is its central purpose, and the counselor/clinician is
intentionally directive in pursuing this goal.68 Prompted voiding
3. Coping strategies: intervention aimed at helping patients to Prompted voiding is used to teach people to initiate their own
live with the condition in the best way possible under the toileting through requests for help and positive reinforcement
circumstances, to regain a feeling of being in control, to from caregivers, often done in combination with a scheduled
adjust their lifestyle where necessary, and to take a positive voiding regimen, typically every 2 h.71
rather than a negative approach.67
Other techniques for bladder and bowel
4. Self-care: the set of activities that comprise daily living,
such as bed mobility, transfers, ambulation, dressing, control
grooming, bathing, eating, and toileting.5 Other techniques consist of doing something that takes the
5. Self-help: various methods by which individuals attempt patient's mind off the condition. Distraction techniques
to remedy their difficulties without making use of formal utilized in urgency may include (but are not limited to)
care providers.5 counting backward from 100 in 7 s, reciting a poem, doing
6. Self-efficacy: an individual's belief that he or she is breathing exercises, reading or working.
capable of successfully performing a certain set of
behaviors.69 Urgency suppression techniques

Urgency suppression techniques are methods/maneu-

Scheduled voiding regimes vers that are used to decrease the feeling of urgency, which
Toileting on a fixed schedule around the patient's normal may include, but are not limited to: distraction, PFM
voiding pattern, which includes a progressive voiding contraction, perineal pressure such as sitting on a hard
schedule using relaxation and distraction techniques for chair, relaxation and breathing, toe curling or plantar
urgency suppression.70 Scheduled voiding regimes have been flexion of the ankle.
categorized as: bladder training, timed voiding, habit training,
and prompted voiding.71 Double voiding

Bladder training In double voiding, the patient is taught to urinate, relax,

and attempt to urinate again.59
In the past, bladder training has also been referred to as
bladder drill, bladder discipline, bladder re-education, and Defecatory dynamics
bladder retraining. It consists of a program of patient
education, along with a scheduled voiding regimen with Defecatory dynamics is a postural and respiratory
gradually adjusted voiding intervals. Specific goals are to technique to aid defecation. The mechanics involves
correct faulty habit patterns of frequent urination, improve co-ordination of the diaphragm, abdominal and PFM, with
control over bladder urgency, prolong voiding intervals, the intent to maintain rectal support whilst releasing the anal
increase bladder capacity, reduce incontinent episodes, and outlet with sufficient expulsion to be effective.72,73

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Bowel habit training e) Local muscle endurance training: training with a low
load and a high number of repetitions or holding the
Bowel habit training is aimed at establishing a regular, contraction over time.
predictable pattern of bowel evacuation by patient teaching f) Muscle power training: all training with the aim of
and adherence to a routine to achieve a controlled response to generating power; can be close to maximal contraction
bowel urgency (modified from NICE guideline).74, endnote 25 training and/or rapid contractions.endnote 26
g) Overload: a situation in which the body is required to
Exercise/exercise training
perform exercise beyond that to which the neuromus-
Exercise is a form of leisure time activity that is usually cular system is accustomed during routine activities.
performed on a repeated basis over an extended period of time Training adaptation occurs in response to a progressive
(exercise training) with specific external objectives, such as “overload”.75
improvement of fitness, physical performance, or health.66 h) Progressive overload: the gradual increase in stress
Exercise training includes: endurance training, strength placed upon the body during exercise training.76
training, flexibility training, and motor control (including
balance), all of which may apply to the PFM. i) Detraining: cessation of training, but also planned or
unplanned reduced volume or intensity of training.77
Therapeutic exercise/exercise therapy j) Maintenance training: a program designed to prevent
loss of the previous level of functioning.
Therapeutic exercise consists of interventions directed k) Isometric/static contraction: a muscular action during
toward maximizing functional capabilities. It includes a broad which no change in the length of the total muscle or
range of activities intended to improve strength, range of motion joint angle takes place.77
(including muscle length), cardiovascular fitness, flexibility, or
to otherwise increase a person's functional capacity.5 l) Isotonic contraction: a muscular action during which
the tension developed by the muscle remains almost
1. Rehabilitation/re-education: help individuals to regain constant while the muscle shortens.78
skills and abilities that have been lost as a result of illness, m) Eccentric contraction: a muscular action in which the
injury or disease, or incarceration, restoring a disabled muscle lengthens in a controlled manner.77, endnote 27
individual to maximum independence commensurate with
n) Repetition: the completion of a whole cycle from the
his or her limitations.
starting position, through the end of the movement,
and back to the start,75 e.g., one PFM contraction with
Mode of exercise training relaxation.
o) Set: the number of times the desired number of
The mode of exercise training is not only the type of repetitions is performed,33 e.g., three sets of 12 PFM
activity to be performed (for instance, fast walking, jogging, or contractions.
swimming, strength training), but also the temporal pattern of p) PFMT: exercise to improve PFM strength, endurance,
activity that is recommended (that is, continuous or intermit- power, relaxation or a combination of these parameters.
tent activity), with a detailed specification of the duration of
exercise and rest periods in the case of intermittent activity q) Kegels: a PFM contraction or PFM exercise. This term
bouts.66 Authors are encouraged to specifically describe all is named after Arnold Kegel, an American gynecolo-
components of the mode of exercise and the dose provided. gist who first described the clinical effect of PFMT in
the late 1940s.49 We recommend the use of the term
1. Muscle training: exercise to increase muscle strength, PFMT (not the word Kegels) to refer to exercises that
endurance, power, flexibility or relaxation. specifically target the PFM.
a) Strength training: training with high resistance (close to r) Individualized PFMT: an individual PFM program
maximal contractions) and few repetitions with the aim aimed at improving the specific deficiencies in PFM
of increasing muscle volume and neural adaptations. structure or function based on assessment of the
b) Resistance: the amount of force opposing a movement.39 woman's ability to contract the PFM.
c) Resistance devices: any object used to increase s) Supervised PFMT: a PFMT program taught and
resistance to contraction, e.g., hand weights. monitored by a health professional/clinician/instructor.
d) Vaginal resistance device: objects inserted into the t) Group PFMT: PFMT conducted in an exercise class.79
vagina or rectum that are inflated or spring-loaded Class participation may occur with or without previous
devices to increase resistance to contraction. individualized PFM instruction.endnote 28

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u) Home training/home PFM exercise program: an b) Progressive muscular relaxation (also known as
unsupervised PFMT program, which the individual Jacobsen's technique): monitoring tension in each
performs at home. specific muscle group, by contracting, then relaxing
v) Weighted vaginal cones: objects of different shapes, the tension, with attention paid to the contrast between
sizes, and weights, which are inserted into the vagina tension and relaxation.82 This type of relaxation is also
above the level of the PFM with the aim of providing termed “contract–relax.”
sensory biofeedback and load on the PFM to increase c) Meditation: a practice of concentrated focus upon a
muscle recruitment and strength.80, endnote 29 sound, object, visualization, the breath, movement, or
3. Facilitation technique: any method of increasing recruit- attention itself to increase awareness of the present
ment/response of a nonresponding muscle. In the case of moment, reduce stress, promote relaxation, and
noncontractile or very weak PFMs, this may include a quick enhance personal and spiritual growth.83
stretch of the PFM, with tapping or stretching the PFM d) Mindfulness: intentionally bringing one's attention to
digitally. An overflow effect from a strong contraction of a the internal and external experiences occurring in the
nearby synergistic muscle (e.g., external rotators) may also present moment. Mindfulness is often taught through a
assist facilitation or recruitment of PFMs. variety of meditation exercises.84
e) EMG relaxation techniques: techniques to decrease
EMG muscle activity or activation through a variety of
Dose–response issues related to exercise training
methods, including a conscious effort to relax.
1. Dose–response: amount/volume of training and its effect
on the speed and degree of the effect of the training
program. Stretching

2. Frequency of exercise: the number of activity sessions per 1. Stretching (also referred to as flexibility training when
day, week, or month.33 the method is used on skeletal muscles where increased
3. Duration of exercise: the unit of time (number of seconds/ range of motion over the joints is the aim): the
minutes) of activity in each repetition or session, e.g., a 10-s application of an external force to muscle and connective
PFM contraction.33 It also refers to the length of the whole tissue to elongate it in the direction opposite to its
training period (intervention), e.g., 3/6 months. shortened position. This can be done parallel or
4. Intensity: the amount of resistance used or the effort perpendicular to the muscle fiber direction. For the
associated with the physical activity.33 For strength PFM this can be applied as a widening of the levator
training, it is often expressed as a percentage of one hiatus in the axial plane (laterolaterally) via a digit or use
repetition maximum: 1RM (the maximum load a person of a dilator, or a caudal movement (via a straining/
can lift once), e.g., 70 % of maximum.75 bearing down maneuver) in the sagittal plane.

5. Session/bout: the block of time devoted to the training, a) Dilator therapy: a conical or cylindrically shaped
e.g., a 1-h session.75 device (made of an inert material) inserted intra-
vaginally or intra-anally, with the aim of increasing the
flexibility or elasticity of the soft tissues via application
of a prolonged elongation or stretch. Dilators may also
Relaxation training be used as a desensitizer device, to reduce fear, anxiety
1. Relaxation: the ability to control muscle activity such that or pain associated with vaginal touch and in conjunc-
muscles not specifically required for a task are quiet, and tion with vaginismus or sexual pain. When combined
those that are required are fired at the minimal level needed with EMG, dilators can be used to train PFM relaxation
to achieve the desired results.81 Relaxation “can be during penetration. Dilators may also be used to
considered a motor skill in itself because the ability to increase the tolerance of skin to sliding when the dilator
reduce muscle firing is as important to control as the is moved in and out.
generation of firing”.40
a) General relaxation technique: a technique that involves Functional training
the whole body, with the aim of effecting a global Functional training consists of training for tasks of daily
relaxation, including a decrease in the skeletal and living and self-care activities, e.g., squatting to train
smooth muscles, a decrease in the heart rate and quadriceps and gluteal muscles.
respiration rate, and an increase in parasympathetic
activity. General relaxation techniques can also be used 1. Functional PFM training: training and exercises that
aimed at relaxing local muscles. incorporate a correct PFM contraction into activities of

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daily living such as lifting, transferring out of bed, or EMG assessment of PFM
sneezing. A PFM contraction before a rise in intra-
abdominal pressure, e.g., a cough (“the Knack”) is part of Electromyography assessment of PFM consists of the use
functional PFM training. and interpretation of the surface EMG recording of a muscle
2. Coordination training: the ability to use different parts of for rehabilitation purposes should be done cautiously,
the body together smoothly and efficiently.7 Related to recognizing that the main goal is the qualitative description
PFM training, coordination training means PFM contrac- of the muscle activation pattern, and not a qualitative
tion with other muscles or other muscle groups, e.g., diagnosis.
respiratory muscles.
1. Baseline muscle activity: amount of microvolts generated
3. Functional mobility training: an intervention directed at by the target muscle during rest.endnote 36
improving the physical ability to perform a daily task. For
2. Peak microvolts: the highest EMG amplitude achieved.
voiding/defecation, this may include: gait training, transfer
training, stair training, and other mobility training to 3. Slow recruitment: slow initiation of muscle activation
improve speed and safety in reaching the toilet. contraction.endnote 37
4. Slow de-recruitment or slow latency to return to baseline:
Biofeedback training slow relaxation of the muscle contraction.88, endnote 38
5. Inconsistent resting baseline: variation of baseline
Feedback
between contractions, between sets, or between days
may be related to a change in patient symptoms, e.g.,
Feedback is sensory information that is available as the
hypertonic PFM.
result of an activity that a person has performed. It can be
provided by an intrinsic source (from within the individual), 6. Excessive accessory muscle contraction: increased ampli-
or an extrinsic source (from the clinician), and can occur tude in accessory muscles often resulting in cross talk and
concurrently with the activity or post-activity, e.g., verbal is indicative of poor isolation of target muscle contraction.
information from the clinician to the patient during or
following PFM assessment.85, endnote 30 EMG training of PFM

1. Up-training: EMG biofeedback training to increase the

Biofeedback
EMG activity of a hypotonic muscle with low EMG
activity.87, endnote 39
Biofeedback is the use of an external sensor to give an
indication with regard to bodily processes, usually with 2. Down-training: EMG biofeedback training to decrease
the purpose of changing the measured quality.86 It is an EMG activity and relax muscles.87, endnote 40
adjunctive therapy.endnote 31
Manual therapy
EMG biofeedback unit instrumentation
Manual therapy is a clinical approach utilizing skilled,
specific hands-on techniques, including but not limited to,
1. EMG signal amplitude: number of microvolts (µV) a
massage, manipulation or mobilization.endnote 41
muscle is generating.87 EMG biofeedback units can
deliver either the actual amount of EMG activity in µV
or an average µV value.endnote 32 Joint therapies

2. Artifact: extraneous information nonrecognizable in the 1. Mobilization: skilled passive movement of a skeletal joint
EMG signal from sources other than the target muscle such including graded passive oscillations at the joint to
as the environment or other body functions.87, endnote 33 improve joint mobility, e.g., movement of the coccyx.
3. Cross talk: muscle activity from nearby muscles that 2. Manipulation: a passive (for the patient) therapeutic
can artificially increase EMG amplitude; a type of movement, usually of small amplitude and high velocity,
artifact.87, endnote 34 at the end of the available joint range.5 Manipulation is a
4. Dual-channel EMG: use of two channels to monitor two sudden small thrust that is controlled by the clinician.endnote 42
separate muscles or muscle groups at the same time, such
as the PFM and abdominal muscles, with the goal of either
Soft-tissue therapies
promoting synergist activity or reducing EMG activity of
one muscle while increasing the other. 1. Touch desensitization: use of finger/hand, vibration or
5. Band pass: limits muscle fiber frequencies that are device to reduce hypersensitivity of soft tissues to touch/
monitored and displayed in the EMG tracing.87, endnote 35 contact.

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2. Massage: the manipulation of the soft tissues of the body Electrical therapy
for the purpose of affecting the nervous, muscular,
Electrical therapy is the use of electric potential or currents to
respiratory, and circulatory systems.5
elicit therapeutic responses. Current may be directed at motor
3. Abdominal massage: therapist or self-directed massage or sensory functions. It is not within the scope of this
of the abdominal wall with the aim of stimulating document to define all electrical stimulation terms. Readers
peristalsis and relieving the symptoms of constipation. are referred to more complete text books.94
Generally, the technique follows the ascending, trans-
verse, and descending colon to aid emptying. The effect Electrical muscle stimulation (also known as neuromuscular
may be mechanical or sensory.89 electrical stimulation or electromyo stimulation)
4. Myofascial release techniques: the use of deep friction
and stroking of the fascia of the body to improve the Electrical muscle stimulation (EMS) is the application
ability of the fascia to deform and move within the body.5 of electric impulses directly to striated PFM (end-plate) to
5. Skin rolling: a manual technique in which skin is pulled facilitate contraction. EMS is often referred to as “pelvic
away from the underlying structures and elongated in floor muscle electrical stimulation” (PFES) or “functional
various directions. electrical stimulation.” PFES is the application of electrical
current to the PFM.95 All of these stimulations may
6. Scar massage: a specific application of soft-tissue
(indirectly) cause inhibition of the detrusor contraction
mobilization to an adherent scar.
(Fig. 9).
7. Perineal massage: intravaginal massage by the woman,
her partner or the clinician. Technique includes alternat- Mode of application
ing downward and sideward pressure, using thumb and
forefinger and a natural oil, with the aim of stretching and
elongating the tissue in preparation for vaginal childbirth, 1. Surface electrodes: non-invasive placement of electrodes,
or for treatment of adherent scarring in the perineum.90 including intravaginal and intra-anal electrodes, in
8. Transverse friction: the operator's fingertip is placed on contrast to electrodes that pierce the skin, i.e., needle
the exact site of the lesion and rubbed firmly across the stimulation.
direction of the fibers of the affected tissue.91 a) Non-invasive electrical nerve stimulation96,97 or trans-
9. Thiele's massage: per rectal digital massage of the levator cutaneous electrical nerve stimulation (TENS): the
application of electrical energy to stimulate cutaneous
ani, sweeping lengthwise along the muscle fibers.
Massage is begun lightly, and pressure is increased as nerve and peripheral motor nerves, via suprapubic,
tenderness decreases.92 perineal or sacral placement of electrodes, or other
external sites, or intravaginal or intra-anal plug electro-
10. TrP treatment: (sometimes called myofascial trigger point des. Tibial nerve stimulation (TNS) is a form of
treatment): soft-tissue mobilization specifically targeting peripheral neuromodulation targeting symptom relief
trigger points and may include ischemic pressure, massage, of overactive bladder (OAB) and urinary urge inconti-
myofascial release, electrotherapy, ultrasound, laser, spray- nence. Indirect access to the sacral plexus is achieved by
and-stretch, injection (a variety of chemicals including
local anesthetic, botox or steroids), dry needling (insertion
of a solid needle into the TrP), and stretching.endnote 43

Thermal modalities
Cold treatment/cryotherapy

Cold treatment is the application of ice for therapeutic

purposes. It is used in the initial management of acute
musculoskeletal injuries, to decrease edema through vaso-
constriction and to reduce secondary hypoxic injury by
lowering the metabolic demand of injured tissues.93

Heat treatment (moist or dry)

Heat treatment consists of the application of heat to a
body part, with the aim of relieving pain and/or stiffness. It is FIG. 9 Enraf-Nonius Myomed pelvic floor machine, including electrical
usually applied when an injury is older than 48 h. stimulation (reproduced with permission from Enraf-Nonius)

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intermittent, electrical stimulation of the tibial nerve, Currents used in therapy:

which lies behind the medial malleolus, using skin
surface electrodes applied to the medial malleolar area a) Faradic current: an alternating and interrupted low-
(transcutaneous TNS).98 There are two main types of frequency current capable of stimulating (depolarizing)
electrical stimulation with surface electrodes: nerve fibers through the skin using surface-stimulating
electrodes. It is used to stimulate innervated muscles,
i) Long-term or chronic electrical stimulation: is
causing them to contract.107
delivered below the sensory threshold. It is aimed
at inhibiting detrusor activity by afferent pudendal b) TENS: an alternating and interrupted low-frequency
nerve stimulation. The device is used 6–12 h per day current capable of stimulating (depolarizing) nerve fibers
for several months.99 through the skin using surface-stimulating electrodes for
pain modulation or pain relief.106
ii) Maximal neuromuscular electrical stimulation: ap-
plies a high-intensity stimulus, set just below the pain c) Interferential current: a medium frequency, amplitude-
threshold. It is aimed at improving urethral closure, modulated electrical current that results from the
via striated muscle recruitment. Detrusor inhibition interference (hence the word interferential) caused by
by afferent pudendal nerve stimulation has also been crossing two or more medium-frequency alternating sine
suggested as a mechanism of effect.96 Maximal wave currents with different carrier frequencies. The
electrical stimulation (35–70 Hz) is applied over short carrier frequency of these medium, alternating sine wave
period (15 to 30 min), is used several times per week currents ranges between 2,000 and 5,000 cycles per
(and up to 1–2 times daily), and may be provided via second.106
in-clinic application or via portable devices at
home).100–102 Neuromuscular electrical stimulation parametersendnote 44

2. Percutaneous electrical nerve stimulation: a therapeutic

modality that stimulates peripheral sensory nerves 1. Pulse frequency (or rate): the number of pulse cycles that
performed with a (few) needle electrode(s) that are placed are generated per unit of time (seconds). This is reported in
in close proximity to the area to stimulate. Percutaneous hertz (Hz).106
neuromuscular electrical stimulation (e.g., posterior TNS) 2. Pulse width: the determined period of time elapsing
is a peripheral neuromodulation technique, in which the from the beginning to the end of one pulse cycle, usually
posterior tibial nerve is electrically stimulated three expressed in microseconds or milliseconds.106
fingerbreadths above the medial malleolus, via insertion 3. Current amplitude: the magnitude of current relative to the
of a percutaneous needle electrode. This is coupled with an isoelectric baseline, expressed in amperes (A). The current
adhesive reference surface electrode placed near to the amplitude of therapeutic electrical stimulators ranges from
needle. This intervention is offered to patients with micro- to milliamps.106
OAB.103–105
4. Train: the continuous series of pulse cycles over time,
Electrophysiological parameters usually lasting seconds. For example, a train of impulses
may be the results of successive pulse cycles delivered at
1. Electrical current: the flow (current) of electrons 50 Hz for a duration of 5 s.106
(electricity) from an electron source (stimulator) the 5. Train ramp-up time and ramp-down time: ramp-up time is
wires and electrodes used to deliver such an electrical the time elapsed from the onset (or baseline) to the plateau
current to soft tissues.106 current amplitude (or maximum) of the train, whereas
There are three types of current: direct, alternating, and ramp-down time is the time elapsed from the plateau
pulsed. – current amplitude to zero baseline.106, endnote 45
a) Direct: the continuous, unidirectional flow of charged 6. Duty cycle (D): the ratio of ON time to the summation of
particles for 1 s or longer, the direction of which is ON time + OFF time, expressed as a percentage (duty
determined by the polarity selected. Polarity refers to two cycle = (ON)/(ON + OFF time) x 100, e.g., a duty cycle of
oppositely charged poles, one positive and one negative. 20 % is calculated when the ON and OFF times equal 10
Polarity determines the direction in which current flows.106 and 40 s respectively.106
b) Alternating: the continuous, bidirectional flow of charged 7. Impedance (electric resistance): the opposition of our
particles, for 1 s or longer, relative to the isoelectric biological tissues to the flow of an electrical current.
baseline.106 Measured in ohms and designated as Z.106
c) Pulsed: the noncontinuous, interrupted, and periodic flow 8. Evoked potentials: electrical potentials recorded from the
of direct (DC) or alternating (AC) currents.106 nervous system following a delivered stimulus.

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Magnetic stimulation underwear, keeping the genital area clean, and emptying the
bladder before and after sexual intercourse.114,115
Magnetic stimulation (or extracorporeal magnetic innerva-
tion: a pulsed magnetic technology developed for the
transmission of nerve impulses that is aimed at causing Vulval hygiene
PFM contraction. Patients receive therapy by sitting in a
chair, which contains the device that produces the pulsing Vulval hygiene involves maintaining a clean perineum by
magnetic fields. means of washing the area on a regular basis, and wearing
cotton underwear. To avoid vulval irritation, shampoo,
Mechanical devices perfumed creams or soap should be avoided.116

Intravaginal devices
Anal hygiene
Intravaginal devices are intended to provide some support
to the bladder neck and possibly some compression to the Anal hygiene involves keeping the perianal region clean,
urethra, to correct urinary stress incontinence. These can be which is especially important when fecal seepage is present.
traditional tampons, pessaries, and contraceptive diaphragms Advice includes using soft toilet paper or moist wipes
and devices designed specifically to support the bladder neck (avoiding any with an alcohol base), always wiping from
(removable, reusable intravaginal ring or single-use dispos- front to back, washing after a bowel movement, then gently
able devices.108 patting dry.89 To avoid irritation from products, the vulval
hygiene advice above should be followed.
Anal plugs
Vaginal lubricants
Anal plugs are containment devices aimed at blocking the
loss of stool to control fecal incontinence. Plugs come in Vaginal lubricants are pharmacological preparations
different designs, sizes, and compositions, such as polyure- aimed at reducing friction during coital or any other sexual
thane and polyvinyl-alcohol.109, endnote 46 activity and thereby alleviating dyspareunia,117 or at reducing
discomfort associated with a clinical (per vaginum or per
Rectal irrigation rectum) examination. Pharmacological preparations and
natural plant-based oils may be used.
Rectal irrigation is the use of liquid solutions given by
enema to remove material from the rectum.110
Aids and appliances
Urethral plugs Absorbent products

Urethral plugs are containment products aimed at Absorbent products are those that have been specifically
blocking urine leakage.111 developed to help manage leakage or soiling, such as
absorbent pads and pants, absorbent bed sheets and chair
Pessaries covers.108,118

Pessaries are intravaginal devices used to try to restore the Catheters

prolapsed organs to their normal position and hence to relieve
symptoms. Vaginal pessaries can be broadly divided into two Urinary catheters are small tubes inserted via the urethra
types: support pessaries (ring, ring with support, Gehrung, or into the bladder suprapubically, to allow the drainage of
Hodge, shelf) and space-filling pessaries (donut, Gellhorn, urine. Catheters are made of plastic, latex, teflon or silicone,
cube, inflatable).111–113
and may be impregnated with antiseptic or antibiotic
solution.119
Hygiene
1. Self-catheterization: a procedure performed intermit-
Bladder hygiene tently to empty the bladder by inserting a catheter into
the urethra when normal voiding is not possible or if the
Bladder hygiene prevents UTI by using techniques such bladder cannot be emptied completely. If a caregiver
as wiping the urethral meatus with clean wipes in an undertakes this procedure it is usually a sterile
anterior-to-posterior direction after voiding, wearing clean procedure; if a patient undertakes it, it is termed

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“self-catheterization” and is generally a clean rather than endnote 6

Muscle tone is evaluated clinically as the resistance provided by
a sterile procedure.120–122 a muscle when a pressure/deformation or a stretch is applied to
it.19–21 Muscle tone may be altered in the presence or absence of
pain. There is no single accepted or standardized way of
measuring muscle tone, and there are no normative values.
CONCLUSION endnote 7
The terms hyper- and hypotonicity are commonly used in
neurology and muscle physiology. Messelink et al.2 introduced
We trust that this consensus-based terminology report for the the terms overactivity and underactivity related to PFM. These
conservative management of female pelvic floor dysfunction terms are not defined with cut-off points, nor are they based on
will be a significant aid to clinical practice and a stimulus for comparison with normal populations. As activity can only relate
research. Future updates will be required to reflect evolving to the active (i.e., contractile) portion of muscle tone, activity
cannot be used interchangeably with muscle tone, unless it can be
knowledge and applications in this field.
shown that the active component of the muscle is altered. If
increased (over-) or decreased (under-) activity in the PFM can
ACKNOWLEDGEMENTS be demonstrated using electromyography (EMG) or another
We thank Professors Jacques Corcos (Urologist McGill measure, then these terms may be used appropriately.
University, Montreal Canada, Mandy Fader (Nurse, Univer- endnote 8
Muscle cramp either during or immediately after exercise is
sity of Southampton, UK), Ingrid Nygaard (Urogynecologist, commonly referred to as “exercise-associated muscle cramp-
University of Utah, Salt Lake City, USA), Marijke van ing”93; however, cramps are not specific to exercise.
endnote 9
Kampen (Physiotherapist, University Hospital Gasthuisberg, Local or referred pain may be reproduced. An active TrP is said
K.U. Leuven, Belgium) and David Vodusek (Neurophysiol- to have a characteristic “twitch” response when stimulated;
however, the twitch response to palpation has been shown to be
ogist, University of Ljubljana, Slovenia) for expert advice on
unreliable.126 The most reliable sign of a TrP is sensitivity to
the draft manuscript.
applied pressure. Trigger points are implicated in myofascial
pain; however, the validity of this theory is controversial and has
recently been refuted.124
endnote 10
COMPLIANCE WITH ETHICAL Palpation is less reliable and responsive than manometers and
dynamometers.42
STANDARDS endnote 11
The pressure measured does not confirm its origin, and pressure
measurement is only valid when used in combination with other
Disclaimer Any products/companies referred to in this
methods, e.g., simultaneous observation of the inward
document are not necessarily recommended or endorsed by movement of the perineum or device during PFM contraction.
the ICS. endnote 12
The term perineometer is somewhat misleading as the pressure-
sensitive region of the manometer probe is not placed at the
CONFLICTS OF INTEREST perineum, but inside the vagina at the level of the levator ani.
Elizabeth Shelly is a consultant to Analytica and Amanda Vaginal pressure devices should be referred to as PFM
Wells is a consultant to ARC Health Services. None of the manometers.42,49
endnote 13
other authors have any conflicts of interest. Today's dynamometers for the pelvic floor also detect resting
and contractile contributions from muscles other than the PFM,
contributing to the force recordings. As dynamometers can be
ENDNOTES
opened at different muscle lengths to measure PFM force, the
endnote 1
Terminology for Female Anorectal Dysfunction.18 process of measurement should respect the maximum
endnote 2
A comprehensive definition of these terms is covered by achievable vaginal aperture without inducing discomfort, so
Doggweiler et al.123 as not to influence the validity of the measurement.
endnote 3 endnote 14
Symptoms of pelvic floor myalgia should be described in terms EMG in this case usually means “concentric needle EMG,” but
of location, quality, intensity, pattern, duration, frequency, other EMG methods exist. EMG is typically distinguished as
moderating factors, and associated symptoms. Pain details may either intramuscular or surface. EMG diagnosis is often used as
include: (a) Whether pain is present at rest or mechanical in a synonym for “neurophysiological diagnosis of the peripheral
nature (related to muscle contraction or relaxation or body neuromuscular system,” and that would also include the
posture) and/or altered with a change of posture (lying to sitting, measurement of motor and sensory conduction, the recording
sitting to standing) or movement (bending, walking, sexual of reflex responses, etc.36 EMG does not directly measure
activity (b) Whether uni- or bilateral in nature (c) Whether muscle strength. The type of electrode being used should be
accompanied by bladder or bowel dysfunction, vulvodynia or specified.
dyspareunia (superficial/deep) endnote 15
This is not typically used in clinical assessment, but may be
endnote 4
The evidence for the existence of trigger points is debated.124 included in research or advanced examinations, for example, to
endnote 5
Atrophy of the urogenital tract is normal at certain diagnose striated muscle denervation/re-innervation.36
endnote 16
points in the life cycle, mainly caused by aging and Surface EMG is considered to be less specific than
hypoestrogenism.8,125 intramuscular EMG. The large surface area of the electrodes

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endnote 25
may result in cross-talk from adjacent muscles and other A bowel habit intervention may: encourage bowel emptying at
artifacts; therefore, technical expertise is required. EMG can a specific time of day, mainly after a meal (to utilize the
reveal the pattern of activity of a particular muscle, as in gastrocolic response), encourage patients to adopt a sitting or
the diagnosis of detrusor sphincter dyssynergia during squatting position where possible while emptying the bowel,
urodynamics.2,36 teach patients techniques to facilitate bowel evacuation and
endnote 17 stress the importance of avoiding straining.74,127,128
Because pain is multidimensional, a single rating scale
endnote 26
combines these dimensions in unknown quantities. One may Speed changes little with training. Thus, power is increased
separately assess pain intensity, pain distress, and interference almost exclusively by gaining strength.35
of pain with activities of daily life. endnote 27
PFM training can be isometric, concentric or eccentric or a
endnote 18
Other urological, gynecological, gastrointestinal and colo- combination of any of these.
endnote 28
rectal pain conditions without related PFM dysfunction, are Whether PFMT is performed with or without previous
well described in standard texts. Many pelvic floor pain- assessment of the ability to contract should be reported.
related conditions or syndromes (e.g., vulvodynia, interstitial endnote 29
The original shape was conical; however, different shapes are
cystitis/bladder pain syndrome, irritable bowel syndrome) currently available. Maintenance of the weight in position can
are described in the Standard for Terminology in Chronic be challenged via different body positions and activities.
Pelvic Pain Syndromes (CPPS): A Report from the Ad Hoc endnote 30
PFM feedback can be provided by the therapist or patient
Working Group of the International Continence Society
during manual palpation internally or externally, or with a
Standardization Steering Committee (ICS-SSC) on Chronic
mirror. The purpose of feedback is to increase accuracy of
Pelvic Pain, ICS Standardization of Terminology document
contraction for maximum benefit.
on Chronic Pelvic Pain.123 Several other systemic disorders
endnote 31
(e.g., chronic fatigue syndrome, diabetes) may have an Biofeedback can be visual, auditory or both. Biofeedback is not
impact on the pelvic floor; however, PFD is not part of their a treatment on its own. It is an adjunct to training and can be
recognized etiology. used to help the patient be more aware of muscle function, and
to enhance and motivate patient effort during training.129 The
endnote 19
We recommend that “behavioral” be limited to studies that correct terminology should be PFM strength training with
evaluate how people do or do not behave as desired, e.g., biofeedback or relaxation training with biofeedback. Types of
commencement or cessation of PFM training or change of PFM biofeedback include: perianal, vaginal, and anal surface
a diet. EMG, urethral, vaginal or anal manometry, vaginal dynamom-
endnote 20
We recommend that the specific treatment is described, e.g., etry, real-time ultrasound.129
PFM training, electrical stimulation, rather than the unspecific endnote 32
Clinicians are to be cautious with regard to the interpretation of
term physiotherapy, the latter also referring to a specific the information, as many factors influence amplitude, including
profession. Publications should report the actual professional muscle activity, skin conductance, and artifact. “EMG
who provided the intervention (e.g., physiotherapist, general amplitude does not equal force”.87 More microvolt activity
practitioner, urogynecologist, urologist, midwife, nurse, fitness means more muscle activity, but does not always mean more
instructor), rather than using the vague term, “therapist”/ strength.
“clinician”/“researcher.” endnote 33
Artifact examples include movement or contact quality artifact,
endnote 21
Adherence is usually reported as the number or percentage cross talk, heart rate, skin electrode shear, and electrode
of clinical visits attended and home exercises or regimen bridging.
components followed or completed by the client/patient. endnote 34
Minimizing cross talk is essential in research into quality EMG
endnote 22
The term “adherence” is generally preferred within health- tracings.
care, as it acknowledges client/patient autonomy and implies endnote 35
Recording with surface electrodes is prone to artifact and cross
a willingness on their part to participate and cooperate rather
talk. The user should be trained appropriately and understand
than the traditional view, inherent in “compliance,” of an
the limits of the EMG instrument and of the methodology. It is
expert clinician dictating to a naive patient.62,63 Simply,
not within the scope of this document to define all EMG terms.
adherence is agreeing what to do; compliance is being told
Readers are referred to other texts for further terminology.87,88
what to do.
endnote 36
endnote 23 Baseline EMG reading can be influenced by many factors and
An increase in the physical activity level may affect UI
therapists must take into account the patient's symptoms,
positively via weight reduction in obese persons. Conversely,
digital palpation results, overall tension of the patient, the
several studies have shown that there is a high prevalence of UI
possibility of artifacts, and other factors in determining the
in physically active women during exercise (especially during
meaning of the baseline muscle activity.
high impact activity, defined as running and jumping).
endnote 37
Strenuous exercise/work has been suggested to be a risk Slow recruitment can be symptomatic of leakage during
factor for the development of PFD.71 A well-functioning coughing and sneezing when a quick muscle contraction is
pelvic floor responds before and during an increase in intra- needed to counteract increased intra-abdominal pressure.
endnote 38
abdominal pressure. Slow de-recruitment can be indicative of a hypertonic PFM.
endnote 24 endnote 39
Ideally, the voiding intervals should be increased by 15–30 min The general principles of strength training are the same with
each week, according to the patient's tolerance to the schedule, and without biofeedback. (See the sections “Mode of exercise
until a voiding interval of 3–4 h is achieved. Use of a bladder training” and “Dose–response issues related to exercise
diary is recommended for self-monitoring of progress.70 training”)

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endnote 40
The general principles of relaxation training are the same with urinary incontinence in women: a systematic review. J Physiother.
and without biofeedback. 2013;59:159–68. doi:10.1016/s1836-9553(13)70180-2.
endnote 41
Manual therapy is used to treat soft tissues and joint structures 10. Bo K, Herbert RD, When and how should new therapies become
for the purpose of modulating pain; increasing the range of routine clinical practice? Physiotherapy. 2009;95:51–7. doi:10.10
motion; reducing soft tissue edema; inducing relaxation; 16/j.physio.2008.12.001.
improving contractile and noncontractile tissue extensibility, 11. IASP Taxonomy. International Association for the Study of
and/or stability; facilitating movement; and improving func- Pain (IASP). 2012. http://www.iasp-pain.org/Taxonomy-Pain.
tion. This broad group of skilled hands-on treatments can be Accessed 5 November 2015.
divided into two groups: joint therapies and soft-tissue
12. Harris P, Nagy S, Vardaxis N. Mosby's dictionary of medicine,
therapies.
nursing and health professions. 2nd ed. Chatswood, NSW:
endnote 42
Neither mobilization nor manipulation should be used when Elsevier Australia; 2010.
referring to muscle.
13. Baranowski A, Abrams P, Berger R, Buffington T, Collett B,
endnote 43
The notion of trigger points causing myofascial pain is Emmanuel A, et al. Classification of chronic pain: descriptions of
controversial.124 chronic pain syndromes and definitions of pain terms. Interna-
endnote 44
Depending on the particular device being used, the type of tional Association for the Study of Pain (IASP). http://www.iasp-
electrical current, the specific health problem and condition pain.org/PublicationsNews/Content.aspx?ItemNumber=1673&n
being treated, and the individual's needs and circumstances, avItemNumber=677. International Association for the Study of
many electrical stimulation parameters may be adjusted by the Pain (IASP); 2012.
therapist administering the treatment. 14. Engeler D, Baranowski AP, Borovicka J, Cottrell A,
endnote 45
The slower the current intensity rises to the preset amplitude or Dinis-Oliveira P, Elneil S, et al. EAU guidelines on chronic
threshold level, the more comfortable the stimulation may feel. pelvic pain. 2012. http://www.uroweb.org/guidelines/online-
Conversely, the faster the ramp, or the more vertical the guidelines. Accessed 20 October 2015.
ramping up signal, the more discomfort may be felt. 15. Giamberardino MA, Affaitati G, Fabrizio A, Costantini R.
endnote 46
Terminology for female anorectal dysfunction.18 Myofascial pain syndromes and their evaluation. Best Pract Res
Clin Rheumatol. 2011;25:185–98. doi:10.1016/j.berh.2011.01.002.
16. Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO,
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nonpharmacological management of female pelvic floor dysfunction
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Neurourology and Urodynamics 31:415–421 (2012)

An International Urogynecological Association

(IUGA)/International Continence Society (ICS) Joint
Report on the Terminology for Reporting Outcomes
of Surgical Procedures for Pelvic Organ Prolapse
Philip Toozs-Hobson,1* Robert Freeman,2 Matthew Barber,3 Christopher Maher,4 Bernard Haylen,5
Stavros Athanasiou,6 Steven Swift,7 Kristene Whitmore,8 Gamal Ghoniem,9 and Dirk de Ridder10
1
Birmingham Women’s Hospital, Birmingham, United Kingdom
2
Plymouth Hospitals NHS Trust, Plymouth, United Kingdom
3
Cleveland Clinic, Cleveland, Ohio
4
Wesley Hospital, Brisbane, Queensland, Australia
5
University of New South Wales, Sydney, North South Wales, Australia
6
Alexandra Hospital, University of Athens, Athens, Greece
7
Medical University of South Carolina, Charleston, South Carolina
8
Drexel University College of Medicine, Philadelphia, Pennsylvania
9
University of California, Irvine, California
10
University Hospital, UZ Leuven, Belgium

Introduction and Hypothesis: Standardized terminology has yet to be developed for reporting the outcomes for
surgery for pelvic organ prolapse (POP). Methods: This report combines the input of the Terminology and Standardi-
zation Committees of the International Urogynecological Association (IUGA) and the International Continence Society
(ICS) and a joint Working Group on this topic, as well as expert external referees. The aim was to present a standard-
ized terminology for the definitions of surgery and propose a structure for reporting the outcomes of surgical procedures
for POP. An extensive drafting and review process was undertaken, as well as open review on both IUGA and ICS
websites. Results: A terminology report was developed outlining the recommended structure for reporting outcomes
of surgical trials involving POP. This document does not define success and failure. The report includes patient-
reported subjective and objective outcomes to enable researchers to report on their results and compare them with
other studies. Conclusions: A consensus-based method for standardizing terminology for reporting outcome meas-
ures of POP surgery was developed to aid clinicians working in this area of research. Neurourol. Urodynam. 31:415–
421, 2012.  2012 Wiley Periodicals, Inc.

Key words: terminology; outcomes; surgical procedures; pelvic organ prolapse; female pelvic floor dysfunction

This document is being published simultaneously in Neuro-

urology and Urodynamics (NAU) and the International Urogy-
necological Journal (IUJ), the respective journals of the
sponsoring organizations, the International Continence Socie-
Christopher Chapple led the peer-review process as the Associate Editor responsi-
ty (ICS) and the International Urogynecological Association ble for the paper.
(IUGA). International Urogynecology Journal, Vol. 23, No. 5, Conflicts of Interest: Philip Toozs-Hobson—Educational Meetings: Astellas and
2012. Copyright 2012. This material is reproduced with per- Pfizer. Robert Freeman—Educational meetings: Astellas and Pfizer (speaker fees).
National Institute for Health Research (NIIHR) Collaboration (PenCLAHRC). UK (the
mission of Wiley Periodicals, Inc., a subsidiary of John Wiley &
views expressed are not necessarily those of the NHS, the NIHR or the Department
Sons, Inc., and the International Urogynecological Association. of Health, UK). Matthew Barber—No disclosures. Christopher Maher—Director, Uro-
gynaecology Society of Australia. Bernard Haylen—No disclosures. Stavros Athana-
siou—No disclosures. Steven Swift—Pfizer: Acceptance of paid travel expenses or
INTRODUCTION honoraria; Acceptance of payment for research. Astellas: Consultant. Kristene Whit-
more—Research grants—Boston Scientific, Pfizer, Allergan, Ortho-McNeill. Gamal
Whereas recommendations for reporting outcomes of sur- Ghoneim—Speaker—Astellas; Consultant—Boston Scientific, Uroplasty, Coloplast.
gery for stress urinary incontinence have been reported1,2 few Dirk de Ridder—Consultant—AMS, Bard, Asyellas, Pfizer, Medtronic, Allergan;
Speaker—AMS, Astellas, Pfizer, Medtronic, Allergan; Investigator—AMS, Astellas,
exist for surgery of pelvic organ prolapse (POP). In addition,
Allergan; Research grants: AMS, Bard, Astellas, Medtronic, Gynecare, Dynamesh.
there has been ambiguity in reporting of ‘‘prolapse surgery Terminology and Standardization Committee IUGA working members: Philip M.
outcomes,’’ particularly with regards to success/failure and Toozs-Hobson, Bernard T. Haylen, Robert M Freeman, Christopher Maher, Stephen
further surgery/re-operation. Within the literature, there is E. Swift, Stavros Athanasiou. Standardisation Steering Committee (ICS) members:
Robert. M Freeman, Dirk de Ridder, Kristene Whitmore. Joint IUGA-ICS Working
limitation in the methodology as evidenced by the recent
Group on Outcomes for Female POP Surgery members: Matthew Barber, Gamal
Food and Drug Administration (FDA) report3,4 and other Ghoneim.
reviews.5 For example, information is often incomplete or lim- *Correspondence to: Philip Toozs-Hobson, Birmingham Women’s Hospital,
ited relative to the inclusion and exclusion criteria and study Birmingham B15 2TG, UK. E-mail: philip.toozs-hobson@bwhct.nhs.uk
Received 8 February 2012; Accepted 10 February 2012
design. In addition, the power calculation is often poorly de-
Published online 5 April 2012 in Wiley Online Library
scribed. Issues such as detection bias (lack of blinding), conflict (wileyonlinelibrary.com).
of interest and reporting of adverse events are problematic DOI 10.1002/nau.22238

 2012 Wiley Periodicals, Inc.

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416 Toozs-Hobson et al.

and make it difficult to interpret the information. In addition, The lack of subjective/patient-reported outcomes was
many studies include both primary and repeat prolapse highlighted in a systematic review on mesh repairs commis-
repairs, as well as additional procedures including other pro- sioned by the National Institute for Clinical Excellence (NICE)
lapse and/or stress incontinence surgery. Long-term follow-up in the UK.18,19 As a consequence of this and the uncertainty
past 2 years is infrequent. As a result, it is difficult to draw following further consideration of the studies mentioned
conclusions from these studies relative to other studies or above, there is a need for clear definitions and standardization
populations in order to provide guidance for patient care. for reporting of outcomes for POP surgery.
Standardized information is required to help answer the im-
portant questions regarding efficacy and safety of traditional NEW DEFINITIONS
and new POP procedures. The aim of this report, therefore, is
It is understood that there is close interaction among
to present a standardized terminology for the definitions of
three commonly defined compartments: apical/vaginal vault,
POP surgery and propose a structure for reporting the out-
anterior, and posterior, when discussing pelvic organ
comes of surgical procedures. Consistency in reporting has the
support or prolapse. However, for ease of use, the definitions
potential to help produce meta-analyses and reliable clinical
are limited to ‘‘primary’’ or ‘‘recurrence at specific sites’’
guidelines.
defined as apical/vaginal vault, anterior and posterior. As our
The document does not define success and failure, but
understanding of how these compartments interact improves,
outlines the recommended structure for reporting outcomes of
the definitions of ‘‘primary prolapse surgery/different site’’
surgical trials involving POP. It complements published IUGA-
and ‘‘repeat surgery/same site’’ will evolve.
ICS Joint Standardization Reports on (i) Terminology for Female
The following standardized terminology is proposed for sur-
Pelvic Floor Dysfunction6 and (ii) Terminology and Classification
gical trials and clinical audit:
of Complications related directly to the insertion of prostheses
and grafts in female pelvic floor surgery7 and (iii) concomitantly
A. Primary Surgery:This indicates the first procedure required
published terminology and classification of complications relat-
for the treatment of POP in any compartment.
ed to native tissue female pelvic floor surgery.8
B. Further Surgery:Provides a global term for the number of
subsequent procedures the patient undergoes, directly or
BACKGROUND
indirectly, relating to the primary surgery. Further surgery
The perceived ambiguity in the reporting of POP surgery per se should not be interpreted as a measure or failure as
outcomes might have arisen from two studies assessing suc- the definitions of success and failure will be defined within
cess/failure and further surgery/re-operation.9,10 The former the context of the individual study. Further surgery is sub-
study by Olsen et al.9 suggested that the lifetime risk of divided into:
requiring incontinence and/or prolapse surgery was 11% (for
prolapse surgery alone, the figure was 6.7%) and 29.2% of
patients required repeat surgery/re-operation. The definition I. Primary prolapse surgery/different site: a prolapse proce-
of repeat surgery was any operation for prolapse or urinary dure in a new site/compartment following previous sur-
incontinence following an index (first) procedure, often some gery (e.g., anterior repair following previous posterior
years previously. While the 29.2% re-operation rate is still repair).
commonly quoted and often interpreted similarly to that stat- II. Repeat surgery: a repeat operation for prolapse arising
ed by the authors (i.e., that this implies a high rate of surgical from the same site. Where combinations of procedures
failure), the failure to adjust for both time and variation in arise, such as new anterior repair plus further posterior
operative site reduces the usefulness of the conclusions and repair, these should be reported separately as primary an-
might be misleading with regards to the true failure rate of terior repair and repeat posterior repair.
POP surgery. This observation is borne out when the same III. Surgery for complications: mesh exposure or extrusion,
cohort was reviewed 10 years later with the authors quoting pain, or patient compromise such as hemorrhage (see
a 17% re-operation rate.11 On further analysis of the same Complications section).
compartment recurrence (i.e., repeat anterior repair), the re- IV. Surgery for non-POP related conditions: subsequent sur-
operation rate was significantly lower at 4.6%.12 More recent- gery for stress urinary incontinence or fecal incontinence.
ly, several investigators have looked specifically at the issue of
site-specific recurrence, with re-operation rates ranging from
2.8% to 9.7%.13–15 A recent Cochrane review16 looking at vault STANDARDIZATION OF REPORTING OUTCOMES—OVERVIEW
suspension suggested that re-operation rates after POP
surgery, which includes suspension of the vaginal vault/apex, One of the major difficulties in reporting the results of pro-
are 1.3–3.9% at 17–32 months respectively, depending upon lapse surgery is that, unlike most surgeries, there is a range of
the type of vault suspension. These data become more useful outcomes which are not reported in a consistent manner; this
in terms of site and timescales. makes uniform assessment of procedures difficult.
The second study10 reported a 58–70% anatomical failure The International Consultation on Incontinence (ICI) has
rate for anterior colporrhaphy. This study has recently been already suggested that POP and urinary incontinence surgery
subject to further analysis, as the definitions of objective suc- should report subjective, objective, and quality of life out-
cess and failure were based on POP quantification (POPQ) comes.1 This is significant in that there are a number of meas-
changes of small magnitude. When more clinically relevant ures that can be used to generate useful information to
criteria for success are used (anatomic recurrence beyond benchmark practice for and against a particular procedure, as
the hymen, symptomatic recurrence and re-operation), the well as inform patients about potential outcomes. Therefore,
outcome is considerably better with only 10% of subjects it is recommended that in clinical research studies, entry crite-
developing anatomic recurrence beyond the hymen, and 5% ria, design, methodology, power, and absence of bias are
developing symptomatic recurrence and re-operations in <1% addressed to allow the reader to assess the reliability of find-
(at 23 months follow-up).17 ings which have the potential to influence clinical practice.

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Efficacy of Desmopressin Orally Disintegrating Tablet 417

Conflict of interest should be reported due to the potential I. Chronic cough,
for positive reporting bias and this declaration should be at J. Chronic constipation,
the start of the paper. K. Smoking.

REPORTING OF METHODOLOGICAL DATA

REPORTING OF RANDOMIZED CONTROLLED TRIALS (RCTs)
General Criteria
The following should be defined: There are already accepted standards for reporting RCTs
A. Inclusion criteria. such as the CONSORT (Consolidated Standards of Reporting
B. Exclusion criteria. Trials)20 which requires detailed information provided by
C. Recruitment time span. authors to reviewers with a checklist added as an appendix.
D. Flow diagram including20 However, many studies fail to provide complete descriptions
of critical information.
(i) Number of patients evaluated.
(ii) Number suitable for inclusion.
(iii) Number agreed to participate. REPORTING OF SYSTEMATIC REVIEWS AND META-ANALYSES
(iv) Clear documentation accounting for all patients’ progress
throughout the study period. Due to the lack of consistent descriptions of critical informa-
tion reported from RCTs, a new instrument, Preferred Report-
Comparative Studies ing Items for Systematic Reviews and Meta-Analyses
(PRISMA),21 has been introduced to evaluate systematic
A. Clear explanation of patient allocation to treatment groups. reviews and meta-analyses. The aim of the PRISMA statement
B. Allocation concealment from surgeon and/or patient. is to give authors an evidence-based minimum set of items
C. Randomized trials: explanation of randomization process. to improve the reporting of systematic reviews and meta-
D. Stratification of associated issues utilized such as concomi- analyses in POP issues. Other standards include the Standards
tant continence surgery or hysterectomy. for the Reporting of Diagnostic (STARD) accuracy studies,22
and STROBE (STrengthening the Reporting of OBservational
Interventions studies in Epidemiology).23 Researchers should quote which
standard they adopt and reference accordingly.
A. Clear documentation of interventions performed, experi-
ence level of surgeons and number of interventions per-
formed prior to study commencement. REPORTING OF PATIENTS’ PRE-OPERATIVE
B. Criteria for performing concomitant surgery. GOALS AND EXPECTATIONS

Evaluation Process To date, few studies have provided data on patients’ preop-
erative goals and expectations.24–27 These might have advan-
A. Who performed the evaluation and the training received. tages over objective measures of outcome. With this in mind,
B. Were reviewers and/or participants blinded. goals should be reported using SMART criteria.28 The aim of
C. Evaluation tools: were validated, patient-completed assess- the SMART criteria is to help clinicians review and confirm the
ments standardized. utility of the chosen endpoint and how it will relate to other
D. Evaluation timeline: studies and reports. Criteria comprise:

i. Very early (up to 3 months). Specific Defining goal (for POP: absence of bulge)
ii. Early (up to 1 year). Measureable Validated symptom scale or objective measure such as
iii. Intermediate (12–36 months). the POPQ
Appropriate Relevant to improving patient lifestyle
iv. Late (3–5 years).
Realistic Achievable by treatment
v. Very late (>5 years). Timely For example at 6 months/2 years

Power Analysis
Details of the assumptions made in the Power calculation, The following is an example of good and poor reporting of
estimate of the type 1 error and sample size should be patient expectations and outcomes, using the SMART Schema:
reported. Good example: ‘‘The absence of bother from a vaginal bulge
as measured using a defined tool at 2 years.’’ This statement
has Specific, Measurable, Appropriate, Realistic, and Timely
REPORTING DEMOGRAPHICS IN POP SURGICAL RESULTS
attributes.
The reporting of minimum demographics in POP surgery Poor example: ‘‘Feeling perfect’’ when followed-up. ‘‘Perfect’’
should include: is not specific (OB compared with absence of bulge), is less
measurable (because it is difficult to define), has no defined
A. Age, timepoint and is not appropriate or relevant to the surgery as
B. Parity, many factors define ‘‘perfect.’’
C. Body mass index (BMI), Definitions relating to the SMART criteria should be derived
D. Menopause status, from the symptoms the researchers feel are important.
E. Hormone replacement therapy (HRT) usage, When designing a study, the symptoms should be listed and
F. Prior hysterectomy, then SMART should be applied. Authors should use this as
G. Prior POP surgery, a checklist to ensure that the methodology is sound and
H. Prior continence surgery, relevant.

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418 Toozs-Hobson et al.

REPORTING OF OUTCOMES FOLLOWING SURGICAL Timelines
TREATMENT OF POP
Timelines should be described chronologically, as outlined
below, using the classification above. Of note, these timescales
Perioperative Data
are different to those described in the classifications of compli-
Perioperative data includes blood loss (ml) and/or hemoglo- cations reports related to female pelvic floor surgery using ei-
bin change, operating time, length of hospital stay, return to ther prosthese and meshes7 or native tissue.8
normal daily activities and complications.
I. Very early (up to 3 months).
II. Early (up to 1 year).
Patient Reported Outcomes
III. Intermediate (12–36 months).
The primary patient reported outcome should be subjective IV. Late (3–5 years).
and would usually be the absence of a bulge.29 This can be V. Very late (>5 years).
regarded as a ‘‘subjective cure’’29 and can be recorded as part
of a symptom scale. Details of validated questionnaires for Economic Evaluation/Cost Analysis
patient reported outcomes can be found on ICI’s website.30 To
adhere with the SMART criteria, patient/subjective outcomes Despite considerable cost, sparse cost-effectiveness data
should be defined at a specific time interval and classified on a exists related to POP surgery. Investigators are encouraged to
7-point Likert scale (i.e., very much better, moderately better, a include economic analyses in their studies whenever possible.
little better, no change, slightly worse, moderately worse, very Further details are below in the section Reporting on Econom-
much worse) such as the Patient Global Impression of ic Evaluation/Cost Analysis.
Improvement (PGI-I) scale.31
COMPLICATIONS
Patient Satisfaction
Complications specifically related to prostheses and grafts7
Patient satisfaction can be measured using qualitative and native tissues8 should be reported as per the IUGA-ICS
measures, such as a patient-defined measure or a validated classifications of complications directly related to the inser-
instrument (PGI-I scale).31 Qualitative assessment can include
tion of prostheses and grafts or the use of native tissue in
Expectations, Goal setting, Goal achievement and Satisfaction female pelvic floor surgery.5,6 These classifications both use
(EGGS).32 Again these should be in accordance with the the CTS Classification System:
SMART acronym. The number of pre-specified goals and
the number achieved post-operatively should be recorded
and reported for responsiveness and reliability of goal (C) Category of complication.
achievement.24 (T) Time the complication was diagnosed in relation to prima-
ry surgery.
Quality of Life (S) Site of the complication.

Appropriate and fully validated quality of life instruments

There are seven Categories with subdivsions of (A–D). For
should be used to cover prolapse, urinary, bowel and sexual
the majority of complications, this would mean:
function.30
New questionnaires can be included when they have dem-
onstrated good psychometric properties (i.e., validity, reliabili- (A) Asymptomatic,
ty and responsiveness) in women with POP. It is important (B) Symptomatic,
to verify that the questionnaire has been validated in the (C) Infection,
language of the trial investigator(s). (D) Abscess.

Objective Outcomes For complications involving bowel or bladder injury or pa-

tient compromise, variations in the pattern of the increasing
Objective outcomes (e.g., POPQ33) should be tabulated with index of severity exist: e.g., Category 5: rectal or bowel injury
percentages achieving each level to allow studies to compare (both classifications—7,8) (A) Small intraoperative defect; (B)
results, as definitions of success will vary among studies (see rectal injury or compromise; (C) small or large bowel injury or
below). This report does not attempt to provide a definition compromise; (D) abscess.
for success and failure, as these are unknown. However, Studies, in particular of a specific surgical procedure, should
authors should report data on the leading edge of the prolapse have a procedure-specific list of complications using the CTS
for each site (e.g., patients who achieve points �1 and 0 post- Classification Systems7,8 as part of the reporting. Only in this
operatively having had prolapse greater than �1 or 0 before way can the nature and chronology of possible complications
surgery). These data, which may help identify the level of ana- be determined (in relation to time of surgery) and at which
tomical restoration that leads to improvement in symptoms, sites they might most commonly occur.
should be reported separately. Note is also made of the generic Clavien-Dindo complication
When possible, raw data should be provided for POPQ, qual- classification34 which consists of four severity grades of
ity of life measures and all primary symptoms. These should complications. This has been modified to include a fifth
be reported in separate tables, which can be published as sup- category:35
plementary material in the electronic (online) version rather
than the printed version.
Grade I Requires no treatment
Grade II Requires drug therapy
Reoperation or Further Surgery
Grade III Requires a procedure or intervention (a: in local;
See Further Surgery in ‘‘New Definitions’’ above. b: general anesthesia)

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Efficacy of Desmopressin Orally Disintegrating Tablet 419

Grade IV IC/ICU organ or system dysfunction (a: single organ; REPORTING ON ECONOMOIC EVALUATION AND COST ANALYSIS
b: multi-organ dysfunction)
Grade V Death Economic evaluation techniques provide systematic meth-
ods of comparing the costs and consequences of clinical and
other health sector interventions. Cost-utility analysis (CUA), a
POSTOPERATIVE PAIN
form of cost-effectiveness analysis (CEA), is by far the most
Pain associated with surgical complications is addressed commonly used and requires quantifying the effects of inter-
separately in the IUGA-ICS classifications of complications of ventions on both morbidity and mortality.
female pelvic floor surgery (7,8). The addition of a letter (a to In a CUA, benefits are measured in units of health gain (or
e), as part of a subclassification to the CTS Classification Sys- loss), most commonly using quality-adjusted life-years
tem, specifies the presence of pain as part or all of the abnor- (QALYs) and combined with estimates of cost to create a
mal finding or complication and the grade in terms of the ratio of incremental costs to incremental consequences (e.g.,
presence and severity of symptoms. ‘‘incremental cost per QALY’’). QALYs are usually calculated
using a generic health status measure, such as Short
(a) Asymptomatic or no pain. Form (SF)36 or EuroQOlEQ-5D, which can be used with a stan-
(b) Provoked pain only (during vaginal examination). dard set of health state values or by other measures of
(c) Pain during sexual intercourse. utility, such as the standard gamble or time-trade off tech-
(d) Pain during during physical activties. nique. These incremental cost effectiveness ratios (ICERs) en-
(e) Spontaneous pain. able comparison of competing interventions on the basis of
the cost at which they create improvements in health-related
Additional information on pain may include ‘‘permanent or
quality-of-life.
temporary’’ and ‘‘severity’’ as measured by impact on quality
In economic evaluations, it is important to consider the per-
of life and treatment required (e.g., simple oral analgesia, com-
spective (e.g., patients, hospital, third-party payer, govern-
pound analgesia, opiates, referral and management by pain
ment and society) of the evaluation, as this will have
team or further surgery).
significant influence on which costs should be included in the
analysis. For example, the perspective of the analysis will in-
REPORTING OF SECONDARY OUTCOMES
fluence whether it should include both direct and indirect
Secondary outcomes to be reported include an assessment costs. Direct medical costs typically relate to the intervention
of other symptoms known to be associated with prolapse: and the immediate impact of the intervention on the health
Lower urinary tract symptoms (LUTS): Overactive bladder, system: e.g., personnel costs/time (physician, nurse, techni-
stress urinary incontinence (either pre-existing or de-novo) cian), diagnostic and laboratory tests, hospital costs, treat-
and voiding dysfunction. ment costs (drugs, operating room time, etc.), treatment of
Bowel dysfunction: Obstructed defecation, feeling of incom- side effects and outpatient visits. Indirect costs will be of
plete emptying, constipation and digitation. more relevance to a patient and/or societal perspective (e.g.,
Sexual dysfunction: Dyspareunia, loss of libido, abstinence loss of productivity, time lost from work, loss of service to
due to prolapse symptoms and change in sexual satisfaction. family and community and premature mortality) and are
Authors should report numbers of all patients who are sexual- often more difficult to quantify and to put a monetary
ly active with and without pain, pre and post-intervention. value on.
Figure 1 has been developed to illustrate the reporting of
these data. All participants in trials should be accounted for DISCUSSION
pre- and post-intervention.
This document was born from the recognition that contem-
De novo/new onset symptoms (if not previously reported):
porary practice lacks sufficient reproducible evidence to help
LUTS, sexual dysfunction, pain and bowel dysfunction.
clinicians translate published literature into clinical practice
Backache: Backache is a common presenting symptom, the
and enable patients to be aware of likely outcomes.
resolution of this may be an important outcome.
For example, the assessment of prolapse surgery has been
subject to a number of limitations. First, and perhaps most
important, is the quality of the studies. The majority are case
series, with very few well-constructed and sufficiently pow-
ered RCT. As a result, the quality of the available evidence is
questionable.3,4 The emphasis then lies within systematic
reviews and meta-analyses, which may be less robust due to
the lack of good quality data.
New surgical procedures for POP reconstructive surgery
have evolved dramatically in recent years, suggesting that
the perceived dissatisfaction with conventional/traditional
surgery as expressed by White36 at the turn of the twentieth
century persists. This perception is based on clinical experi-
ence and reports of anatomical failure and re-operation.9,10 As
the findings of these studies9,10 have been questioned by
more recent studies,12,13,17 this highlights the need for a stan-
dardized method of reporting surgical outcomes so that appro-
priate recommendations for patient care can be provided from
meta-analyses and systematic reviews. This report sets out to
provide a framework through which researchers and clini-
cians can standardize reporting and allow results to become
Fig. 1. Reporting of sexual function. more transferable.

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420 Toozs-Hobson et al.

TABLE I. Recommendations for Reporting in Audit of Clinical Practice and Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and
Surgical Trials fecal incontinence. Neurourol Urodyn 2010;29:213–40.
2. Lose G, Fantl JA, Victor A, et al. Outcome measures for research in adult
women with symptoms of lower urinary tract dysfunction. Neurourol
Audit Research trial
Urodyn 1998;17:255–62.
3. http://www.fda.gov/MedicalDevices/Safety/AlertandNotices/ucm262435
Type of surgery R R 4. http://www.fda.gov/MedicalDevices/Safety/AlertandNotices/
Primary outcome including patient satisfaction R R ucm262760.pdf
Secondary outcomes O R 5. Cavadas V, Branco F, Carvalho F. et al. The quality of reporting of random-
Timelines O R ized controlled trials in pelvic organ prolapse. Int Urogynecol J 2011;22:
1117–25.
Cost analysis N Oa
6. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecologi-
Complications R R cal Association (IUGA)/International Continence Society (ICS) joint report on
Commitment to longer term follow-up O R the terminology for female pelvic floor dysfunction. Int Urogynecol J 2010;
Audit database R O 21:5–26; & Neurourol Urodyn 29:4–20.
7. Haylen BT, Freeman RM, Swift S, et al. An International Urogynecological
R, routine; O, optional; N, not required. Association (IUGA)/International Continence Society (ICS) joint terminology
a
It is recognized that this is ideal and not all researchers will be able to do and classification of the complications related directly to the insertion of
prostheses (meshes, implants, tapes) & grafts in female pelvic floor
this, but it is recommended.
surgery. Int Urogynecol J 2011;22:3–15; & Neurourol Urodyn 30:2–12.
8. Haylen BT, Freeman RM, Lee J, et al. An international Urogynecological As-
sociation (IUGA)/International Continence Society (ICS) joint terminology
and classification of the complications related to native tissue female pelvic
History has taught that surgical complications (particularly floor surgery. Int Urogynecol J Neurourol Urodyn (in press).
in the case of implants) may be long-term and researchers 9. Olsen A, Smith V, Bergstrom J, et al. Epidemiology of surgically managed
should be encouraged to revisit early results (e.g., 1 year) and pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:
501–6.
include long-term data of 5–10 years. 10. Weber AM, Walters MD, Piedmonte MR, et al. Anterior colporrhaphy: A ran-
The Austrian and Finnish experiences with mid-urethral domized trial of three surgical techniques. Am J Obstet Gynecol 2001;185:
slings have demonstrated that, in addition to properly con- 1299–304.
structed prospective trials, there is a moral and ethical respon- 11. Denman M, Gregory W, Boyles S, et al. Reoperation rate 10 years after surgi-
cally managed pelvic organ prolapse and urinary incontinence. Am J Obstet
sibility for users of advanced techniques, such as those Gynecol 2008;198:555.
employing implants, to contribute to clinical governance and 12. Kapoor DS, Freeman RM. Reoperation rate following prolapse surgery. Am J
audit through local, regional or national databases. Obstet Gynecol 2009;200:e15 (author reply e15).
13. Diwadkar GB, Barber MD, Feiner B, et al. Complications and reoperation
rates following surgical repair for apical vaginal prolapse: A meta-analysis.
SUMMARY OF RECOMMENDATIONS FOR Obstet Gynecol 2009;113:3670–3.
POP SURGICAL OUTCOMES 14. Kapoor DS, Nemcova M, Pantaziz K, et al. Re-operation rate for traditional
anterior repair: Analysis of 207 cases with a median 4 year follow up. Int J
In all surgical trials of POP surgery, authors should clearly Urogynecol J Pelvic Floor Dysfunct 2010;21:27–31.
report their Methodology. These should follow CONSORT/ 15. Miedel A, Tegerstedt G, et al. A 5-year prospective follow-up study of vaginal
STROBE and type of surgery (primary or further using the surgery for pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct
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agreed definitions, see above) should be stated. Table I out- 16. Maher C, Baessler K, Glazener C, et al. Surgical management of pelvic organ
lines what should be reported in both clinical audit and surgi- prolapse in women: A short version Cochrane review. Neurol Urodyn
cal trials. In addition, researchers should give a commitment 2008;27:3–12. DOI: 10.1002/nau.20542.
in the original trial design and at publication of early results, 17. Chmielewski L, Walters MD, Weber AM, et al. Reanalysis of a randomized
trial of three techniques of anterior colporrhaphy using clinically relevant
to publish longer term data at a minimum of 5 years. definitions of success. Am J Obstet Gynecol 2011; 205:69.e1–69.e8.
18. Jia X, Glazener C, Mowatt G, et al. Systematic review of the efficacy and
ACKNOWLEDGMENTS safety of using mesh or grafts in surgery for anterior and/or posterior
vaginal wall prolapse; 2008. http//www.nice.org.uk/guidance/index.jsp?
This final document has undergone 23 versions and 7 colla- action¼download&o¼39669
tions prior to being available for review on both the IUGA and 19. Jia X, Glazener C, Mowatt G, et al. Efficacy and safety of using mesh or grafts
in surgery for anterior and/or posterior vaginal wall prolapse: Systematic
ICS websites to allow members to submit comments and rec- review and meta-analysis. BJOG 2008;115:1350–61.
ommendations which have enabled appropriate revisions. 20. www.consort-statement.org/
We acknowledge the comments of Dr. Annette Holden, 21. http://www.prisma-statement.org/
Dr. Giuseppe Di Paola, Dr. Rufus Cartwright, Prof. Hans Peter 22. http://www.stard-statement.org/
23. http://www.strobe-statement.org/
Dietz, Dr. Joseph Gauta, Dr. Jian Wein, and Dr. Alexandros 24. Hullfish KL, Bovbjerg VE, Gibson J, et al. Patient-centered goals for pelvic
Derpapas. In particular, we thank Elektra McDermott, manag- floor dysfunction surgery: What is success, and is it achieved? Am J Obstet
ing editor of the International Urogynecology Journal for Gynecol 2002;187:88–92.
her support and help in the preparation of the final draft 25. Hullfish KL, Bovbjerg VE, Steers WD. Patient-centered goals for pelvic floor
dysfunction surgery: Long-term followup. Am J Obstet Gynecol 2004;191:
and proof reading, and the Peninsula College of Medicine and 201–5.
Dentristry (UK) for the section on Economic Evaluation and 26. Srikrishna S, Robinson D, Cardozo L, et al. Experiences and expectations of
Cost Analysis. We acknowledge the support of the IUGA women with urogenital prolapse: A quantitative and qualitative explora-
and ICS leadership in this Joint Report from the two societies, tion. BJOG 2008;115:1362–8.
27. Srikrishna S, Robinson D, Cardozo L. A longitudinal study of patient and
following on from the Joint Reports on Terminology for surgeon goal achievement 2 years after surgery following pelvic floor dys-
Female Pelvic Floor Dysfunction, and Prostheses and Mesh function surgery. BJOG 2010;117:1504–11.
Complications and, concurrently, Complications Related to 28. Doran George T. ‘‘There’s a S.M.A.R.T. way to write management’s goals and
Native Tissue Female Pelvic Floor Surgery. objectives.’’ Management Review 1981; 70.
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Surgical Procedures for Pelvic Organ Prolapse
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31. Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impres- 34. Dindo D, Demartines N, Clavien P. Classification of surgical complications. A
sion of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J Pelvic New proposal with evaluation in a cohort of 6336 patients and results of a
Floor Dysfunct 2010;21:523–8. survey. Ann Surg 2004;240:205–13.
32. Brubaker L, Shull B. EGGS for patient centred outcomes. Int Urogynecol J 35. Clavien PA, Barkun J, de Oliveira ML. The Clavien-Dindo Classification
Pelvic floor Dysfunct 2005;16:171–3. of surgical Complication: 5 years experience. Ann Surg 2009;250:187–
33. Bump RC, Maittiason A, Bo K, et al. The standardisation of terminology of 96.
female organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 36. White GR. Cystocoele. A radical cure by suturing the lateral sulci of vagina
1996;75:10. to the white line of pelvic fascia. JAMA 1909;LIII:1707–10.

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Neurourology and Urodynamics 30:2–12 (2011)

An International Urogynecological Association (IUGA)/

International Continence Society (ICS) Joint Terminology
and Classification of the Complications Related Directly to
the Insertion of Prostheses (Meshes, Implants, Tapes) and
Grafts in Female Pelvic Floor Surgery
Bernard T. Haylen,1* Robert M. Freeman,2 Steven E. Swift,3 Michel Cosson,4 G. Willy Davila,5 Jan Deprest,6
Peter L. Dwyer,7 Brigitte Fatton,8 Ervin Kocjancic,9 Joseph Lee,10 Chris Maher,11 Eckhard Petri,12
Diaa E. Rizk,13 Peter K. Sand,14 Gabriel N. Schaer,15 and Ralph Webb16
1
University of New South Wales, Sydney, NSW, Australia
2
Derriford Hospital, Plymouth. Devon, UK
3
Medical University of South Carolina, Charleston, South Carolina
4
University Hospital, Lille, France
5
Cleveland Clinic, Weston, Florida
6
University Hospital, UZ Leuven, Belgium
7
Mercy Hospital, Melbourne, Victoria, Australia
8
University Hospital, Clermont-Ferrand, France
9
Department of Urology, University of Illinois, Chicago, Illinois
10
Monash Hospital, Melbourne, Victoria, Australia
11
Wesley Hospital, Brisbane, Queensland, Australia
12
Urogynaecology Department, University of Greifswald, Greifswald, Germany
13
Ain Shams University, Cairo, Egypt
14
Evanston Continence Centre, Evanston, Illinois
15
Kantonsspital, Aarau, Switzerland
16
Norfolk & Norwich University Hospital, Norfolk, UK

Introduction and hypothesis: A terminology and standardized classification has yet to be developed for those
complications arising directly from the insertion of synthetic (prostheses) and biological (grafts) materials in female
pelvic floor surgery. Methods: This report on the above terminology and classification combines the input of members of
the Standardization and Terminology Committees of two International Organizations, the International Urogyneco-
logical Association (IUGA) and the International Continence Society (ICS) and a Joint IUGA/ICS Working Group on
Complications Terminology, assisted at intervals by many expert external referees. An extensive process of 11 rounds of
internal and external review took place with exhaustive examination of each aspect of the terminology and classification.
Decision-making was by collective opinion (consensus). Results: A terminology and classification of complications
related directly to the insertion of prostheses and grafts in female pelvic floor surgery has been developed, with the
classification based on category (C), time (T) and site (S) classes and divisions, that should encompass all conceivable
scenarios for describing insertion complications and healing abnormalities. The CTS code for each complication,
involving three (or four) letters and three numerals, is likely to be very suitable for any surgical audit or registry,
particularly one that is procedure-specific. Users of the classification have been assisted by case examples, colour charts
and online aids (www.icsoffice.org/complication). Conclusion: A consensus-based terminology and classification
report for prosthesis and grafts complications in female pelvic floor surgery has been produced, aimed at being a
significant aid to clinical practice and research. Neurourol. Urodynam. 30:2–12, 2011.  2010 Wiley-Liss, Inc.

This document is being published simultaneously in Neurourology and society; grant sponsored by American Medical Systems; C Maher: No disclosures;
Urodynamics (NAU) and the International Urogynecology Journal (IUJ), the E Petri: No disclosures; DE Rizk: No disclosures; PK Sand: Advisor: Allergan,
respective Journals of the sponsoring organizations, the International Con- Astellas, GSK, Coloplast, Ortho, Pfizer, Sanofi, Aventis, Watson. Speaker: Allergan,
tinence Society (ICS) and the International Urogynecological Association (IUGA) Astellas, GSK, Ortho, Pfizer, Watson. Investigator: Boston Scientific, Pfizer,
in the January 2011 issue of each Journal. Watson, Ortho, Bioform; GN Schaer: Advisor (in Switzerland): Astellas, Novartis,
Conflicts of interest: BT Haylen: Assistance from Boston Scientific to attend Pfizer, Gynecare; R Webb:Travel bursaries: Ethicon, AMS, Pfizer, Astellas. Lecture
London June 2008 Meeting of the Authors of the IUGA-ICS Report on fees: (departmental) Pfizer, Astellas. Research: Allergan Astellas.
Terminology for Female Pelvic Floor Dysfunction; RM Freeman: Educational – Standardization and Terminology Committee (IUGA): Bernard T. Haylen,
meetings: Astellas and Pfizer. All income from commercial trials and some of the Robert M. Freeman, Steven E. Swift, Peter L. Dwyer, Joseph Lee, Diaa E. Rizk,
honoraria go to his research fund. Locality lead for the NIHR Peninsula Eckhard Petri, Peter K. Sand, Gabriel N. Schaer.
Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC). – Standardization and Terminology Committee (ICS): Robert M. Freeman, Ralph
PROSPECT: A grant holder for this nationally funded trial of prolapse surgery; SE J. Webb.
Swift: No disclosures; M Cosson: Consultant: Ethicon. Educational sessions: – Joint IUGA/ICS Working Group on Complications Terminology: Bernard T.
Ethicon, Ipsen. Unconditional grant for fundamental research: Ethicon; G Willy Haylen, Robert M. Freeman, Steven E. Swift, Michel Cosson, Chris Maher, G. Willy
Davila: Travel expenses or honoraria and consultant: AMS, Novosys. Holds a Davila, Jan Deprest, Peter L. Dwyer, Brigitte Fatton, Ralph J. Webb.
position of influence in IUGA and NAFC; J Deprest: Consulting or lecturing: *Correspondence to: Bernard T. Haylen, Associate Professor, Suite 904, St
American Medical Systems, Bard, Johnson and Johnson, (Ethicon Gynaecare). His Vincent’s Clinic, 438 Victoria Street, Darlinghurst, 2010 NSW, Australia.
laboratory has received unconditional grants from the same companies, as well E-mail: haylen@optusnet.com.au
as Covidien (formerly Tyco Healthcare); PL Dwyer: Departmental research grant Received 22 October 2010; Accepted 26 October 2010
from American Medical Systems (AMS); B Fatton: Consulting or lecturing: Boston Published online 15 December 2010 in Wiley Online Library
Scientific, Astellas and Tena; E Kocjancic: Consultant: AMS, Coloplast and Bard. (wileyonlinelibrary.com).
Speaker: Astra Zeneca; Joseph Lee: Travel fellowship awarded by national DOI 10.1002/nau.21036

 2010 Wiley-Liss, Inc.

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) Joint Terminology and Classification of the Complications
Related Directly to the Insertion of Prostheses (Meshes, Implants, Tapes) and Grafts in Female Pelvic Floor Surgery
264

IUGA/ICS Classification of Complications 3

Key words: classification; complication; female pelvic floor surgery; graft; mesh; prosthesis

PREFACE In the mid to late 1990s, suburethral synthetic slings for USI
using mesh were introduced, the tension-free vaginal tape
The Standardization and Terminology Committees of the
(polypropylene mesh) being the most notable.7 Trocars were
International Urogynecological Association (IUGA) and the
used both retropubically and, over the last 8–10 years,
International Continence Society (ICS) and the Joint IUGA/ICS
laterally passing the obturator membrane and the insertion
Working Group on Complications Terminology seek to provide
of the obturator internus muscle.8 These trocars have the
a terminology and a standardized classification for those
potential for causing trocar insertion-related complications in
complications arising directly from the insertion of prostheses
addition to complications due to the use of the prostheses or
and grafts in female pelvic floor surgery. This document would
grafts themselves.
then be, amongst its various other possible applications such
The prosthetic materials used to date have, in retrospect,
as medical records and surgical audits (often procedure-
been of different surgical propriety, not appreciated at
specific), the basis for a registry of such complications. As
the time of their Introduction. Amid9 has presented a
the first aim is to standardize the terminology used in this
classification for different types of meshes for repair of
classification, the terms used in the title need to be initially
abdominal wall herniae (the behavior of meshes around the
defined.
vagina may differ) based on pore size and fiber type used and
the likelihood of complications according to these factors. This
. Classification: A systematic arrangement into classes or has been extremely useful in directing clinicians and the mesh
groups based on perceived common characteristics.1 N.B. and/or device manufacturers to more appropriate mesh types
Division: A separation into two or more parts. and designs. The consensus today is that the least morbidity
. Complication: A morbid process or event that occurs during will be achieved by using a low weight, inert, large pore,
the course of a surgery that is not an essential part of that monofilament prosthesis, with an elasticity between 20% and
surgery (‘‘surgery’’ replacing ‘‘disease’’ in the definition; 35%.10,11
‘‘course’’ includes postoperative of whatever duration).1 Deprest et al.11 have presented an excellent analysis of the
. Directly: Without an intermediary or intervening factor.2 biology behind the use of prostheses (synthetic) and grafts
. Related: Connected.2 (biological) in pelvic organ prolapse repair. The classification
. Insertion: Putting in.1 to be outlined will cover insertion issues as well as infection,
. Prosthesis: A fabricated substitute to assist a damaged body healing abnormalities, and other signs of poor integration of
part or to augment or stabilize a hypoplastic structure.1 these materials, though not the materials themselves.
. Mesh: A (prosthetic) network fabric or structure; open In terms of prolapse surgery, there has been at times a quest
spaces or interstices between the strands of the net.2 The to achieve a prolapse repair with as close to 100% efficacy
use of this term would be for prolapse surgery with synthetic (anatomical success) and reduce the 29% long-term risk for a
materials. woman to undergo a subsequent prolapse surgery after prior
. Implant: A surgically inserted or embedded prosthesis.1 prolapse or continence surgery.12 Anatomical benefits have
(Explant: a surgically excised prosthesis). not been necessarily matched by subjective benefits, that is,
. Tape (Sling): A flat strip of synthetic material.1 The use of functional acceptability for the patient. ‘‘Kits’’ (defined as a
this term would be for incontinence surgery with synthetic set of articles or equipment needed for a specific purpose2)
materials. have been introduced for all types of prolapse repairs, again
. Graft: Any tissue or organ for transplantation.1,2 This term involving the use of different materials with different fixation
will be used to refer to biological materials inserted3: devices or trocars. Papers on such procedures meeting the
(a) Autologous grafts: From patient’s own tissues, for scientific criteria for randomized prospective trials have been
example, dura mater, rectus sheath, or fascia lata. relatively slow to emerge. In addition to ‘‘kits,’’ the same
(b) Allografts: From post-mortem tissue banks. materials have also been independently laid in place or fixed
(c) Xenografts: From other species, for example, modified with surgical sutures. The use of prostheses or grafts has
porcine dermis, porcine small intestine, and bovine progressed questionably in some areas from an indication for
pericardium. recurrent prolapse to that of using them in primary proce-
Terminology for grafts has not been separated into the dures.13
different applications for prolapse and continence surgery. Historically, discontinuation of a surgical procedure occurs
. Trocar: A surgical instrument with either a pyramidal, generally due to either (i) a lack of efficacy or (ii) the nature or
conical, or needle-type cutting or dissecting point. frequency of complications. Native [patient’s own, not an
autologous (transplanted) graft] tissue repairs are also not
without complications. Prostheses or grafts potentially add to
INTRODUCTION
the complication profile the aspects of (i) trauma of insertion;
A significant increase in the use of an ever-widening array (ii) reaction of the body to the prosthesis in terms of
of prostheses and grafts has occurred in female pelvic floor inflammation or infection; (iii) the stability of the prosthesis
surgery over the last 30 years. In the 1980s, silastic slings and over time; (iv) morbidity at the donor site from harvesting an
artificial urinary sphincters4 were used for urodynamic stress autologous graft.
incontinence (USI). McGuire repopularized the rectus sheath One key precept in the Hippocratic oath, often quoted in
fascial sling (an autologous graft) described originally by Latin, is primum non-nocere (first, to do no harm). Surgeons
Aldridge.5 In the early1990s, variations on the Stamey-type6 need to know the possible complications that their surgeries
needle suspension procedures were used involving permanent might cause and when and where they might occur. In respect
sutures and modified needles or bone anchors. of the use of prostheses and grafts, such information might be

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4 Haylen et al.
generated from a table of complications (personal, institu- CATEGORY, TIME, AND SITE (CTS) CLASSIFICATION
tional, or multi-center), classified according to three aspects:
The overall aim of the classification is to summarize
category, time, and site (defined below). In addition, there
any of a large range of possible clinical scenarios into
have been examples of personal, multi-center, national, and
a code (‘‘a numeric system for ordering and classifying
industry-coordinated registries. It is a simultaneous aim, with
information’’1) using as few as three numerals and three
the production of this document, to initiate the development
(or four) letters. No additional verbal description, possibly
of a user-friendly, online accessible joint ICS-IUGA web-based
involving undefined terminology, should be necessary (see
registry of the complications referred in this document. With
Table 2).
the information from a codified table of procedure-specific
complications, possibly involving a registry (at whatever
level): (i) a surgeon might better know the value and risk of
a certain procedure; (ii) informed counseling might be SELECTION OF CATEGORIES
provided before a woman embarks on that procedure; (iii) if The selection of category (C) has used the principal that the
the procedure involves a prosthesis supported by industry, least severe complication would involve the prosthesis
then that group would have detailed feedback on the remaining within the anatomical site into which it was
complications of that procedure. Should the overview in terms inserted. More severe complications would involve (i) increas-
of complications be sufficiently adverse, the procedure and/or ing exposure in surrounding anatomical structures; (ii) open-
the prosthesis or graft should be abandoned. ing into surrounding organs; and (iii) systemic compromise.
In drawing up such a classification of complications based The following seven categories (by number) have been
on category, time, and site, the bias would be towards formed:
optimizing sensitivity, clarity, and interpretability. Increasing
sensitivity comes with the natural risk of the classification
1. Vaginal complication—no epithelial separation: This incor-
appearing overly complex. It is hoped that the following
porates the terms prominence (e.g., due to wrinkling or
outline and explanatory notes, user-friendly tables, case
folding) or contraction (shrinkage). Also incorporated here
examples, and some online aids (to be introduced in
is the palpation of mesh fibers.
conjunction with the publication of this document – see
2. Vaginal complication—(smaller) exposure: A smaller (1 cm
abstract and discussion for web reference) might alleviate any
or less) degree of vaginal epithelial separation is involved.
such concern. It would be of greater concern if the classi-
3. Vaginal complication—(larger) exposure or extrusion: A
fication did not cover all the different complication scenarios,
larger degree (>1 cm) of vaginal epithelial separation or
such that previously undefined additional terminology might
prosthesis or graft extrusion is involved.
be needed.
Categories 1–3 have been separated into the following
PROPOSED NEW DEFINITIONS divisions:

Complications involving the use of meshes, tapes, and 1A–3A: Asymptomatic—abnormal mesh finding: These are
grafts in female pelvic floor surgery need to involve the generally physician-diagnosed at any episode of clinical care.
following viewpoints of (i) local complications; (ii) complica- It can be argued that the ‘‘abnormal prosthesis or graft
tions to surrounding organs; and (iii) systemic complications. finding’’ aspects of category 1A, in particular, aren’t really
The generic term of ‘‘erosion’’ (medically defined as the ‘‘state complications as the patient isn’t bothered by the potential
of being worn away, as by friction or pressure’’1), does not problem. It may be, however, that the woman may not have
necessarily suit the clinical scenarios encountered. Its use is engaged in an activity that is likely to provoke symptoms
best avoided, to be replaced by terms with greater physical for herself, for example, pain or bleeding during sexual
specificity and clarity. intercourse (or for her partner), which would convert these
The additional terms to be used are (see also Table 1): complications to category 1B.
1Aa–3Aa: Asymptomatic—abnormal mesh finding—no
. Contraction: Shrinkage or reduction in size.1 pain: The addition of an ‘‘a’’ specifies that the patient
. Prominence: Parts that protrude beyond the surface1 (e.g., experiences no pain in association with the abnormal
due to wrinkling or folding with no epithelial separation). finding.
. Separation: Physically disconnected,2 for example, vaginal 1B–3B: Symptomatic—unusual discomfort or pain; dyspareu-
epithelium. nia ( for either partner): Bleeding or discharge may be possible
. Exposure: A condition of displaying, revealing, exhibiting, or symptoms.
making accessible1 (e.g., vaginal mesh visualized through 1Bb–3Bb: Symptomatic—provoked pain only (during vagi-
separated vaginal epithelium; Fig. 4). nal examination): The addition of a ‘‘b’’ to the category
. Extrusion: Passage gradually out of a body structure or code specifies that pain, provoked only during vaginal
tissue1 (e.g., a loop of tape protruding into the vaginal examination, is associated with the abnormal finding.
cavity; Fig. 5). 1Bc–3Bc: Symptomatic—pain during sexual intercourse:
. Compromise: Bring into danger.2 The addition of a c to the category code specifies that pain,
. Perforation: Abnormal opening into a hollow organ or provoked during sexual intercourse (patient only), is
viscus.1 associated with the abnormal finding.
. Dehiscence: A bursting open, splitting, or gaping along 1Bd–3Bd: Symptomatic—pain during physical activities:
natural or sutured lines.1 The addition of a d to the category code specifies that pain,
. Sinus tract formation: (Localized) formation of a fistulous provoked during physical activities, is associated with the
tract towards vagina or skin, where there is no visible abnormal finding.
implant material in the vaginal lumen or overlying 1Be–3Be: Symptomatic—spontaneous pain: The addition of
skin. an e to the category code specifies that pain, spontaneously

Neurourology and Urodynamics DOI 10.1002/nau

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) Joint Terminology and Classification of the Complications
Related Directly to the Insertion of Prostheses (Meshes, Implants, Tapes) and Grafts in Female Pelvic Floor Surgery
266

IUGA/ICS Classification of Complications 5

TABLE 1. Terminology Involved in the Classification

present (i.e., without physical activity), is associated with part of the abnormal finding associated with abscess
the abnormal finding. formation.
1C–3C: Clinical infection: This is always a possibility with a
synthetic prosthesis or graft. Signs of local tenderness are Category 4: Urinary tract compromise or perforation. This
suggestive with the combination of redness and a purulent category class has been subdivided into:
discharge being more conclusive.
1C–3C (b–e): Infection—pain. The addition of the letters b 4A: Small intraoperative defect: For example, bladder
through to e specifies that pain (as defined in Table 4) is part perforation. Such a complication does not generally create
or all of the infected abnormal finding. longer-term compromise for the bladder if recognized,
1D–3D: Abscess formation: This is a more serious possibility prosthesis (graft) removed as indicated, defect oversewn
with a synthetic prosthesis or graft. (if necessary), and some minor precautions are taken, for
1D–3D (b–e): Infection—pain: The addition of the letters b example, short-term bladder drainage, with suitable anti-
through to e specifies that pain (as defined in Table 3) is biotics commenced.

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6 Haylen et al.

TABLE 2. A Classification of Complications Related Directly to the Insertion of Prostheses (Meshes, Implants, Tapes) or Grafts in Female Pelvic Floor Surgery

Neurourology and Urodynamics DOI 10.1002/nau

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) Joint Terminology and Classification of the Complications
Related Directly to the Insertion of Prostheses (Meshes, Implants, Tapes) and Grafts in Female Pelvic Floor Surgery
268

IUGA/ICS Classification of Complications 7

TABLE 3. Subclassification of Complication Categories to Specify the Presence of Pain (by the
Patient only, not the Partner) Associated with the Abnormal Finding and the Grade in Terms of the
Presence and Severity of Symptoms
___________________________________________________________________________

GRADE OF PAIN SYMPTOMS

___________________________________________________________________________

a Asymptoma�c or no pain

___________________________________________________________________________

b Provoked pain only (during vaginal examina�on)

___________________________________________________________________________

c Pain during intercourse

___________________________________________________________________________

d Pain during physical ac�vi�es

___________________________________________________________________________

e Spontaneous pain

___________________________________________________________________________

4B: Other lower urinary tract (bladder or urethral) compli- 6D: Abscess formation from skin or musculoskeletal complication.
cation or compromise: This division would incorporate Category 7: Patient compromise. This category recognizes
injuries causing longer-term bladder issues, for example, that the patient might be brought into systemic danger with
ongoing prosthesis or graft perforation, fistula, calculus some of the complications in addition to any localized
around the prosthesis, or graft. This category also incorpo- issue.
rates urinary retention directly related to the procedure
requiring subsequent surgical intervention (apart from any 7A: Bleeding complication including hematoma: This
form of bladder drainage). The time and site divisions division refers to any clinically diagnosed hematoma as
relates to those for the surgical intervention. well as those where blood transfusion or surgical inter-
4C: Ureteric or upper tract complication or compromise: vention is a consideration.
This division is self-explanatory. 7B: Major degree of resuscitation or intensive care: This
division refers to significant hemodynamic or cardiopulmo-
Category 5: Rectal or Bowel compromise or perforation. This nary resuscitation directly related to the procedure, and/or
category class has been subdivided into: patient transfer for management in intensive care facilities.
7C: Mortality: The insertion of the prosthesis, whilst not
5A: Small intraoperative defect: Such a complication may necessarily fatal at the time, has set in train further morbid
not generally be expected to cause compromise if the defect events leading to mortality.
is recognized, prosthesis (graft) removed as indicated,
defect oversewn (as necessary) with appropriate precau- N.B. Because of their systemic nature, 7B and 7C will not
tions taken, for example, short-term bowel rest is instituted have a specific site division. They will be denoted S0.
with suitable antibiotics commenced.
5B: Rectal injury or compromise: This division would
incorporate injuries causing longer-term rectal issues, for
example, ongoing prosthesis (graft) perforation, fistula. SELECTION OF TIME (T) DIVISIONS
5C: Small or large bowel injury or compromise: This division The time (T) for the complication is when it is clinically
would incorporate injuries causing longer-term bowel diagnosed. This section incorporates four time periods, all of
issues, for example, ongoing prosthesis (graft) perforation, the possible episodes where clinical care might be given by
fistula, obstruction. the physician or sought by the patient. It might not always
5D: Abscess formation from bowel injury/compromise. be possible to predict with any prosthesis or graft when
complications might be more frequently seen. This would
Category 6: Skin and/or musculoskeletal complications: depend on the results of a procedure-specific surgical audit
using the classification. The earliest time division (T1) might
6A: Asymptomatic: Physician-diagnosed complication at involve more insertion issues, whilst later divisions (T2–T4)
any episode of care. might be biased towards healing abnormality issues.
6B: Symptomatic: For example, discharge, pain, lump.
6C: Infection from skin or musculoskeletal complication: T1: Intraoperative—48 hr: Insertion complications more
Including sinus tract formation. likely.

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8 Haylen et al.

Fig. 1. 52-year-old female underwent a transobturator tape. At 6 weeks, she Fig. 3. 65-year old with urinary incontinence, underwent a multifilament
was cured of her USI and reported no vaginal discharge. Vaginal transobturator sling. At 14 months follow up, she experienced severe pelvic
examination revealed a smaller mesh exposure away from vaginal suture pain and vaginal discharge. Clinical examination revealed hyperthermia to
line. Classification: 2A T2 S2. 40 C, (i) sling exposure at right vaginal sulcus and (ii) severe cellulitis in the
genito-crural fold. Classification: (i) 3C T4 S2; (ii) 6C T4 S3.

T2: 48 hr–2 months: Healing or infection complications SELECTION OF SITE (S) DIVISIONS
more likely.
The selection of these divisions incorporates the current
T3: 2–12 months: Later healing abnormalities more likely.
sites where prosthesis or graft complications have been
T4: Over 12 months: Late healing abnormalities and other
noted:
mesh complications more likely.
S0: Systemic complications (no specific site): As mentioned
earlier, category divisions 7B and 7C which are systemic
complications will be denoted S0.
S1: Vaginal: area of suture line: Perhaps the commonest site
for prosthesis and graft complications from vaginal surgery
is close to the vaginal suture line.
S2: Vaginal: away from the vaginal suture line: As most
suture lines would be midline, this would generally be
lateral in the vagina.
S3: Trocar passage: The passage of any sharp surgical
instrument can cause damage along the path of insertion.
This division incorporates any extraperitoneal, bladder, or
rectal complication, but not intra-abdominal complications
which are S5.
S4: Other skin or musculoskeletal site: This division is
relevant to any skin or musculoskeletal complications
away from the sites of trocar entry or exit. Included might
be cutaneous sinus or fistula formation.
S5: Intra-abdominal: Included in this section would be
bowel perforation or obstruction.

CTS Classification: (Complete code):

. Example of complete CTS code: 3B/T2/S3 (for simplicity,

there is no ‘‘C’’ in front of the category class and division).
Fig. 2. 55-year-old female had a retropubic tape. At 2 years follow up, she
reported vaginal discharge. Examination revealed a palpable but unseen The letters a–e may be added to the category code, for
lateral mesh exposure, together with a cutaneous fistula with local purulent example, 3Bc/T2/S3 to indicate that pain is part of the
discharge. Classification: (i) 2B T4 S2; (ii) 6C T4 S4. abnormality (c—pain with intercourse).

Neurourology and Urodynamics DOI 10.1002/nau

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) Joint Terminology and Classification of the Complications
Related Directly to the Insertion of Prostheses (Meshes, Implants, Tapes) and Grafts in Female Pelvic Floor Surgery
270

IUGA/ICS Classification of Complications 9

Fig. 4. A 67 year old woman had undergone a vaginal prolapse repair with hysterectomy. She subsequently had a
transvaginal mesh repair for a large recurrent cystocele. At 5 months follow up, she complained of dyspareunia.
Vaginal examination revealed a mesh exposure of 20 mm by 15 mm at anterior vaginal wall and vaginal cuff.
Classification: 3Bc T3 S1.

CLASSIFICATION GUIDELINES vaginal tape exposure from asymptomatic to symptomatic;

an exposure progresses from smaller to larger.
The following should be noted:
CLASSIFICATION LIMITATIONS
. Multiple complications may occur in the same patient: These
should be reported separately as noted in Table 3. . The classification does not note the specific type of mesh: Use
. There may be early and late complications in the same of prostheses other than those with the least morbidity (as
patient: again, these should be reported separately. described in the Introduction Section) might be further
. All complications should be listed. reflected in an increased rate of the healing abnormalities.
. If there is progression of a particular complication over time,
the highest final category is to be used: progression of a

Fig. 6. A 65-year-old woman underwent a transvaginal mesh repair for a

grade 3 prolapse. At 32 months, she had recurrent urinary tract infections,
urgency and urge incontinence, pelvic pain and deep dyspareunia, bladder
pain, and lumbar pain. Radiology: right hydronephrosis and ureteral
Fig. 5. A 47-year-old woman underwent a transoburator tape for USI. At obstruction. (i) Cystoscopy: mesh extrusion (<0.5 cm) with stone. No right
5 months follow-up, she reported vaginal discharge. Clinically she was ureteric patency. (ii) Vaginal examination: severe anterior mesh shrinkage
febrile at 38 C with a large sling extrusion as depicted. Classification: and pain during anterior vaginal wall palpation. Classification: (i) 4C T4 S3;
3C T3 S1. (ii) 1Bc T4 S1.

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10 Haylen et al.
. Urinary tract infections have not been included.
. The small risk (about 1 in 2 million) of prion or viral
infection associated with a xenograft15 is not included.
. Recurrences: It is claimed that meshes are used to prevent
recurrence of pelvic organ prolapse. However, a mesh
procedure might fail resulting in a recurrence. This can
be either by degradation or local release of sutures, the
clinical result being the same. Sometimes local complica-
tions can lead to the removal of the mesh, which
could further increase the risk for recurrence. However,
it should be emphasized that recurrence is not a complica-
tion.
. Intraperitoneal adhesions: Some procedures involve the use
of implant material into the abdomen. As a consequence,
intraperitoneal adhesions can arise either on the implant or
remotely.
. Bulking agents: Complications related to bulking agents
including migration are not included.

DISCUSSION
The present classification has been developed to be
sensitive to all possible physical complications involving
the use of a prosthesis or graft in a female pelvic floor
surgical procedure. Both insertion complications (e.g., trocar
Fig. 7. A 56-year-old woman underwent a posterior vaginal mesh procedure related) and healing abnormalities are covered. Whilst this
using a trocar. At 3 months, clinical examination confirmed an (i) infected
creates a large number of possible complication scenarios,
midline 15 mm vaginal mesh exposure together with (ii) a recto-vaginal
fistula. There had been mesh penetration of the rectum. Classification:
appropriate organization has still been possible by
(i) 3C T3 S1; (ii) 5B T3 S3. category, time and site. The end-point is a code of three
letters (4 if a–e are used) and three numerals. The addition of
the pain subclassification reflects the recognition of the
. Functional issues (e.g., voiding dysfunction) are not authors that chronic pain, especially if in the higher
included: Voiding dysfunction can be defined as abnormally subclasses (c–e), can be amongst the most disabling surgical
slow (assessed by urine flow rate data) and/or incomplete outcomes from the use of prostheses or grafts in female
(assessed by postvoid residual) micturition.14 Surgical pelvic floor surgery.
intervention for severe voiding dysfunction, namely urinary A key advantage of a standardized classification is that
retention is included in Section 4B. all parties involved in female pelvic floor surgery including
surgeons, physicians, nurses, allied health professionals, and
industry will be referring to the same clinical issue. It is
anticipated that a (CTS) codified table of complications will be
a necessary part of reports of surgical procedures relevant
to this document. Many countries already have national
databases for new surgical devices. It is inevitable that
there will be more regulation over time for their introduction.
With a standardized classification in place, quicker
assessment of adverse events will be achieved together with
uniform reporting of prosthetic-related complications.
Any procedure showing a consistently high rate of complica-
tions in a surgical audit would need closer scrutiny and/or
possible abandonment. As result of the use of such a
classification, in terms of patient care, the principle from the
Hippocratic oath, ‘‘first, to do no harm’’ is more likely to be
observed.
It is acknowledged that to optimize the coverage of
complications, the classification might still appear complex
and not immediately mastered. However, as noted in the
Introduction Section, we anticipate that the case examples
provided below, the color charts and the online ICS-IUGA
Complication Classification Calculator (www.icsoffice.org/
complication) will ameliorate any initial concerns.
It has been a consensus view of the authors that a
Fig. 8. A 62-year old woman underwent a transobturator anterior vaginal
formal academic terminology and classification should be
mesh procedure. At 24 months follow up, she reported no vaginal discharge completed prior to attempts at further simplification. This
Clinical examination revealed skin erosion with local inflammation and otherwise might run the risk of compromising coverage of
some discomfort at (trocar) exit point. Classification: 6B T4 S3. complications.

Neurourology and Urodynamics DOI 10.1002/nau

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) Joint Terminology and Classification of the Complications
Related Directly to the Insertion of Prostheses (Meshes, Implants, Tapes) and Grafts in Female Pelvic Floor Surgery
272

IUGA/ICS Classification of Complications 11

TABLE 4. An Example of a Non-Procedure Specific Table of Complications Related Directly to the Insertion of Prosthese (Meshes, Implants,
Tapes) or Grafts in Female Pelvic Floor Surgery using the Category (C), Time (T) and Site (S) system. The CTS Classification Code is Placed
Adjacent to the Description of the Complication. One Might Expect these Tables to be Often Procedure-Specific.

ACKNOWLEDGMENTS Arunkalaivanan, Dr. Kiran Ashok, Professor Peter Dietz, Dr.

Nathan Guerette, Professor Don Ostergard, and Professor Peter
The co-authors acknowledge the support and goodwill of
Petros.
the IUGA and ICS leadership in this second Joint Report from
the two societies, following on from the Joint Report on REFERENCES
Terminology for Female Pelvic Floor Dysfunction.14 We thank
1. Stedman’s Medical Dictionary. Baltimore: Lippincott, Williams and Wilkins;
Mr. Dominic Turner and Mr. Ashley Brookes from the ICS 2006.
Office for their assistance and expertise in developing the 2. Concise Oxford Dictionary. Oxford: Clarendon Press; 1995.
online aids and the progress towards an ICS-IUGA Registry. 3. Dwyer PL. Evolution of biological and synthetic grafts in reconstructive
This document has involved 11 rounds of full review by co- pelvic surgery. Int Urogynecol J 2006;17:S10–5.
4. Duncan HJ, Nurse DE, Mundy AR. Role of the artificial urinary sphincter in
authors. Following website publication (Version 8), there have the treatment of stress incontinence in women. Brit J Urol 1992;69:141–3.
been four rounds of further review. Versions 3 and 10 were 5. Aldridge AH. Transplantation of fascia for relief of urinary stress incon-
subject to live meetings in Cancun (June 2007) and Toronto tinence. Am J Obstet Gynecol 1942;44:398.
(August 2010). The valuable input of Professor Bernard 6. Stamey TA. Endoscopic suspension of the vesical neck for urinary
incontinence. Surg Gynecol Obstet 1973;136:547–54.
Jacquetin is gratefully acknowledged. The comments of the 7. Ulmsten UJ, Johnson P, Rezapour M. A three-year follow-up of tension-free
following reviewers in response to website publication vaginal tape for surgical treatment of stress urinary incontinence. Br J Obstet
(April–June, 2010) are also much appreciated: Dr. Angamuthu Gynaecol 1999;106:345–50.

Neurourology and Urodynamics DOI 10.1002/nau

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1. ICS Standardisations
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12 Haylen et al.
8. Delorme E, Droupy S, de Tayrac R, et al. Transobturator tape (Urotape). A 12. Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed
new minimally invasive procedure to treat female urinary incontinence. Eur pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89: 501–6.
Urol 2004;45:203–7. 13. Davila GW. Introduction to the2005 IUGA Grafts Roundtable. Int Urogynecol
9. Amid P. Classification of biomaterials and their relative complications in an J 2006;17:S4–5.
abdominal wall hernia surgery. Hernia 1997;1:15–21. 14. Haylen BT, Freeman RM, De Ridder D, et al. An International Urogyneco-
10. Rosch R, Junge K, Hölzl F, et al. How to construct a mesh. In: Schumpelick V, logical Association (IUGA) – International Continence Society (ICS) Joint
Nyhus LM, editors. Meshes: benefits and risks. Berlin: Springer; 2004. report on the terminology for female pelvic floor dysfunction. Int Urogynecol
p. 179–84. J Pelvic Floor Dysfunct 2010;21:5–26. Neurourol Urodyn 2010;29:4–20.
11. Deprest J, Zheng F, Konstantinovic M, et al. The biology behind fascial defects 15. Simonds RJ, Homberg SD, Hurwitz RL. Transmission of human immunode-
and the use of implants in pelvic organ prolapse repair. Int Urogynecol J ficiency virus type 1 from seronegative organ tissue donor. N Eng J Med 1992;
Pelvic Floor Dysfunct 2006;17:S16–25. 326:726–30.

Neurourology and Urodynamics DOI 10.1002/nau

An International Urogynecological Association (IUGA)/ International Continence Society (ICS) Joint Terminology and Classification of the Complications
Related Directly to the Insertion of Prostheses (Meshes, Implants, Tapes) and Grafts in Female Pelvic Floor Surgery
274

Neurourology and Urodynamics 31:621–624 (2012)

Developing Evidence-Based Standards for Diagnosis and

Management of Lower Urinary Tract or Pelvic
Floor Dysfunction
Peter F.W.M. Rosier,1 Dirk de Ridder,2 Jane Meijlink,3 Ralph Webb,4
Kristene Whitmore,5 and Marcus J. Drake6*
1
University Medical Centre Utrecht, The Netherlands
2
Department of Urology, University Hospitals KU Leuven, Leuven, Belgium
3
Chairman, International Painful Bladder Foundation, The Netherlands
4
Department of Urology, Norfolk & Norwich University Hospital, Norwich, United Kingdom
5
Pelvic & Sexual Health Institute, Philadelphia, Pennsylvania
6
Bristol Urological Institute, University of Bristol, Bristol, United Kingdom

The International Continence Society (ICS) has a key role in standardizing terminology related to lower urinary tract
and pelvic organ dysfunction. The ICS Standardization Steering Committee (SSC) presents the new structure and
process by which future ICS Standards will be developed. The new processes aim to meet present-day evidence-based
practice requirements, and to foster unbiased, inclusive, and transparent development. For each new ICS Standard,
the SSC will oversee a dedicated ad hoc Working Group (WG). Applications to chair or contribute to a WG will be
invited from the ICS membership. The SSC will select the Chairperson, and work with him or her to select the WG
composition, balanced to represent key disciplines, stakeholders, and regions. Consultants can be invited to contribute
to the WG where specific need arises. Every WG will review current knowledge, adhering to evidence-based medicine
requirements. Progress reports will be reviewed by the SSC, and amendments recommended, culminating in a first
draft. The draft will be offered to the ICS membership and additional relevant experts for comment. Further revision,
if needed, will result in a document, which the SSC will submit to the ICS Trustees, as arbiters of whether the docu-
ment should be adopted as an ICS Standard. The SCC will then coordinate with the WG to ensure that the new ICS
Standard is published and disseminated. Implementation strategies, such as education, audit, accreditation, and re-
search initiatives will be linked to the Standards where appropriate. Revisions of ICS Standards will be undertaken to
maintain contemporaneous relevance. Neurourol. Urodynam. 31:621–624, 2012.  2012 Wiley Periodicals, Inc.

Key words: standards; evidence-based medicine

INTRODUCTION and consensus with input from the ICS membership, but with-
out inclusion of the published evidence in a systematically
One of the most recognized activities of the International
weighed and transparent manner. The most recent report, a
Continence Society (ICS) has been the publication of standard-
joint report with the International Urogynecological Associa-
izations of terminology for diagnosis and testing in functional
tion,4,5 was developed in a similar manner. Ease of modern
urology. This work started in 1976, with subsequent updates.
electronic communication has allowed more experts to moni-
The 19881 and the 20022 reports, with � 1,000 and � 2,500
tor the content of draft editions of newer documents. This has
citations, respectively, are amongst the most widely quoted
meant that expert opinions were included in a ‘‘numerically’’
publications in urology.
more balanced manner. However, no ‘‘methods’’ paragraph
There have been two particularly important categories of
was given to explain explicitly how decisions on topics to in-
publication. The first is the standardization of terminology,
clude were made, nor how evidence and expert opinion were
such as the ‘‘Standardization of Terminology of Lower Urinary
prioritized, included or excluded beyond acknowledgement of
Tract Function’’.2 Standardized definitions of key medical
the commenting experts in a final paragraph.
terms with international consensus are increasingly needed
Ideally, only ‘‘genuine evidence’’ is included in standards
as analysis and registration in healthcare become ever more
and guidelines. Where genuine evidence is lacking or conflict-
automated and communication increasingly global. The estab-
ing, it is preferable that expert opinion is separately added to
lishment of the International Health Terminology Standards
Development Organization (IHTSDO; http://www.ihtsdo.org/
index.php?id¼502) signifies the increasing weight attached to Peter F.W.M. Rosier and Dirk de Ridder contributed equally to this work.
the agreed definitions of terminology to describe conditions at Conflict of interest: M. Drake, Advisory boards/research/speaker engagements
a fundamental level in medicine. The second category deals with Allergan, Astellas, Ferring, J&J, Pfizer.
Roger Dmochowski led the peer-review process as the Associate Editor responsi-
with the provision of guidelines for quality control and im- ble for the paper.
provement of standards, which serve as a benchmark for pro- *Correspondence to: Marcus J. Drake, IInternational Continence Society Standardi-
fessional activity, exemplified by the ‘‘Good Urodynamic zation Steering Committee, International Continence Society, 19 Portland Square,
Practice’’ document.3 Bristol, BS2 8SJ, UK. E-mail: marcus_drake@bui.ac.uk
Received 25 September 2011; Accepted 21 November 2011
ICS standards and standardization have led the way and Published online 6 March 2012 in Wiley Online Library
have been widely accepted. The process by which they have (wileyonlinelibrary.com).
been produced has been based on intensive expert discussion DOI 10.1002/nau.21253

 2012 Wiley Periodicals, Inc.

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622 Rosier et al.

substantial.11 In the modern era of information technology,
transparency, accountability, and complex multidisciplinary
responsibilities cannot be ignored; expert opinion is only ac-
ceptable where evidence is lacking and must be clearly
marked and explained as being expert opinion.
The ICS Standardization Committee recognized the impor-
tance of adhering to EBM principles. In 2010, a reorganization
took place from which the renamed Standardization Steering
Committee (SSC) emerged. A key difference between the new
SSC and the old Standardization Committee is that the SSC
does not itself deliver standardization documents; instead it
oversees ad hoc Working Groups (WGs) (see below) which de-
liver the documents, aiming to ensure transparency, balance,
and adherence to the methods and principles of EBM. The SSC
Chairman is elected from the ICS membership according to
the ICS articles and bylaws. The Chairman and the SSC mem-
bers serve for a term of 3 years, once renewable.
The ICS SSC aims to ensure ongoing development of high
quality terminology and/or practice standards, for guidance of
professionals dealing with the basic scientific investigation,
diagnosis, and management of lower urinary tract, pelvic
floor, genital, and anal function and dysfunction. Developing
these standards requires transparency and integrity; the SSC’s
process and expectations for modern-day development of
some of the most important ICS documents are described be-
low and illustrated in Figure 1.

Fig. 1. Summary diagram of the key stages in development of an ICS Stan- PROCESS OF DEVELOPING AN ICS STANDARD
dard. (SSC, Standardization Steering Committee; WG, Working Group).
Topics selected by the SSC for development or revision of
standardization reports will be based on areas of priority
recommendations in a transparent and explicit manner. In need, whether identified by the SSC itself, or in response to
the mid-eighties a group around David Sackett, a key figure in stakeholder suggestions. The delivery of a standardization
evidence-based medicine (EBM),6 developed a systematic ap- document on a selected topic will be the remit of a specifically
proach to evaluate published evidence, after he analyzed the created ad hoc WG, which will focus on that specific subject
problem of ‘‘observer error’’ in the interpretation of medical (see Table I). The SSC’s role is to agree the scope of the WG’s
literature.7 ‘‘EBM is the conscientious, explicit, and judicious activity, instigating and steering activity, checking compli-
use of current best evidence in making decisions about the ance with suitable working practices, monitoring progress, en-
care of individual patients. The practice of EBM means inte- suring adequate stakeholder input and evaluating the end
grating individual clinical expertise with the best available ex- result.
ternal clinical evidence from systematic research’’.8 Standards Once the need for a new or revised standard has been iden-
to produce evidence-based clinical practice guidelines have tified, the SSC will invite applications from ICS members wish-
been developed,9 with guidance manuals.10 ing to chair the relevant WG. The person selected will have
EBM as a strategy to improve healthcare is not disputed, but submitted the proposal with the best strategy for developing
the implications in a rapidly expanding field of knowledge are the document in the opinion of the majority of SSC members.

TABLE I. Structure and Function of Standardization Document WG

The composition needs to be multidisciplinary and multinational, representing the most important stakeholders (including, e.g., patient representatives,
health economists, and others as appropriate)
Non-ICS members can be part of the WG as experts or representatives of specific stakeholders
The WG should generally not include more than 15 people
Selection of WG members should follow a transparent process, which is recorded and publically available
Additional contributions to a WG’s deliberations can be received from outside individuals
The WG should not receive any sponsorship from industry and the members should disclose all relationships
All members of the WG will be responsible for the entire content of the document as a group.
The WG has a chairman who:
will propose the key question or topics of discussion to the SSC, together with a strategic plan.
will keep a digital working log of the WG activities
will make sure that the composition of the WG is well balanced and that the process of standardization is transparent
will use web-based and e-mail exchange of information and monitor the execution of assignments within the assigned timeline
will adhere to EBM principles, where appropriate
will report to the SSC
will be responsible for production of a first draft of the report within a stipulated time frame (generally 18 months)
will be responsible for submission for publication and dissemination.
After publication of the standard, the WG will be dissolved.
A typical lifespan for an ad hoc WG will maximally be 36 months. If the WG fails to be productive, the SSC dissolves the WG.
The ICS or ICS SSC will not provide financial budget for face-to-face meetings of any ad hoc WG.

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Process of Developing ICS Standards 623

TABLE II. SSC Criteria for Assessing WG Proposals The SSC will ensure a transparent process for selection of
Title of the project
WG members, and will evaluate and adapt the composition to
Name of applicant ensure a balance between different viewpoints (professional,
Description of the topic: The arguments for creating the WG are: patient, and other stakeholders’ perspectives). Once agreed,
(Explain why one or more of the following arguments is relevant) the proposal and the names of the WG’s members will be pub-
area of clinical uncertainty or ‘‘debate’’ exists lished on the ICS website. If a member of the SSC is also a
evidence of better treatment is available member of a WG, he/she will not be included in SSC decisions
evidence for renewal of the existing standard is available related to that particular WG. All (potential) conflicts of inter-
evidence of practice variation is available est will be published on the ICS website.
other clinical or scientific relevance
there is significant controversy in practice or literature
there is conflicting or incomplete evidence Stages of a Standard
there are cultural differences in practices or viewpoints
there is socio-economic relevance Stages through which a standardization document will
List of proposed names (with CVs): progress are summarized in Table III. These will be listed in
confirmation that individuals have agreed to contribute the project management-working log of the WG and the
evidence of multinational and interdisciplinary balance Chairperson of the WG should report progress to the SSC. The
opportunity for ICS members to apply to join the WG and transparent, SSC will provide a mentor for the WG, who will evaluate the
documented process for selection progress at least every 6 months and be available if any prob-
process to register contributions from individuals or groups not in the WG
lems arise. The mentor will keep a log of these contacts.
Description of the methodology and how it will be used:
web-based approach
e-mail Preparation of a Draft Report
conference calls or webcasts
face-to-face meeting (mainly during ICS international meetings) The WG will prepare successive working drafts, circulating
proposed timeline the drafts, and amending according to comments, until the
Description of topic, proposed WG composition, likelihood of group is satisfied that it has developed the best solution for
implementation, likelihood of publication, innovation of approach, the subject being addressed. Standards should adhere to
realistic timeline, use of electronic tools. EBM principles, where appropriate and possible. At an early
stage, therefore, the WG has to devise a strategy for a
comprehensive review of published literature and use an
The SSC will evaluate proposals according to key criteria inclusive and transparent approach to derivation of expert
(Table II). opinion. It might sometimes be necessary to use the Delphi
method.12 Each WG will ensure a strategy for capturing and
assimilating the views of all groups of stakeholders and crite-
WG Composition
ria for inclusion or exclusion of these views in the finished
The selected Chairperson will establish a WG of interested document.
and knowledgeable individuals from a multinational and in- Throughout, the WG’s Chairperson is responsible for:
terdisciplinary background, representing all key stakeholder
groups. Technical expertise relevant to the WG’s remit will be - keeping a digital log of the WG’s activities
taken into consideration in the selection of members. The WG - documenting the methods that were used to produce the
will also be permitted or asked by the SSC to invite input from draft document
outside consultants where this is needed. This will typically - promoting web-based and e-mail exchange of information
be applicable in specialist contexts that are not widely repre- and monitoring the execution of assignments within the
sented within the ICS, such as engineering, computer sciences, agreed timeline
or data handling. It may also be relevant in other fields, such - reporting to the SSC
as consumer perspectives, or economic issues, for example. - producing a first draft of the report within 18 months.

TABLE III. Development of an ICS Standard

Timescale
(months) WG SSC

Proposal stage �6 to 0 Applications for Chairmanship or membership. Call for applications. Review subject, Chair, Group,
criteria, timeline and starting date.
Preparatory stage 0 to 18 WG constituted. Development of draft. Evaluate progress. Appoint mentor. Evaluation
(at least every 6 months).
Committee stage 18 to 21 Draft submitted to SSC. Review of the process and document against criteria.
Approval by consensus.
Enquiry stage 21 to 24 Draft on ICS website. Internal and external review. Comments by ICS
members and stakeholders.
Approval stage 24 to 27 Submit final document to SSC. Process review. Submission to ICS Board of Trustees.
Publication 27 to 36 Final text to ICS office for web Official ICS document. WG dissolved.
publication. Journal submissions.
Implementation stage >36 Support implementation. Education
(with ICS Education Committee). Register of
comments. Identify research needs. Support health technology
and economic assessment.
Revision stage Submit proposal to SSC. Start new process.

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624 Rosier et al.

Committee Stage (Assessing the Process of Standardization) Revision of Standards
As soon as a draft is available, the Chairperson of the SSC The ICS SSC will also keep track of comments that are
will forward it to all the members of the SCC for internal received for consideration during a future revision of the
process review. The process by which the draft standard was standard text, as well as identifying future research needs.
created will be evaluated according to preset criteria. The doc- A revision or update can be proposed by the SSC or any ICS
ument requires SSC approval prior to progressing to the next member or group of ICS members when there is a perceived
stage of development. The SSC may require revisions or need, and the timescale for anticipated revision of a standard
amendments which will need to be undertaken by the WG in will be specified at the time of adoption—subject to future
a defined time frame. A document that fails to meet the objec- developments in the field. The SSC can discuss not to revise
tives or was not developed in accordance with the appropriate outdated documents and declare them obsolete.
approach will be rejected, and the WG will be dissolved.
CONCLUSIONS
Enquiry Stage (Wider Assessment of the Content of the Document)
In developing evidence-based standardization documents,
The actual assessment of the content of the document will the ICS SSC aims to ensure inclusiveness, responsiveness,
be undertaken by internal and external experts (invited by the transparency, accessibility, flexibility, and evolution. The ICS
SSC) and the ICS membership. The draft standard will be circu- SSC presents a structured process for ad hoc WGs to develop
lated to all members by website publication for commenting ICS standards, and a strategy to guide that process. Conse-
over a period of 3 months. quently, each WG will be responsible for several stages of de-
velopment, each clearly documented, until a high quality
Approval Stage document has been approved as an ICS standard.
The presented structure and strategy place emphasis on the
The WG should resubmit the final version based on the
principles of EBM and transparency in the development of ICS
comments received. Explicit criteria for the inclusion or exclu-
standards. They also provide the flexibility necessary for the
sion of comments should be developed and each comment
varied nature of the initiatives established by the ICS, where
should be accompanied by a narrative explaining the reason
multiple stakeholders are generally present, and also circum-
why it was either included in or excluded from the final ver-
stances in which the evidence base may be limited. ICS stand-
sion. All comments and accompanying narrative will be pub-
ards will continue to be adopted and promoted as the basis
lished on the relevant document web forum. The revised
for good professional practice, suitable for the demands of the
version should be resubmitted to the SSC for process review
modern era of EBM.
and assessment of the amendments. If approved, the docu-
ment and the log of the development process will be sent to
the ICS Board of Trustees for confirmation and adoption. REFERENCES
1. Abrams P, Blaivas JG, Stanton SL, et al. The standardisation of terminology
Publication of lower urinary tract function. The International Continence Society Com-
mittee on Standardisation of Terminology. Scand J Urol Nephrol Suppl
Once the Board has confirmed and adopted the document 1988;114:5–19.
and the process, the final text will be published on the ICS 2. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of
website and will then be referred to as the new ICS Standard, lower urinary tract function: Report from the Standardisation Sub-commit-
superseding previous Standards. Thus, the new report must tee of the International Continence Society. Neurourol Urodyn 2002;21:167–
78.
outline where it differs from previous reports. The WG will be 3. Schafer W, Abrams P, Liao L, et al. Good urodynamic practices: Uroflowme-
encouraged to submit the document as an ICS Standard to try, filling cystometry, and pressure-flow studies. Neurourol Urodyn
Neurourology and Urodynamics, and the SSC will advise in 2002;21:261–74.
this process. Co-publication with other journals can be consid- 4. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecologi-
cal Association (IUGA)/International Continence Society (ICS) joint report on
ered if relevant, within copyright regulations. Publication of the terminology for female pelvic floor dysfunction. Neurourol Urodyn
the respective ICS Standard will conclude the WG’s activities. 2010a;29:4–20.
5. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecologi-
cal Association (IUGA)/International Continence Society (ICS) joint report on
Implementation Stage the terminology for female pelvic floor dysfunction. Int Urogynecol J Pelvic
Floor Dysfunct 2010b;21:5–26.
The ICS SSC will promote implementation of the standards 6. Sackett DL, Straus SE, Richardson WS, et al. editors. Evidence-based medi-
by publication, dissemination and education, and the propos- cine: How to practice and teach EBM 2nd edition. Edinburgh & New York:
ing of new standards to its affiliate and collaborating societies Churchill Livingstone; 2000.
and organizations. Additionally, the SSC will monitor the un- 7. Haynes RB, Sackett DL, Tugwell P. Problems in the handling of clinical and
research evidence by medical practitioners. Arch Intern Med 1983;143:
dertaking of clinical audit based on the ICS Standards’ recom- 1971–5.
mendations as a key aspect of successful introduction of the 8. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: What it
documents into mainstream practice,13 and the undertaking is and what it isn’t. BMJ 1996;312:71–2.
of the research and development necessary for ongoing devel- 9. Grimshaw J, Eccles M, Russell I. Developing clinically valid practice guide-
lines. J Eval Clin Pract 1995;1:37–48.
opment of the evidence base. 10. Coopey M, Nix MP, Clancy CM. Evidence-based practice: AHRQ’s role in gen-
Standards will be written in UK English. Translation into erating and disseminating knowledge. AORN J 2007;86:857–60.
other languages will be supported; for terminology standards, 11. Browman GP. Development and aftercare of clinical guidelines: The balance
this will require that appropriate linguistic validation proce- between rigor and pragmatism. JAMA 2001;286:1509–11.
12. Jones J, Hunter D. Consensus methods for medical and health services
dures are followed (for an example of the application of lin- research. BMJ 1995;311:376–80.
guistic validation in the context of translation of symptom 13. SIGN. SIGN50 a guideline developer’s handbook. Edinburgh: Scottish Inter-
assessment tools, see Acquadro et al., 2006). collegiate Guidelines Network; 2008.

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Developing Evidence-Based Standards for Diagnosis and Management of Lower Urinary Tract or Pelvic Floor Dysfunction
278

2. FUNDAMENTALS
The Fundamentals of Assessment articles are commissioned by the ICS Board of Trustees, setting out the
core knowledge for any practitioner needing to assess lower urinary tract dysfunction (LUTD) in their
clinical work. The documents aim to give a solid knowledge basis for several different aspects of LUTD,
suitable for trainees, allied health professionals, and people working in related disciplines like neurology,
primary care, and care of the elderly. They describe what any practitioner really must know for everyday
practice, and provide examples, covering;

• Urinary symptoms in general.

• Specific patient groups: nocturia; neurological disease; chronic pelvic pain

• Pelvic organ prolapse quantification

• Urodynamic tests: flow rate testing; urodynamics; videourodynamics

• The relevance of Standardisation

As well as a knowledge base, the Fundamentals are a starting point for the ICS Standardisations, which
are the basis of specialist practice in LUTD in substantial detail.

Marcus Drake
ICS Trustee

ICS Standards 2019

2. Fundamentals
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Fundamental Assessment of Lower Urinary Tract Dysfunction

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Volume 37 Issue S6 2018
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A
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T A B L E O F C O N T E N T S

EDITORIAL COMMENT EDITOR

S6 Editorial Comment S67 W
Sherif Mourad, Roger Dmochowski, and Marcus Drake D

SOUNDING BOARD SOUND

S7 A Commentary on Expectations of Healthcare Professionals When Applying the International S69 C
Continence Society Standards to Basic Assessment of Lower Urinary Tract Function P
Marcus J. Drake and Paul Abrams

S13 Fundamentals of Terminology in Lower Urinary Tract Function

Marcus J. Drake

S20 Basic Concepts in Nocturia, Based on International Continence Society Standards in Nocturnal
Lower Urinary Tract Function
Hashim Hashim and Marcus J. Drake

S25 Neurological Lower Urinary Tract Dysfunction Essential Terminology

Jerzy B. Gajewski and Marcus J. Drake

S32 The Fundamentals of Chronic Pelvic Pain Assessment, Based on International Continence
Society Recommendations
Neha Rana, Marcus J. Drake, Rebecca Rinko, Melissa Dawson, and Kristene E. Whitmore

S39 How to Use the Pelvic Organ Prolapse Quantification (POP-Q) System?
Chendrimada Madhu, Steven Swift, Sophie Moloney-Geany, and Marcus J. Drake

S44 The Fundamentals of Uroflowmetry Practice, Based on International Continence Society Good
Urodynamic Practices Recommendations
Andrew Gammie and Marcus J. Drake

S50 Fundamentals of Urodynamic Practice, Based on International Continence Society Good

Urodynamic Practices Recommendations
Marcus J. Drake, Stergios K. Doumouchtsis, Hashim Hashim, and Andrew Gammie

S61 Basics of Videourodynamics for Adult Patients With Lower Urinary Tract Dysfunction
Michel Wyndaele and Peter F. W. M. Rosier

ICS Standards 2019

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2018
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T A B L E O F C O N T E N T S

EDITORIAL COMMENT
S67 Why ICS Standardization of Lower Urinary Tract Symptoms Matters
Dirk De Ridder and Marcus Drake

SOUNDING BOARD
ational S69 Critical Steps in Developing Professional Standards for the International Continence Society
Peter F. W. M. Rosier

cturnal

ce

y Good

Fundamental Assessment of Lower Urinary Tract Dysfunction

282

Received:
DOI: 10.1002/nau.23791 DOI: 10.1

EDITORIAL COMMENT SOUN

A co
asked to write succinct and approachable documents,
app
The International Continence Society (ICS) Board of Trustees
is glad to present a special supplement of Neurourology and describing what they feel any practitioner really must asse
Urodynamics which sets out the core knowledge for any know for everyday practice, and providing examples.
practitioner needing to assess lower urinary tract dysfunction Thus, these documents are derivatives of the many reports
(LUTD) in their clinical work. The material will be useful to and publications that represent the ICS Standards but are Marc
trainees, allied health professionals, and people working in not in themselves ICS Standardization documents. Inevi-
related disciplines like neurology, primary care, and care of tably, the choice of content is subjective, but each
1 Transla
the elderly. The documents are written in a simplified way to document seeks to offer simplicity and clarity. For those
Medical
offer a helpful source of education and knowledge of several working to become specialists in the area, this supplement
2 Bristol
different aspects of LUTD. is a starting point for getting to grips with the
Hospital,
A significant motivation for this effort is the need to be comprehensive repository of detailed professional consen-
concise, explicit, and definitionally correct when using a sus documents established by the ICS over the course of Corresp
common lexicon, as with the ICS Standardization documents, several decades and available on the ICS website (https:// Marcus J
that govern the manner in which professionals in our field www.ics.org/folder/189). Institute,
define their research and report results thereof. A sequence of A significant aspect of the knowledge transfer is the Southme
BS10 5N
documents is included which covers; education of those who are students or early career clinicians
Email: m
and investigators. Thus, the supplement aims to facilitate
� Urinary symptoms in general, and in specific patient clarity, accuracy, and specificity of reports in the fields of
groups (nocturia; neurological disease; chronic pelvic pain) urodynamics, neurourology, pelvic floor disorders, and
� Pelvic organ prolapse quantification urogenital reconstruction. Health care practitioners and
� Urodynamic tests (flow rate testing; filling cystometry with clinicians will benefit from these documents, which give a
pressure flow studies; videourodynamics) brief review of those subjects related to LUT dysfunction, and
� The importance of standardization and how the ICS as their knowledge grows, we hope they will feel enthused to
Standards are developed engage with the full ICS Standards.

The knowledge base is drawn from the ICS Standards, Sherif Mourad
which constitute the basis of specialist practice in LUTD, Roger Dmochowski
supplemented by practical application. The authors were Marcus Drake

1 | IN

LUTD
healthc
and all
tology
mental
the term
and th
Likewi
appreci
tract dy

Dr. Roge

S6 | © 2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2018;37:S6. Neurourol

ICS Standards 2019

2. Fundamentals
 283

Received: 24 May 2018

DOI: 10.1002/nau.23732
| Accepted: 25 May 2018

SOUNDING BOARD

A commentary on expectations of healthcare professionals when

uments,
applying the international continence society standards to basic
y must assessment of lower urinary tract function
amples.
reports
but are Marcus J. Drake1,2 | Paul Abrams2
. Inevi-
t each
1 Translational Health Sciences, Bristol
r those
Medical School, Bristol, UK The Continence Society (ICS) has sustained a drive to improve the clinical
plement
th the
2 BristolUrological Institute, Southmead assessment of lower urinary tract function for many years. Increasingly, healthcare
Hospital, Bristol, UK professionals (HCPs) engage with the guidance, and patients benefit from the
consen-
urse of Correspondence
precision that results when their carers apply a sensible and logical approach to
https:// Marcus J. Drake, Bristol Urological assessment. The current supplementary issue of Neurourology and Urodynamics
Institute, 3rd Floor L&R building, (NAU) summarizes the fundamentals derived from major ICS initiatives,
is the Southmead Hospital, Bristol,
BS10 5NB, UK. emphasizing what HCPs must know when dealing with these patients, regardless
inicians
Email: marcus.drake@bristol.ac.uk of the medical discipline in which they work. It also introduces the basics of
acilitate
ields of urodynamics testing to trainees and HCPs who may refer patients for testing. In this
rs, and editorial review we draw out some additional points of consideration. We emphasize
ers and the need to avoid using terms in a clinical context that could imply causative
give a mechanism, until the mechanism has actually been identified. We caution against the
on, and use of severity thresholds, until there is proper data to justify their application for any
hused to
given patient group. Finally, we provide a description of the philosophical basis of
urodynamics testing, including videourodynamics. This commentary should be read
Mourad in the context of the other articles provided in the NAU supplement.
howski
s Drake KEYWORDS
LUTS, overactive bladder, standardization, urodynamics

1 | INTRODUCTION detailed knowledge used in specialist practice. The

International Continence Society (ICS) has developed
LUTD is encountered in some form by a wide range of standards which set the specialist terminology and
healthcare practitioners (HCPs), notably medical, nursing, diagnostic methodology in great precision for the full
and allied professionals working in Primary Care, Geron- scope of practice in LUTD with considerable detail as
tology and Neurology. For these, awareness of a funda- needed by specialists in the area. These documents
mental knowledge base should include the correct use of produced by the Standardization Steering Committee and
the terminology for lower urinary tract symptoms (LUTS), other ICS Committees meet the needs of specialists, and
and the relevant signs and urodynamic observations. professionals who have mastered the fundamentals and who
Likewise, residents in urology and gynaecology need to are strongly encouraged to engage with the full standards.
appreciate the fundamentals of LUTS and lower urinary The ICS approach is founded on the importance of logical
tract dysfunction (LUTD), as a stepping stone for the more and clear-thinking clinical diagnosis and therapy selection,

Dr. Roger Dmochowski led the peer-review process as the Associate Editor responsible for the paper.

018;37:S6. Neurourology and Urodynamics. 2018;37:S7–S12. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | S7

A commentary on expectations of healthcare professionals when applying the international continence society standards to basic assessment of lower
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| DRAKE AND ABRAMS DRAKE A

making sure that treatment options are specifically matched to associated with urgency. Therefore, DO and OAB are not but i
the individual patient. Well-worded terminology has steadily interchangeable terms. cond
evolved over the years to make sure that it is suited to the The categorization of LUTS relates the timing of the diagn
potential presentations. Standards for testing in Urodynamics symptom to the micturition cycle, hence storage LUTS, � All u
have been refined to give practitioners the best chance to voiding LUTS, and LUTS happening straight after voiding has expla
identify abnormalities in their patients and interpret the finished (post-micturition symptoms). Many individuals urod
features appropriately. This supplement of Neurourology and present with several LUTS, and these can be grouped into detru
Urodynamics was commissioned by the Trustees of the ICS to symptom syndromes. OAB is one, in which storage LUTS are even
introduce a new generation of residents and recently appointed principal features. Underactive bladder (UAB) is another, in
consultants to the important work of standardization in which voiding LUTS are prominent. Because OAB and UAB
functional urology. It aims to set out and exemplify the occur mainly in the storage and voiding phases, respectively, it
fundamentals as a starting point to engaging with the ICS is perfectly possible for one person to have both overactive and
4 | F
Standards. Experts have been asked to extract pertinent aspects underactive symptoms, that may or may not be shown by
URO
from some of the most widely used Standards, to facilitate urodynamics to be due to DO and detrusor underactivity (DU).
awareness of key points in LUTS, nocturia, neuro-urology, Practiti
chronic pelvic pain, pelvic organ prolapse quantification, flow is impo
rate testing, urodynamics, and videourodynamics. 3 | SEVERITY THRESHOLDS do a flo
their da
The HCPs need to be careful in setting thresholds to “qualify” that the
2 | LOWER URINARY TRACT FUNCTION someone as having symptoms (eg, not counting someone as they sa
having nocturia because they only get up once per night to pass approp
The description of lower urinary tract function breaks it down urine). Unfortunately, there is only limited robust evidence to liquid i
into symptoms, signs, and urodynamic observations. The warrant thresholds. Furthermore, quantifying the significance quickly
terminology is phrased to ensure that patients and doctors can of symptoms can be difficult as symptoms are subjective, and unreali
align their discussions appropriately. A key requirement is to may vary a lot from day to day, so even a 3 day observation voiding
ensure that the words HCPs use do not imply a mechanism period of a bladder diary may not capture the full story. studies
without good justification. In male patients, words or phrases Furthermore there is considerable variation from person to which
like “obstructive,” “prostatism,” or “prostate symptom score” person, so values are difficult to compare. Thus the ICS People
insinuate that the mechanism of symptoms is already known, emphasises the need to distinguish a symptom's frequency compas
and caused by the prostate. Yet it is wrong to imply this at the from the impact on quality of life and bother it brings, as they much m
start of the patient's assessment; it innately biases the doctor are not necessarily correlated. For example, many men report a informa
(and sometimes the patient) to expect therapy aimed at relatively severe level of slow stream, but do not describe In f
relieving obstruction and dealing with the prostate. That may themselves as particularly bothered by it. In contrast,
come later, but only once other causes which can lead to very symptoms like urgency and post micturition dribble can be � Calib
similar symptoms have been excluded. Weak or slow stream highly bothersome even if severity appears relatively mild to
may be due to the prostate and the possibility of an the impartial observer. For nocturia, people who generally
underactive detrusor being the cause must also be considered. experience a single episode on average each night should be TABLE
Likewise, “irritative” is not appropriate, given that there is cataloged as having nocturia; it will be non-bothersome for UKCS
generally no evidence for irritation in the context of storage many patients, but that does not mean nocturia is absent. Record
LUTS. Fundamentally, the potential to misrepresent mecha- In practice, it seems reasonable to suggest; Detr
nism by careless use of terminology needs to be avoided. Uret
Two areas where clinicians can get a little bit muddled by � A symptom is important if the patient says it is bothersome.
Blad
terminology are frequency and overactivity. “Frequency” For example, the symptom of increased daytime frequency
indicates how often a person passes urine in a given time (the complaint by the patient who considers that he/she
Blad
period, so it is a sign. “Increased daytime frequency” indicates voids too often by day1) is very much dependent on the
Record
that the patient feels he or she voids too often by day, so it is patient's attitude, and there is a large variation in what
whethe
the correct phrase to describe a symptom reported by a patients consider intrusive.
Detr
patient. The word “Overactivity” is used in two terms: firstly, � A symptom or sign is important if it can explain mechanism
Uret
it is used in the context of overactive bladder (OAB), which is or identify disease. For example, nocturia (symptom: the
a symptom syndrome, and by its definition, everyone with complaint that the individual has to wake at night one or Post
OAB experiences urinary urgency. Secondly, detrusor more times to void; sign: the number of times an individual Statem
overactivity (DO), is a urodynamic observation of a bladder passes urine during their main sleep period1) may be non- FSF: first
contraction during filling, which is usually, but not always, bothersome to the patient if they only void once per night, a
The repo

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| S9

are not but it might identify the early stages of a systemic medical � Ask the patient to complete a 3 day bladder diary in
condition, such as chronic kidney disease, needing advance.
of the diagnosis and therapy.2 � Provide a suitable environment for testing (a place to wait,
LUTS, � All urodynamic observations should be noted, as they may rapid access to the meter when needing to pass urine,
ding has explain symptoms or signs, and guide treatment selection. The privacy, a hygienic setting).
ividuals urodynamic observation of detrusor overactivity (involuntary � Validate that the voided volume is representative, by
ed into detrusor contractions during the filling phase) should be noted, comparing with the bladder diary.
UTS are even if the contraction is only very low amplitude. � Check that bladder volume at the start of voiding (derived
other, in by adding voided volume and post void residual) is in a
nd UAB suitable range (150-500 mL).
ively, it � Identify key artefacts; knock, squeeze, and release, to
tive and
4 | FUNDAMENTALS OF ensure the values reported are indicative of the patient
own by
URODYNAMIC PRACTICE rather than an artefact.
y (DU).
Practitioners must show due consideration to their patients. It Some basic principles are important for urodynamic units;
is important that staff recognize that somebody attending to
do a flow rate test may be a patient experiencing urgency in 1. A urodynamic unit must follow the appropriate instructions
their day to day life, so it is not appropriate to demand of them given by the equipment manufacturers, and practitioners
qualify” that they must pass a minimum voided volume of 150 mL, if should calibrate and check their equipment regularly. All
eone as they say that they are desperate to go! Furthermore, it is not staff must be trained and properly supported by experienced
t to pass appropriate to load somebody with very large volumes of clinicians.
dence to liquid in an attempt to try to make them pass urine a bit more 2. Before a test, each patient's symptoms should be fully
ificance quickly for the convenience of the flow rate clinic. This is an understood, with a symptom score and bladder diary
ive, and unrealistic expectation, and is often detrimental to reliable completed. Ideally, potential treatment options should be
ervation voiding behavior. For filling cystometry and pressure flow considered before the test by the referring clinician, who
l story. studies, patients are apprehensive about undertaking a test in has already discussed them with the patient. Thereby, the
rson to which their urethra and anus are going to be cannulated. test can be done so as to help select the treatment, based on
he ICS People may feel the whole process is very undignified and chance of success and identification of potential adverse
equency compassionate handling by staff is essential. Patients are outcome.
as they much more satisfied after urodynamics if they received an 3. When running a test, the pressure traces should be
report a information leaflet before they come for their tests. scrutinized throughout the study to be confident recordings
describe In flow rate testing, some key points are; are genuinely picking up the pressures. This requires
ontrast, looking to see that the bladder and abdominal pressure
can be � Calibrate the equipment for reliable results. lines detect breathing and movement similarly, and that
mild to
enerally
ould be TABLE 1 Contents of a urodynamics report proposed in the UK continence society (UKCS) minimum standards for urodynamics3
ome for UKCS recommendation Possible urodynamic observations
ent. Record of the urodynamic findings during filling, whether normal or abnormal
Detrusor function during filling Normal/detrusor overactivity
Urethral function during filling Competent/incompetent
ersome.
Bladder and urethral sensation • At what volume did the patient report FSF, NDV and SDV?
quency • Did they experience urgency?
he/she
Bladder capacity Report volume
on the
Record of the urodynamic findings during voiding,
n what
whether normal or abnormal
Detrusor function during voiding Normal/underactive or acontractile
hanism
Urethral function during voiding Normal/obstructed
om: the
one or Post void residual Report volume
dividual Statement on whether the patient's everyday symptoms were reproduceda
be non- FSF: first sensation of filling; NDV: normal desire to void; SDV: strong desire to void?
r night, a
The report should document whether the patient's everyday symptoms were fully reproduced/ partly reproduced/ not reproduced.

A commentary on expectations of healthcare professionals when applying the international continence society standards to basic assessment of lower
urinary tract function
286

S10
| DRAKE AND ABRAMS DRAKE A

coughs are done throughout filling, plus before and after 4. After the test, the trace must be scrutinized to make sure may
voiding to monitor trace quality. that crucial pressure and flow values are genuinely prac
a) Regular labels must be applied during the study; these indicative of the patient's urinary tract function. High ity,
annotations will help anyone not present at the study to pressures caused by knocking the equipment, or low priat
interpret the findings later on. pressures because a tube got blocked, must be identified, mov
b) The “zero” button is a software button which drops the corrected if possible, and interpreted accordingly. valu
vesical and abdominal pressure lines onto zero. This Urodynamic machines and software are not reliably
must only be clicked when recording from atmosphere, able to identify artefacts with current technology. Key The
not when the transducers are connected to the patient- parameters such as maximum flow rate, bladder outlet whethe
this is a common mistake. obstruction (BOO) index or bladder contractibility index encoun
observa
sympto
namic
enuresi
observa
as the
see” ap
treatme

5 | V

Conven
there is
situatio

� Post-
wher
phys
� Void
benig
exam

For
assume
inconti
probab
enlarge
present
range o
the uro
momen
greater
present
FIGURE 1 Additional information with radiological imaging during urodynamics. Top left; identifying the site of BOO in a man with additio
Parkinson's disease. In this case, the obstruction is at the bladder neck (yellow upper arrow). This man also had significant pooling in the bulbar include
urethra (black lower arrow), which caused post micturition dribble. Top right; a man with large bladder diverticula, the one on the right entering
an inguinal hernia (arrow). These diverticula made it very difficult to measure bladder pressure. Middle pictures; a man with prior transurethral
1. Insta
resection of the prostate (TURP) whose presenting complaint was urgency. He did not have detrusor overactivity. During filling cystometry,
a) I
contrast was not present in the proximal urethra to begin with (middle left image), but it was seen to enter the urethra (arrow, middle right)
synchronous with the patient's report of urgency, which was the typical sensation of his presentation. Lower pictures; images taken at the end of
f
voiding in a boy with vesico-ureteric reflux. The left hand image confirmed bladder emptying was complete. The right hand image was taken n
30 s later, and a lot of contrast had re-entered the bladder- a “pseudo-residual.” If this patient had been studied with a bladder scanner instead of b) W
videourodynamics, a post void residual might wrongly have been presumed n

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| S11

ke sure may be reported by a urodynamic machine, but This precision on identifying timing of leakage allows the
nuinely practitioners must check the source traces for plausibil- urodynamicist to know the detrusor pressure at the precise
n. High ity, noting any spikes which the machine may inappro- moment when it matters.
or low priately have used for deriving those parameters, and 2. Identifying the exact location of bladder outlet obstruction;
ntified, moving the cursors to instruct the machine where the bladder neck (Figure 1a), prostate, urethral sphincter/
rdingly. values can be taken. pelvic floor, stricture. This can be very valuable for
reliably establishing the cause of BOO, and hence deciding on
y. Key The final report must be carefully phrased, describing treatment.
r outlet whether symptoms reported by the patient were actually 3. Detecting muscle function deficits in patients with
y index encountered during the test, and what was the urodynamic neurological disease.
observation at that time (Table 1). Of course, certain a) An open bladder neck may indicate a deficit in
symptoms simply cannot be reproduced during a urody- sympathetic innervation.
namic test- obvious examples being nocturia, nocturnal b) A poorly supported bladder base and proximal
enuresis, and coital incontinence. For these symptoms, urethra, which can be seen to descend on straining,
observations made during urodynamics must not be claimed may be due to pelvic floor weakness and may reflect
as the cause of the symptom. The “only report what you muscle denervation in men, or women with no
see” approach is crucial for safer consideration to making obstetric history.
treatment recommendations. 4. Explaining difficulty in detecting expected increased
pressure change, due to dispersal into a low pressure region.
a) A large bladder diverticulum (Figure 1b).
5 | VIDEOURODYNAMICS b) Significant vesico-ureteric reflux (VUR).
5. Identifying VUR in its early stages; potentially it may be
Conventional urodynamic tests principally can be used if possible to treat early VUR with a bulking injection of the
there is a relatively evident underlying mechanism. The main ureteric orifice.
situations are; 6. Correlating a patient's reported urgency sensation with
urine entering the proximal urethra (Figure 1c); this might
� Post-obstetric stress incontinence in a healthy woman, help explain why some people with urgency do not gain
where urethral hypermobility has been identified on benefit from medical therapy of OAB.
physical examination. 7. Demonstrating whether the bladder empties fully; a well-
� Voiding LUTS in a man in the right age range, where timed X-ray taken at the exact end of voiding confirms
benign prostate enlargement is identified on rectal whether the bladder has emptied fully. This is more
examination. accurate than bladder scanning, since the scanner takes a
while to get in position, during which time people with
For these individuals, the underlying mechanism can be VUR may have had enough liquid come back in to the
assumed with reasonable confidence. Thus, if stress urinary bladder to show up on a scanner- a “pseudo-residual”
incontinence is seen in the first situation, the hypermobility is (Figure 1d).
probably the cause. In the second, if BOO is seen, the prostate 8. Identifying pooling in patients with post micturition
enlargement is probably the cause. However, many other dribbling.
presentations throw up more complex possibilities and a a) Pooling in the male urethral bulb (Figure 1a).
range of causes should be considered. Using X-ray contrast as b) Vaginal pooling.
the urodynamic filling medium, and taking images at key
moments during the tests (“videourodynamics”) allows
greater confidence when deciding what mechanism(s) are
present, and potentially linking them to symptoms. The 6 | CONCLUSIONS
h additional information that X-ray screening can achieve
bulbar includes; The ICS has pushed a logical and systematic approach to
ntering
terminology and assessment in lower urinary tract
rethral
1. Instantaneous detection of leakage. function. In the current review we emphasize the
try,
a) If there is delay for the leakage reaching the flow meter, importance of being specific with the language used, the
ht)
end of
for example, in men with post prostatectomy inconti- need to justify severity thresholds, the philosophy
aken nence due to sphincter damage. underlying urodynamic testing and the potential benefits
tead of b) When evaluating leak point pressures in a patient with of videourodynamics in patients whose underlying patho-
neurological disease. physiology is potentially complex.

A commentary on expectations of healthcare professionals when applying the international continence society standards to basic assessment of lower
urinary tract function
288

S12
| DRAKE AND ABRAMS
Received:
DOI: 10.1
ORCID 3. Abrams P, Personal Communication, on behalf of the Working Group on
the UK Continence Society Minimum Standards for Urodynamics 2018.
Marcus J. Drake http://orcid.org/0000-0002-6230-2552 SOUN

How to cite this article: Drake MJ, Abrams P.

REFERENCES A commentary on expectations of healthcare
professionals when applying the international
Fun
1. Abrams P, Cardozo L, Fall M, et al. The standardisation of continence society standards to basic assessment of
terminology of lower urinary tract function: report from the
lower urinary tract function. Neurourology and
Standardisation Sub-committee of the International Continence Marc
Society. Neurourol Urodyn. 2002;21(2):167–178.
Urodynamics. 2018;37:S7–S12.
2. Drake MJ. Should nocturia not be called a lower urinary tract https://doi.org/10.1002/nau.23732
symptom?. Eur Urol. 2015;67(2):289–290. 1 Transla

Medical
2 Bristol

Hospital,

Corresp
Marcus J
Institute,
Southme
UK.
Email: m

1 | IN

The Int
led the
sympto
associa
current
LUTD
LUTD
workin
termino
gynaec
not inte

Roger D

Neurourol

ICS Standards 2019

2. Fundamentals
 289

ABRAMS
Received: 30 April 2018
DOI: 10.1002/nau.23768
| Accepted: 2 July 2018

Group on
mics 2018.
SOUNDING BOARD

Fundamentals of terminology in lower urinary tract function

of
Marcus J. Drake1,2

1 Translational Health Sciences, Bristol

Medical School, Bristol, UK Aims: To summarize basic definitions in the International Continence Society (ICS)
2 BristolUrological Institute, Southmead Standardization of Terminology in lower urinary tract (LUT) function and their
Hospital, Bristol, UK application.
Correspondence
Methods: Fundamental terminology in the ICS Standardization of Terminology LUT
Marcus J. Drake, Bristol Urological Function was identified and summarized.
Institute, 3rd Floor L&R Building, Results: Evaluation of LUT requires appreciation of symptoms, signs and
Southmead Hospital, Bristol BS10 5NB,
UK. urodynamic observations. Symptoms are categorized according to their occurrence
Email: marcus.drake@bristol.ac.uk during the micturition cycle into storage symptoms (eg, increased daytime frequency
[IDF], urgency, nocturia, or incontinence) or voiding and post-voiding symptoms
(eg, slow stream or post micturition dribbling). Several problems may be present,
giving rise to symptom syndromes, notably overactive bladder (during the storage
phase) or underactive bladder (during the voiding phase). Signs may be derived from
a bladder diary or may be elicited on physical examination. Urodynamic observations
may be made by assessing flow rate, and this is combined with pressure measurement
when undertaking filling cystometry and pressure flow studies. Key elements of flow
and pressure measurement are described.
Conclusions: The review provides a succinct summary of symptoms, signs, and
urodynamic observations as set out in the ICS Standard on LUT Function.

KEYWORDS
LUTS, overactive bladder, standardization, urodynamics

1 | INTRODUCTION urogynaecology, and neuro-urology, for whom the ICS has

developed a range of standardizations (see www.ics.org).
The International Continence Society (ICS) has for many years These cover the full scope terms in different contexts and
led the development of standardized definitions of the patient groups for use in subspecialty research and clinical
symptoms, signs, urodynamic observations, and conditions practice, which are beyond the scope of the current review.
associated with lower urinary tract dysfunction (LUTD). The
current document is a summary of core terminology related to
LUTD for use in a general medical context. For example, 2 | METHODS
LUTD is commonly encountered by healthcare professionals
working in gerontology, neurology, and nephrology. The Recommendations in the ICS Standard on LUTD1 were
terminology is also useful for residents in urology or reviewed and summarized, this document being selected as
gynaecology preparing for examinations. This document is the terminology is applicable to all patients regardless of gender.
not intended for subspecialists working in functional urology, Definitions of nocturia,2 underactive bladder,3 and pelvic organ

Roger Dmochowski led the peer-review process as the Associate Editor responsible for the paper.

Neurourology and Urodynamics. 2018;37:S13–S19. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | S13

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prolapse (POP)4 are those given in subsequent context-specific b) Nocturia is waking at night to pass urine.2 If a person e) Post
ICS consultations or documents. Definitions and key terms are typically passes urine once per night, they should be urin
generally transcribed verbatim. In the original document, many documented as having nocturia even if it does not cause urin
of the definitions are accompanied by explanatory or exemplary them impairment of quality of life.
footnotes. The footnotes have been adapted (non-verbatim) in “Day” and “night” for IDF and nocturia refer to the All
certain cases for the current review, or have been excluded for patient's sleeping pattern, not environmental daylight and even fl
the sake of brevity, and additional explanatory text is included. night-time. sional n
Readers should note that in urogynaecology practice, some These symptoms are strongly influenced by fluid intake, with th
terms have been updated in the International Urogynecology and healthcare practitioners need to factor in whether the to try to
Association/ICS joint report on the terminology for female symptom reflects LUTD, or rather a physiological of a sy
pelvic floor dysfunction,4 where there is some divergence from mechanism dealing with excessive intake of free water quality
the reported definitions in the current review. Accordingly, users or salt, or a pathological consequence of a systemic conside
are advised to specify the source of the definitions they employ medical condition (eg, chronic kidney disease).5 LUTS.
when publishing in the area. c) Urgency is the complaint of a sudden compelling desire to
pass urine which is difficult to defer.1
3.1 | S
d) Urinary incontinence is the complaint of any involuntary
3 | LOWER URINARY TRACT
leakage of urine.1 Initial m
SYMPTOMS
after cl
Incontinence is subclassified according to the circum- basic in
Normal lower urinary tract (LUT) function relies on the facility
stances most typically eliciting the problem the pur
for storage of urine in the bladder, and the ability to pass urine
and do
(voiding) at a time to suit the individual. The alternation
(i) Urgency urinary incontinence is the complaint of
between these two modes of storage and voiding is known as
involuntary leakage accompanied by or immediately 1. Ove
the micturition cycle (Figure 1). lower urinary tract symptoms
preceded by urgency. urin
(LUTS) are categorized according to the time at which they are
(ii) Stress urinary incontinence is the complaint of involun- nenc
experienced in relation to the micturition cycle;
tary leakage on effort or exertion, or on sneezing or infec
coughing. 2. Und
1. Storage symptoms
(iii) Mixed urinary incontinence is the complaint of a slo
a) Increased daytime frequency (IDF) is the complaint by
involuntary leakage associated with urgency and also with
the patient who considers that he/she voids too often by
with exertion, effort, sneezing, or coughing. som
day.1 There is no minimum voiding frequency serving
as a threshold for the symptom, since it is highly
2. Voiding and post-voiding symptoms OA
subjective, and there is a wide overlap between normal
Voiding symptoms micturi
and symptomatic.
possibl
a) Hesitancy is the term used when an individual describes syndrom
difficulty in initiating micturition resulting in a delay in the
onset of voiding after the individual is ready to pass urine.1
b) Slow stream is reported by the individual as his or her
4 | S
perception of reduced urine flow, usually compared to
URIN
previous performance or in comparison to others.1
c) Intermittency is the term used when the individual
4.1 | V
describes urine flow which stops and starts, on one or Freque
more occasions, during micturition.1 time pe
with ID
In addition, a person may report splitting of the stream, or asking
FIGURE 1 The micturition cycle as anchor for categorizing LUTS. spraying. They may also describe straining to void, which is
Each individual person stores urine until they make an active decision to
muscular effort used to either initiate, maintain, or improve 1. A m
switch to voiding in response to a sensation or a social reason (eg,
the urinary stream. mict
anticipation that toilets will be difficult to access in the foreseeable future
Post-voiding symptoms are experienced immediately 2. A fr
as a result of a meeting or journey, or when going to bed for sleep). Once
voiding is complete, storage mode is re-established. Voiding occupies only after voiding. volu
a very small part of the cycle (eg, if frequency is six times daily, and day
duration of each void is 20 s, then only 2 min of 24 h may be in voiding d) Feeling of incomplete emptying is experienced by the 3. A bl
mode). NDV, normal desire to void; SDV, strong desire to void individual after passing urine.1 void

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| S15

person e) Post-micturition dribble describes the involuntary loss of appropriate for the individual being evaluated. It could
ould be urine immediately after an individual has finished passing include incontinence episodes, pad usage, fluid intake, the
ot cause urine.1 degree of urgency, and the degree of incontinence.

to the All these symptoms may vary considerably over time, Three-day recordings are generally used in clinical
ght and even fluctuating on successive days. The healthcare profes- practice. Any of these charts make it possible to identify
sional needs to take into account this variability, and clarify 24-h frequency of voiding; provided the waking and sleeping
intake, with the patient how often each symptom may be experienced times are marked, this can be broken down into the daytime
ther the to try to build a representative picture. Likewise, the presence frequency and nocturia (Figure 2). The sign of nocturia is the
ological of a symptom (severity) does not always lead to impact on number of times an individual passes urine during their main
e water quality of life (bother), and healthcare professionals should sleep period.2 Polyuria is the measured production of more
ystemic consider both severity and bother for a complete evaluation of than 2.8 L of urine in 24 h in adults.1 Nocturnal polyuria is
LUTS. present when an increased proportion of the 24-h output
esire to occurs at night. If polyuria or nocturnal polyuria is present, the
observation of a high voiding frequency may reflect a cause
3.1 | Symptom syndromes
oluntary other than LUTD (eg, systemic illness or behavioral factors
Initial management may rely on empirical diagnoses applied such as a high fluid intake).
after clinical assessment of a patient's LUTS, combined with A diary that includes fluid intake and urine output
circum- basic investigations, such as urinalysis. These may be used for measurement generally shows the former exceeds the latter
the purposes of applying initial conservative management, each day, but on some days there can be a discrepancy (as seen
and do not rely on invasive urodynamic observations. on the totals for the second day in Figure 2). Such
aint of discrepancies generally even out if the diary is completed
ediately 1. Overactive bladder syndrome (OAB) is characterized by over a longer time. Alternatively, they may suggest inaccurate
urinary urgency, with or without urgency urinary inconti- completion of the diary, or inability to measure the liquid
nvolun- nence, usually with IDF and nocturia, if there is no proven content of the person's food intake.
zing or infection or other obvious pathology.6
2. Underactive bladder syndrome (UAB) is characterized by
4.2 | Physical examination
aint of a slow urinary stream, hesitancy, and straining to void,
nd also with or without a feeling of incomplete bladder emptying In LUTD, examination should cover abdominal, pelvic, and
sometimes with storage symptoms.3 perineal examination. In general, a focused neurological
examination is needed, and this will be more extensive for
OAB is applicable during the storage phase of the patients with possible neurogenic LUTD.7
micturition cycle, and UAB during the voiding phase, so it is
possible for one individual to manifest both symptom 1. Urinary incontinence (the sign) is urine leakage seen
escribes syndromes. during examination.1
ay in the a) Stress urinary incontinence is the observation of
s urine.1 involuntary leakage from the urethra, synchronous
or her
4 | SIGNS SUGGESTIVE OF LOWER
with exertion/effort, or sneezing or coughing
ared to
URINARY TRACT DYSFUNCTION
b) Extra-urethral incontinence is the observation of urine
1
leakage through channels other than the urethra.
dividual
4.1 | Voiding frequency
2. POP is the descent of one or more of the anterior vaginal
one or Frequency refers to the number of voids observed in a defined wall, posterior vaginal wall, the uterus (cervix), or the apex
time period1; it is not a symptom (ie, it should not be confused of the vagina (vaginal vault or cuff scar after hysterec-
with IDF). The frequency of voiding is generally identified by tomy).4 The presence of any such sign should be correlated
eam, or asking the patient to complete a record; with relevant POP symptoms. More commonly, this
which is correlation would occur at the level of the hymen or
mprove 1. A micturition time chart, which records only the times of beyond.4
micturitions for at least 24 h. 3. Pelvic floor muscle function can be qualitatively evaluated
ediately 2. A frequency volume chart (FVC), which also records the according to the tone at rest, and the strength of a voluntary
volumes voided, as well as the time of each micturition, or reflex contraction.1 Strength, duration, displacement,
day and night, for at least 24 h. and repeatability should be considered. It may be reported
by the 3. A bladder diary: this records the times of micturitions and qualitatively as strong, weak, or absent, and there are
voided volumes (VV), and additional information validated grading systems.

Fundamentals of terminology in lower urinary tract function

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| DRAKE DRAKE

FIGURE 2 Information abstracted from a bladder diary,10 showing some commonplace features. “Woke” indicates the start of each day,
“sleep” for the start of each night. Daytime frequency is the number of voids recorded during waking hours and includes the last void before sleep
and the first void after waking and rising in the morning. Frequency was 4-5 over the three complete days of the study period. Twenty-four hour
production is measured by collecting all urine for 24 h. This is usually commenced after the first void produced after rising in the morning and is
completed by including the first void on rising the following morning. The range in the current example was 1450-1800 mL/for the two complete
24 h using this definition. Nocturia (nocturnal frequency) is the number of voids recorded during a night's sleep: each void is preceded and followed
FIGUR
by sleep. It was 0-1 over the two complete nights of the study period. Nocturnal urine volume (NUV) is the total volume of urine passed between
good ma
the time the individual goes to bed with the intention of sleeping and the time of waking with the intention of rising; it excludes the last void before
The patt
going to bed but includes the first void after waking. NUV was high on the second night, perhaps due to alcohol consumption in the preceding
spike (A
evening. This also is associated with a high nocturnal polyuria index (NPi, calculated from NPi = NUV/24 h volume) at 0.47. The maximum VV
(eg, an a
was normal (450 mL). Bladder sensation was generally 1 or 0; the only 2 was on day 3, and followed a couple of caffeine drinks
correcte
gives a l
4. Pad testing may be used to quantify the amount of urine means that no tube is present for recording bladder pressure.
when th
lost during incontinence episodes and methods range from Urine flow is either continuous or intermittent, depending on
a short provocative test to a 24-h pad test.2 whether any interruptions happen during flow. A continuous
flow curve may be a smooth arc-shaped curve, or it may be in the b
fluctuating, when there are multiple peaks during a period of by subt
filling
5 | URODYNAMIC OBSERVATIONS continuous urine flow. Maximum flow rate (Qmax) is the
maximum measured value of the flow rate after correction for two m
artefacts. VV is the total volume expelled via the urethra. Post (Figure
Bladder and bladder outlet function both need to be
void residual (PVR) is the volume of urine left in the bladder Fill
considered for a full understanding of a person's LUT.
at the end of micturition.1 If, after repeated voiding, no patient
Urodynamics is a general term for tests that assess bladder and
residual urine is demonstrated, then the finding of a PVR describ
urethra function during the micturition cycle, and includes
should be considered an artifact, due to the circumstances of activity
tests such as uroflowmetry, ambulatory urodynamics and
the test. Bladde
videourodynamics. Urodynamics is also commonly used
change
more specifically to indicate filling cystometry and pressure
pressur
flow studies (PFS). 5.2 | Measurement of bladder pressure
by the
Both vesical pressure in the bladder (pves) and abdominal volume
pressure (Pabd) are measured together, since the bladder is start o
5.1 | Measurement of urine flow
an abdominal organ. Pabd is generally estimated from volume
Flow rate is defined as the volume of fluid expelled via the rectal or vaginal recordings. Detrusor pressure (Pdet) is that at cyst
urethra per unit time (in mL/s) (Figure 3). “Free flow rate” component of intravesical pressure that is created by forces any de

ICS Standards 2019

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 293

DRAKE DRAKE
| S17

y,
e sleep
hour
nd is
mplete
ollowed
FIGURE 3 Uroflowmetry (free flow rate testing). On the left is a normal flow rate test for a women. It shows a continuous flow, with a
ween
good maximum flow rate (Qmax) and complete emptying, with a suitable VV. On the right is an abnormal test suggesting voiding dysfunction.
d before
The pattern of flow is interrupted. The Qmax reported by the machine was 9 mL/s, but inspection of the trace shows the machine interpreted a
ng
spike (A) as the maximum flow, which will not be indicative of the patient's own urinary tract function, but rather is likely to be an artefact
m VV
(eg, an aberration of flow delivery to the meter, a strain by the patient, or the patient moving on the commode). By definition, Qmax must be
corrected to exclude artefacts.1 Correcting the Qmax to a part of the curve (B) that is likely to be properly representative of urinary tract function
gives a lower Qmax of 6 mL/s. The VV was low, but when the PVR of 108 mL is factored in, the bladder volume can be considered adequate
ressure.
when the flow test was done (96 + 108 = 204 mL)
ding on
tinuous
may be in the bladder wall (passive and active), and it is calculated Both points are measured excluding any detrusor
eriod of by subtracting Pabd from Pves.1 Pdet is computed throughout contraction. Detrusor overactivity (DO) is a urodynamic
) is the filling cystometry and PFS, and is plotted alongside the observation characterized by involuntary detrusor con-
tion for two measured pressures (Pves and Pabd) and flow (Q) tractions during the filling phase which may be
ra. Post (Figure 4). spontaneous or provoked. Provocative maneuvers are
bladder Filling cystometry assesses the storage phase of the techniques used during urodynamics in an effort to
ing, no patient's micturition cycle. Filling cystometry should be provoke DO, for example, rapid filling, use of cooled
a PVR described according to bladder sensation, detrusor medium, postural changes, and hand washing.1
nces of activity, bladder compliance, and bladder capacity. Cystometric capacity is the bladder volume at the end
Bladder compliance describes the relationship between of the filling cystometrogram. It is the volume voided, plus
change in bladder volume and change in detrusor any PVR. The PFS starts when “permission to void” is
pressure, and is calculated by dividing the volume change given (Figure 4), or when uncontrollable voiding begins,
by the change in pdet during that change in bladder and ends when the patient considers voiding has finished.
ominal volume1 (Figure 4). The standards points are (i) pdet at the PFS is a model of the patient's voiding phase and combines
adder is start of bladder filling and the corresponding bladder synchronous flowmetry with measurement of pves. Thus,
d from volume (usually zero) and (ii) the pdet and bladder volume flow rate testing in PFS differs from free flowmetry by the
) is that at cystometric capacity or immediately before the start of presence of a fine tube to enable pressure measurement.
y forces any detrusor contraction that causes significant leakage. Normal voiding is achieved by a voluntarily initiated

Fundamentals of terminology in lower urinary tract function

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S18
| DRAKE DRAKE

and
Uro
6. Dra
syn
7. Gaj
Soc
urin
115
8. Abr
inde
blad
9. Dra
tals

FIGURE 4 Pressure measurement. The record shows continuous tracings of two measured pressures; the abdominal pressure pabd in red, and the
vesical bladder pressure pves in blue. These are continuously subtracted (pves-pabd) to give the detrusor pdet, in green. Also shown are the volume instilled
in orange, and flow rate in black. Filling cystometry precedes permission to void (indicated with “void”), and the pressure flow study (PFS) follows it.
The zero reference point is atmospheric pressure (purple arrows), so when the transducers are connected to the patient (blue arrows), there is an obvious
rise in pabd and pves, referred to as “resting pressures”—the blue oval indicates the resting pressures for this patient at one timepoint. Coughs (indicated
with “c”) are used to check that pabd and pves detect a short spike of pressure (larger green oval), and that the pdet has a deflection which is equal above
and below the line, the biphasic artefact (smaller green oval). It is important to check pressure recording with a cough at the start of filling, and on each
side of the PFS. Normal detrusor function allows bladder filling with little or no change in pressure, and there should be no involuntary phasic
contractions despite provocation.1 In this study, the pdet was 2 cmH2O at the beginning of the filling cystometry, and eight at the end; since filled
volume was 500 mL, the compliance (change in volume/change in pressure = 100/[8-2]) was 17 mL/cmH2O. Sensations are reported by the patient and
annotated on the trace. First sensation of bladder filling (FSF) is the feeling the patient has, during filling cystometry, when he/ she first becomes aware
of the bladder filling. First desire to void (FDV) is the feeling that would lead the patient to pass urine at the next convenient moment, but voiding can
be delayed if necessary. Strong desire to void (SDV) is a persistent desire to void without the fear of leakage.1 A provocation was applied to try to elicit
DO by making the sound of running water “taps”; no change in pves or pdet was seen, so this patient had a stable detrusor. In the PFS, the key
parameters derive from the time of maximum flow rate (Qmax). The current patient had a Qmax of 8 mL/s and detrusor pressure at Qmax of 51 cmH2O, so
his BOO Index was 35 and Bladder Contractility Index was 91. Pabd did not change at that time, so no allowance has to be made for the effect on Pdet

continuous detrusor contraction that leads to complete ORCID

bladder emptying within a normal time span, and in the
Marcus J. Drake http://orcid.org/0000-0002-6230-2552
absence of obstruction. Detrusor underactivity (DUA) is a
contraction of reduced strength and/or duration, resulting
in prolonged bladder emptying and/or a failure to achieve
complete emptying within a normal time span. Bladder REFERENCES
outlet obstruction (BOO) is the generic term for obstruc- 1. Abrams P, Cardozo L, Fall M, et al. The standardisation of
tion during voiding and is characterized by increased terminology of lower urinary tract function: report from the
detrusor pressure and reduced urine flow rate.1 For male Standardisation Sub-committee of the International Continence
patients, BOO and DUA can be quantified using the BOO Society. Neurourol Urodyn. 2002;21:167–178.
Index and the Bladder Contractility Index.8 They rely on 2. Hashim H, Drake MJ. Basic concepts in nocturia, based on
measuring Qmax and detrusor pressure at maximum flow, International Continence Society standards in nocturnal lower
urinary tract function. Neurourol Urodyn. 2018;37:S20–S24.
which is the lowest pressure recorded at maximum
3. Chapple CR. Terminology report from the International Continence
measured flow rate (see 9). Society (ICS) working group on underactive bladder (UAB).
Neurourol Urodyn. 2018;In press.
6 | CONCLUSIONS 4. Haylen BT, de Ridder D, Freeman RM, et al. An International
Urogynecological Association (IUGA)/International Continence
Society (ICS) joint report on the terminology for female pelvic floor
The ICS Standardization provides a logical framework and dysfunction. Neurourol Urodyn. 2010;29:4–20.
definitions to describe symptoms, signs, and urodynamic 5. Cornu JN, Abrams P, Chapple CR, et al. A contemporary
observations in relationship to the micturition cycle. assessment of nocturia: definition, epidemiology, pathophysiology,

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and management—a systematic review and meta-analysis. Eur society good urodynamic practices recommendations. Neurourol
Urol. 2012;62:877–890. Urodyn. 2018;37:S44–S49.
6. Drake MJ. Do we need a new definition of the overactive bladder 10. Bright E, Cotterill N, Drake M, Abrams P. Developing and
syndrome? ICI-RS 2013. Neurourol Urodyn. 2014;33:622–624. validating the International Consultation on Incontinence Ques-
7. Gajewski JB, Schurch B, Hamid R, et al. An International Continence tionnaire bladder diary. Eur Urol. 2014;66:294–300.
Society (ICS) report on the terminology for adult neurogenic lower
urinary tract dysfunction (ANLUTD). Neurourol Urodyn. 2018;37:
1152–1161. How to cite this article: Drake MJ. Fundamentals
8. Abrams P. Bladder outlet obstruction index, bladder contractility of terminology in lower urinary tract function.
index and bladder voiding efficiency: three simple indices to define
Neurourology and Urodynamics. 2018;37:S13–S19.
bladder voiding function. BJU Int. 1999;84:14–15.
9. Drake MJ, Doumouchtsis SK, Hashim H, Gammie A. Fundamen-
https://doi.org/10.1002/nau.23768
tals of urodynamic practice, based on international continence

nd the
e instilled
ows it.
obvious
dicated
l above
on each

d
ent and
s aware
ng can
to elicit

mH2O, so
on Pdet

0-2552

ation of
rom the
ntinence

based on
al lower
S24.
ntinence
(UAB).

rnational
ntinence
lvic floor

mporary
ysiology,

Fundamentals of terminology in lower urinary tract function

296

HASHIM
Received: 9 May 2018
DOI: 10.1002/nau.23781
| Accepted: 16 July 2018

summa
general
SOUNDING BOARD
is inclu
from th
for the
Basic concepts in nocturia, based on international continence source
they em
society standards in nocturnal lower urinary tract function The
reporte
sympto
Hashim Hashim1 | Marcus J. Drake2 post-vo
to the m
1 Bristol Urological Institute, Bristol, United
sympto
Kingdom Aims: To review the recommendations on nocturia in the International Continence phase o
2 University Society (ICS) Standardization documents, setting out key definitions and parameters key sig
of Bristol and Bristol
Urological Institute, Bristol, United during
for use in clinical practice.
Kingdom a frequ
Methods: Definitions and evaluations described in the ICS Standards on Nocturia “Ni
Correspondence and Terminology for Lower Urinary Tract Function were identified and summarized. refers t
Hashim Hashim, Bristol Urological Results: The terms have been divided into signs and symptoms. Nocturia as a cycle (f
Institute, Office 4, Gate 38, Level 3, Pink
Atrium, Brunel Building, Southmead symptom is waking at night to pass urine and as a sign is the number of times an sleepin
Hospital, Bristol, BS10 5NB, United individual passes urine during their main sleep period. Nocturnal polyuria as a dayligh
Kingdom.
symptom is passing large volumes of urine at night and as a sign is the excessive
Email: h.hashim@gmail.com
production of urine during the individual's main sleep period. These should be 3 | U
quantified using a 3-day bladder diary, thereby facilitating identification of 24-h
polyuria, nocturnal polyuria, lower urinary tract dysfunction, or sleep disorder. The pr
process
Conclusions: The summary reflects the multifactorial influences in nocturia and
and sol
provides a pragmatic insight into bladder diary analysis for deriving key parameters to bala
relevant to clinical therapy. homeos
result o
KEYWORDS
water i
enuresis, International Continence Society, nocturia, nocturnal polyuria, terminology
also in
also se
The

1 | INTRODUCTION wake at night one or more times to void.3 In 2014, a new ICS � Diur
Nocturia working group was set up to review the terminology � Natr
Nocturia is a significant problem affecting a large proportion related to that document and will be reporting in 2018. The � Prod
of the population, especially in older age groups.1,2 Increasing current review sets out the principles underlying the that
recognition of its prevalence and potential health impact for fundamental nocturia terminology, and describes how they diabe
individual patients and for population health has led to are applied in an example bladder diary to help direct � Dysf
recognition of the need to establish the specific underlying healthcare professionals toward the most logical approach to
mechanisms relevant for anyone presenting with the investigation and therapy. The aim is for this to be a practical Tub
symptom. Crucially, a range of observations need to be and pragmatic guide for use in both clinical and research If assoc
properly understood by any clinician responsible for caring settings. glomer
for these patients. abnorm
In 2002, the International Continence Society (ICS) creatini
2 | METHODS
defined nocturia as the complaint that the individual has to The
urinary
Recommendations in the ICS standards on Nocturia4 and
and sto
Roger Dmochowski led the peer-review process as the Associate Editor Lower Urinary Tract Function,5 and the 2018 ICS
(LUT).
responsible for the paper. consultation on nocturia terminology, were reviewed and
S20 | © 2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2018;37:S20–S24.

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| S21

summarized. From these, definitions and key terms are the LUT serves these two contrasting tasks of urine storage
generally transcribed verbatim. Additional explanatory text and voiding. Voiding generally can be initiated by someone at
is included for context. Explanatory or exemplary footnotes any time that suits them, but the main driver prompting people
from the original documents have been adapted or excluded to take active steps to pass urine is when they feel their
for the sake of brevity. Users are advised to refer to the bladder is “full.”
source documents and specify the source of the definitions The number of times someone has to pass urine over a
they employ when citing definitions. specified time period reflects;
The terminology is broken into symptoms, that is, as
reported by the patient, and signs. Lower urinary tract 1. How fast the UUT is producing urine
symptoms (LUTS) are broken down into storage, voiding and 2. The bladder volume at which the LUT signals “fullness”
post-voiding symptoms, depending on their timing in relation
to the micturition cycle. Nocturia is categorized as a storage Renal regulation tends to see the rate of urine production
symptom, based on the fact that a person is in the storage reduced when the person is asleep. In young people living a
nence phase of the micturition cycle when asleep. For nocturia, the healthy lifestyle, rate of UUT urine production is low and
meters key signs are the voiding frequency and the voided volumes LUT storage volume is high, so nocturia is uncommon.
during the main sleep period; these are usually captured from
a frequency/volume chart (FVC) or bladder diary.
cturia 3.1 | Voiding frequency
“Night-time” for the purposes of the nocturia terminology
rized. refers to the individual's sleep cycle, rather than the solar The symptom of nocturia is present if the patient reports
a as a cycle (from sunset to sunrise). For this reason, a shift worker waking at night to pass urine. Nocturia is also a sign indicated
mes an sleeping between shifts may experience nocturia during by the number of times an individual passes urine during their
a as a daylight hours. main sleep period.
essive
uld be 3 | URINE OUTPUT 3.2 | Volume of voiding
f 24-h In order to decide whether the presence of nocturia reflects
er. The production of urine by the kidneys is a continuous
production of large quantities of urine from the UUT, an
process of filtration in the glomeruli, and reabsorption (water
a and estimate of urine output is needed. 24-h voided volume is the
and soluble nutrients) in the tubules. Urine production serves
meters total volume of urine passed during a 24-h period excluding
to balance water, salt, and acid levels according to the
the first morning void of the period. A 24-h polyuria indicates
homeostatic needs of the person, and this is principally a
that 24-h urine output is more than 40 mL/kg, in men and
result of adjustments to the tubular reabsorption. Surplus
women. The general increase in urine output will elevate the
water increases urine production (diuresis), and surplus salt
voiding frequency in the daytime and night-time, outstripping
also increases urine production (natriuresis). Making urine
even normal bladder capacity. The symptom of nocturnal
also serves to dispose of toxins and by-products.
polyuria is present if the patient reports passing large volumes
The rate of urine production increases if there is;
of urine at night. Nocturnal polyuria is also a sign indicated by
excessive production of urine during the individual's main
ew ICS � Diuresis
sleep period. It is often expressed as a proportion of the 24-h
inology � Natriuresis
voided volume. The nocturnal polyuria index is the nocturnal
18. The � Products in the glomerular filtrate in such large quantities
urine volume/24-h voided volume, expressed as a percentage.
ng the that the tubules cannot reabsorb it all (poorly controlled
NP is said to be present if the NPi is more than 33% in the
ow they diabetes mellitus can cause this, due to glucosuria)
elderly (eg, aged more than 65), and more than 20% in
p direct � Dysfunction of the renal tubules
younger individuals.
oach to
ractical Tubular dysfunction can occur in chronic kidney disease.
esearch If associated with disease affecting the glomeruli, estimated 4 | CAPTURING THE SYMPTOMS
glomerular filtration rate (eGFR), and creatinine levels will be
abnormal. If it is a selective tubular dysfunction, eGFR and The ICS emphasises the need to distinguish a symptom's
creatinine levels may be normal. severity from the bother it brings, as they are not necessarily
The continuous production of urine is the task of the upper correlated. In nocturia, there are various symptom scores
urinary tract (UUT). Expelling the urine at appropriate times, which can assess both the severity and associated bother of
ia4 and
and storing at other times, is the task of the lower urinary tract nocturia and other LUTS, such as the International
8 ICS
(LUT). The “micturition cycle” is a concept describing how Consultation on Incontinence Questionnaires (ICIQ).6 There
wed and
:S20–S24.

Basic concepts in nocturia, based on international continence society standards in nocturnal lower urinary tract function
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| HASHIM AND DRAKE HASHIM

is a specific score for quality of life in nocturia (ICIQ- identify whether the person has risk factors for NP (eg, a 6 | E
NQoL7). Practitioners need to be clear that waking once per physical body habitus suggesting risk of obstructive sleep
night to pass urine, on average, means nocturia is present. apnoea or the presence of peripheral oedema), or whether they For any
Research shows that a single episode of nocturia is generally have chronic urinary retention. diary c
of relatively low bother to the patient (assuming they return to A well-completed FVC or bladder diary8 recorded for and the
sleep satisfactorily). However, even if causing low bother, it three days9 is invaluable. The time of going to bed and the
still constitutes nocturia. Future research is needed to identify time of waking up from sleep must be clearly marked by the � 24-h
whether nocturia once per night might actually be medically patient (it is rather common for patients to overlook noting as di
significant (eg, the start of a medical problem for which early these, rending the diary uninterpretable for analyzing mell
identification and treatment might avoid future progression). nocturia). From the chart or diary the following can be � NP;
Direct questioning is needed to establish the symptom of calculated (Figure 1): or pe
NP. Some discussion is also needed to review “reason for � LUT
waking”; the symptom of nocturia implies that the need to � The daytime and night-time voiding frequency incre
pass urine was the reason for waking. This is distinct from the � 24-h voided volume: the total volume of urine passed � Sleep
situation that sleep disturbance may actually have been for during a 24-h period excluding the first morning void of the desc
some other reason, but the person went to pass urine because period. walk
they happened to be awake. � Nocturnal urine volume: the total volume of urine produced
during the individual's main sleep period. Sim
5 | ASSESSING THE SIGNS � Nocturnal polyuria index: the nocturnal urine volume/24-h exampl
voided volume. who do
The fundamental tools for assessing signs in LUTS are the � Maximum voided volume, average voided volume, and relative
physical examination and the bladder diary. Examination can bladder sensation scores popula
identify
or gyn
indicat

7 | E

Enures
intermi
It is als
as wak
to reac
Enu
dysregu
regarde
(sporad
Thus, t
and enu

8 | C

The sy
FIGURE 1 Analysis of a 3-day bladder diary. On the first day, the person woke at 9 am (1), went to bed at 10 pm (3), and woke the following waking
morning at 9 am (5). To calculate the first complete 24-h voided volume, we need to exclude the first morning void of Day 1 as that is part of the
indicate
previous night's volume. Thus, the first 24 h voided volume includes the voids between points 2 and 5 (400 + 300 + 300 + 400 + 200 + 200 + 250 + 400
during
[1st morning void from Day 2]) = 2450 mL. The contribution of night-time voided volume is from point 4 to 5 (200 + 250 + 400) = 850. The nocturnal
reports
polyuria index (NPi) was 850/2450 = 35%. Nocturia is the voids between points 3 and 5 but excludes the voids at points 3 and 5 (so the voids at 2 am
and 5 am), that is, nocturia was twice. For the second complete 24-h period, the voided volume should be taken from points 6 to 9, and totals 4050 mL. quantif
The nocturnal voided volume is from points 8 to 9, totaling 1050 mL. The NPi was 26% (1050/4050), and nocturia was twice (3 am and 6 am). This diary is
patient was 32 years old, so they had nocturnal polyuria (NPi >20% in a patient below the age of 65). Their body weight was 60 kg, so they also had polyuri
24-h polyuria (>40 mL/kg/24 h). A 3-day diary contains two complete 24-h periods and two complete nights, since there is no information to complete distingu
the third night (unless the patient keeps recording up until they wake on Day 4) passing

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| S23

P (eg, a 6 | EXPLAINING THE PROBLEMS CONFLICT OF INTEREST

e sleep
Dr. Hashim reports personal fees and non-financial support
her they For anyone with nocturia, a basic interpretation of the bladder
from Ferring, personal fees from Astellas, personal fees from
diary can be used to categorise likely contributory factors,10
Medtronic, personal fees from Boston, personal fees and non-
ded for and thereby guide subsequent evaluation and treatment.11,12
financial support from Allergan, outside the submitted work.
and the
Dr. Drake reports grants, personal fees and non-financial
d by the � 24-h polyuria; caused by a range of medical problems, such
support from Ferring, during the conduct of the study; grants,
noting as diabetes insipidus, salt loss, or poorly controlled diabetes
personal fees and non-financial support from Astellas, grants,
alyzing mellitus. These people often report constant thirstiness.
personal fees and non-financial support from Allergan,
can be � NP; caused by problems such as obstructive sleep apnoea
outside the submitted work.
or peripheral oedema.
� LUTD; generally associated with storage LUTS, and with
increased bladder sensation scores on the bladder diary. ORCID
passed � Sleep disturbance; should be considered if the patient
d of the describes anxiety, restless legs, nightmares, and sleep- Hashim Hashim http://orcid.org/0000-0003-2467-407X
walking. Marcus J. Drake http://orcid.org/0000-0002-6230-2552
oduced
Simple behavioral tendencies should be considered, for
me/24-h example identification of a high fluid intake in someone REFERENCES
who does not experience constant thirst. LUTD is actually a
relatively uncommon explanation for nocturia in the wider 1. Tikkinen KA, Johnson TM, Tammela TL, et al. Nocturia frequency,
me, and bother, and quality of life: how often is too often? A population-
population, so urologists or urogynecologists should
based study in Finland. Eur Urol. 2010;57:488–496.
identify the other possible situations and avoid urological 2. van Doorn B, Blanker MH, Kok ET, Westers P, Bosch JL.
or gynecological interventions, where not specifically Prevalence, incidence, and resolution of nocturnal polyuria in a
indicated. longitudinal community-based study in older men: the Krimpen
study. Eur Urol. 2013;63:542–547.
3. van Kerrebroeck P, Abrams P, Chaikin D, et al. The standardisation
7 | ENURESIS of terminology in nocturia: report from the Standardisation Sub-
committee of the International Continence Society. Neurourol
Enuresis is a symptom in which the patient complains of Urodyn. 2002;21:179–183.
intermittent incontinence that occurs during periods of sleep. 4. Van Kerrebroeck P, Abrams P, Chaikin D, et al. The standardization
It is also a sign of “wetting” while asleep. This is not the same of terminology in nocturia: report from the standardization
as waking with urinary urgency and having insufficient time subcommittee of the International Continence Society. BJU Int.
to reach the toilet, which is urgency urinary incontinence. 2002;90:11–15.
5. Abrams P, Cardozo L, Fall M, et al. The standardisation of
Enuresis may have more in common with voiding
terminology of lower urinary tract function: report from the
dysregulation (urination in situations which are generally Standardisation Sub-committee of the International Continence
regarded as socially inappropriate) or involuntary voiding Society. Neurourol Urodyn. 2002;21:167–178.
(sporadic bladder emptying when awake)13 than nocturia. 6. Abrams P, Avery K, Gardener N, Donovan J. The international
Thus, they must be clearly distinguished when both nocturia consultation on incontinence modular questionnaire: www.iciq.net.
and enuresis are reported by a patient. J Urol. 2006;175:1063–1066. discussion 1066.
7. Abraham L, Hareendran A, Mills IW, et al. Development and
validation of a quality-of-life measure for men with nocturia.
8 | CONCLUSION Urology. 2004;63:481–486.
8. Bright E, Cotterill N, Drake M, Abrams P. Developing and
The symptom of nocturia is present if the patient reports validating the International Consultation on Incontinence Ques-
wing waking at night to pass urine and nocturia is also a sign tionnaire bladder diary. Eur Urol. 2014;66:294–300.
he 9. Bright E, Drake MJ, Abrams P. Urinary diaries: evidence for the
indicated by the number of times an individual passes urine
50 + 400 development and validation of diary content, format, and duration.
during their main sleep period. NP is present if the patient
octurnal Neurourol Urodyn. 2011;30:348–352.
reports passing large volumes of urine at night, and this can be
t 2 am 10. Cornu JN, Abrams P, Chapple CR, et al. A contemporary
050 mL. quantified with the nocturnal polyuria index. The bladder assessment of nocturia: definition, epidemiology, pathophysiology,
This diary is an important diagnostic tool, helping identify 24-h and management-a systematic review and meta-analysis. Eur Urol.
o had polyuria, NP, LUTD, and sleep disturbance. Enuresis is 2012;62:877–890.
omplete distinguished from nocturia, as the patient fails to wake up for 11. Sakalis VI, Karavitakis M, Bedretdinova D, et al. Medical treatment
passing urine. of nocturia in men with lower urinary tract symptoms: systematic

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Received:
DOI: 10.1
review by the european association of urology guidelines panel for
male lower urinary tract symptoms. Eur Urol. 2017;72:757–769. How to cite this article: Hashim H, Drake MJ. SOUN
12. Gratzke C, Bachmann A, Descazeaud A, et al. EAU guidelines on the Basic concepts in nocturia, based on international
assessment of non-neurogenic male lower urinary tract symptoms
continence society standards in nocturnal lower
including benign prostatic obstruction. Eur Urol. 2015;67:1099–1109.
urinary tract function. Neurourology and
13. Gajewski JB, Schurch B, Hamid R, et al. An International
Continence Society (ICS) report on the terminology for adult
Urodynamics. 2018;37:S20–S24. Neu
neurogenic lower urinary tract dysfunction (ANLUTD). Neurourol https://doi.org/10.1002/nau.23781
Urodyn. 2018;37:1152–1161.
Jerzy

1 Dalhou

Scotia, C
2 Transla

Medical
3 Bristol

Hospital,

Corresp
Marcus J
Institute,
Southme
UK.
Email: m

1 | IN

Adult n
refers t

Alan We
for the p

Neurourol

ICS Standards 2019

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D DRAKE
Received: 1 May 2018
DOI: 10.1002/nau.23758
| Accepted: 11 June 2018

SOUNDING BOARD
l

Neurological lower urinary tract dysfunction essential terminology

Jerzy B. Gajewski1 | Marcus J. Drake2,3

1 Dalhousie University, Halifax, Nova

Scotia, Canada Aims: To introduce basic concepts and definitions in the International Continence
2 Translational
Health Sciences, Bristol Society (ICS) Standardisation of Terminology in adult Neurogenic Lower Urinary
Medical School, Bristol, UK Tract Dysfunction (NLUTD).
3 BristolUrological Institute, Southmead Methods: Fundamental terminology in the ICS Standardisation of Terminology of
Hospital, Bristol, UK
Adult NLUTD was identified and summarized.
Correspondence Results: NLUTD is often associated with impairment of cognitive, motor, sensory,
Marcus J. Drake, Bristol Urological
and/or autonomic functions. Lesions are categorized into suprapontine, pontine/
Institute, 3rd Floor L&R building,
Southmead Hospital, Bristol, BS10 5NB, suprasacral spinal, sacral spinal, cauda equina/peripheral nerve, or mixed lesions.
UK. People affected with neurological disease are also at risk of the conditions seen in the
Email: marcus.drake@bristol.ac.uk
general population, such as benign prostate enlargement. Symptoms of NLUTD
include alterations in bladder or urethral sensation and incontinence. Loss of urine can
result from incontinence, involuntary passing of urine and factors that impair toilet
use, incorporating problems such as impaired cognition urinary incontinence,
impaired mobility urinary incontinence, and voiding dysregulation. Signs may be
discerned by physical examination and recording of a frequency volume chart or
bladder diary. Urodynamic observations during filling cystometry may include
altered sensations, neurogenic detrusor overactivity, and reduced bladder compli-
ance. During pressure flow studies, there may be detrusor underactivity or bladder
outlet obstruction (BOO). BOO may be caused by various forms poorly co-ordinated
muscle activity in the bladder outlet. Symptoms, signs, and urodynamic observations
may be useful in diagnosing the presence and specific location of neurological
impairment.
Conclusion: The review provides a succinct summary of symptoms, signs, and
urodynamic observations as set out in the ICS Standard on Adult NLUTD.

KEYWORDS
incontinence, LUTS, neurological disease, standardization

1 | INTRODUCTION (and/or prostate in men) in mature individuals in the context

of clinically confirmed relevant neurologic disorder. NLUTD
Adult neurogenic lower urinary tract dysfunction (NLUTD) is a key subgroup of the broad range of lower urinary tract
refers to abnormal or difficult function of the bladder, urethra symptoms (LUTS), due to the severity of the symptoms, and
the implications of urinary dysfunction for wider health. The
Alan Wein led the peer-review process as the Associate Editor responsible International Continence Society (ICS) categorizes symp-
for the paper. toms, signs, urodynamic observations, and conditions
Neurourology and Urodynamics. 2018;37:S25–S31. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | S25

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| GAJEWSKI AND DRAKE GAJEWS

associated with lower urinary tract dysfunction (LUTD) in set out in the ICS Standardisation of Terminology of Lower
relationship to the storage and voiding phases of the Urinary Tract Function2 (for summary see3). A summary of
micturition cycle. Neurological disease brings additional the classification of neurological lesions,1 including the
dimensions to the LUTD as experienced in the lives potential clinical and urodynamic features, is given in
of affected individuals. The current document is a summary Figure 2.
of core terminology in NLUTD for use in the wider context of
LUTS in people known to have a neurological disease, or
suspected of potentially having one which has not yet been 4 | NLUTD SYMPTOMS
diagnosed.
People with NLUTD may describe storage, voiding, and post
voiding symptoms consistent with the definitions used for the
2 | METHODS general population.2,3 Sometimes, a patient may not express
that a symptom is present, so it is appropriate to discuss with
Recommendations in the ICS Standard on Adult Neuro- the caregiver as well when establishing the presenting
genic Lower Urinary Tract Dysfunction1 were reviewed and complaint. Storage symptoms may converge in Neurogenic
summarized. Definitions and key terms are generally Overactive Bladder, which is a symptom syndrome
transcribed verbatim and highlighted in bold. In the original characterized by urgency, with or without urgency
document, many of the definitions are accompanied by urinary incontinence, usually with increased daytime
explanatory or exemplary footnotes which have been frequency and nocturia in the setting of a clinically
adapted or excluded for the current review for the sake of FIGUR
relevant neurologic disorder with at least partially
brevity. Readers requiring more detailed information are preserved sensation.
referred to the full ICS Standard, and other documents contrac
produced by the ICS Standardisation Steering Committee. Variou
4.1 | Bladder and urethral sensation
1. Inco
3 | NEUROLOGICAL CONTROL Neurologically healthy people are intermittently aware of urge
bladder sensations related to filling and voiding, and urethral refle
The nervous system controls many facets that are essential for sensation with voiding. Someone with NLUTD may describe are t
the normal micturition cycle (storage and voiding). Particu- alterations, for example: 2. Invo
larly crucial are cognition (eg, decision making, anticipation, Increased bladder sensation: the desire to void during nece
awareness of environment/social context, and conscious bladder filling occurs earlier or is more persistent than that activ
perception of sensation), motor functions (eg, mobility, previously experienced. Reduced: the definite desire to This
balance, and dexterity), sensory nerve activity, and autonomic void occurs later to that previously experienced despite an soci
functions (eg, regulation of the detrusor and sphincter). The awareness that the bladder is filling. Absent: the individual cere
neurological functions act together to make sure that both reports no sensation of bladder filling or desire to void. void
urine storage and voiding reflect timings and contexts Such patients may have a significant post voiding residual in pass
appropriately, with full voluntary control (Figure 1). the bladder, without any sensation of incomplete emptying. 3. Fact
Neurological diseases are diverse and differ in terms of Non-specific bladder awareness: the individual re- disa
the parts of the nervous system affected (eg, the cognitive- ports no specific bladder sensation, but may perceive, for
predominant effects of dementia) and their behavior (eg, example, abdominal fullness, vegetative symptoms, ure- Thu
progressive, such as multiple sclerosis, or non-progressive, thral sensations, or spasticity as bladder filling awareness standar
such as spinal cord injury). Thus, neurological disease may or a sign of bladder fullness. This may indicate that the usual
have differing effects on cognitive, sensory, motor, and sensory nerve pathways are not communicating centrally. � Imp
autonomic functions which manifest in the specific NLUTD Instead anatomical routes which do not usually contribute to urin
experienced by the patient. Inevitably, the consequences of everyday sensations may be intact and functional. impa
neurological disease extend beyond LUTD, and mean that In addition, some people report they are unable to feel awar
affected patients have a range of issues that influence flow of urine along the urethra. They may report that they can � Imp
treatment potential and health risk. Problems with bowel only discern whether bladder emptying is finished by looking, reac
function, sexual and reproductive function, cognition, or listening for the splash of urine in the toilet to stop. or m
mobility, and blood pressure control are particularly comb
relevant. caus
4.2 | Loss of urine
In describing the features of an individual patient's shou
dysfunction, clinicians should appreciate the distinction Mature CNS regulation ensures storage (detrusor relaxation profe
between symptoms, signs, and urodynamic observations as with outlet contraction) and the transition to voiding (detrusor urina

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Lower
mary of
ing the
ven in

nd post
d for the
express
uss with
senting
rogenic
ndrome
rgency
aytime
inically
FIGURE 1 The micturition cycle viewed from the context of the person's social and environmental context. PMC, pontine micturition center
artially

contraction with outlet relaxation) is under voluntary control. “Mobility impairment urinary incontinence” with “stress
Various situations in NLUTD may lead to a loss of urine: urinary incontinence.
� Voiding dysregulation is urination in situations which
1. Incontinence; categorized into stress urinary incontinence, are generally regarded as socially inappropriate, such
ware of urgency incontinence and mixed urinary incontinence, and as while still fully dressed, or in a public setting away
urethral reflecting LUT dysfunction. Definitions used in NLUTD from toilet facilities.
describe are the same as those used in the general population. � Involuntary voiding is both a symptom and a diagnosis
2. Involuntary passing of urine; no LUT abnormality is of sporadic bladder emptying when awake, without
during necessarily present, but instead the voiding reflex may intention to void. Usually the voiding reflex is
an that activate at times not consciously initiated by the patient. preserved, and there is only lack of proper inhibition
esire to This may be during occasions generally considered of the voiding reflex. If that happens when asleep it is
spite an socially inappropriate. It may reflect a dysfunction in the called Acquired Enuresis.
ividual cerebrum, for example, a stroke or dementia. Abnormal � Enuresis is intermittent incontinence that occurs
o void. voiding reflexes, or disinhibition, may result in the person during periods of sleep. Enuresis is considered different
idual in passing urine without voluntary control. from urgency urinary incontinence. Confirming the precise
tying. 3. Factors that impair toilet use, such as immobility, cognitive underlying mechanism(s) is often not possible in routine
ual re- disability, and decreased motivation. clinical practice.
ive, for
� Continuous (urinary) incontinence: complaint of con-
ms, ure- Thus, some additional incontinence definitions are tinuous involuntary loss of urine.
areness standardized in NLUTD:
he usual
entrally. � Impaired cognition urinary incontinence is periodic
ibute to 4.3 | Signs
urinary incontinence that the individual with cognitive
impairment reports to have occurred without being NLUTD evaluation incorporates the examination used for the
to feel aware of it. general population, since people with neurological disease are
hey can � Impaired mobility urinary incontinence is inability to the same risk of aging-related and other changes as any other
ooking, reach the toilet on time for voiding because of physical person. Accordingly, physical examination must include
p. or medical disability. This inability includes (any abdominal, pelvic and perineal examination, and should elicit
combination of) the individual's physical as well as social the following where present:
causes or reasons. Other signs or symptoms of LUTD
should not be present, or should be reported by the � Incontinence
axation professional (as primary or as accessory) (eg, “Urgency � Pelvic organ prolapse
detrusor urinary incontinence” with “mobility impairment”; or � Pelvic floor muscle function

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| GAJEWSKI AND DRAKE GAJEWS

important in NLUTD, where the underlying condition may

give rise to an endocrine dysfunction, such as central diabetes
insipidus.
Physical examination is also used to identify signs which
could point toward the localization of the exact neurological
deficits caused by the responsible condition, for example,
perineal numbness.

5 | URODYNAMIC OBSERVATIONS

Bladder and bladder outlet function both need to be

considered for a full understanding of a person's LUT. Since
the pathophysiology is complex in NLUTD, and symptoms
cannot be relied on for understanding mechanism, urody-
namic testing provides a valuable insight into mechanisms
and may identify observations that could indicate a risk to the
patient's future health.

5.1 | Filling cystometry

� Neurogenic detrusor overactivity is characterized by
involuntary detrusor contractions during the filling
phase which may be spontaneous or provoked in the
FIGUR
setting of a clinically relevant neurologic disease.
phase du
Provoked contraction may be elicited by cough, change
The upp
FIGURE 2 Classification of neurological lesions. Suprapontine of position, etc., or by urethral/sphincter to bladder in press
Lesion (SPL) is a neurological lesion above the pons (forebrain or reflex. Neurogenic Detrusor Overactivity Incontinence Detrusor
midbrain). NLUTD in SPL: there is a reflex contraction of the is incontinence due to involuntary neurogenic detrusor or low c
detrusor with impaired cerebral regulation and central inhibition and overactivity. pressure
usually synergistic voiding/bladder emptying. Suprasacral spinal cord/ � Detrusor Overactivity Leak Point Pressure (DOLPP) is strains,
pontine lesion (SSL) is a neurological lesion in suprasacral spine and/ defined as the lowest detrusor pressure rise with detrusor
or pons. NLUTD in SSL: Detrusor overactivity (DO) and DO detrusor overactivity at which urine leakage first multiple
incontinence are common, with or without detrusor-urethral sphincter occurs in the absence of voluntary detrusor contraction
dyssynergia (DSD), often resulting in a significant post void residual
or increased abdominal pressure. This is in contrast to
(PVR) and “high pressure” bladder. Sacral Spinal Cord Lesion
(SSCL) is a neurological lesion in the sacral spinal cord. NLUTD in
Detrusor Leak Point pressure where urine leakage occurs in 5.2 | P
SSCL; findings include acontractile detrusor with or without
the absence of either a detrusor contraction or increased
When
decreased bladder compliance and usually with impaired sphincter abdominal pressure.2
impaire
activity. Infrasacral (cauda equina and peripheral nerves) Lesion (BOO)
(CEPNL) is a neurological lesion affecting the cauda equina and/or Reduced bladder compliance (the relationship between
neurog
peripheral nerves. NLUTD in CEPNL: acontractile detrusor and/or change in bladder volume and change in detrusor
SUI may be present. Mixed Neuronal Lesion results from lesions of pressure2) is an important observation (Figure 3) in
� Non
the neural pathway at different levels of the central nervous system interpreting the clinical risk for renal function.
concurrently. Note that in the adult, vertebral levels and spinal cord
non-
In neurogenic LUTD, the cystometric capacity cannot be
levels do not lie adjacent. Thus a T12/L1 prolapsed intervertebral disc in re
defined in the same terms as for filling cystometry for the
(classified by its vertebral level) will affect the sacral part of the � Dela
general population. In the absence of sensation, the cystometric
spinal cord (red arrow) teriz
capacity is the volume at which the clinician decides to
sphi
terminate filling. The reason(s) for terminating filling should be
urin
� Palpable bladder after voiding defined in the report, for example, high detrusor filling pressure,
� Detr
� Pad testing large infused volume or pain. If there is uncontrollable voiding/
scrib
bladder emptying, it is the volume at which this begins. In the
invo
A frequency micturition chart, frequency volume chart, or presence of sphincter incompetence the cystometric capacity
uret
bladder diary2 is needed within the constraints of patient may be significantly increased by occlusion of the urethra, for
prev
capacity or carer availability. This may be particularly example, by a Foley catheter balloon.

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| S29

on may
diabetes

s which
ological
xample,

NS

to be
T. Since
mptoms
urody-
hanisms
k to the

zed by
filling
in the
FIGURE 3 Filling cystometry in a sacral spinal cord lesion (SSCL) showing reduced compliance; the lower orange line indicates the
disease.
phase during which the detrusor pressure (green trace, second from bottom) is climbing, even though the filling rate is slow (10 mL/min).
change
The upper orange line indicates the detrusor leak point pressure. The change in volume over this time was 123-34 = 89 mL, and the change
bladder in pressure was 33-7 = 26 cm H2O. Compliance (change in volume divided by change in pressure) was thus 89/26 = 3.4 mL/cm H2O.
tinence Detrusor Leak Point Volume (DLPV) is defined as a bladder volume at which first urine leakage occurs (1), either with detrusor overactivity
etrusor or low compliance (orange arrow). The leakage is seen in the flow trace (black, bottom trace), and the leakage causes the elevated detrusor
pressure to dissipate. The arrow indicates permission to void. However, there is no flow generated, and the patient does several Valsalva
LPP) is strains, shown by the substantial pressure rises in both abdominal pressure, and hence bladder pressure (2), signifying neurogenic acontractile
e with detrusor. At time of urodynamics, neurological diagnosis had not previously been suspected, and subsequently he was identified to have
e first multiple system atrophy
raction
ntrast to
ccurs in 5.2 | Pressure flow studies DSD is an indicator that the pontine micturition center is
creased not communicating effectively with the sacral spinal cord,
When passing urine, a slow stream may be explained by
and occurs in people with a suprasacral spinal cord/pontine
impaired detrusor contraction, bladder outlet obstruction
lesion. The term should not be used in other forms of NLUTD,
(BOO), or a combination of both. Potential causes of
etween and it is not a general term for neurogenic BOO.
neurogenic BOO include:
etrusor Other causes of BOO present in the general population,
3) in such as benign prostatic obstruction, bladder neck obstruc-
� Non-relaxing urethral sphincter, characterized by a
tion, or urethral stricture in men, can also be present in people
non-relaxing, obstructing urethral sphincter resulting
nnot be with neurological disease, and videourodynamics may be
in reduced urine flow.
for the appropriate to discern the proximal site of BOO.
� Delayed relaxation of the urethral sphincter, charac-
ometric Impaired detrusor contraction can indicate:
terized by impaired and hindered relaxation of the
ides to
sphincter during voiding attempt resulting in delay of
hould be
urine flow. � Neurogenic detrusor underactivity; a contraction of
ressure,
� Detrusor-Sphincter Dyssynergia (DSD), which de- reduced strength and/or duration, resulting in pro-
voiding/
scribes a detrusor contraction concurrent with an longed bladder emptying and/or a failure to achieve
s. In the
involuntary contraction of the urethral and/or peri- complete bladder emptying within a normal time span
capacity
urethral striated muscle. Occasionally flow may be in the setting of a clinically relevant neurologic
thra, for
prevented altogether. disorder.

Neurological lower urinary tract dysfunction essential terminology

306

S30
| GAJEWSKI AND DRAKE GAJEWS

� Neurogenic acontractile detrusor; the detrusor cannot 7 | DIAGNOSING NEUROLOGICAL CONF

be demonstrated to contract during urodynamic studies DYSFUNCTION
The au
in the setting of a clinically relevant neurologic lesion
(Figure 3). In order to understand the full picture of the neurological ORCI
deficit, the history may be used to identify features which
Jerzy B
Balanced bladder emptying is a bladder emptying with could localize the site of a problem or suggest the causative
Marcus
physiological detrusor pressure and low residual as condition and its behavior. Such observations can be helpful
perceived by the investigator, and should be defined in to a patient's neurologist in localising areas of deficit. These
the report. features are important in defining a patient's condition, since
it guides subsequent testing (such as the anatomical sites REFE
and scan protocols for MRI). For example, retrograde
6 | NLUTD CLINICAL DIAGNOSES 1. Gaje
ejaculation reported by a man who has not had bladder neck Socie
or prostate surgery may indicate a neurological deficit in the urina
� Spinal Shock Phase is usually temporary following
thoracolumbar spine or related peripheral nerves; this may 2018
acute neurologic insult or SCI that is characterized by
be accompanied by visualization of an open bladder neck 2. Abra
loss of sensory, motor, and reflex activity below the level termi
during videourodynamic filling cystometry. Signs can also
of injury. NLUTD in Spinal Shock is usually a temporary
help; for example, loss of the anal reflex indicates a lesion
complete painless urinary reten`tion.
affecting the sacral spinal cord or its sensory or motor
� Autonomic Dysreflexia is a syndrome resulting from
nerves.
an upper thoracic or cervical spinal cord injury
In rare but important cases, urinary dysfunction may
above T6, elicited by a stimulus in the field of
present for urological evaluation in a patient with no known
distribution of the autonomous sympathetic nucleus,
neurological background whose ultimate cause may subse-
characterized by unregulated sympathetic function
quently prove to be a neurological disease. This can occur
below the lesion and compensatory autonomic
for example in MS, normal pressure hydrocephalus,
responses. It is potentially a medical emergency charac-
multiple system atrophy, and early Parkinson's disease.4
terized by hypertension, bradycardia, severe headaches,
Key symptoms include erectile dysfunction, retrograde
and flushing above, with pallor below the cord lesion, and
ejaculation, enuresis, loss of filling sensation, or unex-
sometimes convulsions. An increase of blood pressure
plained stress urinary incontinence.4 If there is any
without any other symptoms is called Asymptomatic
suspicion that an undiagnosed neurological disease could
Autonomic Dysreflexia.
be present, questioning should enquire about visual
symptoms, back pain, anosmia, bowel dysfunction and
Urinary retention is an inability to properly empty the incontinence, or memory loss.4 Specialist evaluation is
bladder. Retention may be complete or incomplete: likely to be needed.

� Acute retention of urine is an acute event of painful,

palpable or percussable bladder, when the patient is 8 | CONCLUSIONS
unable to pass any urine when the bladder is full.
Although acute retention is usually thought of as painful, in NLUTD is categorized into: suprapontine; pontine/suprasacral
certain circumstances pain may not be a presenting feature, spinal; sacral spinal; cauda equina/peripheral nerve; mixed
for example, when due to prolapsed intervertebral disc, lesions. Loss of urine can result from impaired cognition
post-partum, or after regional anesthesia such as an urinary incontinence, impaired mobility urinary incontinence,
epidural anesthetic. The retention volume should be and voiding dysregulation. Urodynamic observations during
significantly greater than the expected normal bladder filling cystometry may include altered sensations, neurogenic
capacity. detrusor overactivity, and reduced bladder compliance. During
� Chronic retention is a non-painful bladder, which pressure flow studies, there may be detrusor underactivity or
remains palpable or percussable after the patient has bladder outlet obstruction (BOO). BOO may be caused by
passed urine. Such patients may be incontinent. Chronic various forms poorly co-ordinated muscle activity in the
retention, excludes transient voiding difficulty, for exam- bladder outlet. Symptoms, signs, and urodynamic observations
ple, after surgery for stress incontinence, and implies a may be useful in diagnosing the presence and specific location
significant residual urine. of neurological impairment.

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 307

D DRAKE GAJEWSKI AND DRAKE

| S31

AL CONFLICT OF INTEREST Standardisation Sub-committee of the International Continence

Society. Neurourol Urodyn. 2002;21:167–178.
The authors declare no conflict of interest. 3. Drake MJ. Fundamentals of terminology in lower urinary tract
function. Neurourol Urodyn. 2018;37:S13–S19.
ological ORCID
4. Wei DY, Drake MJ. Undiagnosed neurological disease as a potential
s which
Jerzy B. Gajewski http://orcid.org/0000-0003-0769-583X cause of male lower urinary tract symptoms. Curr Opin Urol.
usative 2016;26:11–16.
Marcus J. Drake http://orcid.org/0000-0002-6230-2552
helpful
. These
n, since
al sites REFERENCES
rograde How to cite this article: Gajewski JB, Drake MJ.
1. Gajewski JB, Schurch B, Hamid R, et al. An International Continence Neurological lower urinary tract dysfunction
er neck Society (ICS) report on the terminology for adult neurogenic lower
it in the essential terminology. Neurourology and
urinary tract dysfunction (ANLUTD). Neurourol Urodyn.
his may Urodynamics. 2018;37:S25–S31.
2018;37:1152–1161.
er neck 2. Abrams P, Cardozo L, Fall M, et al. The standardisation of https://doi.org/10.1002/nau.23758
an also terminology of lower urinary tract function: report from the
a lesion
motor

on may
known
subse-
n occur
phalus,
isease.4
rograde
unex-
is any
e could
visual
on and
ation is

rasacral
mixed
ognition
tinence,
during
rogenic
During
ivity or
used by
in the
rvations
ocation

Neurological lower urinary tract dysfunction essential terminology

308

RANA ET
Received: 28 May 2018
DOI: 10.1002/nau.23776
| Accepted: 1 July 2018

rheuma
attribut
SOUNDING BOARD
are mu
standar
special
The fundamentals of chronic pelvic pain assessment, based on
international continence society recommendations 2 | M

A stan
Neha Rana1 | Marcus J. Drake2,3 | Rebecca Rinko1 | Melissa Dawson1 | develop
Kristene E. Whitmore1,4 Society
odolog
aspects
1 Division of Female Pelvic Medicine and practic
Reconstructive Surgery, Department of Aims: Chronic pelvic pain (CPP) is defined as a noncyclical pain that has duration of
Obstetrics and Gynecology, Drexel at least 6 months and can lead to decreased quality of life and physical performance.
University College of Medicine,
Philadelphia, Pennsylvania
The pain can be attributed to problems in the pelvic organs and/or problems in related 3 | O
2 Translational
Health Sciences, Bristol
systems, and possible psycho-social attributes may contribute to the manifestation.
Medical School, Bristol, UK Due to the complex nature, CPP syndromes are multifactorial and the terminology For a p
crucial
3 BristolUrological Institute, Southmead needs to reflect the setting.
Hospital, Bristol, UK for at le
Methods: The current review is a synthesis of key aspects of the recent International event a
4 Divisionof Female Pelvic Medicine and
Continence Society Standardization for Terminology in CPP Syndromes. indicat
Reconstructive Surgery and Urology,
Drexel University College of Medicine, Results: Nine domains can be used for a detailed description of CPP. They include obscure
Philadelphia, Pennsylvania four domains specific to the pelvic organs (lower urinary tract, female genital, male primary
genital, gastrointestinal), two related to other sources of pain which may be perceived varied
Correspondence
sets ou
Kristene E. Whitmore, Division of Female in the pelvis (musculoskeletal, neurological) and three which may influence the
Pelvic Medicine and Reconstructive of poss
response to the pain or its impact on the individual (psychological, sexual, and
Surgery and Urology, Department of
Obstetrics and Gynecology, Drexel comorbidities). For an individual patient with CPP, each domain should be reviewed
University College of Medicine, in terms of symptoms and signs, noting that positive findings could reflect either a TABLE
207 North Broad Street, 4th Floor
primary cause or a secondary consequence. The findings will guide further Sympt
Philadelphia, PA 19107.
Email:bladder1@aol.com evaluations and subsequent treatment. Bladde
Conclusion: We present a synthesis of the standard for terminology in CPP Incre
syndromes in women and men, which serves as a systematic framework to consider Incre
possible sources of pain (pelvic organs or other sources) and the individual responses
and impact. Urge

KEYWORDS Hype
chronic pelvic pain, lower urinary tract dysfunction, LUTS, pelvic floor muscle pain, standardization

Pain
with
Hesi
1 | INTRODUCTION life and physical performance.1 The presentation can be a
Inter
challenge to assess and treat. This is because the pain
Feeli
CPP is defined as a noncyclical pain that has duration of at can potentially be attributed to several contributory
empt
least 6 months, and it can lead to decreased quality of factors, in the context of the varied nature of pain
Urethra
responses manifested by individuals. Healthcare profes-
sionals (HCPs) need to consider gynecological, urological, Freq
Roger Dmochowski led the peer-review process as the Associate Editor
urina
responsible for the paper. gastrointestinal, musculoskeletal, neurological, or
S32 | © 2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2018;37:S32–S38.

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2. Fundamentals
 309

RANA ET AL.
| S33

rheumatological factors, with possible psycho-social The domains of chronic pelvic pain (CPP) syndromes
attributes. Due to its complex nature, CPP syndromes include four which consider the pelvic organs;
are multifactorial and the current terminology aims to
standardize descriptions, regardless of which type of 1. Lower urinary tract domain
specialist is performing the evaluation. 2. Female genital domain
n 3. Male genital domain
4. Gastrointestinal domain
2 | METHODS
Two domains consider other sources of pain which may
A standard for terminology in CPP syndromes was be perceived in the pelvis, even if the actual site of the
developed in accordance with the International Continence problem may not be within the pelvis;
Society (ICS) Standardization Steering Committee meth-
odology.2 The current review is a synthesis of the key 5. Musculoskeletal domain
aspects of the standard for practical use in everyday 6. Neurological domain
practice.
ion of The final three domains relate to general factors that could
mance. influence the response to the pain or its impact on the
elated 3 | OVERVIEW individual;
ation.
ology For a patient presenting with pelvic pain, thorough history is 7. Psychological domain
crucial, including establishing that the pain has been present 8. Sexual domain
for at least 6 months, identification of any potential inciting 9. Comorbidities
tional event and/or triggers, character, radiation, and severity. An
indication of the source of pain is vital, yet it can be In any domain, features may be present as a result of a
nclude obscured in individual cases by the range of possible primary problem, or a secondary consequence. Each domain
, male primary sources and secondary consequences, and the is evaluated with directed history-taking and a comprehensive
ceived varied responses. To ensure a systematic approach, the ICS physical examination done with a focus on the lower
sets out a series of “domains” which facilitate consideration abdomen/pelvis to identify pain triggers and patterns of
ce the
of possible issues. referred pain. The HCP can surmize the possible source of the
l, and
iewed
ther a TABLE 1 Lower urinary tract domain
urther Symptoms Signs Evaluation Syndrome/Disease
Bladder
CPP Increased daytime frequency Suprapubic tenderness Questionnaires Hypersensitivity bladder
nsider Increased night-time frequency Tenderness of bladder Voiding diary Interstitial cystitis/bladder pain
onses syndrome
Urgency Tenderness of the pelvic floor Urine analysis Interstitial cystitis/Hunner lesion
muscles
Hypersensitivity Optional: urine culture/
zation cytology
Intravesical anesthetic
challenge
Pain, pressure, discomfort Urodynamics
with filling Cystoscopy (biopsy)
Hesitancy
an be a
Intermittency
he pain
Feeling of incomplete bladder
ibutory
emptying
of pain
Urethra
profes-
logical, Frequency/urgency painful Tenderness of the urethra Urine analysis Urethral pain
urination
l, or
:S32–S38.

The fundamentals of chronic pelvic pain assessment, based on international continence society recommendations
310

S34
| RANA ET AL. RANA ET

3.1 | Domains related to the pelvic organs TABLE

The lower urinary tract domain (Table 1) incorporates the

bladder and urethra. The global definitions for bladder pain Sympt

syndrome (BPS) and interstitial cystitis (IC) are not fully Pain
LUTS
standardized, as several professional organizations have an
Dyspar
interest in the area. Society for Urodynamics, Female Pelvic
Erectile
Medicine and Urogenital Reconstruction proposed the
definition of IC/BPS as “an unpleasant sensation (pain
pressure, discomfort) perceived to be related to the urinary
bladder, associated with lower urinary tract symptoms of
more than 6 weeks duration in the absence of other
identifiable causes.”6 For the bladder, patients may
complain of increased urinary frequency (day and night),
FIGURE 1 The endoscopic appearances of bleeding and urgency, hypersensitivity, pain, pressure, discomfort, hesi-
ulceration during general anesthetic cystoscopy indicate that the lower tancy, pain with filling, and sensation of incomplete
urinary tract domain is a contributory factor in CPP, especially if emptying. The situation may be associated with relevant TABLE
there are pain reactions such as tachycardia, tachypnoea, and findings on general anesthetic cystoscopy (Figure 1). If the
hypertension Sympt
urethra is a significant contributor, pain is perceived usually
Pain w
when voiding and can be combined with a dull pressure that
Evacua
may radiate towards the groin or perineum.
Pain/pr
pain, relevant additional factors, and potential secondary The genital domains comprise the female genital domain
Abdom
consequences. Specific assessment and treatment requires (Table 2) and the Male Genital Domain (Table 3). Female
Nausea
access to multidisciplinary support, and awareness of the patients may report pain with menstruation, abnormal Constip
initiatives and guidance developed by a range of organiza- bleeding, dyspareunia, vaginal discharge or itching, void- Persiste
tions and expert groups.3–5 Imaging, endoscopy and special ing/defecatory pain, and/or abdominal/pelvic pain. Pain
tests may be needed for evaluation of each domain considered mapping with a Q-tip is done to elicit localized areas of
influential for a patient. With the individual evaluation in tenderness, which may be identified in the vagina or external
mind, further investigation and initial therapy can be planned genitalia. Generalized vulvar pain syndrome refers to pain/
based on the multidisciplinary support and up-to-date burning that cannot be localized by pain mapping. It is TABLE
awareness of clinical recommendations and guidelines. important to identify any ulcers, fissures, or cysts of the vulva.
Sympt
As an example, chronic prostatitis will be associated In addition, intra-abdominal signs related to the uterus and
Abdom
with history and examination features in the male genital adnexa may indicate other pathology, such as fibroids, cysts,
domain (the primary site of the problem), and the lower pelvic masses, endometriosis, or adhesive disease. These can
Pain at
urinary tract and musculoskeletal domains (where second- present with uterine tenderness, cervical discharge or
sitting/
ary problems such as increased urinary frequency and tenderness, or adnexal tenderness Pain w
muscle spasms may be experienced). The full scope of Male patients may reports symptoms related to the Unilate
impact on the patient may be further driven by issues in the lower urinary tract and sexual dysfunction. There may be Persiste
psychological and sexual domains. complaints of dysuria, sensation of incomplete emptying,

TABLE 2 Female genital domain

Symptoms Signs Evaluation Syndrome/Disease
TABLE
Vagina
Sympt
Dyspareunia Tenderness Erythema Pain mapping Vaginal/vulvar/perineal pain
Charac
Sharp burning and/or stabbing Q-tip touch sensitivity
Burnin
Provocation of pain with touch
Throbb
Intraabdominal female genital Stabbin
Dysmenorrhea Tenderness: uterine/adnexal Laboratory testing Ovarian Shootin
Abnormal uterine bleeding Pelvic ultrasound Pelvic congestion Electric
Dyspareunia Laparoscopy/biopsy Uterine paresth
Itching, stabbing, burning pain CT-scan Tubal Atroph
Cyclic (episodic or persistent) Persiste

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NA ET AL. RANA ET AL.

| S35

s TABLE 3 Male genital domain

ates the Syndrome/

der pain Symptoms Signs Evaluation Disease

ot fully Pain Tenderness on rectal/genital examination Questionnaires Prostate pain

LUTS Urethral discharge Culture
have an
Dyspareunia PSA/biopsy
e Pelvic
Erectile dysfunction (Persistent) or episodic Cystoscopy/biopsy
ed the Ultrasound
n (pain
Tenderness on physical Questionnaires Scrotal pain
urinary examination Ultrasound Epididymal pain
oms of Scars Testicular pain
f other Penile pain
s may
night),
t, hesi-
omplete
elevant TABLE 4 Gastrointestinal domain
). If the
Symptoms Signs Evaluation Syndrome/Disease
usually
Pain with defecation Tenderness on rectal exam Questionnaires Anorectal pain
ure that
Evacuation dysfunction Culture
Pain/pressure with sitting Colonoscopy/biopsy
domain
Abdominal pain Abdominal tenderness Ultrasound CT/barium Colorectal pain
Female
Nausea Bloating enema/MRI
bnormal Constipation/diarrhea
g, void- Persistent or episodic
n. Pain
reas of
external
to pain/
g. It is TABLE 5 Musculoskeletal domain
e vulva.
Symptoms Signs Evaluation Syndrome/Disease
rus and
Abdominopelvic pain Altered muscle tone Questionnaires Pelvic muscle pain syndrome
s, cysts,
Tension: spasms Pain mapping Coccyx pain syndrome
ese can
Pain at rest, with movement/ Stiffness Ultrasound Pelvic joint, ligament, bony pain
rge or
sitting/sexual activity Trigger point tenderness
Pain with voiding/defecation Taut band
to the Unilateral/bilateral Twitch response, referred pain
may be Persistent or episodic
mptying,

TABLE 6 Neurological aspects domain

Symptoms Signs Evaluation Syndrome/Disease
pain
Characteristic sensation of: Tenderness (nerve Questionnaires Somatic neuropathic pain
Burning distribution) Quantitative sensory Complex regional pain syndrome
Throbbing Referred pain testing
Stabbing Possible skin change Pain mapping
Shooting Nerve block
Electric shock-like Sensation imaging: Ultrasound MRI
paresthesia
Atrophy
Persistent or episodic

The fundamentals of chronic pelvic pain assessment, based on international continence society recommendations
312

S36
| RANA ET AL. RANA ET

increased daytime frequency, change in urinary stream, 3.2 | D

urgency, and dyspareunia (assuming infection, surgical
Muscul
complications, or other pathology have been excluded).
hard to
The assessment of CPP in males should prompt questioning
cause o
to assess for onset, duration, inciting factors, laterality and
physica
any effect on urination and sexual function. A rectal
(Table
examination is needed, and thorough evaluation of the
muscul
genitalia, which may be performed in the supine and
ment a
standing positions to identify any lesions, masses, and
spasms
discharge.
origina
Patients affected in the gastrointestinal domain (Table 4)
familia
commonly report constipation, diarrhea, defecatory pain,
examin
obstructive defecation, abdominal cramping, or rectal pain/
pressure/burning. The main components are the anorectum or
� Mus
colorectum. Anorectal problems may result from hemor-
lowe
rhoids, abscesses, fissures, ulcers, levator ani syndrome, or
� Joint
chronic proctalgia. Colorectal problems may give rise to
sacro
abdominal tenderness, watery/bloody diarrhea, or rectal
sacro
bleeding and systemic features (weight loss and fever).
ischi
Inflammatory bowel disease and malignancy must be
excluded. Functional disorders should be ruled out, including
FIGURE 2 Observation of a sacral nerve root “Tarlov” cyst Wh
suggests the neurological domain may be a factor in a patient's CPP irritable bowel syndrome.7
(Table
describ
ing, el
Somati
TABLE 7 Psychological aspects domain
injury,
Symptoms Signs Evaluation Syndrome/Disease distribu
Worry Helplessness Formal psychological assessment Worry/anxiety/fear/depression (Figure
Anxiety Hopelessness Asking patient what is wrong and gastric,
Fear Avoidance of certain activities what worries him/her about pain
surgery
Catastrophizing Questionnaires
the spe
Persistent or episodic
remove
Com
whose
by burn
and cha
TABLE 8 Sexual aspects domain
type 1
Symptoms Signs Evaluation Syndrome/Disease nerve i
Lack of desire, arousal, orgasm Depression Questionnaires Sexual dysfunction nerve i
Dyspareunia Relationship issues Laboratory Pai
Persistent or episodic Doppler ultrasound
placem
during
or expo

TABLE 9 Comorbidities 3.3 | D

Symptoms Signs Evaluation Syndrome/Disease
Psycho
Allergies Fatigue General medical evaluation Allergies
Fatigue Skin lesions Laboratory Imaging Chronic pain and fatigue syndrome
individ
Widespread muscular and joint pain Dry eye Systemic autoimmune diseases of anxi
Irritation of the eyes Muscular skeletal tenderness ness, ho
Dryness ing enj
Sleep disorder person

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NA ET AL. RANA ET AL.

| S37

stream, 3.2 | Domains related to other causes of pain Sexual function may be affected by CPP in both men and
surgical women, and relationships may be affected (Table 8). Patients
Musculoskeletal problems are common, and sometimes are
cluded). may report decreased libido, inability to become aroused,
hard to localize for the patient. In CPP, they may be the principle
tioning dyspareunia, and difficulty achieving an orgasm, and there
cause of pain, or they may be consequential as the patient makes
lity and may also be partner concerns. Several disorders can be
physical adaptations to deal with their primary problem
rectal identified;
(Table 5). Features that indicate a primary or secondary
of the
musculoskeletal problem include; tenderness, abnormal move-
ne and � Sexual desire disorders; Hypoactive sexual disorder or
ment and alterations in the muscle (tone, stiffness, tension,
es, and Sexual aversion disorder
spasms, cramping, fasciculation, and trigger points). Pain may
� Sexual arousal disorder
originate from muscles, fascia, ligaments, joints, or bones, so
Table 4) � Orgasmic disorder
familiarity with the anatomy and approaches to clinical
y pain, � Sexual pain disorder
examination is needed. Particularly key regions include;
al pain/
ctum or A comorbidities domain is also included (Table 9), as
� Muscular: the pelvic floor8 (levator ani group/perineum), the
hemor- patients with CPP syndromes have a higher prevalence of
lower abdominal wall, or posterior pelvic and gluteal regions.
ome, or problems such as allergies, chronic fatigue syndromes,
� Joints, ligaments and bones: Coccyx pain syndrome,
rise to fibromyalgia, and autoimmune diseases that may affect
sacroiliac or pubic symphysis joints, sacrospinous or
rectal multiple systems.
sacrotuberous ligaments, or the pubic ramus, ilium, and
fever).
ischial spine
must be
4 | CONCLUSIONS
cluding
Where there is an issue in the neurological domain
(Table 6), patients commonly use characteristic terms to The current document extracts some of the pertinent elements
describe pain (burning, stabbing, throbbing, tingling, sting- that should be identified in order to understand fully the range
ing, electric shock-like) or they may report paresthesia. of factors potentially present in CPP. The domain structure
Somatic Neuropathic pain is secondary to a specific nerve serves as a checklist to aid consideration of the several issues,
injury, and is associated with symptoms related to the nerve and thereby ensure key relevant factors are not overlooked.
distribution. In CPP, the relevant nerves could be sacral The approach aids a logical sequence in considering the pelvic
ession (Figure 2), pudendal, thoracolumbar, ilioinguinal, iliohypo- organs, other potential sources of pain, and factors that affect
gastric, genitofemoral or obturator. A neuroma secondary to individual pain response and its impact.
surgery or other trauma may give a localized tender point in
the specific location, and if present should be identified and
CONFLICTS OF INTEREST
removed.
Complex regional pain syndrome (CRPS)9 is a situation Drs Neha Rana, Marcus J. Drake, Rebecca Rinko, and Melissa
whose precise etiology is uncertain, but it can be categorized Dawson have nothing to disclose. Dr Kristene Whitmore
by burning pain and changes in the skin (increased sensitivity, reports grants from Allergan, grants from Astellas,and grants
and changes in skin temperature, color, and/or texture). CRPS from Coloplast clinical research during the conduct of the
type 1 is triggered by tissue injury without an underlying study.
sease nerve injury and CRPS type 2 is attributed to a history of a
ction nerve injury.
ORCID
Pain in someone with a history of surgery which involved
placement of synthetic is a specific issue. It can present as pain Marcus J. Drake http://orcid.org/0000-0002-6230-2552
during physical activity, dyspareunia, vaginal discharge, and/ Kristene E. Whitmore http://orcid.org/0000-0002-0135-
or exposure of the mesh in the vagina or surrounding tissues. 1158

3.3 | Domains affecting response or impact

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Hospital,
2 Departm

Gynaeco
Carolina
3 Departm

Bristol U
Hospital,
4 Bristol

Medical
Bristol, U

Corresp
Chendrim
Subspeci
of Wome
Institute,
Hospital,
Email: cm

1 | IN

The In
Urogyn
Surgeo
describ
organ p
Quantif
system
as reco
Associa

Jan-Paul
responsib

Neurourol

ICS Standards 2019

2. Fundamentals
 315

NA ET AL.
Received: 30 April 2018
DOI: 10.1002/nau.23740
| Accepted: 17 May 2018

ilva JC,
of pelvic
SOUNDING BOARD
vic pain.

onal pain
h edition.
How to use the Pelvic Organ Prolapse Quantification (POP-Q)
system?
ko

onal
Chendrimada Madhu1 | Steven Swift2 | Sophie Moloney-Geany3 |
gy Marcus J. Drake4

1 Department of Women's Health and

Bristol Urological Institute, Southmead Aims: To set out the basic description of pelvic organ prolapse (POP) using the
Hospital, Bristol, UK International Continence Society/International Urogynecology Association Pelvic
2 Department of Obstetrics and Organ Prolapse Quantification (POP-Q) system.
Gynaecology, Medical University of South
Carolina, Charleston, South Carolina
Methods: The basic approach to use of the POP-Q was identified and summarized.
3 Department of Women's Health and Results: Six defined points in the vagina are identified; points Aa and Ba for the
Bristol Urological Institute, Southmead anterior vagina, Ap and Bp for the posterior vagina, and C and D for the cervix/vault.
Hospital, Bristol, UK
Point D is not used in women who previously had a hysterectomy. The patient is asked
4 BristolUrological Institute and Bristol
to strain, ideally when in the standing position, to elicit the POP to its maximum
Medical School, University of Bristol,
Bristol, UK extent. The location of the defined points is then gauged relative to the hymenal ring
and recorded on a grid. Three additional measurements are taken to achieve a full
Correspondence
Chendrimada Madhu, Consultant
description; the genital hiatus length, perineal body length, and total vaginal length.
Subspecialist Urogynaecologist, Department Staging a POP relies on identifying the lowest extent of any part of the six defined
of Women's Health and Bristol Urological points; if any point reaches close to the hymenal ring (at least stage 2), the prolapse is
Institute, The Chilterns, Southmead
Hospital, Bristol BS10 5NB. usually symptomatic.
Email: cmadhu@nhs.net Conclusions: The POP-Q system is readily cataloged and offers detailed description
of considerable benefit in clinical practice and research.

KEYWORDS
Pelvic organ prolapse quantification. POP-Q, Prolapse assessment

1 | INTRODUCTION pelvic floor dysfunction.2,3 The POP-Q has been used

variably in both clinical practice and research.4,5 The ICS/
The International Continence Society (ICS), the American IUGA have recently made some suggestions to better define
Urogynecologic Society, and the Society of Gynecologic the disease of pelvic organ prolapse.3 The aim of this article is
Surgeons published a consensus document in 1996 to to briefly summarize the key points in performing the POP-Q
describing an objective system to describe female pelvic examination system to assist in its routine use.
organ prolapse, which was called the Pelvic Organ Prolapse
Quantification system (POP-Q).1 This is the classification
system that should be used to describe pelvic organ prolapse, 2 | METHODOLOGY
as recommended by the ICS/International Urogynecology
Association (IUGA) joint report on terminology for female The technique of performing the POP-Q has been described in
detail in the ICS/IUGA documents.2,3 We have summarized
Jan-Paul Roovers led the peer-review process as the Associate Editor
the key points that should be considered while performing the
responsible for the paper. POP-Q examination.
Neurourology and Urodynamics. 2018;37:S39–S43. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | S39

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| MADHU ET AL. MADHU

TABLE 1 Showing the POPQ measurements (Adapted from Haylen et al2)

POPQ: Measurements
The locations of the six defined points when the prolapse is fully reduced.
Anterior vaginal wall:
1. Point Aa: A point located in the midline of the anterior vaginal wall three (3) cm proximal to the external urethral meatus.
The potential range of position of Point Aa relative to the hymen is −3, indicating no anterior vaginal POP,to +3 cm which is full prolapse
2. Point Ba: A point that represents the most distal (ie, most dependent) position of any part of the upper anterior vaginal wall (between the
vaginal cuff or anterior vaginal fornix and Point Aa).
Point Ba coincides with Point Aa (−3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C.
Upper vagina:
3. Point C: A point on either the most distal (ie, most dependent) edge of the cervix or the leading edge of the vaginal cuff (hysterectomy
scar).
4. Point D: The posterior fornix in a woman who still has a cervix.a
FIGUR
Posterior vaginal wall:
perineal
5. Point Ap: A point located in the midline of the posterior vaginal wall three (3) cm proximal to the hymen.
The potential range of position of Point Ap relative to the hymen is −3 to +3 cm
6. Point Bp: A point that represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or prolaps
posterior vaginal fornix and Point Ap). digital p
Three further descriptive landmarks and measurements. standin
1. The genital hiatus (GH) is measured from the middle of the external urethral meatus to the posterior margin of the hymen. necessa
2. The total vaginal length (TVL) is the length of the vagina (cm) from posterior fornix to hymen when Point C or D is reduced to its full assess f
normal position. be reco
3. The perineal body (PB) is measured from the posterior margin of the hymen to the mid-anal opening. Step 2
a
Figure
Point D is included as a point of measurement to differentiate suspensory failure of the uterosacral-cardinal ligament “complex” from cervical elongation. When the
location of Point C is significantly more positive than the location of Point D, this is indicative of cervical elongation which may be symmetrical or eccentric. Point D is
omitted in the absence of the cervix. � Ther
cons
3 | RESULTS Examination should be performed with an empty bladder repo
and if possible an empty rectum. A full bladder is potentially vagin
POP-Q can be performed using the following four steps: associated with underestimation of the POP-Q severity.6 Any � The
Step1: Pre-procedure considerations position that best demonstrates the maximum extent of the durin
hym
mea
mea
integ

FIGURE 1 The six defined points used to quantify POP in women without (left) or with (right) a previous hysterectomy. Aa and Ap are
3 cm from the hymen when there is no POP, or any POP is fully reduced. POP-Q identifies where these points come to lie relative to the
hymenal plane with the POP fully evident. Ba and Bp reflect the lowest point reached by a POP, relative to the hymenal plane. Any part of the
vagina could potentially descend furthest, so Ba may lie anywhere from Aa-C. Bp may lie anywhere from Ap-D, or Ap-C in a woman post
hysterectomy, from respectively reaching the locoincide with Aa and Ap in a woman who does not have POP. Three measurements complete the
description; the genital hiatus (Gh), the perineal body (Pb), and the total vaginal length (not shown) FIGUR

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HU ET AL. MADHU ET AL.

| S41

lapse
en the

int C.

tomy

FIGURE 2 How the six defined point and three measurements relate to a 3 × 3 grid used for clinical documentation. Gh, genital hiatus; Pb,
perineal body; TVL, total vaginal length

ff or prolapse and which can be confirmed by the woman, by measured in centimeters and described as positive
digital palpation or use of a mirror, should be used (left lateral, integers. For example, if point C remains 4 cm above
standing, lithotomy, or standing). Use a Sim's speculum if the hymen during Valsalva/cough it is recorded as
necessary to retract the anterior and posterior vaginal walls to −4 cm. If point C descends 4 cm beyond the hymen
s full assess for prolapse. The techniques and positions used should during Valsalva/cough it is recorded as +4 cm.
be recorded, as they may influence findings.7 � There are three further descriptive measurements, which
Step 2: Measurements (“points to remember”) (Table 1, are also recorded independent of the hymen (genital hiatus-
Figure 1): point GH, perineal body-point PB, and total vaginal length
When the
Point D is
at rest-point TVL). Of note, all of the POP-Q points are
� There are six defined points (Aa, Ba, C, D, Ap, Bp) that are recorded during maximal Valsalva or cough except for
considered while recording the POP-Q, which are used to point TVL which is recorded at rest with the prolapse
bladder report the extent of descent or prolapse of the anterior reduced.
entially vaginal wall, vaginal apex, and posterior wall.
y.6 Any � The positions of these six defined points are measured Step 3: Recording the measurements (Figure 2):
t of the during maximal Valsalva or cough in relation to the The above measurements are recorded on a 3 × 3 grid.
hymen. If the point descends to the hymen it is The anterior vaginal wall and the cervix or vault are
measured as 0 cm, if it remains above the hymen it is documented on the top row, the posterior vaginal wall,
measured in centimeters and described as negative and the posterior fornix on the bottom row. The
integers and if it descends beyond the hymen it is descriptive measurements of the genital hiatus, perineal

are

of the
ost
plete the
FIGURE 3 POPQ staging of a second stage anterior (left) and second stage posterior (right) vaginal wall prolapse

How to use the Pelvic Organ Prolapse Quantification (POP-Q) system?

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| MADHU ET AL. MADHU

� Stage I: The most distal portion of the prolapse is more than 4.1 | C
1 cm above the level of the hymen (points Aa, Ba, C, D, Ap,
Women
and Bp are all <−1 cm).
of blad
� Stage II (Figure 3): The most distal portion of the prolapse
sympto
is situated between 1 cm above the hymen and 1 cm below
and cor
the hymen (any of the points Aa, Ba, C, D, Ap, and Bp has a
is gene
value between −1 cm and +1 cm).
edge of
� Stage III: The most distal portion of the prolapse is more than
(>stage
1 cm beyond the plane of the hymen, but not completely
prolaps
everted meaning no value is >/ = TVL −2 cm (any of the
level 0
points Aa, Ba, C,D,Ap, Bp is >/ = +2 and </ = tvl −3 cm)
hiatus s
� Stage IV (Figure 4): Complete eversion or eversion to
support
within 2 cm of the total vaginal length of the lower genital
conside
tract is demonstrated (any of the Points Ba, C, D, or Bp is
options
>/ = to TVL −2 cm).

The steps of performing a POP-Q are summarized in 5 | C

Figure 5 and some examples of POPQ recording and staging
FIGURE 4 POPQ staging of a stage 4 pelvic organ prolapse of various prolapse are demonstrated in Figures 3 and 4. POP-Q
(procidentia) pelvic
finding
body, and total vaginal length at rest are recorded in the 4 | DISCUSSION a symp
middle row.
Step 4: Staging of the prolapse Since its introduction in 1996, POP-Q has been used variably in
peer-reviewed publications.8 It may be perceived as complex, ORCI
Depending on the measurements, prolapse of each of the
compartments is staged based on its relationship to the but it has shown good inter-observer agreement and is the most Chendr
hymen. common system used in peer-reviewed literature.9–11 It has been 6117
criticized as being too complicated, difficult to use, teach, and Marcus
� Stage 0: No prolapse is demonstrated (points Aa, Ba, C, D communicate.12 Various approaches and tools have been used to
Ap, and Bp are all </ = −3 cm). teach POP-Q and have all been shown to be effective.13,14
REFE
1. Bum
term
dys
2. Hay
Uro
Soc
dys
3. Hay
Inte
Con
fem
655
4. Bum
Int
5. Ris
and

FIGURE 5 Practical aspects of performing POP-Q

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HU ET AL. MADHU ET AL.

| S43

ore than 4.1 | Clinical relevance of POP-Q 6. Haya N, Segev E, Younes G, Goldschmidt E, Auslender R,
, D, Ap, Abramov Y. The effect of bladder fullness on evaluation of pelvic
Women with POP generally present with several complaints organ prolapse. Int J Gynecol Obstet. 2012;118:24–26.
of bladder, bowel, and pelvic dysfunction; however, the 7. Visco AG, Wei JT, McClure LA, Handa VL, Nygaard IE. Effects of
rolapse
symptom of a vaginal bulge is considered specific to prolapse examination technique modifications on pelvic organ prolapse
m below
and correlates well with the severity for the prolapse.15,16 POP quantification (POP-Q) results. Int Urogynecol J. 2003;14:136–140.
Bp has a 8. Oyama IA, Steinberg AC, Watai TK, Minaglia SM. Pelvic organ
is generally considered to be symptomatic when the leading
edge of the prolapse is at or beyond the level of the hymen prolapse quantification use in the literature. Female Pelvic Med
ore than Reconstr Surg. 2012;18:35–36.
(>stage 2 POP-Q).17 Another study suggested that the
mpletely 9. Parekh M, Swift S, Lemos N, et al. Multicenter inter-examiner
prolapse becomes symptomatic if it descends lower than a agreement trial for the validation of simplified POPQ system. Int
y of the
level 0.5 cm above the hymen (>Stage 2 POP-Q).18 Genital Urogynecol J. 2011;22:645–650.
−3 cm)
hiatus size is associated with and predictive of apical vaginal 10. Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic organ
sion to
support loss.19,20 These factors need to be taken in to prolapse quantification system (POP-Q) − a new era in pelvic
genital
consideration when diagnosing and offering treatment prolapse staging. J Med Life. 2011;4:75–81.
or Bp is 11. Boyd SS, O’Sullivan D, Tulikangas P. Use of the Pelvic Organ
options to women with prolapse.
Quantification System (POP-Q) in published articles of peer-
reviewed journals. Int Urogynecol J. 2017;28:1719–1723.
ized in 5 | CONCLUSION 12. Harmanli O. POP-Q 2.0: its time has come! Int Urogynecol J.
staging 2014;25:447–449.
d 4. POP-Q is a useful way of objectively assessing and recording 13. Parnell BA, Dunivan GC, Geller EJ, Connolly A. A novel approach
to teaching the pelvic organ prolapse quantification (POP-Q) exam.
pelvic organ prolapse and helps in better communication of
Int Urogynecol J. 2011;22:367–370.
findings. Stage 2 or above POP-Q seems to correlate well with 14. Geiss IM, Riss PA, Hanzal E, Dungl A. A simple teaching tool for
a symptomatic prolapse. training the pelvic organ prolapse quantification system. Int
Urogynecol J. 2007;18:1003–1005.
iably in 15. Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet
omplex, ORCID [Internet] 2007;369:1027–1038.
he most Chendrimada Madhu http://orcid.org/0000-0002-8571- 16. Ghetti C, Gregory WT, Edwards SR, Otto LN, Clark AL. Pelvic
has been organ descent and symptoms of pelvic floor disorders. Am J Obstet
6117
Gynecol. 2005;193:53–57.
ach, and Marcus J. Drake http://orcid.org/0000-0002-6230-2552
17. Swift SE, Tate SB, Nicholas J. Correlation of symptoms with degree
n used to
13,14 of pelvic organ support in a general population of women: what is
pelvic organ prolapse? Am J Obstet Gynecol 2003;189:372–7-9.
18. Gutman RE, Ford DE, Quiroz LH, Shippey SH, Handa VL. Is there
REFERENCES
a pelvic organ prolapse threshold that predicts pelvic floor
1. Bump RC, Mattiasson A, Bø K, et al. The standardization of symptoms? Am J Obstet Gynecol. 2008;199:683.e1–683.e7.
terminology of female pelvic organ prolapse and pelvic floor 19. Medina CA, Candiotti K, Takacs P. Wide genital hiatus is a risk
dysfunction. Am J Obstet Gynecol. 1996;175:10–17. factor for recurrence following anterior vaginal repair. Int J Gynecol
2. Haylen BT, De Ridder D, Freeman RM, et al. An International Obstet. 2008;101:184–187.
Urogynecological Association (IUGA)/International Continence 20. Lowder JL, Oliphant SS, Shepherd JP, Ghetti C, Sutkin G. Genital
Society (ICS) joint report on the terminology for female pelvic floor hiatus size is associated with and predictive of apical vaginal
dysfunction. Int Urogynecol J. 2010;21:5–26. support loss. Am J Obstet Gynecol. 2016;214:718.e1–718.e8.
3. Haylen BT, Maher CF, Barber MD, et al. Erratum to: An
International Urogynecological Association (IUGA)/International
Continence Society (ICS) joint report on the terminology for How to cite this article: Madhu C, Swift S,
female pelvic organ prolapse (POP). Int Urogynecol J. 2016;27:
Moloney-Geany S, Drake MJ. How to use the Pelvic
655–684.
Organ Prolapse Quantification (POP-Q) system?
4. Bump RC. The POP-Q system: two decades of progress and debate.
Int Urogynecol J. 2014;25:441–443. Neurourology and Urodynamics. 2018;37:S39–S43.
5. Riss P, Dwyer PL. The POP-Q classification system: looking back https://doi.org/10.1002/nau.23740
and looking forward. Int Urogynecol J. 2014;25:439–440.

How to use the Pelvic Organ Prolapse Quantification (POP-Q) system?

320

GAMMIE
Received: 23 April 2018
DOI: 10.1002/nau.23777
| Accepted: 1 July 2018

Ar
specific
SOUNDING BOARD
quality
article
Interna
The fundamentals of uroflowmetry practice, based on ments i
and inte
International Continence Society good urodynamic practices
recommendations 2 | M

The IC
Andrew Gammie | Marcus J. Drake (SSC),
ogy an
evidenc
Bristol Urological Institute, Southmead practice
Hospital, Bristol, UK Aims: To review the recommendations on uroflowmetry in the International
Urodyn
Continence Society (ICS) Standardization documents in order to identify a systematic
Correspondence
minolo
approach to the delivery and interpretation of free flow rate testing in clinical practice. synthes
Andrew Gammie, Bristol Urological
Institute, Southmead Hospital, Bristol BS10 Methods: Expectations of service and good practice in uroflowmetry described in the
5NB, UK. ICS standards on Urodynamic Practice, Urodynamic Equipment, and Terminology
Email: andrew.gammie@bui.ac.uk 3 | G
for Lower Urinary Tract Function were identified and summarized.
Results: Urodynamic centers should provide a suitable uroflowmetry testing A good
environment. Equipment should be calibrated and maintained according to and app
manufacturer requirements. Patients should be well-informed in advance of the procedu
test. They should be advised to avoid: knocking the machine; allowing the stream to and co
reportin
move; squeezing the urethra; and body movements. It is generally appropriate to get
forms o
more than one flow trace for each patient. Voided volume should be representative for Dep
the patient, for example by comparing with values recorded on a Bladder Diary. Post the bas
void residual (PVR) should be measured soon after testing. After the test, the facilita
urodynamicist should review the trace and ensure maximum flow rate and end of evaluat
micturition are correctly identified in case the equipment has inappropriately taken Standar
signs,
the values from a trace artefact.
meet th
Conclusions: The summary provides a systematic approach to ensure a representa-
perform
tive, high quality, non-invasive flow test is carried out for individual patients. Uro
volume
KEYWORDS
Maxim
free flows, standards
reporte
remain
after co
cathete
1 | INTRODUCTION the clinical assessment of LUT symptoms (LUTS), evaluating
the nature of an individual's voiding is a fundamental
Urodynamics is the general term to describe the measure- component of the diagnostic pathway, especially for men. 4 | E
ments that assess the function and dysfunction of the Uroflowmetry is a non-invasive urodynamic test in which ENV
lower urinary tract (LUT) by any appropriate method. In specific measurements are made of the rate of flow of
urine and the volume voided. It is normally followed by The ba
The work was undertaken at Bristol Urological Institute, Southmead an ultrasonically scanned measurement of post void in Figu
Hospital, Bristol, UK. residual (PVR) urine volume, and an interpretation of the can con
Roger Dmochowski led the peer-review process as the Associate Editor
flow pattern recorded by the machine over the duration of the tot
responsible for the paper. the void. measur
S44 | © 2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2018;37:S44–S49.

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| S45

A recent think tank on uroflowmetry1 recommended that be to ±1 mL/s of true flow rate and to ±5% of true volume
specific, practical guidance be made available to increase the voided (or ±2 mL if that is greater than 5%).5
quality of uroflowmetry testing. Accordingly, the current Units should regularly check the performance of their
article reviews the recommendations on uroflowmetry in the system and calibrate according to manufacturer recommen-
International Continence Society (ICS) Standardization docu- dation.5 Flowmeter calibration can be verified by pouring a
ments in order to identify a systematic approach to the delivery precise volume into the flowmeter and checking the recorded
and interpretation of free flow rate testing in clinical practice. volume. Calibration should be verified regularly, for
example, at the start of every clinic or week of clinics, and
documented. If frequent recalibration is necessary, the flow
2 | METHODS
transducer might need to be replaced.
Uroflowmetry equipment should be placed in a private,
The ICS, through its Standardization Steering Committee
quiet environment3 that can be easily cleaned, with the machine
(SSC), has an ongoing strategy to standardize LUT terminol-
ready for immediate use, as many LUTS patients having flow
ogy and functional assessment, and link it to published
rate testing will experience urgency. PVR measurement is
evidence.2 We reviewed key expectations of service and good
ideally done in the same room and immediately following the
practice in uroflowmetry described in the ICS standards on
tional void. A sluice room with connecting door to the flow test room is
Urodynamic Practice,3,4 Urodynamic Equipment,5 and Ter-
matic preferable to an unconnected room.
minology for LUT Function.6,7 The current document is a
actice. synthesis of the key aspects applicable to uroflowmetry.
in the 5 | PREPARATIONS IN ADVANCE OF
ology A UROFLOWMETRY TEST
3 | GENERAL COMMENTS

esting An explanatory leaflet about uroflowmetry with sufficient

A good urodynamic practice comprises: a clear indication for,
information, which uses clear, unambiguous wording, will be
ng to and appropriate selection of, relevant test measurements and
appreciated by most patients. To reduce possible waiting
of the procedures; precise measurement with data quality control
time, patients can be asked to attend the clinic with a
am to and complete documentation; accurate analysis and critical
comfortably full bladder.
reporting of results. These general principles apply to all
to get When sent the explanatory leaflet, the patient can also be
forms of urodynamic testing, including uroflowmetry.
ve for asked to complete a frequency volume chart (FVC) or Bladder
Departments should develop uroflowmetry protocols on
y. Post Diary. A FVC records the time of each micturition and the
the basis of the ICS Urodynamic standards,3–5 they should
voided volumes, while a Bladder Diary also captures
st, the facilitate specific staff training and undertake regular
symptoms and events such as fluid intake, urgency, pain,
end of evaluation of performance and adherence.3 ICS Terminology
incontinence episodes, and pad usage.6,8 Average and
taken Standards should be used when alluding to LUT symptoms,
maximum voided volumes, voiding frequency, and day/night
signs, and urodynamic observations.6,7 Equipment should
urine production can be determined.
meet the requirements of the ICS guideline on equipment
senta-
performance.5
Uroflowmetry is a test that measures the urinary stream as
volume passed per unit time in milliliters per second (mL/s).4
Maximum flow rate (Qmax) and total volume voided must be
reported.4 The PVR should also be reported. This is the
remaining intravesical fluid volume determined immediately
after completion of voiding. The technique (eg, ultrasound or
catheter) used to measure the PVR should be specified.
aluating
amental
or men. 4 | EQUIPMENT AND
n which ENVIRONMENT
low of
FIGURE 1 A suitable environment for uroflowmetry. The
wed by The basic set up for a flow test environment is illustrated flowmeter can be accessed quickly from the waiting area if the
t void in Figure 1. The requirement of a uroflowmeter is that it patient experience surgency, achieves privacy (here by having a
of the can continuously measure the flow rate of urine voided and curtain in addition to a locked doorway), is easy to clean, and has
ation of the total volume voided. The method used to make this direct access to a sluice room (not in above picture). Female
measurement is not clinically significant. Accuracy need only uroflowmetry would have a commode seat in addition to the funnel
:S44–S49.

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| GAMMIE AND DRAKE GAMMIE

6 | FLOW RATE TESTING flow rate should be minimized, for example, by asking the TABLE
patient to relax and not to strain.4 Men should be asked not to Task
Patients should be asked to pass urine when they feel a move the urine stream around the funnel, and not to squeeze No.
“normal” desire to void,4 and should undergo uroflowmetry the penis, both of which will affect the flow rate measurement 1
in their preferred position. Intracorporeal modulations of the (Figure 2).7
2
3
4
5
6
7
8

10
11
12

13

Pra
based
informa
volume

FIGURE 2 Some artefacts encountered in uroflowmetry, and the importance of correcting for the error in Qmax to establish the representative
parameter. A, A male patient moving the urine stream back-and-forth across the funnel. B, A male squeezing and releasing the urethra at the start
of flow, with straining toward the end of flow. C, A “knock artefact” (arrowed), resulting from a patient inadvertently kicking the uroflowmetry
machine. In each case, the uroflowmetry machine has given a Qmax value which is a result of the artefact, displayed on the right hand side, and FIGUR
taken from the point marked with arrow “1.” This is not representative of the patient's own function, so the urodynamicist has scrutinized the curve. T
trace after the test and selected the highest point in the trace that does appear to result from the patient's own unimpeded bladder and outlet reads Qm
behavior, at the point marked with arrow “2.” This means the representative values change, for instance in A from 41 to 22 mL/s, which may to the po
well result in a clinically significant difference in interpretation. Before a flow test, the patient should be instructed to keep his stream in the and repr
same part of the funnel, not to squeeze his penis, and try to avoid knocking the machine was repr

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| S47

king the TABLE 1 Task list to assist good practice in uroflowmetry

d not to Task
squeeze No. Good practice question If “No,” correction needed
urement 1 Has equipment calibration been checked? Check calibration
2 Is the patient aware of the reason for the test and what is required of them? Explain to patient
3 Has the bladder diary been completed and examined? Discuss with patient to gain estimates
4 Does the patient have a normal desire to void? Wait until normal desire
5 Is the equipment set at the right height and position? Adjust to suit patient
6 After the void, has urinalysis been carried out? Perform urinalysis
7 Is the void known to be a representative normal void? Repeat flow test after drinking
8 Is the trace clear of artefacts from movement of body, flowmeter or urine stream? Adjust trace markers if possible, and instruct
patient for improved next flow
9 Is Qmax marked at a point away from artefacts? Move Qmax marker to smoothed maximum
position
10 Are the markers for start and end of void away from artefacts or drops of urine? Move markers away from artefacts
11 Does the scale of printing make the flow trace clearly visible? Adjust scale of display/print
12 Has the residual urine volume been measured immediately after voiding? Measure volume, including comment on any
time delay
13 Does the report include: Qmax, voided volume, residual volume, Void%, flow and Complete report
voiding times, flow trace shape description, whether flow is representative?
The report may also include if required: Clinical history summary, urinalysis,
bladder diary summary and any lifestyle advice given.

Practitioners should check if the voiding is representative, range from empty up to 150-250 mL. At volumes higher than 400-
based on the patient's report, and comparing with other 500 mL, the detrusor may become overstretched and contractile
information, such as Bladder Diary volumes. Increasing bladder strength may decrease. Thus, interpretation should evaluate the
volume increases the potential bladder power,4 notably in the bladder volume at time of testing (voided volume plus PVR).

sentative
the start
wmetry
e, and FIGURE 3 Example of a female patient who may have some pelvic floor contractions during voiding, leading to the uneven shape of the
the curve. This patient may also have moved about on the commode seat, giving rise to the particularly sharp spike. The computer-generated report
et reads Qmax = 15 mL/s, taking the value at arrow “1.” After the test, the urodynamicist identified this is not representative, and moved the cursor
may to the position of arrow “2,” where a portion of the flow unaffected by pelvic floor contraction and patient movement suggests an interpretable
the and representative flow. Qmax value was accordingly corrected to 10 mL/s, and should be recorded as such, with comment on whether the flow
was representative

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| GAMMIE AND DRAKE GAMMIE

Consider repeating the uroflowmetry if the result has not grants,

been representative for the patient or it indicates abnormality, Astella
with reasonable fluid intake and diuresis time before the flow submitt
is repeated.9
A list of tasks to aid good practice is contained in Table 1.
ORCI
Andrew
7 | QUALITY CONTROL
Marcus
Several artefacts can occur which are readily identified:
knocking of the flowmeter (Figure 2C), passing of feces or
disposal of tissues result in high, sudden values of flow rate REFE
FIGURE 4 Similar to correcting the Qmax value after a test, the
and/or volume. If such fast changes are observed and 1. Gam
indicator identifying the end of micturition may need to be moved,
confirmed with the patient, instruction of the patient will diagn
from the point marked by arrow “1” to the point marked by arrow
improve the next flow test. 2018
“2” arrow, if the patient experiences a post micturition dribble, or if
Moving the urine stream back and forth across the funnel the machine gets knocked as the patient moves away
2. Rosie
results in phasic variations around the true flow rate Deve
(Figure 2A). Some men have developed the habit of of low
2012
squeezing the penis to build up pressure, in order to give a Volume,” where flow rate is rounded to the nearest integer and 3. Rosie
faster flow after release. This “squeeze and release” habit volume rounded to the nearest 10 mL.3 Scaling of the printout good
gives gaps in the flow followed by high flow rate spurts, has been suggested as follows: 1 mm can equal 1 s on the x-axis flowm
illustrated in Figure 2B. In both cases, the patient should be and 1 mL/s and 10 mL voided volume on the y-axis,3 but the 2017
instructed not to do so, in order to better evaluate the LUT trace must be clearly readable whatever scale is used. 4. Scha
itself. For some patients, pelvic floor muscle action or body Nomograms have been produced (summarized in Gam- pract
movement can result in smaller, artefactual variations in flow studi
mie et al1) that show the likelihood of the Qmax and voided
rate, see Figure 3. Uroflowmetry machines will automati- volume recorded resulting from a normal urinary tract.
cally, and perhaps wrongly, measure the highest peak of flow, Clinicians must be aware that these nomograms are not
rather than smooth out the flow rate to remove these artefacts. diagnostic, but may be a useful screening tool for dysfunction.
Accordingly, in each of these situations, the operator will Comment may also be made when reporting on the voided
need to move the Qmax marker to a nearby point, or smooth the percentage (Void%) and the flow curve shape. Void% is the
flow signal by eye, in order to establish the clinically numerical description of the voiding efficiency, which is the
representative value (Figures 2 and 3). A moving average proportion of bladder content emptied. Calculation: volume
using a 2 s window is advised.3 voided/(volume voided + PVR) *100%.
If the flow and voiding times are being reported, the The shape or pattern of the flow curve may suggest
operator will need to check that the end of flow is correctly specific types of abnormality, but reliable and specific
marked by the machine. If drops due to coughs or other information about the cause cannot be derived from a flow
movement are included in the voiding time, the final marker curve alone.1,3 The shape of the flow curve can be described
will need to be moved back to the true end of micturition as continuous or intermittent, and smooth or fluctuating.6
(Figure 4) and only then should the time values be recorded.
9 | CONCLUSIONS
8 | REPORTING
This summary provides a systematic approach to ensure a
All results and observations should be carefully reported. It is representative, high quality, non-invasive flow test is carried
good clinical practice to integrate the uroflowmetry results out for individual patients. Adherence to the fundamentals of
with the history, examinations and Bladder Diary summary. A the ICS Standards, as synthesized in this review and
urinalysis should also be evaluated and reported with the flow summarized in Table 1, will enable urodynamic units to
results, since current urinary tract inflammation could alter deliver high quality of uroflowmetry studies.
the patient's flow characteristics.
The report after uroflowmetry should include; voiding
CONFLICTS OF INTEREST
position, Qmax (corrected for any artefacts), voided volume and
PVR. Flow time and voiding time may be reported if required. Dr Andrew Gammie reports grants from Andromeda,
The ICS suggests a standard reporting format of “VOID: Digitimer, and Laborie, other from Astellas and Ipsen,
Maximum Flow Rate/Volume Voided/Post Void Residual outside the submitted work. Dr Marcus J. Drake reports

ICS Standards 2019

2. Fundamentals
 325

D DRAKE GAMMIE AND DRAKE

| S49

grants, personal fees, and non-financial support from Allergan, 5. Gammie A, Clarkson B, Constantinou C, et al. International
Astellas, and Ferring, personal fees from Pfizer, outside the Continence Society guidelines on urodynamic equipment perfor-
submitted work. mance. Neurourol Urodyn. 2014;33:370–379.
6. Abrams P, Cardozo L, Fall M, et al. The standardization of
terminology of lower urinary tract function: report from the
ORCID Standardisation Sub-committee of the International Continence
Society. Neurourol Urodyn. 2002;21:167–178.
Andrew Gammie http://orcid.org/0000-0001-5546-357X 7. Haylen BT, de Ridder D, Freeman RM, et al. An International
Marcus J. Drake http://orcid.org/0000-0002-6230-2552 Urogynecological Association (IUGA)/International Continence
Society (ICS) joint report on the terminology for female pelvic
floor dysfunction. Neurourol Urodyn. 2010;29:4–20.
8. Bright E, Cotterill N, Drake M, Abrams P. Developing and validating
REFERENCES the International Consultation on Incontinence Questionnaire bladder
st, the
1. Gammie A, Rosier P, Li R, Harding C. How can we maximize the diary. Eur Urol. 2014;66:294–300.
oved,
diagnostic utility of uroflow?: ICI-RS 2017. Neurourol Urodyn. 9. Reynard JM, Peters TJ, Lim C, Abrams P. The value of multiple
rrow free-flow studies in men with lower urinary tract symptoms. Br J
e, or if 2018. https://doi.org/10.1002/nau.23472
2. Rosier PF, de Ridder D, Meijlink J, Webb R, Whitmore K, Drake MJ. Urol. 1996;77:813–818.
Developing evidence-based standards for diagnosis and management
of lower urinary tract or pelvic floor dysfunction. Neurourol Urodyn.
2012;31:621–624. How to cite this article: Gammie A, Drake MJ. The
ger and 3. Rosier P, Schaefer W, Lose G, et al. International continence society fundamentals of uroflowmetry practice, based on
printout good urodynamic practices and terms 2016: urodynamics, uro- International Continence Society good urodynamic
e x-axis flowmetry, cystometry, and pressure-flow study. Neurourol Urodyn. practices recommendations. Neurourology and
but the 2017;36:1243–1260.
Urodynamics. 2018;37:S44–S49.
4. Schafer W, Abrams P, Liao L, et al. Good urodynamic
https://doi.org/10.1002/nau.23777
n Gam- practices: uroflowmetry, filling cystometry, and pressure-flow
studies. Neurourol Urodyn. 2002;21:261–274.
voided
y tract.
are not
unction.
voided
% is the
h is the
volume

suggest
specific
a flow
scribed
ing.6

nsure a
carried
ntals of
ew and
units to

omeda,
Ipsen,
reports

The fundamentals of uroflowmetry practice, based on International Continence Society good urodynamic practices recommendations
326

DRAKE E
Received: 20 April 2018
DOI: 10.1002/nau.23773
| Accepted: 1 July 2018

1 | IN
SOUNDING BOARD
Urodyn
that ass
(LUT) b
Fundamentals of urodynamic practice, based on make c
order to
International Continence Society good urodynamic quantify

practices recommendations establis

its clin
diagnos
The
Marcus J. Drake1,2 | Stergios K. Doumouchtsis3 | Hashim Hashim2 | Standar
2
Andrew Gammie strategy
assessm
publica
1 Translational Health Sciences, Bristol
namic t
Medical School, Bristol, UK Aims: To review the recommendations on basic urodynamic testing in the
and the
2 BristolUrological Institute, Southmead International Continence Society (ICS) standardization documents, specifying key the key
Hospital, Bristol, UK recommendations for delivery and interpretation in clinical practice. tests us
3 Gynaecology Department, Epsom and
Methods: Fundamental expectations described in the ICS standards on good
St Helier University Hospitals NHS Trust,
urodynamic practices, urodynamic equipment, and terminology for lower urinary
Epsom, UK 2 | M
tract (LUT) function were identified and summarized.
Correspondence
Results: The ICS standard urodynamic protocol includes clinical history, We re
Marcus J. Drake, Bristol Urological
Institute, 3rd Floor L&R Building, including symptom and bother score(s), examination, 3-day voiding chart/diary, urodyn
Southmead Hospital, Bristol BS10 5NB, representative uroflowmetry with post-void residual, and cystometry with namic
UK.
pressure-flow study (PFS). Liquid filled catheters are connected to pressure publica
Email: marcus.drake@bristol.ac.uk and PF
transducers at the same vertical pressure as the patient's pubic symphysis, taking
and wit
atmospheric pressure as the zero value. Urodynamic testing is done to answer and vid
specific therapy-driven questions for treatment selection; provocations are applied
to give the best chance of reproducing the problem during the test. Quality of
2.1 | G
recording is monitored throughout, and remedial steps taken for any technical
issues occurring during testing. Labels are applied during the test to document A good
and app
events, such as patient-reported sensation, provocation tests, and permission to
procedu
void. After the test, the pressure and flow traces are scrutinized to ensure artefacts
and com
do not confound the findings. An ICS standard urodynamic report details the key results
aspects, reporting clinical observations, technical, and quality issues. Urodynamic them in
services must maintain and calibrate equipment according to manufacturer Dep
stipulations. cols on
Conclusions: The review provides a succinct summary of practice expectations for a should
evaluat
urodynamic unit offering cystometry and pressure flow studies (PFS) to an
standar
appropriate standard. signs, a
the cath
KEYWORDS
the ICS
LUTS, overactive bladder, standardization, urodynamics

2.2 | E
Alan Wein led the peer-review process as the Associate Editor responsible for the paper. The ba
that it
S50 | © 2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2018;37:S50–S60.

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DRAKE ET AL.
| S51

1 | INTRODUCTION detrusor pressure (pdet) in real time, defined as the

simultaneous difference between intravesical (pves) and
Urodynamics is the general term to describe the measurements abdominal (pabd) pressures. It can measure the flow rate of
that assess the function and dysfunction of the lower urinary tract the voided volume and regulate the rate of fluid infusion. It
(LUT) by any appropriate method. The aim of urodynamics is to has an on-line display of pressures and flow, with adequate
make clinical observations while taking these measurements, in scale and resolution; no information should be lost
order to surmise the underlying causes for the symptoms, and to electronically when tracings go off-scale on display. It is
quantify the related pathophysiological processes. This should possible to record standard information about sensation and
establish objectively the presence of a dysfunction and understand additional comments (event recording).5
its clinical implications. This may either confirm a clinical Systems using liquid-filled catheters and external trans-
diagnosis or give a new, specifically urodynamic, diagnosis. ducers are recommended by the ICS.2,3 The transducer is
The International Continence Society (ICS), through its levelled to the pubic symphysis, an anatomical landmark for
Standardization Steering Committee (SSC), has an ongoing the bladder, and the zero-point set to atmospheric pressure.
strategy to standardize LUT terminology and functional Equipment should have the facility to move the transducers
assessment, and link it to published evidence.1 Several ICS vertically in order to bring the transducers back to the level of
publications underpin the professional standard in Urody- the symphysis pubis, since patients may change position
namic testing, and describe in detail the underlying thinking during a test. Micro-tip or air-filled catheters are not
n the
and the evidence base. The current document is a synthesis of interchangeable with liquid-filled systems2; centers that
g key the key aspects applicable for the more common Urodynamic utilize them should provide reference values for their data.
tests used in clinical pathways. Using ICS standard pressures based on liquid-filled
good systems allows comparison of data between patients and
rinary centres. New technologies need to prove their usefulness and
2 | METHODS
accuracy compared to existing ICS standard urodynamic tests
before clinical application.11 To date, there are no standard-
story, We reviewed recommendations in the ICS standards on
ized pressure measurements for air-charged catheters.
diary, urodynamic practice,2,3 pressure flow studies (PFS),4 urody-
with namic equipment,5 terminology for LUT function,6,7 and a
essure publication on artefacts.8 The review focusses on cystometry 2.2.1 | Calibration
and PFS in adults without relevant neurological abnormalities
aking Pressure transducer calibration is achieved by exposing the
and with intact “normal” anatomy of the LUT. Flow rate testing9
nswer catheter tip to two different well-defined pressures (a pressure
and video-urodynamics10 are described in separate documents.
pplied difference of ≥50 cmH2O is recommended).5 The calibration
should be verified regularly (eg, every 10 urodynamic
ity of
2.1 | General comments measurements for non-disposable transducers) and
hnical documented.
ument A good urodynamic practice comprises: a clear indication for
Flowmeter calibration can be achieved by pouring a
and appropriate selection of relevant test measurements and
ion to precise volume at a constant flow into the flowmeter and
procedures; precise measurement with data quality control
efacts checking the recorded volume. Calibration should be verified
and complete documentation; accurate analysis; reporting of
he key regularly (eg, every 10 urodynamic measurements). If
results which evaluates urodynamic observations and places
frequent recalibration is necessary, the flow transducer might
namic them into the patient's clinical context.
need to be replaced.
cturer Departments should develop urodynamic practice proto-
Infusion pumps are tested by measuring the time to deliver a
cols on the basis of the ICS urodynamic standards,2,3,5 they
known volume. The filling catheter should be connected, as
s for a should facilitate specific staff training and undertake regular
peristaltic type pumps (where a series of rollers compress a
evaluation of performance and adherence.2 ICS terminology
to an flexible tube) may show errors due to downstream resistance.
standards should be used when alluding to LUT symptoms,
Load cell measurement of infused volume is advised, as peristaltic
signs, and urodynamic observations.6,7 Equipment, including
pumps may turn even when the downstream tube is blocked.
the catheters and transducers, should meet the requirements of
the ICS guideline on equipment performance.5
2.3 | Preparations in advance of a urodynamic
test
2.2 | Equipment
A leaflet clearly explaining urodynamic investigation in
The basic requirement of a standard urodynamic system is adequate detail will be appreciated by most patients. A table
that it can measure at least two pressures and calculate suggesting content to include in an information leaflet is
:S50–S60.

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| DRAKE ET AL. DRAKE E

available.2 Instructions must be given to the patient regarding � Relevant clinical examination (abdominal/pelvic/genital 2.5 | P
continuation of usual LUT management (eg, medication). examination, and checking for possible neurological studie
A urinalysis to screen for infection or haematuria should disease or oedema).
A good
be evaluated. � Three day FVC or bladder diary.13
with th
Patients should attend with a completed frequency � Representative uroflowmetry with post-void residual
sympto
volume chart (FVC) or bladder diary.6,12 They can be used (PVR).9
There s
to determine fluid intake, maximum and average voided � A complete ICS standard urodynamic test2: Uroflowmetry
are coll
volume, voiding frequency, and day/night urine produc- and PVR plus cystometry and pressure-flow study (PFS).
Direct
tion. This information supports the patient's symptom
during,
reporting, and aids plausibility control of subsequent Cystometry2: Continuous liquid filling of the bladder via a
allows
urodynamic studies (eg, to prevent over-filling of the transurethral (or other route eg, suprapubic) catheter, at least
elimina
patient's bladder). with intravesical and abdominal pressure measurement and
tive of
Urodynamic tests should be requested with the goal of display of detrusor pressure, including quality checks and
trace is
answering a specific question.3 “Formulating the urodynamic provocations to aid eliciting symptoms. Cystometry ends with
Ele
question” is a process of reviewing the clinical assessment “permission to void” or with severe incontinence. The fluid type
analysi
already available and what potential therapy options may and temperature, filling method and rate, catheter sizes, pressure
after t
subsequently be appropriate, so the test can identify recording technique, and patient position should all be specified.
abbrevi
appropriate treatment options and potential adverse effects. Pressure-Flow study2: The intravesical and abdominal
pressures are measured, from “permission to void,” while
uroflowmetry is performed with a transurethral (or supra- 2.5.1
2.4 | ICS standard urodynamics protocol
pubic) catheter in place. The position of the patient, the
Zero p
� Clinical history, including valid symptom and bother score catheter sizes and the pressure and flow recording technique
transdu
(s) and medication list. should be specified.

FIGURE 1 A specimen urodynamic test for a female patient. Transducers are zeroed to atmosphere at the start, as the pabd and pves are at FIGUR
zero (1), before patient pressures are exposed to the transducers. When the transducers are connected to the patient (2), the clear rises in pabd and manoeuv
pves are termed the “resting pressures”; the resting pressures of pabd and pves are never zero (unless the urodynamic practitioner makes the urodyna
technical mistake of zeroing the displayed pressures while recording from the patient, or the transducers are not placed in the required plane level provoke
with the pubic symphysis). In this case, pabd and pves are both within normal limits, and similar magnitude, so pdet is zero. A cough test shows abdomin
equal response on pabd and pves (2). Some artefactual noise is recorded when the pves line is knocked (3). Cough tests are carried out and live floor). In
signal is present throughout the test (4). At (5), filling is paused and a Valsalva manoeuvre and a stress cough test is carried out, but no leak fluctuati
occurs. Further filling is done, and these two tests repeated at (6) where leakage occurs on both (markers confirm this, and small changes in the change i
flow trace have occurred but are not visible at this scale). After “permission to void” is given, the patient voids (7) and care is taken with the indicatin
placement of the Qmax marker, and with the slight fall in pabd at this point. Finally, a cough test (8) verifies that pressure transmission has pabd; a p
remained good throughout the voiding phase respectiv

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AKE ET AL. DRAKE ET AL.

| S53

/genital 2.5 | Practice of cystometry and pressure flow from any tubes, or when the open end of a connected liquid-
ological studies filled tube is at the same vertical level as the transducer). “Set
zero” or “balance” can then be undertaken, making
A good urodynamic investigation is performed interactively
atmospheric pressure the zero baseline for the test. Intra-
with the patient.3 It should be established how the patient's
residual vesical pressure (pves) or abdominal pressure (pabd) is thus the
symptoms relate to what they experienced during the test.
excess pressure above atmosphere at the hydrostatic level of
There should be continuous observation of the signals as they
wmetry the symphysis pubis. “Set zero” is not done when catheters are
are collected, and assessment of the plausibility of all signals.
(PFS). already recording from the patient; this is a common mistake
Direct inspection of the raw pressure and flow data before,
in many urodynamic units.
during, and at the end of micturition is essential, because it
er via a
allows artefacts and untrustworthy data to be recognized and
at least
eliminated.4 The flow pattern in a PFS should be representa- � ICS standard cystometry is performed using liquid filled
ent and
tive of free flow studies in the same patient. An overall study catheters, with external transducers at the reference level of
cks and
trace is illustrated in Figure 1. the top of the symphysis pubis.2,3,6 To achieve this, most
ds with
Electronic marking of events is important for subsequent urodynamic machines have a movable platform for the
uid type
analysis; the position of event markers should be adjustable transducers, so they can easily be placed at the same height
pressure
after the test has finished, and the meaning of any from the ground as the patient's symphysis.
pecified.
abbreviations used for labels should be clear.5 � Use the thinnest possible transurethral double or triple
dominal
lumen catheter or a suprapubic catheter. Two-catheter
” while
techniques (separate filling and pressure recording cath-
supra- 2.5.1 | Pressure recording eters) are an acceptable alternative.2
ent, the
Zero pressure is the value recorded when a liquid-filled � Fix the catheters as close as possible to the anus and urethral
chnique
transducer is open to the environment (either disconnected meatus with tape, without blocking the urinary meatus.

re at FIGURE 2 Urodynamic observations during filling cystometry. A, USI; the filling pump is stopped, and the patient is asked to do a Valsalva
pabd and manoeuvre (1) and to do a sequence of 2 or 3 good coughs (2). This patient leaked with the coughs (3), and no DO was present, so the
e urodynamic observation of USI was documented. B, DO is the presence of a bladder contraction during filling (1), which may be spontaneous or
ane level provoked. It is essential to review all the lines in the trace before reporting DO, to confirm there is a bladder contraction (2) and minimal
hows abdominal activity (3; though a small abdominal contraction might be seen if the patient tries to prevent leakage by contracting their pelvic
live floor). In this case, there is also incontinence (4), so the urodynamic observation here is DO incontinence (DOI). In the same trace, there are also
eak fluctuations in the calculated detrusor pressure (5) which might be misinterpreted as DO. However, these are below the baseline, and there is no
in the change in bladder pressure associated with them (6). Instead, there are phasic pressure changes visible in the abdominal pressure trace (7),
the indicating the presence of rectal contractions. Practitioners need to recognise that a true change in abdominal pressure shows up in both pves and
s pabd; a phasic change in one line which is absent in the other indicates a contraction of the organ containing the catheter tip (bladder or rectum,
respectively)

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| DRAKE ET AL. DRAKE E

� Rectal placement of a fully liquid filled open catheter, or 2. FDV: “Tell me when you have the sensation that normally
punctured balloon catheter, to measure pabd is ICS tells you to go to the toilet, without any hurry, at the next
standard. Vaginal or stoma placement is used only if convenient moment.”6
rectal placement is impossible. 3. SDV: “The moment that you would definitely visit the
nearest toilet to pass urine.” There should be no pain or any
Prevention of liquid leaks and air bubbles in the fear of losing urine.
pressure tubing system is needed throughout testing, and
should be corrected when identified.3 Coughs or other The end of filling should relate to a “strong but not
abdominal pressure rises are used to ensure that the uncomfortable need to void,” indicated by SDV on the
abdominal and intravesical pressure signals respond urodynamic graph. A specific marker to indicate permis-
equally (see Figure 3). sion to void must be used if there is a delay between
halting the pump and permission to void. If another
reason is chosen for concluding filling, this should be
2.5.2 | Cystometry
indicated.
Filling cystometry is done in the upright/vertical position Incontinence, fear of leakage, pain, or other signs or
(standing or normally seated) whenever physically possible. symptoms during the test should be specifically marked on the
Detection of detrusor overactivity (DO) and urodynamic urodynamic graph.
stress incontinence (USI) are influenced by the position of the
patient; sitting or standing has a higher sensitivity.2
2.5.5 | Provocation
Urodynamic stress test2 (Figure 2) is used for any physical
2.5.3 | Filling rate
effort of the person tested, to elevate abdominal pressure
Maximum physiological filling rate is estimated by body during cystometry, with the aim of examining USI. The
weight in kg divided by four,6 thus typically in the range of exact approach to stress testing during urodynamics has
20-30 mL/min. More rapid filling is referred to as non- not been standardized. Thus, the provocation method,
physiological filling rate.3 pressure measuring catheter (size) and method, the leak
For a balance between a filling rate that is slow enough to detection method, and the intravesical volume(s) may be
be representative and fast enough to complete the cystometry reported.
efficiently, consider a filling rate in mL/min of roughly 10% Leak point pressure (LPP)2 is the pressure (spontaneous
of the largest voided volume (reported on a FVC; and or provoked) that has caused fluid to be expelled from the
allowing for PVR).2 bladder at the moment that it is visible outside the urethra.
Diuresis adds bladder volume that is not recorded by the No ICS (or commonly agreed) standard technique or
urodynamics system, but that is relevant for interpretation of protocol is available and a variety of terms and techniques
the results. Cystometric capacity is most reliably determined are used.
by calculation of voided volume plus PVR immediately after DO (Figure 2) is characterised by involuntary detrusor
PFS.3 contractions during the filling phase which may be
spontaneous or provoked.6 Cough-associated DO2: Reported FIGUR
when the onset of the DO (with or without leakage) occurs
2.5.4 | Sensations only a s
immediately following the cough pressure peak. Cough- importan
Three sensation parameters are recorded6: first sensation associated DO incontinence is a form of DO and must not be case, Qm
of filling (FSF), first desire to void (FDV), and strong confused with USI. was 56,
desire to void (SDV). The patient also may report voiding
sensation(s) suggesting “urgency,” which can be marked Detrusor
2.5.6 | Pressure-flow studies failure t
specifically. When indicating the volumes at which these
sensations occurred, the report should make allowance The relevance of instruction, position, and privacy while with a w
Cough s
for the fact that the volume instilled into the bladder by undertaking PFS is equal to uroflowmetry. PFS is done
a slight
the machine is not necessarily the actual liquid volume in comfortably seated (women, some men) or standing if that is
exact m
the bladder (eg, if the bladder was not empty at the start of the preferred position (men). Pressure-flow analysis is only
by a pat
the filling cystometry, or if the patient is experiencing validated for voluntarily initiated micturitions and not for but at th
diuresis). incontinence. needed
but not
1. FSF: “Tell me the moment when you perceive that your � PFS begins immediately after permission to void and ends explaini
bladder is not empty anymore.”2 when the detrusor pressure has returned to the baseline complet

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AKE ET AL. DRAKE ET AL.

| S55

ormally
he next

visit the
n or any

but not
on the
permis-
etween
another
ould be

igns or
d on the

hysical
ressure
SI. The
ics has
method,
he leak
may be

taneous
rom the
urethra.
que or
hniques

detrusor
may be
eported FIGURE 3 Urodynamic observations during PFS.4 A, Bladder outlet obstruction (BOO) is indicated by a high pressure generated yet
occurs only a slow stream. It is ascertained by evaluating the detrusor pressure (PdetQmax; 1) at the time of maximum flow rate (Qmax: 4). It is
Cough- important to check that the detrusor pressure reflects the bladder pressure (2), rather than a drop in the abdominal pressure (3). In this male
t not be case, Qmax was 8, PdetQmax was 72, and there was no drop in abdominal pressure, so the bladder outlet obstruction index (PdetQmax-2Qmax)
was 56, that is, BOO was present. Fidelity of pressure recording must always be checked by asking patient to cough before (5) and after (6)
voiding to be sure both Pves and Pabd detect the pressure spike equally. This patient also had DO (7). B, Detrusor underactivity (DUA);
Detrusor underactivity is defined as a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or a
failure to achieve complete bladder emptying within a normal time span.6 In this case, detrusor pressure is low (1) and Qmax (4) is slow,
y while with a weak bladder contraction (2) and no change in pabd (3). There is a marked delay between permission to void (5) and start of flow.
Cough subtraction before (5) and after (6) the void are good. At 6, the cough subtraction (orange circle) shows a biphasic artefact, meaning
is done
a slight deflection upwards and an equal deflection downwards: this is acceptable, and is a consequence of the slight discrepancy in the
f that is
exact moment the impulse reaches the respective transducer for the two measured pressures (pves and pabd). C, Straining is sometimes done
is only
by a patient to try and help initiate or sustain voiding, or to speed it up. In this case, there is a small detrusor contraction during voiding (1),
not for but at the same time there are marked strains indicated by the intermittent peaks in vesical (2) and abdominal (3) pressure. Caution is
needed to decide the corrected value of Qmax (4), as it should not be taken during a strain. The cough subtraction before voiding is fine (5),
but not so after voiding (6), where this is a spike elicited by coughing only in the pabd trace. A reduced signal is seen in the pves at (7),
nd ends explaining the poor post void cough subtraction. The last moment of proper vesical pressure recording is at (8), and since this is after the
baseline completion of flow, the PFS can be considered meaningful

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| DRAKE ET AL. DRAKE E

value and/or the flowrate to zero and/or the patient Correction for delay between pressure and flow recording
considers the micturition completed. may be needed.
� Use the shortest possible meatus-to-flowmeter distance, � Cough checking of catheter response is always required
raising the flowmeter to suit the individual patient. after pressure-flow.

FIGUR
cough p
filled ca
trace is u
cough p
signal,”
(4). Flus
with a su
lumen is
pump is
in either
means it
question

Nor
within
permiss
“Si
FIGURE 4 Calculating the bladder outlet obstruction index (BOOI) and bladder contractility index (BCI), for describing PFS in men (no void a
equivalent parameters have been identified as yet for women). A, Pressure flow study for a man with voiding LUTS. The machine placed commu
the maximum flow rate at point 1. However, this was on the tip of an unnatural spike, so the urodynamicist checked the shape of the flow has not
trace, and considered that point 2 reflected the flow of the patient's urine most faithfully. Thus, this was considered the corrected maximum Bla
flow rate (Qmax), with a value of 9 mL/s. pdet at this point (pdetQmax) was 74. From the equation BOOI = pdetQmax-2.Qmax, the value for this as a (sp
patient was 74 − 18 = 56. Any value of BOOI above 40 in a man (with a prostate) indicates obstruction. From the equation the pre
BCI = pdetQmax + 5.Qmax, the value of BCI for this patient was 74 + 45 = 119. Any value of BCI above 100 in a man (also with a prostate) relevan
indicates normal contractility. B, The ICS recommends that the PFS is plotted graphically on a PQ plot. On the P/Q plot, “1” shows the
A
artefactual peak due to the flow spike. The P/Q plot allows the investigator to see how the artefact almost changes the diagnosis, by nearly
underac
crossing one of the lines on the nomogram. “2” shows the corrected position, away from the flow spike and clearly in the obstructed region.
should b
Failure of machine software using current technology to identify artefacts, like that shown at 1, means that traces must be checked for
plausibility, since otherwise obstruction and contractility may be wrongly derived from the pressure flow study, leading to inappropriate
X-axis
treatment decisions for the patient addition

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| S57

cording

equired

FIGURE 5 Artefacts that can cause difficulty with identifying representative information and misinterpretation of urodynamic findings. A, A
cough pressure peak (1) is recognizable during post-test evaluation as a phasic positive pressure change observed in pves and in pabd. With liquid-
filled catheters, it is usual that the bladder line is of smaller diameter than the abdominal line, so complete cancellation of a cough in the detrusor
trace is unlikely. Thus, a symmetric biphasic wave on the detrusor trace (2) is acceptable. Poor pressure transmission is suggested when the
cough pressure peak signals on pves and pabd are not nearly equal, or one of them is absent, as illustrated at 3. This follows a phase of “dead
signal,” meaning that it is not showing small pressure fluctuations and is not adequately responding on straining, patient movements, or coughing
(4). Flushing the vesical pressure line (5) is a common approach to solving a dead signal or poor pressure transmission, and should be verified
with a subsequent cough test, as illustrated. B, Pump vibrations: visible as stable frequency oscillations of small but constant amplitude if a dual-
lumen is used, or if the filling tube touches the pressure connecting tube and the pump is switched on (1), clearly identified as they stop when the
pump is off (2). This patient was observed to have DO (3; pump turned off at this time). C, Expelled catheter: this is observed as a sudden drop
in either pves or pabd, usually below zero (1). In this case, the vesical catheter was expelled before Qmax (2) in a pressure flow study, which
means it is not possible to interpret the pressure-flow relationship at this key point during voiding. If this hinders answering the urodynamic
question, the test will have to be repeated

Normal voiding function: Flow rate (and pressure rise) are nomogram can be used to present this data for male patients, for
within normal limits; flow begins more or less directly after whom BOO can be quantified with the BOO Index, and
permission to void, and ends with an empty bladder. underactivity with the bladder contractility index14 (Figure 4).
“Situational inability to void” or “Situational inability to While these indices are often stated by the urodynamic software,
men (no void as usual”2; when the person performing the test, the urodynamicist is duty-bound to check the plausibility of the
laced communicating with the patient, feels the attempted voiding results, as the machine may wrongly identify an artefact as the
e flow has not been representative. Qmax, and give entirely wrong results with potentially disastrous
ximum Bladder outflow obstruction (BOO) (Figure 3) is defined consequences for the patient.
or this as a (specified) cut-off of bladder outflow resistance based on
the pressure/flow relation (ratio) that is considered clinically
state) 2.5.7 | Repeat testing
relevant.2
the
A slow stream may be caused by BOO or detrusor � When an error or artefact is observed, the person
nearly
underactivity (Figure 3). Presentation of pressure-flow studies performing the test should act accordingly, and prevent
region.
should be with a plot of the flow rate (delay corrected) rate on the continuation in case of an error.
or
ate
X-axis and the synchronous detrusor pressure on the Y-axis, in � Do not routinely undertake immediate repetition of
addition to the time-based graphs.2 The ICS pressure flow invasive urodynamics “for confirmation” if the test was

Fundamentals of urodynamic practice, based on International Continence Society good urodynamic practices recommendations
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| DRAKE ET AL. DRAKE E

technically adequate and representative, and has answered contractions,5 seen as positive waves on pabd and reflected as
the clinical question. negative pdet waves. If either detrusor or rectal contractions TABLE
� Immediate repetition of the test is appropriate when doubt occur, the recorded pressures in pves and in pabd will differ. Questio
exists as to whether the test has answered the clinical question. The relation between signal changes and patient sensation/
� Repetition of a urodynamic test subsequently is needed activity are checked for plausibility and documented during
when technical errors and artefacts have been observed at the test.
post-test analysis.
2.6.1 | Features, artefacts, and errors
Artefacts such as a signal which is non-responding (dead),
Setup
has stepwise changes in pressure, or has negative pressures, Patient movement, external manipulation of the catheter and
Calibra
often can be corrected only with speculation about the other influences cause signal patterns that should be
underlying causes. Studies with such artefacts should be recognized during the test and at (re-) evaluation of graphs.
Prepare
repeated. A few common artefacts can be accepted, for
example, rectal activity, biphasic spikes at cough tests � Position change2: A change in patient position, either
(Figure 3B), or insufficient pabd response during straining. active or passive (eg, tilting), is visible on the cystometry
The urodynamic findings and the interpretation of the trace by a lasting change of equal magnitude in both pves
results should be documented immediately, that is, before the and pabd.
patient has left the urodynamic laboratory. Doing so allows
Quality
for a second test if required. A position change should be followed by adjustment of
the external pressure sensors height to the new level of the Zero to
pubic symphysis, so that the physiological pves and pabd are
2.6 | Technical and clinical quality control Check
observed again; pdet should be unaffected.
press
The following three criteria form the minimum recommen- norm
� Rectal contractions: temporary phasic increases visible in
dations for ensuring quality control of pressure recordings:
the pabd trace, without synchronous change in pves,
Contin
resulting in negative deflections of pdet (Figure 2B).
1. Resting values for abdominal, intravesical, and detrusor mon
� Dropped pabd at void: during the voiding time, pabd
pressure are in a typical range (see below);
decreases below the previous resting pressure (as a
2. The abdominal and intravesical pressure signals are “live,”
consequence of pelvic [and abdominal] muscle relaxation).
with minor variations caused by breathing or talking being
This will artefactually increase pdet, and so affect the
similar for both signals; these variations should not appear
pressure-flow analysis result.
in pdet;
� Straining: observable as a temporary increase in both pves
3. Coughs or other abdominal pressure rises are used
and pabd pressure.
throughout, including before and after voiding, to ensure
� After-contraction: a continued or new detrusor pressure
that the abdominal and intravesical pressure signals
rise immediately after flow ends. It is important to note if
respond equally. This is because pressure recording
this occurs with the complete emptying of the bladder. This
quality can deteriorate quickly during a test, and wrong
may be the reason why some patients feel they have an
conclusions might be drawn if not identified quickly. Since
urgency sensation at the end of voiding.
the test is used to recommend treatment options, possibly
including surgery, the consequence of a wrong conclusion
Artefacts affect interpretation of urodynamic findings
can be detrimental for the patient. Interpr
(Figure 5), and could lead to mis-diagnosis in severe
examples. Step-wise or prolonged constant slope pressure
Initial resting pressure2 is the pves and the pabd pressure at
changes imply a non-physiological cause (eg, movement,
the beginning of the cystometry. Typical ranges for pves and
blockage or disconnection, or leakage of a catheter), which
pabd are: supine 5-20 cmH2O; sitting 15-40 cmH2O; standing
should be resolved.3 A detailed review of urodynamic
30-50 cmH2O.3 Usually both recorded pressures are almost
artefacts has been published.8
identical (and they must not be zero: see Figure 1), so that the
initial pdet is is between −5 and +5 cmH2O in the majority.15
Gentle flushing of both catheter channels and/or filling Report
2.6.2 | Post-test analysis
20-30 mL into the bladder may be needed before the initial
resting pressures are registered. Once a test is completed, it should be scrutinized to confirm
The use of rectal transducers assumes they measure technical quality and exclude the possibility that artefacts
resting abdominal pressure, but they can also measure rectal have influenced key observations. Liquid leaks and air

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| S59

ected as bubbles in the pressure tubing system should be recognized

ractions TABLE 1 Checklist for fundamentals of urodynamic practices and reported during post-test analysis, if not identified during
l differ. Question What is the urodynamic question? the procedure, to prevent mis-diagnosis.8
nsation/ Will patient management change as a Post-processing automated analysis is an optional extra in
during result? urodynamic equipment, and established nomograms and
Does the bladder diary/symptom score calculated parameters may also be provided. Such analysis
affect these?
could be affected by artefacts (eg, Qmax caused by knocking the
Does the patient's report match the
above?
flow meter, pmax from cough),5 and the urodynamicist must
check the trace to be certain that misinterpretation does not
Setup
eter and result. The user should have the ability to check the values for
Calibrate Check that the equipment is registering
uld be feasibility and change the relevant ones if necessary. Software
pressure and volume accurately
graphs. should not filter or remove artefacts, but should be able to
Prepare Fill the domes and tubes with water, and
ignore them for analysis.
mount them on the transducers
, either
Catheterise the patient, connect tubes and
tometry
flush with water
2.7 | The urodynamics report
oth pves
Level transducers with symphysis pubis Bladder storage function should be described according to bladder
bone sensation, detrusor activity, bladder compliance, and bladder
Quality capacity.6 The urethral closure mechanism during storage may be
ment of
l of the Zero to atmosphere Ensure taps are closed to patient, and competent or incompetent. Voiding is described in terms of
pabd are
open to air when zero is pressed. detrusor and urethral function and assessed by measuring urine
Check resting Supine: pabd and pves 5-20 cmH2O flow rate and voiding pressures. An “ICS standard urodynamic
pressures are Seated: pabd and pves 15-40 cmH2O (time based) graph” and an “ICS standard pressure-flow plot” are
normal Standing: pabd and pves 30-50 cmH2O for required elements in the ICS standard urodynamics report.
sible in all positions, pdet −5-+5 cmH2O
n pves,
Continuous Check regularly that pressure � Reporting includes the following elements (summarized
B). monitoring transmission is equal on both lines, for
e, pabd from GUP2016 2):
example, coughs, blowing
(as a Check that live patient signal is present
xation). throughout
ect the a Overall judgement of the technical quality, clinical
Check that baseline pressures do not drift reliability, representativeness, and methods of assessment.
Troubleshoot above during the test, b Uroflowmetry: voiding position, Qmax, voided volume,
oth pves temporarily stopping recording/filling if PVR.
necessary
pressure c Introduction of catheters: sensation, muscular defence,
Stop or reduce fill rate if urgency is obstruction(s).
note if excessive, or compliance poor
er. This d Patient position(s) during cystometry and PFS.
Change patent position as required (eg, e Patient's ability to report filling sensations and/or urgency
have an discomfort, stress testing)
and/or urine loss.
Consider repeating test if urodynamic f Method of urodynamic stress test and accessory tests (if
question not answered
indings applicable).
Interpretation Place markers on the trace frequently, for g Diagnoses: filling sensation (with volumes); cystometry;
severe example, sensation, patient position,
PFS (bladder outflow function, detrusor contraction).
pressure stress tests, permission to void
vement, Adjust positions of markers after
, which All results and observations should be carefully reported.
completion of test if needed
It is good clinical practice to integrate the urodynamic test
ynamic Take a when interpreting, for example,
results with the history, examinations, and other tests.
rectal contractions, knocking of
Table 1 gives a proposed checklist for Fundamentals of
flowmeter
Urodynamic Practice.
Report Bladder during filling
Urethra during filling
Bladder during voiding 3 | CONCLUSIONS
confirm Urethra during voiding
rtefacts Reproduction of symptoms A good study is one that is easy to read and one from which
and air Management plan any experienced urodynamicist will abstract the same

Fundamentals of urodynamic practice, based on International Continence Society good urodynamic practices recommendations
336

S60
| DRAKE ET AL.
Received:
DOI: 10.1
results and come to the same conclusions (GUP2002). Subcommittee on Standardization of Terminology of Pressure-
Adherence to the fundamentals of the ICS standards, as Flow Studies. Neurourol Urodyn. 1997;16:1–18.
SOUN
synthesized in this review, will enable urodynamic units to 5. Gammie A, Clarkson B, Constantinou C, et al. International
Continence Society guidelines on urodynamic equipment perfor-
ensure the quality of urodynamic studies and compare
mance. Neurourol Urodyn. 2014;33:370–379.
findings with other units.
6. Abrams P, Cardozo L, Fall M, et al. The standardisation of
terminology of lower urinary tract function: report from the Bas
CONFLICT OF INTEREST Standardisation Sub-committee of the International Continence
Society. Neurourol Urodyn. 2002;21:167–178. urin
Dr. Drake reports grants, personal fees, and non-financial 7. Haylen BT, de Ridder D, Freeman RM, et al. An International
support from Astellas, Allergan, and Ferring, outside the Urogynecological Association (IUGA)/International Continence
submitted work. Dr. Doumouchtsis has nothing to disclose. Society (ICS) joint report on the terminology for female pelvic floor Mich
dysfunction. Neurourol Urodyn. 2010;29:4–20.
Dr. Hashim reports personal fees and non-financial support
8. Hogan S, Gammie A, Abrams P. Urodynamic features and artefacts.
from Ferring and Allergan, personal fees from Astellas,
Neurourol Urodyn. 2012;31:1104–1117. Departm
Medtronic, and Boston, outside the submitted work. 9. Gammie A, Drake MJ. The fundamentals of uroflowmetry practice, Center U
Dr. Gammie reports other from Astellas and Ipsen, grants based on international continence society good urodynamic
from Andromeda, Digitimer, and Laborie, outside the practices recommendations. Neurourol Urodyn. 2018;37:S44–S49. Corresp
submitted work. 10. Wyndaele M, PFWM Rosier. Basics of videourodynamics for adult Michel W
patients with lower urinary tract dysfunction. Neurourol Urodyn. (Fellow o
2018;37:S61–S66. Function
11. Harding C, Rosier PFWM, Drake MJ, et al. What research is needed Neurouro
ORCID to validate new urodynamic methods? ICI-RS2017. Neurourol C04.236;
Urodyn. 2018;37:S32–S37. Utrecht,
Marcus J. Drake http://orcid.org/0000-0002-6230-2552 Email: m
12. Bright E, Drake MJ, Abrams P. Urinary diaries: evidence for the
Hashim Hashim http://orcid.org/0000-0003-2467-407X
development and validation of diary content, format, and duration.
Andrew Gammie http://orcid.org/0000-0001-5546-357X Neurourol Urodyn. 2011;30:348–352.
13. Bright E, Cotterill N, Drake M, Abrams P. Developing and
validating the International Consultation on Incontinence Ques-
tionnaire bladder diary. Eur Urol. 2014;66:294–300.
REFERENCES
14. Abrams P. Bladder outlet obstruction index, bladder contractility
1. Rosier PF, de Ridder D, Meijlink J, Webb R, Whitmore K, Drake index and bladder voiding efficiency: three simple indices to define
MJ. Developing evidence-based standards for diagnosis and bladder voiding function. BJU Int. 1999;84:14–15.
management of lower urinary tract or pelvic floor dysfunction. 15. Sullivan JG, Swithinbank L, Abrams P. Defining achievable
Neurourol Urodyn. 2012;31:621–624. standards in urodynamics—a prospective study of initial resting
2. Rosier P, Schaefer W, Lose G, et al. International continence pressures. Neurourol Urodyn. 2012;31:535–540.
society good urodynamic practices and terms 2016: urodynamics,
uroflowmetry, cystometry, and pressure-flow study. Neurourol
Urodyn. 2017;36:1243–1260. How to cite this article: Drake MJ, Doumouchtsis
3. Schafer W, Abrams P, Liao L, et al. Good urodynamic practices: SK, Hashim H, Gammie A. Fundamentals of
uroflowmetry, filling cystometry, and pressure-flow studies.
urodynamic practice, based on International
Neurourol Urodyn. 2002;21:261–274.
Continence Society good urodynamic practices
4. Griffiths D, Hofner K, van Mastrigt R, Rollema HJ, Spangberg A,
recommendations. Neurourology and Urodynamics.
1 | D
Gleason D. Standardization of terminology of lower urinary tract
function: pressure-flow studies of voiding, urethral resistance, 2018;37:S50–S60. https://doi.org/10.1002/nau.23773
The ICS
and urethral obstruction. International Continence Society
urodyn
urodyn
medium
pictures
report s
total pa
namics
docume
in this m

Roger D
responsib

Neurourol

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2. Fundamentals
 337

AKE ET AL.
Received: 25 May 2018
DOI: 10.1002/nau.23778
| Accepted: 11 July 2018

Pressure-

SOUNDING BOARD
rnational
t perfor-

ation of
rom the Basics of videourodynamics for adult patients with lower
ntinence
urinary tract dysfunction
rnational
ntinence
lvic floor Michel Wyndaele | Peter F. W. M. Rosier
artefacts.
Department of Urology, University Medical
practice, Center Utrecht, Utrecht, The Netherlands Aims: Videourodynamics is the addition of imaging to invasive urodynamics and one
dynamic of the methods to ensure objective diagnosis in persons with signs or symptoms of
S44–S49. Correspondence
lower urinary tract dysfunction. This manuscript has the aim to outline the basics of
for adult Michel Wyndaele, MD, PhD, FEBU
Urodyn. (Fellow of the European Board of Urology), the practice of videourodynamics and to elementary explain interpretation of the
Functional Reconstructive Urology and results.
s needed Neurourology, Department of Urology
C04.236; University Medical Center
Methods: Literature sources and expert opinion were arranged to provide the reader
eurourol
Utrecht, Utrecht, The Netherlands. with an introductory overview of current knowledge.
e for the Email: m.i.a.wyndaele@umcutrecht.nl Results: Videourodynamics was—like most diagnostics in health care—introduced
duration. on the basis of plausibility and expert conviction but has stood the test of time.
ping and
Videourodynamics has, especially in patients with congenital or acquired neurogenic
ce Ques- dysfunction of the lower urinary tract, undisputedly although not precisely
quantifiable, added to (lower urinary tract) health care quality.
tractility
Conclusion: The manuscript summarizes the basic elements of indication, practice,
to define
and interpretation of videourodynamics.
hievable
l resting KEYWORDS
meningomyelocele, neurogenic lower urinary tract dysfunction, practice recommendations, spinal cord
injury, videourodynamics

is

cs.
1 | DEFINITION and technique as well as the clinical purpose and application of
the test to the not-expert.
773
The ICS good urodynamic practice1 states that standard invasive
urodynamics may be combined with imaging. Invasive
urodynamics performed with contrast fluid as the filling
2 | REQUIREMENTS
medium is termed videourodynamics: X-ray (image amplifier)
In addition to the standard urodynamic (UDS) set-up,1
pictures or cine-loops are made at relevant moments.1 This
videourodynamics (VUDS) requires that the bladder is filled
report states that the contrast medium should be specified and the
with (iodine) contrast fluid. The technique of VUDS has been
total patient radiation dose should be reported. Videourody-
introduced in the early seventies of last century2,3 and the
namics is not further discussed in the good urodynamic practices
technique as was introduced in those early days has remained
document and we provide the basic principles of this technique
throughout the years.4,5 All publications that explain the
in this manuscript, with the goal to briefly introduce the practice
principles are expert opinion driven and all clinical studies,
describing the application of the technique are single center
Roger Dmochowski led the peer-review process as the Associate Editor retrospective reviews. We have extracted practical elements
responsible for the paper. from a few reviews and instructional manuscripts.6,7
Neurourology and Urodynamics. 2018;37:S61–S66. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | S61

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| WYNDAELE AND ROSIER WYNDAE

Diverse brands and types of contrast fluid are available. accuracy, and the radiation time and dose should always TABLE
In general it is reasonable to use the contrast that is used on be reported, making patient dose monitoring essential.1 anatomi
the radiology department to perform cysto-urethrography. Urodynamicists that wish to perform VUDS, as well as Anatom
As an example, the American College of Radiology physicians should be well-trained to ensure that video- Ureters
provides a detailed description of the technique8 and links, monitoring is performed adequately. Snapshots at clini-
Bladde
to documents that list available contrast agents. Recent cally relevant moments (eg, during provocative measures
studies about the type of contrast media and the quality of or bladder pressure rises) are usually sufficient and long
imaging are rare but earlier fundamental research demon- cine-loops are rarely relevant. The radiation field should
strates that very dense medium may obscure details.9 be limited to the anatomical region of interest (sparing the
Contrast agents have a different density compared to that of gonads if possible). Pulsed digitally enhanced or low-dose
urine and or saline, which are usually applied for setting continuous fluoroscopy with spectral beam filtra-
urodynamic measurements. The difference in weight tion, optimal selection of the tube current and high voltage Bladde
requires specific calibration of the UDS equipment; the by an automatic brightness control system should be used
infusion pump and the flow meter, to ensure the machine to reduce radiation exposure. Certainly regular servicing Bladde
does not overestimate volumes, because of the larger as per local maintenance plan is important. A relatively
relative weight of the fluid. low effective dose is achievable, as was demonstrated in a
A fixed X-ray unit that can move from 90° to 180° cohort with historical controls. A mean fluoroscopic time
(allowing an antero-posterior, lateral as well as an oblique of around 60 s for VUDS including filling, stress testing,
view), or a C-arm can provide for imaging in a fluoroscopy- and voiding observations has been possible.10 Plausibly,
proof room. Modern image intensifier, flat-panel and digital observations done do not often need reconfirmation (with Urethra
radiology equipped systems significantly reduce radiation repeated images), and a few snapshots at critical moments
dose when compared to the “old” x-ray film. Fluoroscopy are conceivably sensitive to observe anatomical abnor-
rooms (also for VUDS) require shielded walls, shielded malities in combination with the (dys) function of the
door(s) and usually have an x-ray glass control window. LUT. Regrettably not much scientific evidence is
Shielding must be calculated by a physicist or radiation expert published, regarding this.
and is based on the specific imaging equipment utilized. The
shielding typically will involve several different lead elevate
thicknesses depending upon primary beam and secondary 3 | VIDEO-URODYNAMIC FINDINGS synchro
scatter radiation fields, surrounding occupancy factors and during—
other considerations. The patient and the medical team The possible findings during VUDS are listed in Table 1. The to note
involved should be adequately protected and wear key to VUDS is to adequately relate the anatomical findings
dosimeters. (see Figures 1-4) to the urodynamic observations.
VUDS should be performed in the patient's natural For example, a critical part in the follow-up and
position, if possible. This will require a radiolucent toilet seat management of patients with neurogenic dysfunction
to allow fluoroscopy of voiding in a sitting position. A (NLUTD) is to ensure low-pressure urine storage, thereby
standing position should also be available to enable (stress) protecting the upper urinary tract (UUT). An unsafe bladder,
evaluation of urinary incontinence in men and women and or prone to cause UUT damage, was defined in adult patients
voiding in the standing position. Many patients, however, with spinal dysraphism as a bladder with a high end filling
especially those with neurogenic dysfunction of the lower pressure (>40 cmH2O), poor compliance (<10 mL/cmH2O)
urinary tract (LUT) never void and or are unable to sit or and high detrusor leak point pressure (>40 cmH2O)11 criteria
stand. For those patients it should be considered, or preferred, that can be deducted from conventional UDS.12 High bladder
to perform UDS in supine position. Both in seated as well as in pressures during the storage phase can, however, cause
supine position the relevant elements of the system should be vesico-ureteral reflux (VUR) (eg, Figure 4). Secondary, this
upholstered adequately to prevent skin damage, especially VUR can create a pop-off of bladder pressure as (one of) the
again, for the patients with loss of sensation and LUT UUT(s) now absorbs the pressure. This may lead to
dysfunction. overestimation of bladder compliance. Therefore, VUDS
VUDS software combining the X-ray images with the have a clear advantage over conventional UDS when
UDS trace, and presenting the data either on a split screen or hydronephrosis was documented in the patient or when
by superposition, is widely commercially available although VUR is suspected or known by other means. VUR can be
the precise association of the images with synchronous related to bladder function; passive VUR at low intravesical
pressures is rarely reported. pressures, for example, due to an insufficient ureteric orifice FIGUR
Radiation exposure should be As Low As Reasonably as is frequently existing in congenital ureteral anomalies, for Pressure
Achievable (ALARA) without sacrificing diagnostic example, doubling versus active VUR occurring during BOOI: 7

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| S63

always TABLE 1 Video-urodynamic observations in relation during abnormalities of the LUT are more prevalent than in patients
ential.1 anatomical site and urodynamic phase with acquired NLUTD due to the abnormal muscle functional
well as Anatomical site Video-urodynamic finding as well as anatomical development of the LUT and pelvic
video- Ureters and renal pelvis Vesico-ureteral reflux + grade floor even before birth, as a consequence of the lack of (early)
t clini- normal innervation.
Bladder Trabeculation
easures Diverticula Abnormalities in the shape or outline of the bladder
nd long Christmas tree appearance should be related to the functional and the cystometric
should Postvoid residual (+ quantification) capacity. Bladder diverticula, for example, can serve as a
ing the Vesico-vaginal fistula pressure sink or can be responsible for postvoid residual (eg,
w-dose Filling “defect” (eg, prostate median Figure 3).
m filtra- lobe, bladder tumor, bladder stone) VUDS can also aid in the diagnosis of urinary
voltage Bladder base Cystocoele + grade (at rest, during incontinence. Male (post-prostatectomy) PRP-UI has been
be used stress testing, and during voiding) suggested as an indication for VUDS on the basis of expert
rvicing Bladder neck Filling: Bladder neck incompetence conviction.13,14 Whether VUDS is of advantage in
atively (during stress testing) uncomplicated PRP-UI; men without any other urological
Filling: Bladder neck opening during
ted in a history or (neuro-) urological co-morbidity, than UDS has
detrusor overactivity contractions
ic time not been assessed yet. In women with recurrent signs and
Voiding: Bladder neck dysfunction or
testing, dyssynergia symptoms of UI on the other hand, VUDS can aid in the
ausibly, Voiding: Bladder neck fibrosis evaluation and may guide the management, but this also has
n (with Urethra Urinary incontinence not been evaluated prospectively with regard to improve-
oments Urethral stricture ment in management selection and or outcome. Therefore,
abnor- Urethral diverticula the added value of fluoroscopy to UDS in women with
of the Urethrovaginal fistula recurrent UI after initial (surgical) intervention has yet to be
nce is (Neurogenic) detrusor—(external determined. In NLUTD, VUDS can also be used to
urethral) sphincter dyssynergia determine detrusor leak point pressure; it is possible to
observe contrast fluid entering the urethra via the X-ray;
elevated pressure as a consequence of reduced compliance or however, all leak points are designed or calibrated with
NGS synchronous with a detrusor contraction during filling or externally visible leakage.
during—high pressure—dyssynergic voiding. It is important In young men with non-neurogenic LUTS, a single center
e 1. The to note that in patients with spinal dysraphism, anatomical report suggests that VUDS can offer guidance in diagnosing
indings

up and
unction
thereby
bladder,
patients
d filling
mH2O)
criteria
bladder
, cause
ary, this
of) the
ead to
VUDS
S when
r when
can be
avesical
orifice FIGURE 1 Voiding phase of VUDS bladder contour has normal appearance and bladder neck and prostatic urethra are clearly visible.
lies, for Pressure flow analysis demonstrate that this patient has a normal contraction (BCI 144) and a bladder outflow obstruction grade 4 (or ICS-
during BOOI: 74)

Basics of videourodynamics for adult patients with lower urinary tract dysfunction
340

S64
| WYNDAELE AND ROSIER WYNDAE

the location or cause of bladder outflow obstruction (BOO):

bladder neck dysfunction versus bladder neck fibrosis15
versus urethral stricture. Some reports also suggest that
VUDS can be useful for women with voiding difficulties to
distinguish the effect of pelvic organ prolapse or dyssynergia
in women with consistent intermittent or fluctuating flow,16,17
however, the precise predictive value of observations with the
video-part of the study are poorly described and difficult to
reproduce.
Other indications for VUDS are listed in Table 2. In
general, fluoroscopy can be added to the urodynamic
evaluation if there is suspicion of an anatomical anomaly
contributing to the patient's LUTD or when a relevant
neurological disease is causing the dysfunction and an
anatomical cause or consequences are expected.

4 | GUIDELINES

The evidence supporting VUDS in non-neurogenic LUTS is

low grade; sparse, incomplete, and almost exclusively based
on expert opinion and single center uncontrolled studies.18
Data on the effect of VUDS with or without comparison with
FIGURE 2 Cystogram showing trabeculation over the entire UDS on management selection and outcomes are also
bladder FIGUR
lacking. Nevertheless, the aim of VUDS is to achieve a
more accurate diagnosis in these patients and hence improve
the therapeutic decision-making, however, usually at the cost TABLE
Neurol
(Histor
Bladde
History
History
Suspici
Suspici
Pre- an

of patie
outcom
neurolo
The
mends,
proced
tients.1
if this
pathop
though
British
(NICE)
FIGURE 3 A relatively large diverticulum, filled during voiding; normal appearance of urethra, but pressure flow parameters (over- known
projected: not zeroed to atmosphere as per ICS standard; low flow and relatively high detrusor pressure) indicate bladder outflow obstruction LUT f
(should be graded on [ICS] pressure flow plot) injury,

ICS Standards 2019

2. Fundamentals
 341

D ROSIER WYNDAELE AND ROSIER

| S65

(BOO):
brosis15
est that
ulties to
ynergia
ow,16,17
with the
icult to

e 2. In
ynamic
nomaly
elevant
and an

LUTS is
y based
udies.18
on with
re also
FIGURE 4 Vesico-ureteral reflux initially at the right hand side and subsequently on both sides
hieve a
mprove
the cost TABLE 2 Indications for considering fluoroscopy during the urodynamic evaluation
Neurological findings or history of relevant neurologic disease
(History of) congenital genitourinary anomaly (eg, ectopic ureter, posterior urethral valves, prune-belly syndrome, vesico-ureteral reflux)
Bladder outflow obstruction or urinary retention associated with complex history
History of pelvic radiotherapy or intrapelvic surgery
History of pelvic reconstructive surgery, SUI surgery, urethral stricture repair, POP reconstruction, urethral diverticulectomy
Suspicion of vesico-vaginal or urethro-vaginal fistula
Suspicion of urethral diverticulum
Pre- and post-renal transplant

of patient comfort, making the chance of not representative The American Urological Association (AUA) and Society
outcome of studies more likely, especially in patients without of Urodynamics, Female Pelvic Medicine and Urogenital
neurological disease. Reconstruction (SUFU) states that, when available, clinicians
The European Association of Urology (EAU) recom- may perform VUDS in patients with relevant neurologic
mends, based on level 4 evidence, VUDS as the optimum disease at risk for neurogenic bladder dysfunction, in patients
procedure for invasive UDS in neuro-urological pa- with other neurologic disease and elevated PVR.23 Clinicians
tients.19,20 In male LUTS VUDS are considered applicable may also perform VUDS in properly selected patients to
if this is needed for the clinician to understand the urodynamically grade and to anatomically localize bladder
pathophysiological mechanism of a patient's LUTS al- outflow obstruction, based on this association statement.23
though this is also based on experts impressions.21 The
British National Institute for “Health” and Care Excellence
(NICE) recommends to offer VUDS to people who are 5 | CONCLUSION
known to have a high risk of renal complications from their
tion LUT function (eg, people with spina bifida, spinal cord Medical imaging has developed in a century.24 Imaging finds
injury, or anorectal abnormalities).22 its application in healthcare via the evolution of technical

Basics of videourodynamics for adult patients with lower urinary tract dysfunction
342

S66
| WYNDAELE AND ROSIER
Received:
DOI: 10.1
possibilities in combination with plausibility, and expert with spinal dysraphism—new recommendations for urodynamic
opinion. Randomized prospective studies that demonstrate followup guidelines? J Urol. 2014;192:477–482.
EDITO
the effect of diagnosis with and without imaging, on outcome 12. Groutz A, Blaivas JG, Chaikin DC, Weiss JP, Verhaaren M. The
pathophysiology of post-radical prostatectomy incontinence: a
of management have not been published. The development of
clinical and video urodynamic study. J Urol. 2000;163:
videourodynamic evaluation is no exception. It is difficult to
precisely delineate the indications for the study, as well as to 13.
1767–1770.
Jura YH, Comiter CV. Urodynamics for postprostatectomy Wh
assess its precise surplus for predictive value of the diagnostic
strategy, however, it is undoubtedly plausible and useful to
incontinence: when are they helpful and how do we use them?
Urol Clin North Am. 2014;41:419–427, viii. mat
combine reliable objective functional physiological measure- 14. Nitti VW, Lefkowitz G, Ficazzola M, Dixon CM. Lower urinary
ments (UDS) with anatomical information of synchronous tract symptoms in young men: videourodynamic findings and
Why do
imaging in a proportion of patients with lower urinary tract correlation with noninvasive measures. J Urol. 2002;168:135–138.
15. Nitti VW, Tu LM, Gitlin J. Diagnosing bladder outlet obstruction in
why ar
dysfunction. the wor
women. J Urol. 1999;161:1535–1540.
16. Brucker BM, Fong E, Shah S, Kelly C, Rosenblum N, Nitti VW. that illu
Urodynamic differences between dysfunctional voiding and commo
ORCID primary bladder neck obstruction in women. Urology. 2012;80: Sta
55–60. depend
Peter F. W. M. Rosier http://orcid.org/0000-0003-0445-
17. Anding R, Rosier P, Smith P, et al. When should video be added to drinkin
4563
conventional urodynamics in adults and is it justified by the
creation
evidence? ICI-RS 2014. Neurourol Urodyn. 2016;35:324–329.
18. Drake MJ, Apostolidis A, Cocci A, et al. Neurogenic lower urinary
healthc
tract dysfunction: clinical management recommendations of the Sta
REFERENCES
Neurologic Incontinence committee of the fifth International about. T
1. Rosier PFWM, Schaefer W, Lose G, et al. International continence Consultation on Incontinence 2013. Neurourol Urodyn. but also
society good urodynamic practices and terms 2016: urodynamics, 2016;35:657–665. It is im
uroflowmetry, cystometry, and pressure-flow study. Neurourol 19. Stöhrer M, Blok B, Castro-Diaz D, et al. EAU guidelines on disease
Urodyn. 2017;36:1243–1260. neurogenic lower urinary tract dysfunction. Eur Urol. 2009;56:
profess
2. Bates CP, Corney CE. Synchronous cine-pressure-flow cystog- 81–88.
raphy: a method of routine urodynamic investigation. Br J Radiol.
at a con
20. Nosseir M, Hinkel A, Pannek J. Clinical usefulness of urodynamic
1971;44:44–50. assessment for maintenance of bladder function in patients with in orde
3. Arnold EP, Brown AD, Webster JR. Videocystography with spinal cord injury. Neurourol Urodyn. 2007;26:228–233. with pa
synchronous detrusor pressure and flow rate recordings. Ann R Coll 21. Gratzke C, Bachmann A, Descazeaud A, et al. EAU guidelines on saying.
Surg Engl. 1974;55:90–98. the assessment of non-neurogenic male lower urinary tract Contine
4. Marks BK, Goldman HB. Videourodynamics: indications and symptoms including benign prostatic obstruction. Eur Urol. of evid
technique. Urol Clin North Am. 2014;41:383–391, vii-viii. 2015;67:1099–1109. develop
5. McGuire EJ, Cespedes RD, Cross CA, O'Connell HE. Video- 22. https://www.nice.org.uk/guidance/cg148/evidence/full-guideline-
coverin
urodynamic studies. Urol Clin North Am. 1996;23:309–321. 188123437
6. Gray M. Traces: making sense of urodynamics testing—part 12: 23. Winters JC, Dmochowski RR, Goldman HB, et al. Urodynamic
dysfunc
videourodynamics testing. Urol Nurs. 2012;32:193–202. studies in adults: AUA/SUFU guideline. J Urol. 2012;188: Sim
7. Cardozo L, Shakir F, Araklitis G, Rantell A, Robinson D. Narrated 2464–2472. languag
video demonstrating the procedure of videourodynamics. Neuro- 24. Scatliff JH, Morris PJ. From Roentgen to magnetic resonance languag
urol Urodyn. 2018;37:1176–1177. https://www.acr.org/-/media/ imaging: the history of medical imaging. N C Med J. 2014;75: differen
ACR/Files/Practice-Parameters/cysto-urethro.pdf 111–113. exampl
8. McAlister WH, Griffith RC. Cystographic contrast media: clinical and
urinary
experimental studies. AJR Am J Roentgenol. 1983;141:997–1001.
this dif
9. Giarenis I, Phillips J, Mastoroudes H, et al. Radiation exposure during How to cite this article: Wyndaele M, Rosier
videourodynamics in women. Int Urogynecol J. 2013;24:1547–1551. in ove
PFWM. Basics of videourodynamics for adult associa
10. Galloway NT, Mekras JA, Helms M, et al. An objective score to
patients with lower urinary tract dysfunction. consist
predict upper tract deterioration in myelodysplasia. J Urol.
1991;145:535. Neurourology and Urodynamics. 2018;37:S61–S66. Overac
11. Veenboer PW, Bosch JL, Rosier PF, et al. Cross-sectional study of https://doi.org/10.1002/nau.23778 countri
determinants of upper and lower urinary tract outcomes in adults criteria
importa
those d
in man
Such te
researc

Neurourol

ICS Standards 2019

2. Fundamentals
 343

D ROSIER
Received: 10 May 2018
DOI: 10.1002/nau.23736
| Accepted: 17 May 2018

dynamic

EDITORIAL COMMENTS
n M. The
nence: a
000;163:

atectomy Why ICS standardization of lower urinary tract symptoms

se them?
matters
r urinary
ngs and
Why does as a red traffic light mean “STOP” everywhere? Or Standards allow sharing of technology and innovation and
135–138.
uction in
why are you able to browse the Internet from anywhere over information. If we would not use a standardized terminology
the world? These are just a few examples from our daily life and a set of standards in urodynamics, results from one center
Nitti VW. that illustrate the need for standardization and the use of a would not be interchangeable with those from another center.
ing and common and correct terminology. This would lead to an unnecessary duplication of examina-
2012;80: Standards make the world a safer place. Our health is tions, when a patient would be referred to another center.
dependent on standards, going from the definition of safe Technology is highly dependent on terminology and
added to drinking water, over the quality of medical equipment to the standardization.5 Standards also make information retrievable
d by the
creation of terminology, standards, and guidelines in and speed up research. Every book or published article can be
–329.
r urinary
healthcare. found with internet search engines or through library systems,
ns of the Standards and terminology define what is being talked thanks to unique identifiers that have been attributed
rnational about. This is especially necessary in critical communication, according to international standards. Just imagine to have
Urodyn. but also to ensure the safe diagnosis and treatment of patients. go back in time and to be dependent on an old-fashioned
It is important that the term for a symptom, condition or librarian and his reference system on little cards, before you
lines on disease has the same meaning for every healthcare could read an interesting article or book. Standards help
2009;56:
professional on this planet. If you hear of a new development tremendously in speeding-up research and interaction
at a congress or in publication, you need to understand it fully between researchers.
dynamic
ents with in order to adopt it properly into your practice. When talking We strongly encourage all healthcare professionals to
with patients, both of you need to understand what the other is engage with the ICS standardizations, so as to push forward
elines on saying. Achieving this is the aspiration of the International the progress in this field. Once it is in universal use, the ICS
ary tract Continence Society (ICS) standardizations.1 They are a series terminology offers a backbone for communications between
ur Urol. of evidence based pragmatic documents, some of them professionals and also with patients.
developed in partnership with other professional bodies,
ideline-
covering the field of lower urinary tract function and
dynamic
dysfunction, and urodynamic assessment.2–4 CONFLICTS OF INTEREST
012;188: Similar words can have different meanings in different
Dr. De Ridder reports grants from Astellas, grants from
languages, or translation. Notably an English term in another
Janssen-cilag, grants from Medtronic, other from Coloplast,
esonance language can change the linguistic meaning or can have
outside the submitted work.
2014;75: different connotations than in the original language. For
example many languages do not make a distinction between Dirk De Ridder MD, PhD, FEBU 1
urinary urge and urinary urgency. The ICS has clearly defined Marcus Drake BM, BCh, MA(Cantab.),
this difference to make it clear that urgency is pathological, as DM (Oxon.), FRCS(Urol)2
1
in overactive bladder, and urge is the normal sensation Dept. of Urology, University Hospitals KU Leuven,
associated with a strong desire to pass urine. So as to be Herestraat 49, 3000 Leuven, Belgium
2
consistent for inclusion of patients in clinical trials on Office C39b, Bristol Urological Institute, University of
66. Overactive Bladder Syndrome potentially being run in several Bristol, Level 3 Learning and Research Building, BS10
countries, correct interpretation of the inclusion and exclusion 5NB, Bristol, United Kingdom
criteria is essential. For these trials it is of paramount
importance to recruit only patients with urgency, and not *Correspondence
those describing the normal sensation of urge. Standards help Dirk De Ridder, MD, PhD, FEBU, Department of Urology,
in managing cultural and linguistic diversity and differences. University Hospitals KU Leuven, Herestraat 49, 3000
Such terminology efforts are crucial for the advancement of Leuven, Belgium.
research and clinical practice. Email: dirk.deridder@uzleuven.be

Neurourology and Urodynamics. 2018;37:S67–S68. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | S67

Why ICS standardization of lower urinary tract symptoms matters

344

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| DE RIDDER AND DRAKE
Received:
DOI: 10.1
REFERENCES Society (ICS) joint report on the terminology for reporting outcomes
of surgical procedures for pelvic organ prolapse. Int Urogynecol J.
1. Rosier PF, de Ridder D, Meijlink J, Webb R, Whitmore K, Drake MJ. SOUN
2012;23:527–535.
Developing evidence-based standards for diagnosis and management
5. Seth JH, Sahai A, Khan MS, et al. Nerve growth factor (NGF): a
of lower urinary tract or pelvic floor dysfunction. Neurourol Urodyn.
potential urinary biomarker for overactive bladder syndrome (OAB)?
2012;31:621–624.
2. Haylen B, Freeman R, de Ridder D, et al. An international
BJU Int. 2013;111:372–380.
Crit
urogynecological association (iuga) − international continence
society (ics) joint report on the terminology for female pelvic floor Inte
dysfunction. Neurourol Urodyn. 2009;28:787.
3. Haylen BT, de Ridder D, Freeman RM, et al. An International How to cite this article: De Ridder D, Drake M.
Urogynecological Association (IUGA)/International Continence Why ICS standardization of lower urinary tract
Society (ICS) joint report on the terminology for female pelvic
Peter
symptoms matters. Neurourology and Urodynamics.
floor dysfunction. Neurourol Urodyn. 2010;29:4–20.
2018;37:S67–S68. https://doi.org/10.1002/nau.23736
4. Toozs-Hobson P, Freeman R, Barber M, et al. An International
Function
Urogynecological Association (IUGA)/International Continence
C04.236,
Utrecht,

Corresp
Peter F.W
Urology,
Universi
Netherla
Email: P

1 | IN

The M
NASA
Howev
spacecr
insertio
produc
(lbf/s)
specifie
spacecr
close t
atmosp
technic

Clinical
Roger D
responsib

Neurourol

ICS Standards 2019

2. Fundamentals
 345

D DRAKE
Received: 12 April 2018
DOI: 10.1002/nau.23779
| Accepted: 5 July 2018

outcomes
ynecol J.
SOUNDING BOARD
NGF): a
(OAB)?

Critical steps in developing professional standards for the

International Continence Society

Peter F. W. M. Rosier
ics.
736
Functional Urology, Department of Urology
C04.236, University Medical Center Aims: Standardization on the basis of systematic assessment of evidence has become
Utrecht, Utrecht, The Netherlands an indispensable element of modern healthcare. International Continence Society
(ICS) has initiated and produced extremely well cited standardization documents.
Correspondence
Peter F.W.M. Rosier, MD, PhD, Functional The process of standardization is recently depicted in a published manuscript, to keep
Urology, Department of Urology C04.236, up with modern society healthcare demands.
University Medical Center Utrecht, The
Netherlands.
Methods: A narrative review of the ICS history and current state of standardizations
Email: P.F.W.M.Rosier@umcutrecht.nl for the terms, assessment and the management of patients with lower urinary tract
dysfunction.
Results: This article highlights the philosophy and the historical context of
standardization and explains the core elements of modern day standardization. The
article also demonstrates the scientific relevance of the ICS standards, on the basis of
reference-counts.
Conclusion: The history and the relevance of ICS standards are summarized.

KEYWORDS
health care quality, lower urinary tract dysfunction, systematic assessment and diagnosis

1 | INTRODUCTION technical issues. Standardization is relevant, in technical

science as well as in medical science. Standard terms,
The Mars Climate Orbiter was a space probe launched by classifications and disease and management patterns were
NASA on December 11, 1998 to study the Martian climate. sought, in fact since the early days of healthcare, for example,
However, on September 23, 1999, communication with the by Hippocrates. Maybe in the more modern society further
spacecraft was lost as the spacecraft went into orbital standardization began in the 16th century, where parish clerks
insertion, due to ground-based computer software which were asked to classify mortality and standard terms were
produced output in non-SI units of pound (force)-seconds developed with this aim. This can be seen as the later basis for
(lbf/s) instead of the SI units of newton-seconds (N/s) health epidemiological observations. In the beginning of 20th
specified in the contract between NASA and Lockheed. The century a standard nomenclature for diseases was developed
spacecraft encountered Mars on a trajectory that brought it too that progressed into the nowadays International Classification
close to the planet, causing it to pass through the upper of Diseases (ICD) and Systematized Nomenclature of
atmosphere and disintegrate.1 SI units are standard units of Medicine (SNOMED, now SNOMED-CT).2
technical measurement, allowing communication about Medical societies are established around (clinical-medi-
cal) specialisms to improve knowledge and accountability.
The Continence Club was established in Exeter (UK) in 1971,
Clinical trial: No. renamed to International Continence Society that same year
Roger Dmochowski led the peer-review process as the Associate Editor and had the purpose to “. . . provide a link for the interchange
responsible for the paper. of ideas and results for clinicians and physicists interested in
Neurourology and Urodynamics. 2018;37:S69–S74. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | S69

Critical steps in developing professional standards for the International Continence Society
346

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| ROSIER ROSIER

TABLE 1 “General” (not specific) ICS standardization documents with publication year and between brackets, a double or triple publication are TABLE
showed
Scopus
Scopus EXPORT DATE: 15 May 2018 searched quote: “standard* lower urinary tract function” Bates C
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A. The 2002 (1) Cited 4360 Stand
standardization of terminology of lower urinary tract function: Report from the standardization sub-committee times. mictu
of the international continence society (2002) Neurourology and Urodynamics, 21 (2), pp. 167–178. CON
Bump, RC, Mattiasson, A, Bo, K, Brubaker, LP, DeLancey, JOL, Klarskov, P, Shull, BL, Smith, ARB. The “ICS Cited 2616 Bates P
standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction (1996) American approved” times. Stand
Journal of Obstetrics and Gynecology, 175 (1), pp. 10–17. Cont
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A.The 2002 (2) Cited 1583 Abrams
standardization of terminology in lower urinary tract function: Report from the standardization sub-committee times. stand
of the International Continence Society (2003) Urology, 61 (1), pp. 37–49. inves
Good Urodynamic Practices: Uroflowmetry, filling cystometry, and pressure-flow studies (2002) Neurourology Cited 1006 testin
and Urodynamics, 21 (3), pp. 261–274. times. May

Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract 1988 (1) Cited 951 Nevéus
function. The International Continence Society Committee on Standardization of Terminology. (1988) times. Yeun
Scandinavian Journal of Urology and Nephrology, Supplement, 114, pp. 5–19. adole
(ICC
Haylen, BT, De Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Cited 771
Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) times. Bates P
joint report on the terminology for female pelvic floor dysfunction (2010) International Urogynecology lowe
Journal, 21 (1), pp. 5–26. Anders
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A. The 2002 (3) Cited 607 urina
standardization of terminology of lower urinary tract function: Report from the Standardization Sub- times. and N
committee of the International Continence Society (2002) American journal of obstetrics and gynecology, 187 Abrams
(1), pp. 116–126. stand
Griffiths D, Hofner K, Van Mastrigt R, Rollema HJ, Spangberg A, Gleason D. Standardization of terminology of Cited 324 inves
lower urinary tract function: Pressure-flow studies of voiding, urethral resistance, and urethral obstruction times. testin
(1997) Neurourology and Urodynamics, 16 (1), pp. 1–18. Bates P
Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract 1988 (1) Cited 305 Prod
function recommended by the international continence society (1990) International Urogynecology Journal, 1 times. Augu
(1), pp. 45–58. Bates P
Bates P, Bradley WE, Glen E, Griffiths D, Melchior H, Rowan D, Sterling A, Zinner N, Hald T. The Cited 233 termi
standardization of terminology of lower urinary tract function (1979) Journal of Urology, 121 (5), pp. 551– times units
554.. The third
First Report on the Standardization of Terminology of Lower Urinary Tract Function: PRODUCED BY THE Cited 215
INTERNATINAL CONTINENCE SOCIETY, FEBRUARY, 1975 (1976) British Journal of Urology, 48 (1), times.
pp. 39–42. urodyn
Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig Sø, Vande Walle J, Von Gontard A, Cited 193 aim, as
Wright A, Yang SS, Nevéus T. The standardization of terminology of lower urinary tract function in children times. (ICS)]
and adolescents: Update report from the standardization committee of the international children's continence “standa
society (2014) Journal of Urology, 191 (6), pp. 1863–1865.
functio
The standardization of terminology of lower urinary tract function (1990) BJOG: An International Journal of Cited 118 diverse
Obstetrics & Gynecology, 97, pp. 1–16. times.
develop
Glen ES, Bradley WE, Melchior H, Rowan D, Sterling AM, Sundin T, Thomas D, Torrens M, Warwick RT, Cited 90 ments
Zinner NR, Chairman TH. Fourth Report on the Standardization of Terminology of Lower Urinary Tract times.
urinary
Function: Terminology related to neuromuscular dysfunction of the lower urinary tract: PRODUCED BY
express
THE INTERNATIONAL CONTINENCE SOCIETY (1981) British Journal of Urology, 53 (4), pp. 333–335.
ments h
Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract 1998-9 (3) Cited 52
function − Produced by the international continence society committee on standardization of terminology times.
(1989) World Journal of Urology, 6 (4), pp. 233–245.
Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle J.V, Von Gontard A, Wright A, Cited 47
2 | M
Yang SS, Nevéus T. The standardization of terminology of lower urinary tract function in children and times.
adolescents: Update report from the standardization committee of the International Children's Continence A narr
Society (2016) Neurourology and Urodynamics, 35 (4), pp. 471–481. standar
(Continues) is prese

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2. Fundamentals
 347

ROSIER ROSIER
| S71

ation are TABLE 1 (Continued)

Scopus EXPORT DATE: 15 May 2018 searched quote: “standard* lower urinary tract function”
Bates CP, Bradley WE, Glen ES, Griffiths D, Melchior H, Rowan D, Sterling A, Hald T. Third Report on the 1977 (3) Cited 43
4360 Standardization of Terminology of Lower Urinary Tract Function: Procedures related to the evaluation of times.
es. micturition: Pressure-flow relationships. Residual urine: PRODUCED BY THE INTERNATIONAL
CONTINENCE SOCIETY, FEBRUARY 1977* (1980) British Journal of Urology, 52 (5), pp. 348–350.
2616 Bates P, Bradley WE, Glen E, Griffiths D, Melchior H, Rowan D, Sterling AM, Zinner N, Hald T. 1977 (4) Cited 34
es. Standardization of terminology of lower urinary tract function First and second reports: International times.
Continence Society (1977) Urology, 9 (2), pp. 237–241.
1583 Abrams P, Blaivas JG, Stanton SL, Andersen JT, Fowler CJ, Gerstenberg T, Murray K. Sixth report on the 1985 (1) Cited 26
es. standardization of terminology of lower urinary tract function. Procedures related to neurophysiological times.
investigations: electromyography, nerve conduction studies, reflex latencies, evoked potentials and sensory
1006 testing. The International Continence Society Committee on Standardization of Terminology, New York,
es. May 1985. (1986) Scandinavian Journal of Urology and Nephrology, 20 (3), pp. 161–164.

951 Nevéus T, Von Gontard A, Hoebeke P, Hjälmas K, Bauer S, Bower W, Jørgensen TM, Rittig S, Van De Walle J, Cited 20
es. Yeung, C-K, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and times.
adolescents: Report from the Standardization Committee of the International Children's Continence Society
(ICCS) (2007) Neurourology and Urodynamics, 26 (1), pp. 90–102.
771
es. Bates P, Bradley WE, Glen E, Melchior H, Rowan D, Sterling A, Hald T. The standardization of terminology of Cited 15
lower urinary tract function (1976) European Urology, 2 (6), pp. 274–276. times.
Andersen JT, Blaivas JG, Cardozo L, Thuroff J. Seventh report on the standardization of terminology of lower Cited 14
607 urinary tract function: Lower urinary tract rehabilitation techniques (1992) Scandinavian Journal of Urology times.
es. and Nephrology, 26 (2), pp. 99–106.
Abrams P, Blaivas JG, Stanton SL, Andersen JT, Fowler CJ, Gerstenberg T, Murray K. Sixth report on the 1985-6 (2) Cited 9
standardization of terminology of lower urinary tract function − Procedures related to neurophysiological times.
324 investigations: Electromyography, nerve conduction studies, reflex latencies, evoked potentials and sensory
es. testing (1986) World Journal of Urology, 4 (1), pp. 2–5.
Bates P, Rowan D, Glen E. Second report on the standardization of terminology of lower urinary tract function. 1977 (2) Cited 8
305 Produced by the International Continence Society committee on standardization of terminology Copenhagen, times.
es. August 1976 (1977) European Urology, 3 (3), pp. 168–170.
Bates P, Bradley WE, Glen E, Melchior H, Rowan D, Sterling A Hald T. First report on the standardization of 1977 (1) Cited 7
233 terminology of lower urinary tract function: Incontinence, cystometry, urethral closure pressure profile and times.
es units of measurement (1977) Urologia Internationalis, 32 (2–3), pp. 81–87.

The third column shows the number of citations to the specific document as obtained from Scopus.com (May 2018).
215
es.
urodynamic studies . . . treating related disorders.”3 To this the scientific relevance of the published manuscripts of ICS
193 aim, as a logical consequence, “. . . to set it [the new society standards.
es. (ICS)] on the way to becoming a professional body”3 a
“standardization of terminology of lower urinary tract
3 | RESULTS
function” was developed and published simultaneously in
118 diverse journals.4 Terms for urodynamic observations were
es. 2.1 | Standard for standards
developed since then and refined, together with improve-
90 ments in the techniques used to objectively measure lower Early standards in health care have been eloquence based. A
es.
urinary tract functions, independent from the patients group of renowned experts sat together and developed the text
expression of symptoms. New ICS standardization docu- of the standard, on the basis of their knowledge. That actual
ments have been published in the years that followed. knowledge failed against big data was demonstrated in the
52
late 1960s. A clinical epidemiological book discussed the
es.
complexity of medical decision making, and was the starting
47
2 | MATERIAL AND METHODS point for nowadays clinical epidemiology. Clinical epidemi-
es. ology became a tool to be the more reliable basis for (more)
A narrative review of the evolution of the process of systematic diagnosis and management.5 This clinical epide-
standardization in healthcare, in general and specific for ICS miology, and systematic reviewing of research data were
nues) is presented. Scopus—website counts are used to demonstrate deployed into evidence based medicine later.6

Critical steps in developing professional standards for the International Continence Society
348

S72
| ROSIER ROSIER

Also early ICS standards have been developed in the “good and has also defined an implementation stage.7 An idea for a Objecti
old boys sat around the table” (GOBSAT)—manner. In 2012, new standard should be proposed to the ICS standardization system
however, the ICS standardization committee has published a steering committee who will establish an opinion- and and Ox
standard to deviate from GOBSAT and to introduce—evidence background-balanced working group with a chairperson. applica
based-(healthcare and) ICS standards.7 This manuscript The “balance,” referred to in the standard7 includes that the this pro
highlights also that the ICS standardization committee had background should as diverse as possible, around the topic of danger
modernized itself and became a standardizing steering the standardization, not only in opinion and profession but also overest
committee, with the aim to oversee and guide (ad hoc) including partnership of other organizations (outside ICS) of the e
working groups to deliver new ICS standards. The renewed when that is deemed potentially rewarding. The working exampl
process and structure of standards production were defined, to group, when established, searches for relevant evidence and allowin
ensure careful inclusion of evidence in the standard and to makes summaries of answers for clinical questions associated poor te
explicitly grade evidence and also indicate expert opinion with the topic of the standard. Terms may also be searched for respons
where evidence is lacking. In summary of the earlier published existence in scientific databases or in the, here above the dem
document, the process consists of a proposal stage, a mentioned, international nomenclature—sets, or medical of repo
preparatory stage, a committee stage and an approval stage dictionaries, before introduction in the (new) standard. variatio
the app
terms a
TABLE 2 The top ranking documents with (clinical OR practice) standard* in the title with the number of citations to the specific document Sensitiv
(may 2018) are showed prevent
Scopus EXPORT DATE: 15 May 2018 Search quote: “Standard*”- in Title. evidenc
Standardization of spirometry (2005) European Respiratory Journal, 26 (2), pp. 319–338. Cited 6495 terms. F
times. draft st
Standardization of spirometry: 1994 Update (1995) American Journal of Respiratory and Critical Care Medicine, 152 (3), Cited 5248 for mis
pp. 1107–1136. times. Details
Bone histomorphometry: Standardization of nomenclature, symbols, and units: Report of the asbmr histomorphometry Cited 4397 essentia
nomenclature committee (1987) Journal of Bone and Mineral Research, 2 (6), pp. 595–610. times. membe
The standardization of terminology of lower urinary tract function: Report from the standardization sub-committee Cited 4360 invited
of the international continence society (2002) Neurourology and Urodynamics, 21 (2), pp. 167–178. times. meeting
The consortium to establish a registry for Alzheimer's disease (CERAD). Part II. Standardization of the neuropathologic Cited 3495 exampl
assessment of Alzheimer's disease(1991) Neurology, 41 (4), pp. 479–486. times. and ma
The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction (1996) American Journal of Cited 2616 present
Obstetrics and Gynecology, 175 (1), pp. 10-17 times. standar
Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Cited 2523
Community for Steel and Coal. Official Statement of the European Respiratory Society. (1993) The European respiratory times.
3.2 | S
journal. Supplement, 16, pp. 5-40
Standard of spirometry- 1987 update. Statement of the American Thoracic Society. (1987) The American review of Cited 2070 The Int
respiratory disease, 136 (5), pp. 1285–1298. times. most c
Design and standardization of PCR primers and protocols for detection of clonal immunoglobulin and T cell receptor gene Cited 1834 number
recombinations in suspect lymphoproliferations: Report of the BIOMED 2 concerted action BMH4- CT98-3936 (2003) times. the bas
Leukemia, 17 (12), pp. 2257–2317. May 15
The standardization of terminology in lower urinary tract function: Report from the standardization sub- committee Cited 1583 the 200
of the International Continence Society (2003) Urology, 61 (1), pp. 37–49. times. with “p
A Specific Laboratory Test for the Diagnosis of Melancholia: Standardization, Validation, and Clinical Utility (1981) Cited 1579 when th
Archives of General Psychiatry, 38 (1), pp. 15-22 times. are gro
Revised Recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment Cited 1471 6650 c
outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia (2003) Journal of Clinical Oncology, times. day sin
21 (24), pp. 4642–4649.
Standardization of uveitis nomenclature for reporting clinical data. Results of the first international workshop (2005) Cited 1435
American Journal of Ophthalmology, 140 (3), pp. 509-516 times. 4 | D
A working formulation for the standardization of nomenclature in the diagnosis of heart and lung rejection: Heart rejection Cited 1301
study group (1990) Journal of Heart Transplantation, 9 (6), pp. 587-592 times. The mo
When the number of citations to the three versions of the 2002 document are added (4360 + 1583 + 607), 3th not shown, see Table 1), the total of 6650 would rank this
basis fo
document number 1 clinical standard in healthcare. Note also that the number 6 document is an “ICS-collaboration-endorsed” standard. of car

ICS Standards 2019

2. Fundamentals
 349

ROSIER ROSIER
| S73

ea for a Objective evidence for management in new standard should be dysfunction as has been aimed in 1971. Objective assessment
dization systematically gathered with structured searches of literature of dysfunction meets patients expectations also (or espe-
n- and and Oxford grading. Theoretically a Delphi process would be cially?) to date.11 Modern era healthcare, however, also
person. applicable for sub-topics where evidence is lacking, however, demands, more than in the early days of ICS, that patients
that the this procedure is not without pitfalls, for example, has the quality of life and well-being are taken into account and that
topic of danger of devaluating to the “old GOBSAT” manner,8,9 by minimal or not invasive management is recommended to them,
but also overestimation of the experts knowledge8 and underestimation where possible. Not only terms and techniques for objective
de ICS) of the existence of evidence. Potential other pitfalls are, for assessment and diagnosis should be renewed, in an evidence
working example, imposing preconceptions of a problem and not based fashion, also the assessment of the patients well-being
nce and allowing for the contribution of other related perspectives; deserves evidence based standardization. Furthermore
sociated poor techniques of summarizing and presenting the group standards for management may lead the way to improvements.
ched for responses; not exploring disagreements and; underestimating The ICS standard for standardization may become the basis for
above the demanding nature of a Delphi.8 A recent systematic review systematic evidence based documents to enforce the Interna-
medical of reports based on the Delphi method found substantial tional Consultation on Incontinence management recommen-
andard. variation in quality as consequence of lack of rigorousness of dations12 and may also expand to management of lower
the application of the process.9 Ultimately the (new) standard urinary tract dysfunctions without urinary incontinence.
terms are selected on the basis of arguments made transparent.
ocument Sensitive and systematic searching for existing evidence 5 | CONCLUSION
prevents reinvention of knowledge and has to provide the
evidence base for the practice recommendations or for the Standardization prevents miscommunication and therefore
495 terms. Finally the members and board of the ICS will see the mismanagement, also in healthcare. ICS started with standardi-
. draft standard and control, for process and structure, but also zation, based on scientific progress and development and has
248 for missed evidence that may change the recommendations. continued this, in the lead, for almost 50 years. ICS Standardiza-
. Details of this process are given in the original publication but tion is now standardized within the framework of Evidence Based
397 essentially the draft document is made available for all ICS Medicine and apart from further standardization of urodynamic
. members via the ICS website, and is also submitted to internal assessment and evidence based objective pelvic floor muscle
360 invited peer review and or discussed during an annual society function evaluation standardization of quality of life assessment
. meeting. The finally approved standard is published and, for as well as standards for management may be future goals.
495 example, relevant committees can take out relevant elements
. and make these into educational modules to be published as
616 presentation on the ICS website to enhance implementation of CONFLICT OF INTEREST
. standard good practice and terms by education.
No.
523
.
3.2 | Scientific relevance
ORCID
070 The International Continence Society has produced one of the
Peter F. W. M. Rosier http://orcid.org/0000-0003-0445-
. most cited standards in healthcare.10 Table 1 shows the
4563
834 number of citations for the most “general” ICS standards on
. the basis of the counts given in Scopus.com website on
May 15, 2018. Table 2 shows that the number of citations to
583 the 2002 standardization document exceeds all documents REFERENCES
. with “practice guideline” or “practice standard” in the title 1. https://mars. jpl.nasa.gov/msp98/news/mco990930.html.
579 when the three versions of the 2002 document (see Table 1) 2. Chute CG. Clinical classification and terminology: some history
. are grouped. (source: scopus.com). The references total of and current observations. J Am Med Inform Assoc. 2000;7:298–303.
471 6650 contains that the document is referred to every single 3. Arnold T, Glenn E, Zinner N. The First 40 Years, History of ICS.
. day since its publication. Bristol, UK: Conticom Limited; 2011.
4. No authors listed. First report on the standardisation of terminology
435 of lower urinary tract function. Br J Urol. 1976;48:39–42. Report
published also in other journals: Bates et al.
. 4 | DISCUSSION
5. Feinstein AR. Clinical Judgement. Baltimore: Williams & Wilkins;
301
1967.
. The modern era standards should aim at that level and be the 6. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS.
d rank this
basis for good practice. ICS is still leading in the development Evidence based medicine: what it is and what it isn't. BMJ.
of careful objective assessment of lower urinary tract 1996;312:71–72.

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S74
| ROSIER

7. Rosier PF, de Ridder D, Meijlink J, Webb R, Whitmore K, Drake 11. Makanjee CR, Bergh AM, Hoffmann WA. Healthcare provider and
MJ. Developing evidence-based standards for diagnosis and patient perspectives on diagnostic imaging investigations. Afr J
management of lower urinary tract or pelvic floor dysfunction. Prim Health Care FamnMed. 2015;7:art#801.
Neurourol Urodyn. 2012;31(5):621–624. 12. Abrams P, Andersson KE, Birder L, et al. Fourth International
8. The Delphi Method: Techniques and Applications. In: Linstone HA, Consultation on Incontinence Recommendations of the Interna-
Turoff M, eds. Addison-Wesley Pub. Co., Advanced Book tional Scientific Committee: evaluation and treatment of urinary
Program; 1975. University of Michigan, ISBN0201042940, incontinence, pelvic organ prolapse, and fecal incontinence.
9780201042948 (digitalized august 27 2007). https://web.njit. Neurourol Urodyn. 2010;29:213–240.
edu/~turoff/pubs/delphibook/delphibook.pdf
9. Jünger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance
on Conducting and REporting DElphi Studies (CREDES) in How to cite this article: Rosier PFWM. Critical
palliative care: recommendations based on a methodological
steps in developing professional standards for the
systematic review. Palliat Med. 2017;31:684–706.
10. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology
International Continence Society. Neurourology and
in lower urinary tract function: report from the standardisation sub- Urodynamics. 2018;37:S69–S74.
committee of the International Continence Society. Urology. https://doi.org/10.1002/nau.23779
2003;61:37–49. Review. PubMed PMID: 12559262.

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2. Fundamentals
 351

3. THE INTERNATIONAL CONSULTATION ON

INCONTINENCE ALGORITHMS
Since its inception in 1998, the International Consultation on Incontinence, now in its 6th iteration, has
brought together many of the worlds leading experts to produce a unique scholarly knowledge syn-
thesis of scientific work in the field of continence. Viewed by many senior and junior academics and
clinicians as the “bible” of continence, the 6th edition is part of a productive partnership with the Interna-
tional Continence Society, seen by many as the “natural” home of the consultation. Its 23 or so chapters
cover the range of scientific endeavour, from fundamental cellular mechanisms underlying incontinence
and pelvic floor dysfunction to applied research in policy and health services research. In addition to
providing an expert view of the state of the science, each committee rigorously examines the latest sci-
entific evidence using the Oxford Grading system to produce recommendations for research and clinical
practice in its areas of focus.

Each committee’s findings were presented to a wide audience of ICS members at the 2016 ICS Annu-
al Scientific Meeting in Tokyo where feedback was offered and considered prior to publication of the
book “Incontinence”. As part of its work, committees with a clinical focus produce an evidence informed
algorithm for assessment and care for both initial and specialist assessment and management. The al-
gorithms and their accompanying notes are published in Neurourology and Urodynamics as part of the
Scientific Report from the Consultation1 and are reproduced here as part of the programme of knowl-
edge dissemination for the Consultation. Clearly production of such work is irrelevant without use, we
therefore hope that you use these algorithms in practice and in presentation form in order to enhance to
promote the highest quality of clinical care to patients.

Adrian Wagg
ICI Editor

on behalf of the Editors of the ICS and the ICS-ICI Steering Committee

1. Abrams P, Andersson KE, Apostolidis A, Birder L, Bliss D, Brubaker L, et al. 6th International Con-
sultation on Incontinence. Recommendations of the International Scientific Committee: EVALUATION
AND TREATMENT OF URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND FAECAL INCONTINENCE.
Neurourol Urodyn. 2018 Sep;37(7):2271-2.
352

6th International Consultation on

2017 Incontinence
Co-sponsored by
InternatIonal ConsultatIon on Recommendations of the
Urological DIseases (ICUD)
International Continence
International scientific
Society (ICS) Committee:
In collaboration with
major international
associations of urology,
gynaecology and EVALUATION AND TREATMENT
urodynamics
and other medical
OF URINARY INCONTINENCE,
associations PELVIC ORGAN PROLAPSE
AND FAECAL INCONTINENCE
P. Abrams, K-E. Andersson, A. Apostolidis,
L. Birder, D. Bliss, L. Brubaker, L. Cardozo,
D. Castro, P.R. O’Connell, A. Cottenden,
N. Cotterill, D. de Ridder, R. Dmochowski,
C. Dumoulin, M. Fader, C. Fry, H. Goldman,
P. Hanno, Y. Homma, V. Khullar, C. Maher,
I. Milsom, D. Newman, J.M. Nijman,
K. Rademakers, D. Robinson, P. Rosier,
E. Rovner, S. Salvatore, M. Takeda, A. Wagg,
T. Wagner, A. Wein

and the members of the committees

INTRODUCTION
The 6th International Consultation on Incontinence met between September 13-15th 2016 in Tokyo and was
organised by the International Consultation on Urological Diseases and the International Continence Society
(ICS), in order to develop consensus statements and recommendations for the diagnosis, evaluation and treat-
ment of urinary incontinence, faecal incontinence, pelvic organ prolapse and bladder pain syndrome.
The consensus statements are evidence based following a thorough review of the available literature and the
global subjective opinion of recognised experts serving on focused committees. The individual committee re-
ports were developed and peer reviewed by open presentation and comment. The Scientific Committee, con-
sisting of the Chairs of all the committees then refined the final consensus statements.These consensus state-
ments published in 2017 will be periodically reevaluated in the light of clinical experience, technological pro-
gress and research.

2549

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3. The International Consultation on Incontinence Algorithms
 353

CONTENTS

1. DEFINITIONS 2551
2. EVALUATION 2552
3. MANAGEMENT CONSENSUS STATEMENTS 2557

I. URINARY INCONTINENCE IN CHILDREN 2559

II. URINARY INCONTINENCE IN MEN 2564

III. URINARY INCONTINENCE IN WOMEN 2568

IV. FISTULAE 2572

V. PELVIC ORGAN PROLAPSE 2577

VI. URINARY INCONTINENCE IN NEUROLOGICAL PATIENTS 2582

VII. BLADDER PAIN SYNDROME 2587

VIII. FAECAL INCONTINENCE IN ADULT PATIENTS 2592

IX. FAECAL INCONTINENCE IN NEUROLOGICAL PATIENTS 2597

X. URINARY AND FAECAL INCONTINENCE IN FRAIL OLDER MEN AND WOMEN 2601

4. RECOMMENDATIONS FOR FURTHER RESEARCH IN EPIDEMIOLOGY 2606

5. RECOMMENDATIONS FOR FURTHER BASIC SCIENCE RESEARCH 2607
6. RECOMMENDATIONS FOR PRIMARY PREVENTION, CONTINENCE PROMOTION, MODELS OF
CARE AND EDUCATION 2608
7. RECOMMENDATIONS FOR TRANSLATIONAL AND CLINICAL RESEARCH 2610
8. INTERNATIONAL CONSULTATION ON INCONTINENCE MODULAR QUESTIONNAIRE (ICIQ):
QUESTIONNAIRES AND BLADDER DIARY 2613

2550

Evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence
354

1. DEFINITIONS

The consultation agreed to use the current Interna- Detrusor overactivity is divided into:
tional Continence Society definitions (ICS) for lower
urinary tract dysfunction (LUTD) including inconti- o Idiopathic Detrusor Overactivity, defined
nence, except where stated. These definitions were as overactivity when there is no clear cause
published in the journal Neurourology and Urodynam- o Neurogenic Detrusor Overactivity is de-
ics (2002; 21:167-178 and 2006; 25: and can be fined as overactivity due to a relevant neu-
viewed on the ICS website: www.ics.org rological condition.
The following ICS definitions are relevant: • Urodynamic stress incontinence is noted dur-
ing filling cystometry, and is defined as the invol-
1. LOWER URINARY TRACT untary leakage of urine during increased ab-
dominal pressure, in the absence of a detrusor
SYMPTOMS (LUTS) contraction.

LUTS are divided into storage and voiding symptoms. 3. BLADDER PAIN SYNDROME
Urinary incontinence is a storage symptom and de-
fined as the complaint of any involuntary loss of urine. Bladder pain syndrome is defined by ESSIC as
This definition is suitable for epidemiological studies, chronic pelvic pain, pressure or discomfort of greater
but when the prevalence of bothersome incontinence than 6 months duration perceived to be related to the
is sought, the previous ICS definition of an “Involun- urinary bladder accompanied by at least one other
tary loss of urine that is a social or hygienic problem“, urinary symptom like persistent desire to void or uri-
can be useful. nary frequency. Confusable diseases as the cause
of the symptoms must be excluded.
Urinary incontinence may be further defined accord-
ing to the patient’s symptoms
4. PELVIC ORGAN PROLAPSE
• Urgency Urinary Incontinence is the complaint
of involuntary leakage accompanied by or imme-
diately preceded by urgency. • Urogenital prolapse is defined as the sympto-
matic descent of one or more of: the anterior vag-
• Stress Urinary Incontinence is the complaint of inal wall, the posterior vaginal wall, and the apex
involuntary leakage on effort or exertion, or on of the vagina (cervix/uterus) or vault (cuff) after
sneezing or coughing. hysterectomy. Urogenital prolapse is measured
using the POP-Q system.
• Mixed Urinary Incontinence is the complaint of
involuntary leakage associated with urgency, • Rectal prolapse is defined as circumferential full
and also with effort, exertion, sneezing and thickness rectal protrusion beyond the anal mar-
coughing. gin.

• Nocturnal Enuresis is any involuntary loss of

urine occurring during sleep.
5. ANAL INCONTINENCE
• Post-micturition dribble and continuous uri- Anal incontinence defined as “any involuntary loss
nary leakage denotes other symptomatic forms of faecal material and/or flatus and/or mucus” and
of incontinence. may be divided into:
Overactive bladder is characterised by the storage • Faecal incontinence, any involuntary loss of
symptoms of urgency with or without urgency in-con- faecal material
tinence, usually with frequency and nocturia.
• Flatus incontinence, any involuntary loss of gas
2. URODYNAMIC DIAGNOSIS (flatus)
• Mucus incontinence, any involuntary loss of
• Detrusor Overactivity is a urodynamic observa- mucus only (not faeces)
tion characterised by involuntary detrusor con-
* At the time of this consultation, these definitions are
tractions during the filling phase, which may be
not included in the current ICS terminology.
spontaneous or provoked.

DEFINITIONS 2551

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3. The International Consultation on Incontinence Algorithms
 355

2. EVALUATION

The following phrases are used to classify diagnos-

tic tests and studies: 1. HISTORY AND GENERAL
• A highly recommended test is a test that should ASSESSMENT
be done on every patient.
Management of a disease such as incontinence re-
• A recommended test is a test of proven value quires caregivers to assess the sufferer in a holis- tic
in the evaluation of most patients and its use is manner. Many factors may influence a particular indi-
strongly encouraged during evaluation. vidual’s symptoms, some may cause incontinence,
• An optional test is a test of proven value in the and may influence the choice and the success of
evaluation of selected patients; its use is left to treatment. The following components of the medical
the clinical judgement of the physician history are particularly emphasised:

• A not recommended test is a test of no proven 1.1. Review of Systems:

value. • Presence, severity, duration and bother of any
urinary, bowel or prolapse symptoms. Identifying
This section primarily discusses the Evaluation of Uri- symptoms in the related organ systems is critical
nary Incontinence with or without Pelvic Organ Pro- to effective treatment planning. The use of vali-
lapse (POP) and Faecal Incontinence. dated questionnaires to assess symptoms are
recommended.
The recommendations are intended to apply to chil-
dren and adults, including healthy persons over the • Effect of any symptoms on sexual function: vali-
age of 65. dated questionnaires including impact on quality
of life are a useful part of a full assessment.
These conditions are highly prevalent but often not
reported by patients. Therefore, the Consultation • Presence and severity of symptoms suggesting
strongly recommends case finding, particularly in neurological disease
high risk groups.
1.2. Past Medical History:
A. HIGHLY RECOMMENDED • Previous conservative, medical and surgical
treatment, in particular, as they affect the genito-
TESTS DURING INITIAL urinary tract and lower bowel. The effectiveness
EVALUATION and side effects of treatments should be noted.
• Coexisting diseases may have a profound effect
The main recommendations for this consultation on incontinence and prolapse sufferers, for ex-
have been abstracted from the extensive work of the ample asthma patients with stress incontinence
23 committees of the 6th International Consultation will suffer greatly during attacks. Diseases may
on Incontinence (ICI, 2016). also precipitate incontinence, particularly in frail
older persons.
Each committee has written a report that reviews and
evaluates the published scientific work in each field of • Patient medication: it is always important to re-
interest in order to give Evidence Based recommen- view every patient’s medication and to make an
dations. Each report ends with detailed recommenda- assessment as to whether current treatment may
tions and suggestions for a programme of research. be contributing to the patient’s condition.

The main recommendations should be read in con- • Obstetric and menstrual history.
junction with the management algorithms for children, • Physical impairment: individuals who have com-
men, women, the frail older person, neurogenic pa- promised mobility, dexterity, or visual acuity may
tients, bladder pain, pelvic organ prolapse, and anal need to be managed differently
incontinence
1.3. Social History:
The initial evaluation should be undertaken, by a cli-
nician, in patients presenting with symptoms/ signs • Environmental issues: these may include the so-
suggestive of these conditions. cial, cultural and physical environment.

2552 RECOMMENDATIONS OF THE INTERNATIONAL SCIENTIFIC COMMITTEE

Evaluation
356

• Lifestyle: including exercise, smoking and the • Bimanual pelvic and anorectal examination for
amount and type of fluid and food intake. pelvic mass,
1.4. Other Treatment Planning Issues: • Digital rectal examination to assess pelvic floor
muscle function and the function of internal and
• Desire for treatment and the extent of treatment external anal sphincter as well as puborectalis
that is acceptable muscle.
• Patient goals and expectations of treatment • Stress test for urinary incontinence.
• Patient support systems (including caregivers). 2.4. Neurological testing (see chapter on
• Cognitive function: all individuals need to be assessment)
assessed for their ability to fully describe their
symptoms, symptom bother and quality of life im- 3. URINALYSIS
pact, and their preferences and goals for care.
They must be able to understand proposed man-
In patients with LUTS, the possibility of a urinary tract
agement plans and to discuss, where appropri-
infection should be evaluated, with appropriate test-
ate, alternative treatment options. In some groups
ing (ranging from dipstick to urine microscopy and
of patients, formal testing is essential e.g. cogni-
culture when indicated as UTI is a readily detected,
tive function testing for individuals for whom the
and easily treatable cause of LUTS,
clinician has concerns regarding memory deficits
and/or inattention or confusion, and depression
Conclusion
screening for individuals for whom the clinician
has concerns about abnormal affect. Proxy re- For simple treatments, particularly non- invasive and
spondents, such as family and caregivers, may inexpensive therapies, management may start with-
be used to discuss the patient’s history, goals of out the need for the further investigations listed be-
care, and treatment for individuals with dementia, low.
but only if the individual is incapable of accurate
reporting or weighing treatment decisions.
B. RECOMMENDED FURTHER
2. PHYSICAL EXAMINATION ASSESSMENT PRIOR TO, OR
The more complicated the history and the more ex-
DURING, SPECIALIST
tensive and/or invasive the proposed therapy, the ASSESSMENT
more complete the examination needs to be. De-
pending on the patient’s symptoms and their severity,
The tests below are recommended when the appro-
there are a number of components in the examination
priate indication(s) is present. Some recom-
of patients with incontinence and/or pelvic organ pro-
mended tests become highly recommended in spe-
lapse.
cific situations.
Physical examination should be performed regard-
This section should also be read in conjunction with
less of whether the patient is a child, a woman, a man,
the relevant committee reports.
someone with neurological disease or a frail elderly
person.
1. FURTHER SYMPTOM AND
2.1. General status:
HEALTH-RELATED QOL
• Mental status
ASSESSMENT
• Obesity (BMI)
• Physical dexterity and mobility 1.1. Bladder Diary
2.2. Abdominal/flank examination: for In patients with urinary symptoms the use of a blad-
masses, bladder distention, relevant sur- der diary (examples in Annex 1) is highly recom-
gical scars mended to document the frequency of micturition, the
volumes of urine voided, incontinence episodes and
2.3. Pelvic examination: the use of incontinence pads.
• Examination of the perineum and external geni- 1.2. Questionnaires
talia including tissue quality and sensation.
The use of the highest quality questionnaires (GoR
• Vaginal (half-speculum/Sims) examination for A, where available) is recommended for the assess-
pelvic organ prolapse (POP), which should be ment of the patient’s perspective of symptoms of in-
done in the vertical position continence and their impact on quality of life.

EVALUATION 2553

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3. The International Consultation on Incontinence Algorithms
 357

The ICIQ is highly recommended (GoR A) for the • Urodynamic studies which show evidence of
basic evaluation of the patient’s perspective of urinary poor bladder compliance or high pressure detru-
incontinence, with other GoR A questionnaires rec- sor overactivity.
ommended for more detailed assessment. Further
development is required in the areas of pelvic or- 6. INVESTIGATIONS IN FAECAL
gan prolapse, bladder pain syndrome, and for specific
patient groups, as only GoR B questionnaires are cur- INCONTINENCE AND RECTAL
rently available (see Assessment Chapter).
PROLAPSE
2. RENAL FUNCTION ASSESSMENT
• Endoanal US or MRI prior to anal sphincter sur-
gery is highly recommended, even when obvious
Standard biochemical tests for renal function are rec- anatomic defects are not evident.
ommended in patients with urinary incontinence
when there is the possibility of renal impairment. • Defaecating proctography or dynamic MRI is rec-
ommended in suspected rectal prolapse which
3. UROFLOWMETRY cannot be adequately confirmed by physical ex-
amination.
Uroflowmetry with the measurement of post void re- • Anorectal manometry is useful to assess resting
sidual urine is recommended as a screening test for and squeeze anal pressures. The resting and
symptoms suggestive of urinary voiding dysfunction squeeze pressures represent the function of the
or physical signs of POP or bladder distension. internal and external anal sphincter, respectively.
Uroflowmetry should be part of the initial assessment
if the result is likely to influence management eg in 7. ENDOSCOPY
older men with possible prostatic obstruction.
Although routine cysto-urethroscopy is not recom-
4. ESTIMATION OF POST VOID mended, LUT endoscopy is highly recommended:
RESIDUAL URINE (PVR) • When initial testing is abnormal, e.g. haematuria
and suggests other pathologies,
In patients with suspected voiding dysfunction, PVR
should be part of the initial assessment if the result is • When pain or discomfort feature in the patient’s
likely to influence management, for example, in neu- LUTS, these may suggest an intravesical lesion
rological patients. • When appropriate in the evaluation of vesicovag-
inal fistula and extra-urethral urinary inconti-
5. IMAGING nence (in childbirth fistulae, endoscopy is often
unnecessary).
Although routine imaging is not recommended, imag- In anorectal conditions, proctoscopy or flexible sig-
ing of the lower urinary tract and pelvis is highly rec- moidoscopy should routinely be performed in the
ommended in those with urinary symptoms whose in- evaluation of patients with faecal incontinence. Co-
itial evaluation indicates a possible co- existing lower lonoscopy, air contrast barium enema or CT colog-
tract or pelvic pathology. Initial imaging may be by ul- raphy is highly recommended in the presence of un-
trasound, or plain X-ray. explained change in bowel habit, rectal bleeding or
Imaging of the upper urinary tract is highly recom- other alarm symptoms or signs (see Basic Assess-
mended in specific situations. These include: ment chapter).

• Haematuria, 8. URODYNAMIC TESTING

• Neurogenic urinary incontinence e.g. myelodys-
plasia, spinal cord trauma, 8.1. Urodynamic (multi channel pressure
subtracted cystometry) evaluation is
• Incontinence associated with significant post-
recommended
void residual,
• When the results may change management,
• Co-existing renal disease such as pyelonephritis
such as prior to most invasive treatments for UI
or reflux, or loin/kidney pain,
and POP,
• Severe pelvic organ prolapse, not being treated
• After treatment failure, if more information is
• Suspected extra-urethral urinary incontinence, needed in order to plan further therapy,

• Children with incontinence and UTIs, where indi-

cated

2554 RECOMMENDATIONS OF THE INTERNATIONAL SCIENTIFIC COMMITTEE

Evaluation
358

• As part of both initial and long-term surveillance If initial urodynamics have failed to demonstrate
programmes in some types of neurogenic lower the cause for the patient’s incontinence then the fol-
urinary tract dysfunction, lowing tests are optional:

• In “complicated incontinence” (for details please • Repeated routine urodynamics or video-urody-

see relevant subcommittee reports). namics
8.2. The aims of urodynamic evaluation are • Ambulatory urodynamics
often diagnostic, but may also relate to
prognostic factors, direct management 2. PAD TESTING
or assess response to prior therapy,
and also:
Pad testing is an optional test for the routine evalua-
• To reproduce the patient’s symptoms and corre- tion of urinary incontinence and, if carried out, a 24 hr
late these with urodynamic findings test is suggested.

• To assess bladder sensation

3. NEUROPHYSIOLOGICAL TESTING
• To detect detrusor overactivity AND IMAGING
• To assess urethral competence during filling
The information gained by clinical examination and
• To determine detrusor function during voiding
urodynamic testing may be enhanced by neuro-
• To assess outlet function during voiding physiological testing of striated muscle and nerv-
ous pathways.
• To assess residual urine
Appropriately trained personnel should perform these
tests. The following neuro-physiological tests can be
9. SMALL BOWEL FOLLOW- considered in patients with peripheral lesions prior to
THROUGH, CT ENTOGRAPHY OR treatment for lower urinary tract or anorectal dysfunc-
tion.
CAPSULE ENDOSCOPY
• Concentric needle EMG
These tests are recommended in those with faecal in- • Sacral reflex responses to electrical stimulation
continence and the presence of unexplained diar- of penile or clitoral nerves.
rhoea or when Crohn’s disease is suspected.
Imaging of the nervous system (and neighbouring
structures, including spine, the abdominal cavity and
C. FURTHER DIAGNOSTIC TESTS pelvis) by MRI or CT, may confirm suspected involve-
TO BE USED AS APPROPRIATE ment of the nervous system, and the nature of the
cause.

1. ADDITIONAL URODYNAMIC 4. FURTHER IMAGING

TESTING
Cysto-urethrography, US, CT and MRI may have an
indication:
Video-urodynamics may be useful in the manage-
ment of UI in children, in patients who fail surgery and • Suspected pelvic floor dysfunction
in some neurogenic patients, to obtain additional an-
atomical information. Either X-ray or US imaging can • Failed surgery, such as recurrent posterior vagi-
be used depending on the needs of the individual pa- nal wall prolapse or failed sling surgery
tient. • Suspected fixed urethra
If a more detailed estimate of urethral function is
required, then the following optional tests may give 5. CYSTO-URETHROSCOPY
useful information:
• Urethral pressure profilometry This is an optional test in patients with complicated,
persistent or recurrent UI (e.g. after failed SUI sur-
• Abdominal leak point pressures gery)
• Video-urodynamics
• Electromyography of pelvic floor or urethral
sphincter

EVALUATION 2555

ICS Standards 2019

3. The International Consultation on Incontinence Algorithms
 359

anorectal malformations and/or previous anal sphinc-

6. ANORECTAL PHYSIOLOGY ter surgery.
TESTING Defaecography may be useful and is recommended
in patients with faecal incontinence, who have failed
Endocoil MRI has high accuracy for detecting anal conservative therapies, and are possible candidates
sphincter injury but is second line after endoanal ul- for laparoscopic ventral rectopexy.
trasound. Patients with faecal incontinence may ben-
efit from assessment with MRI, particularly those with

2556 RECOMMENDATIONS OF THE INTERNATIONAL SCIENTIFIC COMMITTEE

Evaluation
360

3. MANAGEMENT CONSENSUS
STATEMENTS

The consensus statements are derived from the de- • Surgical therapy
tailed work in the committee reports on the man-
agement of incontinence in children, men, women, • Conservative therapy includes
the frail elderly and neurological patients, as well as o Lifestyle interventions e.g. weight loss
those with obstetric fistula, pelvic organ prolapse,
bladder pain syndrome, and faecal incontinence. The o Bladder training
management of incontinence is presented in algo-
rithm form with accompanying notes. o Pelvic floor muscle training (PFMT)

The chapters analyze the evidence and give it a level o Containment products e.g. pads
of evidence (LoE) and this generates a GoR of rec- o Dependent continence strategies eg regular
ommendation (GoR) toileting
The Consultation recognises that no algorithm Consensus does not exist as to the use of the term
can be applied to every patient and each patient’s “behavioural therapy” as some state that this term
management must be individualised. only includes bladder training and PFMT, whilst oth-
There are algorithms for ers consider that all conservative management con-
tains a behavioural element, for example wearing and
I. Urinary Incontinence in Children changing pads constitutes a change in behaviour.
Hence the consultations recommendations list the el-
II. Urinary Incontinence in Men ements of conservative management as relevant are
III. Urinary Incontinence in Women intended for use by all clinicians including health care
assistants/aides, nurses, physiotherapists, generalist
IV. Fistulae doctors and family doctors as well as by specialists
such as urologists, geriatricians and gynaecologists.
V. Pelvic Organ Prolapse
The consultation has attempted to phrase the recom-
VI. Urinary Incontinence in Neurological mendations in the basic algorithms in such a way that
Patients they may be readily used by clinicians in all countries
of the world, both in the developing and the devel-
VII. Bladder Pain Syndrome oped world.
VIII. Faecal Incontinence in Adults
The algorithms for initial management
IX. Urinary and faecal Incontinence in frail
Older Men and Women are intended for use by all clinicians including health
These algorithms are divided into two for groups I to care assistants/aides, nurses, physiotherapists, gen-
III, VII and X. The two parts, initial management and eralist doctors and family doctors as well as by spe-
specialised management require a little further ex- cialists such as urologists, geriatricians and gynae-
planation. cologists. The consultation has attempted to phrase
the recommendations in the basic algorithms in such
Although the management algorithms are designed a way that they may be readily used by clinicians in
for patients whose predominant problem is inconti- all countries of the world, both in the developing and
nence, there are many other patients in whom the al- the developed world.
gorithms may be useful such as those patients with
urgency and frequency, so-called “OAB dry The specialised algorithms
Management definitions
The specialised algorithems are intended for use by
Management may be divided into specialists. The specialised algorithms, as well as
the initial management algorithms are based on evi-
• Conservative, all methods that are non-medical dence where possible, and on the expert opinion
and non-surgical, some of which do not target the of the 400 healthcare professionals who took part in
disease process the Consultation. In this consultation, committees as-
cribed levels of evidence to the published work on the
• Medical (pharmacological) therapy

MANAGEMENT CONSENSUS STATEMENTS 2557

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3. The International Consultation on Incontinence Algorithms
 361

subject and devised GoRs of recommendation to in- In the initial management algorithms, treatment is
form patient management. empirically based, whilst the specialised manage-
ment algorithms usually rely on precise diagnosis
It should be noted that these algorithms, dated April from urodynamics and other testing.
2017, represent the Consultation consensus at that
time. Our knowledge, developing from both a re- The assumption is made that patients will be reas-
search base and because of evolving expert opinion, sessed at an appropriate time to evaluate their pro-
will inevitably change with time and relate to the gress.
unique context of individual patients seeking
care. The Consultation does not wish those using the 3. USE OF CONTINENCE PRODUCTS
algorithms to believe they are “carved in tablets of
stone”: there will be changes both in the relatively
short term and in the long term. The possible role of continence products to pre-
vent, contain and/or manage bladder and/or bowel
leakage should be considered at each stage of pa-
1. ESSENTIAL COMPONENTS OF tient assessment and treatment, to maintain dignity
BASIC ASSESSMENT and social functioning, and/or to support self-man-
agement or care by others.
Each algorithm contains a core of recommendations Consider temporary use of continence products:
in addition to a number of essential components of
basic assessment listed in sections I to III. • While treatment is awaited.
• In addition to treatment; for example using pads
• General assessment and/or urinals when taking anti-muscarinics or
carrying out pelvic floor exercises, until sufficient
• Symptom assessment
improvement is achieved.
• Assessment of quality of life impact
Consider permanent use of continence products:
• Assessment of the desire for treatment
• When treatment is not chosen or not suitable for
• Physical examination the individual

• Urinalysis • When treatment does not achieve (complete)

cure
• For intermittent use; for example when the pa-
tient has a cough, or needs to travel without reli-
2. JOINT DECISION MAKING able toilet access
• For continuous use if incontinence is unpredict-
The patient’s desires and goals for treatment: able and/or frequent or if complications related to
Treatment is a matter for discussion and joint decision incontinence (e.g. skin breakdown) are imminent
making between the patient and his or her health care or present
advisors. This process of consultation includes the
specific need to assess whether or not the patient Consider offering a mixture of continence products
wishes to receive treatment and, if so, what treat- (disposable/washable; absorbent/non-absorbent) to
ments he or she would favour. Implicit in this state- optimise effectiveness and to reduce costs; e.g. dif-
ment is the assumption that the health care provider ferent products for day and night; or for staying at
will give an appropriate explanation of the pa- home and for going out/travel/specific activities.
tient’s problem and the alternative lines of man-
Further guidance on management with continence
agement, and the potential benefits and risks of
products is given in Chapter 20 and at the ICI/ICS
treatment. The assumption that patients almost al-
supported website:
ways wish to have treatment is flawed, and the need
to incorporate patient values and preferences is par- www.continenceproductadvisor.org
amount.
In each algorithm, treatments are listed in order of At the foot of each of the treatment algorithms below,
simplicity, the least invasive being listed first. This the phrase “Consider CONTINENCE PRODUCTS for
order does not imply a scale of efficacy or cost, two temporary support during treatment”, emphasizes the
factors which need to be considered in choosing the importance of continence products for many sufferers
sequence of therapy. The order is likewise not meant of incontinence
to imply a suggested sequence of therapy, which
should be determined jointly by the treating health
care provider and the patient, considering all the rel-
evant factors listed above.

2558 RECOMMENDATIONS OF THE INTERNATIONAL SCIENTIFIC COMMITTEE

Management Conseneue Stements

 362

ICS Standards 2019

I. URINARY INCONTINENCE IN CHILDREN

A. INITIAL MANAGEMENT

Children present specific management problems for a variety of reasons: assess- • Comorbid behavioural (e.g. ADHD and ODD) and emotional disorders.
ment requires help from their parents and caregivers; consent to treatment may be
problematic; and cooperation in both assessment and treatment may be difficult.  Initial treatment is recommended for the remaining patients who have:
• Nocturnal enuresis without other symptoms (monosymptomatic enuresis).
1. INITIAL ASSESSMENT SHOULD INVOLVE A DETAILED
• Daytime symptoms of frequency, urgency, voiding postponement, straining, in-
INVESTIGATION OF VOIDING AND BOWEL HABITS USING terrupted voiding, urgency incontinence with or without nighttime wetting.
BLADDER/BOWEL DIARIES AND STRUCTURED AND

3. The International Consultation on Incontinence Algorithms

VALIDATED QUESTIONNAIRES.
2. TREATMENT
The child’s social environment and general and behavioural development should
also be formally assessed and recorded. Physical examination should be done to  Initial treatment for mono-symptomatic nocturnal enuresis should include:
detect a palpable bladder, faecal loading and exclude anatomic and neurogenical
• Parental and child counselling and motivation
causes. Urine analysis and culture is sufficient to exclude the presence of infection.
If possible, the child should be observed voiding. • Review of bladder diary with attention to night-time polyuria
 Referrals for specialist treatment are recommended for children who • Age appropriate education and demystification or explanation
have complicated incontinence associated with:
 A choice between either bed wetting alarm (GoR A) or anti-diuretic hormone
• Recurrent and febrile urinary infection analogues of desmopressin (GoR A). It may be a parental and child choice if
advantages and disadvantages are well explained.
• Voiding symptoms or evidence of poor bladder emptying
 Daytime incontinence should be managed holistically including:
• Urinary tract anomalies
• Counselling, timed voiding, behaviour modification and bowel management
• Previous pelvic surgery when necessary (GoR B);
• Neuropathy or neuropathic origin • Antimuscarinics may be used if the child has OAB symptoms (GoR A)
• Bowel dysfunction not responsive to treatment

2559
 INITIAL MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN

2560
Nocturnal enuresis Daytime ± Nighttime “Complicated” Incontinence associated with:
HISTORY / (monosymptomatic) wetting ± Urgency / • Urinary tract anomaly
SYMPTOM frequency • Neuropathy
• Pelvic surgery
ASSESSMENT • Voiding (emptying) symptoms
• Recurrent urinary infection
• Bowel dysfunction not responsive to treatment
• Comorbid behavioural and emotional disorders

General assessment (see relevant chapter)

CLINICAL • Physical examination: abdominal, perineal, ext. genitalia, back/spine, neurological
ASSESSMENT • Assess bowel function -> if constipated, treat and reassess
• Urinalysis ± Urine culture -> if infected, treat and reassess
• Assess post-void residual urine by abdominal examination (optional : by ultrasound)

Monosymptomatic Urgency Recurrent Infection Dysfunctional Any other

PRESUMED Nocturnal Enuresis Incontinence Voiding abnormality
DIAGNOSIS detected e.g.
Post void
residual

• Explanation/education • Explanation/education
TREATMENT* • Enuresis Diary • Fluid/voiding regimen (A)
• Alarm (A) • Bladder training (B)
• Desmopressin (A) • Antimuscarinics (A)
• Alarm (bed wetting) (B)

Failure Failure

SPECIALISED MANAGEMENT

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

363
 364

ICS Standards 2019

I. URINARY INCONTINENCE IN CHILDREN

B. SPECIALISED MANAGEMENT

 Two groups of children with ‘‘complicated’’ incontinence should have spe- • If invasive treatment is under consideration, for example, stress incontinence
cialist management from the outset (Fig. 2). surgery if there is sphincteric incompetence, or bladder augmentation if there
is detrusor overactivity. (GoR B)
• Children whose incontinence is due to, or associated with, urinary tract anom-
alies and neuropathy. • If upper tract dilation exists and is thought to be due to bladder dysfunction.
(Gor A)
• Children without urinary tract anomalies, but with recurrent febrile infection
and, proven or suspected, lower urinary tract dysfunction. • Invasive urodynamic studies are generally not recommended if the child
has normal upper tract imaging and is to be treated by noninvasive means.
 Children who fail the basic treatment, but who have neither neurogenic nor

3. The International Consultation on Incontinence Algorithms

(Gor B)
anatomical problems, should also receive specialist management.
 Spinal Imaging (US/X-ray/MRI) may be needed if a bony abnormality or
Children with comorbid behavioural and emotional disorders require referral to
neuro-logical condition is suspected. (GoR A)
mental health services, as compliance and treatment outcomes are lower.
Assessment and treatment should follow evidence-based practice guidelines 2. TREATMENT
1. ASSESSMENT The treatment of incontinence associated with urinary tract anomalies is complex
and cannot easily be dealt with in an algorithm. In many children more than one
 As part of further assessment, the measurement of urine flow (in children old pathology demands treatment. If there are complex congenital abnormalities
enough), together with the ultrasound estimate of residual urine and ap- present, the treatment is mostly surgical and it should be individualised according
pearance of the bladder wall and rectum are highly recommended. An evalua- to the type and severity of the problem (please see Children’s Committee Report).
tion of the upper urinary tracts with ultrasound is also highly recom-
Care should be given by specialist children’s nurses and therapists.
mended.
 Initial treatment should be non-surgical.
Those who do not improve with treatment and have neither neurogenic nor an-
atomical problems should be reassessed using bladder diaries, symptom ques- • For stress urinary incontinence (SUI): pelvic floor muscle training (GoR C).
tionnaires, urinalysis, uroflowmetry and residual urine determination.
• For OAB symptoms: fluid/voiding regimens and antimuscarinics (GoR A).
If there are recurrent and febrile infections, upper tract imaging and possibly
a VCUG should be considered. However, endoscopy is rarely indicated. • For voiding dysfunction: timed voiding, voiding re-education, pelvic floor
muscle relaxation (+/- biofeedback), alpha-blocker therapy, and intermittent
 Urodynamics should be considered: catheterisation (when PVR >30% of bladder capacity) (GoR A/B).
• If the type and severity of lower tract dysfunction cannot be explained by • For bowel dysfunction: high fibre diet and laxatives as appropriate, and.
clinical findings or in the presence of possible relevant neuropathy or urinary transanal irrigation in severe cases (GoR A).
tract anomalies. (GoR B)

2561
 The child’s progress should be assessed and, if quality of life is still significantly • For DO/poor compliance, botulinum toxin (for DO, and off-label) and bladder
impaired, or if the upper urinary tracts are at risk, surgical treatment is likely to be augmentation may be performed (GoR B).

2562
necessary.
• If the child cannot do IC then a Mitrofanoff channel may be needed (GoR A).
 If surgical treatment is required, then urodynamic studies are recommended
to confirm the diagnosis.
• For USI, colposuspension, sling surgery, bulking agent injection and AUS may
be considered (GoR B).

Management Conseneue Stements

365
 366

ICS Standards 2019

SPECIALISED MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN
Incontinence without Incontinence with
EXPERT HISTORY suspicion of urinary tract suspicion of urinary tract
& PHYSICAL anomaly anomaly
EXAMINATION

CLINICAL • Urinalysis: if UTI, treat and reassess (A) Consider:

• Treat bowel dysfunction and reassess (A) • Micturating cystogram (B)
ASSESSMENT • Renal / bladder ultrasound (A) • Renal nuclear medicine scan (B)
Medicine scan • if abnormal --> Urodynamics (A)
• Assess post void residual (A)
• Flow rates ± electromyography (A) • Cystourethroscopy (B)

3. The International Consultation on Incontinence Algorithms

• Behavioural Evaluation (B) • Spinal imaging (A)

UrodynamicStress Detrusor Overactivity / Dysfunctional voiding Anatomical Causes of

DIAGNOSIS Incontinence Poor Compliance Urinary Incontinence

• Pelvic floor muscle training • Fluid/ voiding regime (A) • Timed voiding (B) • Correct anomaly (see:
TREATMENT* (A) • Antimuscarinics (A) • Pelvic floor relaxation ± surgical treatment in
• Bowel management biofeedback. (A) children) (A)
including transanal irrigation • Pharmacotherapy
(A) • Antimuscarinics (B)
• α-blockers (B)
• Intermittent cath. (B)
• Bowel management including
transanal irrigation (A)
• SNS (B)

Failure Failure Failure

• Colposuspension (B) • Botulinum toxin (B) • Mitrofanoff if IC fails (A)

• AUS (B) • Bladder augmentation (B)
• Sling (B) • SNS (B)
• Bulking agent injection (C)

* Consider CONTINENCE PRODUCTS for temporary support during treatment

2563
 II. URINARY INCONTINENCE IN MEN

2564
A. INITIAL MANAGEMENT

 For men with stress, urgency or mixed urgency / stress incontinence, initial
1. INITIAL ASSESSEMENT SHOULD IDENTIFY: treatment should include appropriate lifestyle advice, pelvic floor muscle train-
ing, scheduled voiding regimens, behavioural therapies and medication. In
 “Complicated” incontinence group particular:
Those with pain or with haematuria, recurrent infection, suspected or proven poor • Lifestyle interventions (eg weight loss GoR B)
bladder emptying (for example due to bladder outlet obstruction), or incontinence
following pelvic irradiation or radical surgery, are recommended for specialised • Supervised pelvic floor muscle training for men with post radical prostatectomy
management. SUI accelerates recovery time(GoR B)
Poor bladder emptying may be suspected from symptoms, physical examination • Scheduled voiding regimen for OAB (GoR C)
or if imaging has been performed by X-ray or ultrasound after voiding.
• Antimuscarinic/beta 3 agonist drugs for OAB symptoms with or without urgency
 Four other main groups of men should be identified by initial assessment as incontinence (GoR B) if the patient has no evidence of significant post-void
being suitable for initial management. residual urine
• Those with post-micturition dribble alone, • α-adrenergic antagonists (a-blockers) can be added if it is thought that there
may also be bladder outlet obstruction. (GoR C)
• Those with overactive bladder (OAB) symptoms: urgency with or without ur-
gency incontinence, together with frequency and nocturia  Should initial treatment be unsuccessful after a reasonable time (for exam-
ple, 8-12 weeks), specialist advice is highly recommended.
• Those with stress urinary incontinence (most often post-prostatectomy),
Clinicians are likely to wish to treat the most bothersome symptom first in men
• Those with mixed urinary urgency and stress incontinence (most often post- with symptoms of mixed incontinence.
prostatectomy)

2. MANAGEMENT

 For men with post-micturition dribble, this requires no assessment and can
usually be treated by teaching the man how to do a strong pelvic floor muscle
contraction after voiding, or manual compression of the bulbous urethra directly
after micturition. (GoR B)

Management Conseneue Stements

367
 368

ICS Standards 2019

INITIAL MANAGEMENT OF URINARY INCONTINENCE IN MEN
Post-micturition Incontinence on Incontinence with Urgency / “Complicated”
HISTORY dribble exertion (usually mixed symptoms frequency, with or Incontinence:
post-prostatectomy) without urgency • Recurrent or “total”
incontinence
incontinence
• Incontinence associated
with:
o Pain
• General assessment (see relevant chapter) o Haematuria
CLINICAL • Urinary symptom assessment and symptom score (including bladder diary or o Recurrent infection
ASSESSMENT frequency-volume chart and questionnaire) o Prostate irradiation
• Assess quality of life and desire for treatment o Radical pelvic surgery
• Physical examination: abdominal, rectal, sacral, neurological
• Urinalysis ± urine culture -> if infected, treat and reassess

3. The International Consultation on Incontinence Algorithms

• Assessment of pelvic floor muscle function
• Assess post-void residual urine any other abnormality
detected e.g. significant
post void residual

STRESS MIXED URGENCY

PRESUMED INCONTINENCE INCONTINENCE INCONTINENCE
DIAGNOSIS presumed due to Treat most presumed due to
sphincteric bothersome detrusor
incompetence symptom first overactivity

• Urethral milking (B) DISCUSS TREATMENT OPTIONS WITH THE PATIENT

MANAGEMENT* • Pelvic floor muscle • Lifestyle interventions
contraction (B) • Pelvic floor muscle training ± biofeedback (B)
• Scheduled voiding/bladder training in OAB (C)
• Antimuscarinics/beta 3 agonist for OAB ± urgency incontinence (B)
• α-adrenergic antagonists (if suspected bladder outlet obstruction)

Failure

SPECIALISED MANAGEMENT

* Consider CONTINENCE PRODUCTS for temporary support during treatment

2565
 II. URINARY INCONTINENCE IN MEN

2566
B. SPECIALISED MANAGEMENT

The specialist may first reinstitute initial management if it is felt that previous • For sphincter incompetence the recommended option is the artificial urinary
therapy had been inadequate. sphincter (GoR B). Other options, such as a male sling, may be considered
(GoR C).
1. ASSESSMENT • For refractory idiopathic detrusor overactivity, (with intractable overactive
bladder symptoms) the recommended therapies are: Botulinum toxin A (GoR
• Patients with “complicated” incontinence referred directly to specialised B), and SNS (GoR C),
management, are likely to require additional testing, such as cytology, cys-
tourethoscopy and urinary tract imaging. • When incontinence has been shown to be associated with poor bladder emp-
tying due to detrusor underactivity, it is recommended that effective means
If additional testing is normal then those individuals can be treated for inconti- are used to ensure bladder emptying, for example, intermittent catheterisation
nence by the initial or specialised management options as appropriate. (GoR B/C).
If symptoms suggestive of detrusor overactivity, or of sphincter incompetence per- • If incontinence is associated with bladder outlet obstruction, then consideration
sist, then urodynamic studies are advisable in order to arrive at a precise diagno- should be given to surgical treatment to relieve obstruction (GoR B). α-blockers
sis, prior to invasive treatment. and/or 5α- reductase inhibitors would be an optional treatment (GoR C).
• There is increased evidence for the safety of antimuscarinics for overactive
2. TREATMENT
bladder symptoms in men, chiefly in combination with an α-blocker (GoR B).

When basic management has been unsuccessful and if the patient’s incontinence
markedly disrupts his quality of life then invasive therapies should be considered.

Management Conseneue Stements

369
 370

ICS Standards 2019

SPECIALISED MANAGEMENT OF URINARY INCONTINENCE IN MEN
Post-prostatectomy Incontinence with urgency / “Complicated” Incontinence:
HISTORY/ incontinence frequency • Recurrent incontinence
SYMPTOM • Incontinence associated with:
ASSESSMENT o Prostate or pelvic irradiation
o Radical pelvic surgery

• Consider urodynamics and imaging of the urinary tract

CLINICAL • Urethrocystoscopy (if indicated)
ASSESSMENT

3. The International Consultation on Incontinence Algorithms

STRESS INCONTINENCE MIXED INCONTINENCE URGENCY INCONTINENCE Consider:
DIAGNOSIS due to sphincteric Treat major component due to detrusor overactivity • Urethrocystoscopy
incompetence first (during filling) • Further imaging
• Urodynamics

with coexisting with coexisting Lower urinary tract

bladder outlet underactive anomaly/ pathology
obstruction detrusor (during
voiding)

If initial therapy fails: • α-blockers, 5aRI (C) If initial therapy fails: • Intermittent • Correct anomaly
TREATMENT* • Artificial urinary • Correct anatomic • Botulinum toxin A catheterisation • Treat pathology
sphincter (B) bladder outlet • SNS (B) • Antimuscarinics /
• Male sling (C) (see obstruction (C) beta 3 agonists
chapter 13) • Antimuscarinics/beta
3 agonists (B)

* Consider CONTINENCE PRODUCTS for temporary support during treatment

2567
 III. URINARY INCONTINENCE IN WOMEN

2568
A. INITIAL MANAGEMENT

PFMT), scheduled voiding regimes, behavioural therapies and medication. In

1. INITIAL ASSESSMENT SHOULD IDENTIFY: particular:
• Advice on caffeine reduction for OAB (GoR B) and weight reduction (GoR A).
 “Complicated” incontinence group.
Those with pain or haematuria, recurrent infections, suspected or proven voiding • Supervised pelvic floor muscle training (GoR A), supervised vaginal cones
problems, significant pelvic organ prolapse or who have persistent incontinence or training for women with stress incontinence (GoR B).
recurrent incontinence after pelvic irradiation, radical pelvic surgery, previous in- • Supervised bladder training (GoR A) for OAB.
continence surgery, or who have a suspected fistula, should be referred to a spe-
cialist. • If oestrogen deficiency and/or UTI is found, the patient should be treated at
initial assessment and then reassessed after using vaginal oestrogens for a
 Three other main groups of patients should be identified by initial assess- suitable period (GoR B).
ment.
• Antimuscarinics/beta 3 agonist for OAB symptoms with or without urgency
• Women with stress incontinence on physical activity incontinence (GoR A); duloxetine* may be considered for stress urinary incon-
• Women with urgency, frequency with or without urgency incontinence: over- tinence (GoR B)
active bladder (OAB) PFMT should be based on sound muscle training principles such as specificity,
• Those women with mixed urgency and stress incontinence overload progression, correct contraction confirmed prior to training and use of “the
Knack” for 12 weeks before reassessment and possible specialist referral.
Abdominal, pelvic and perineal examinations should be a routine part of physical
examination. Women should be asked to perform a “stress test” (cough and strain Clinicians are likely to wish to treat the most bothersome symptom first in women
to detect leakage likely to be due to sphincter incompetence). Any pelvic organ with symptoms of mixed incontinence. (GoR C).
prolapse or urogenital atrophy should be assessed. Vaginal or rectal examination  Some women with significant pelvic organ prolapse can be treated by vaginal
allows the assessment of voluntary pelvic floor muscle function, an important step devices that treat both incontinence and prolapse (incontinence rings and
prior to the teaching of pelvic floor muscle training. dishes).
*Duloxetine is not approved for use in United States. In Europe it is approved for
2. TREATMENT use in severe stress incontinence (see committee report on pharmacological man-
agement for information regarding efficacy, adverse events, and 'black box' warning
 For women with stress, urgency or mixed urinary incontinence, initial treat- by the Food and Drug Administration of the United States).
ment should include appropriate lifestyle advice, pelvic floor muscle training,

Management Conseneue Stements

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ICS Standards 2019

INITIAL MANAGEMENT OF URINARY INCONTINENCE IN WOMEN
Incontinence on physical Incontinence with mixed Incontinence / frequency “Complicated” Incontinence:
HISTORY activity symptoms with urgency • Recurrent incontinence
• Incontinence associated with:
o Pain
o Haematuria
• General assessment (see relevant chapter) o Recurrent infection
CLINICAL • Urinary symptom assessment (including bladder diary and questionnaire) o Significant voiding
ASSESSMENT • Assess quality of life and desire for treatment symptoms
• Physical examination: abdominal, pelvic and perineal o Pelvic irradiation
• Cough test to demonstrate stress incontinence if appropriate o Radical pelvic surgery
• Urinalysis ± urine culture -> if infected, treat and reassess If appropriate o Suspected fistula
• Assess oestrogen status and treat as appropriate

3. The International Consultation on Incontinence Algorithms

• Assess pelvic floor muscle function
• Assess post-void residual urine
• If other abnormality found e.g.
• Significant post void residual
STRESS INCONTINENCE MIXED INCONTINENCE OAB with or without • Significant pelvic organ
PRESUMED presumed due to Treat most bothersome URGENCY prolapse
DIAGNOSIS sphincteric incompetence symptom first INCONTINENCE • Pelvic mass
presumed due to
detrusor overactivity

• Life style interventions.

MANAGEMENT* • Pelvic floor muscle training for SUI, MUI, or OAB (A)
• Bladder retraining for OAB (A)
• Antimuscarinics/beta 3 agonist OAB ± urgency incontinence (A) or Duloxetine** for SUI (B)

• Other adjuncts, such as electrical stimulation

• vaginal devices eg cones (B)
** Subject to local regulatory
approval (see black box Failure
warning).

SPECIALISED MANAGEMENT

* Consider CONTINENCE PRODUCTS for temporary support during treatment

2569
 III. URINARY INCONTINENCE IN WOMEN

2570
A. SPECIALISED MANAGEMENT

1. ASSESSMENT 2. TREATMENT
Women who have “complicated” incontinence (see initial algorithm) may need
• If stress incontinence is confirmed then the treatment options that are rec-
to have additional tests such as cytology, urodynamics, cystourethroscopy or uri-
ommended for patients include the full range of non-surgical treatments, as
nary tract imaging. If these tests are normal then they should be treated for incon-
well as colposuspension procedures, (GoR A) and bladder neck/sub-urethral
tinence by the initial or specialised management options as appropriate.
sling operations (GoR A). All of these procedures have potential risks and as-
• Those women with persistent symptoms despite initial management and sociated complications which should be discussed with the individual. The cor-
whose quality of life is impaired are likely to request further treatment. If initial rection of symptomatic pelvic organ prolapse may be desirable at the same
management has been given an adequate trial then interventional therapy time. For selected patients injectable bulking agents (GoR B) and the artificial
may be desired. When the results of urodynamic testing may change man- urinary sphincter (GoR C) can be considered.
agement, we highly recommend testing prior to intervention in order to diag-
• Refractory urgency incontinence (overactive bladder) secondary to idio-
nose the incontinence type and, therefore, inform the management plan. Ure-
pathic detrusor overactivity may be treated by botulinum toxin A (GoR A), sa-
thral function testing by urethral pressure profile or leak point pressure is op-
cral nerve stimulation (GoR B) or bladder augmentation/intestinal cystoplasty
tional.
(GoR D).
• Systematic assessment for pelvic organ prolapse is highly recommended
• Those patients with voiding dysfunction leading to significant post-void re-
and the POP-Q method should be used in research studies. Women with co-
sidual urine (for example, >30% of total bladder capacity) may have bladder
existing pelvic organ prolapse should have their prolapse treated as appropri-
outlet obstruction or detrusor underactivity. Prolapse is a common reversible
ate.
cause, of voiding dysfunction.

Management Conseneue Stements

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ICS Standards 2019

SPECIALISED MANAGEMENT OF URINARY INCONTINENCE IN WOMEN
Incontinence on physical Incontinence with mixed Incontinence with “Complicated” Incontinence:
HISTORY/ activity symptoms urgency / frequency • Recurrent incontinence
SYMPTOM • Incontinence associated with:
ASSESSMENT o Pain
o Haematuria
o Recurrent infection
o voiding symptoms
o Pelvic irradiation
• Assess for pelvic organ mobility / prolapse o Radical pelvic surgery
CLINICAL • Consider imaging of the UT/ pelvic floor o Suspected fistula
ASSESSMENT • Urodynamics (see notes)

3. The International Consultation on Incontinence Algorithms

URODYNAMIC MIXED DETRUSOR INCONTINENCE Consider:
DIAGNOSIS STRESS INCONTINENCE OVERACTIvITY associated with • Urethrocystoscopy
INCONTINENCE USI/DOI INCONTINENCE poor bladder • further imaging
(USI) Treat most (DOI) emptying • Urodynamics
bothersome
symptom first

Bladder outlet Underactive Lower urinary

obstruction detrusor tract anomaly /
pathology

If initial therapy fails**: If initial therapy fails*: • Correct anatomic bladder outlet • Correct anomaly
TREATMENT* • Stress incontinence • Botulinum toxin (A) obstruction (e.g. genito-urinary • Treat pathology
surgery • Sacral Nerve Stimulation prolapse)
o Bulking agents (B) (B) • Intermittent catheterisation
o Tapes and slings (A) • Bladder augmentation (D)
o Colposuspension (A)

** Note procedures in
increasing level of
invasiveness * Consider CONTINENCE PRODUCTS for temporary support during treatment

2571
 IV. FISTULAE

2572
In the developing world fistulae occur as a consequence of poor perinatal care. • Level 3 evidence indicates that the routine use of cystoscopy with dye testing
Despite vast surgical experience in some centres, published research is of low qual- at gynaecological surgery has high sensitivity, specificity and negative predic-
ity. tive value in the detection of ureteric injury, although false positive tests do
occur. (GoR C)
In the developed world, iatrogenic urogenital fistulae are known complications of
pelvic surgery and oncological treatments such as radiotherapy, chemotherapy or • Ureteric injury or fistula may be suspected in patients following pelvic surgery
a combination of both. In the oncological context, fistulae may also occur as a result if a fluid leak or pelvi-calyceal dilatation occurs postoperatively. (GoR D)
of primary or recurrent malignancy. The development of fistula following radiother-
apy for primary treatment should trigger a search for evidence of tumour recurrence • Uretero-arterial fistula may be suspected in patients presenting with haematu-
(GoR D). The use of neoadjuvant or adjuvant therapies is likely to be associated ria with a history of relevant pelvic surgery and indwelling ureteric stent. (GoR
with a greater risk of fistula development than the primary treatment alone. D)

The most common non-obstetric causes of fistulae involving the gastro-intestinal • Elevated levels of creatinine in drainage fluid following pelvic surgery are sug-
tract are diverticular disease, Crohn’s disease, malignancy and radiotherapy. gestive of urine leaking due to a urinary tract injury. (GoR D)

1. INITIAL ASSESSMENT 2. MANAGEMENT OF NEW AND ESTABLISHED VVF

Early detection of fistulae could be improved by examining all women after their Management of VVF depends on whether the fistula is diagnosed within a few
delivery, or prevented by Caesarian section for women who suffer prolonged labour weeks of its occurrence or whether the woman presents late with an established
and who are at risk of developing an obstetric fistula. Associated pathologies should fistula.
be actively searched for and should be taken into account in the treatment plan: all
Early fistulae are those which are not re-epithelialised, and ischaemic and necrotic
components of the ‘obstructed labour injury complex’ should be examined. Preven-
tissue can be present at the time of examination. There is evidence that early cath-
tion by better health education, and by avoiding harmful practices must be encour-
eter care will result in the cure of a significant minority of VVFs. (GoR C)
aged.
Established fistulae are re-epithelialised and show no oedema, ischaemic changes
Classification of fistulae is recommended. Although many classification systems
or inflammation. These fistulae and those that fail catheter treatment should be
exist, the committee recommends the use of the Goh, WHO or Tafesse classifica-
treated surgically by an experienced surgeon. (GoR C)
tion systems (GoR B)
The formal classification of the fistula should be done under anaesthesia when the 3. TREATMENT
patient is on the operation table, just before surgery.
• Leakage of stool, urine, or possibly both is the hallmark sign of a fistula. The If catheter drainage fails, then fistula repair will be necessary. There are certain
leakage is usually painless, may be intermittent if it is position dependent, or principles behind fistula repair:
may be constant.
• Necrotic tissue must be removed prior to fistula repair.
• CT and cystoscopy appear more consistent in the confirmation and location of
possible intestino-vesical fistulae, than other investigations (GoR C) • Fistula repair must only be undertaken by a properly trained surgeon.
• Adequate post-operative care is essential.

Management Conseneue Stements

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ICS Standards 2019

• Proper follow-up should be arranged. A period of continuous bladder drainage is crucial to successful fistula repair; there
are no high level data to support any particular type, route, or duration of catheter-
In principle, most fistulae can be dealt with by the vaginal approach, but an abdom- isation. Current practice suggests, 10-14 days for simple and/or post-surgical fistu-
inal approach may be needed in some cases (e.g. concomitant reconstructive pro- lae; 14-21 days for complex and/or post-radiation fistulae. (GoR D)
cedures e.g. ureteral reimplantation or bladder augmentation).(GoR C)
Whilst diversion is used more widely in radiation-associated fistulae of all types as
A tension-free single layer closure of the bladder wall and closure of the vaginal compared to non-radiated fistulae, there is low-level evidence that repair proce-
wall in a separate layer is advocated. A Martius flap in primary fistula repair is not dures can achieve successful fistula closure and continence in appropriately se-
recommended. lected cases. (GoR C)
When reporting on outcome after fistula repair, authors should make a clear dis- Where urinary and/or faecal diversions are required, attempts should be made to
tinction between fistula closure rates and post-operative incontinence rates and the avoid using irradiated tissues wherever possible, and to minimise the potential for
time at which the follow-up was organised. anastomotic complications. (GoR C)
Prevention of post-operative stress incontinence must be added to the surgical pro- There is low-level evidence to support the use of interposition grafts when repair of
cedure if the urethral closing mechanism is involved. This can be done by a good radiation-associated fistulae is undertaken. (GoR C)

3. The International Consultation on Incontinence Algorithms

repair of the pubocervical fascia and refixation or by adding a sling procedure.
Attention should be given as appropriate to skin care, nutrition, rehabilitation, coun- 4. MANAGEMENT OF THE COMPLICATIONS OF VVF
selling and support prior to and following fistula repair. (GoR D)
There is no proven benefit to delayed repair of vesicovaginal fistulae; the timing of The complications of vesico-vaginal fistulae are many but include:
repair should be tailored to the individual patient and surgeon requirements, but
• Persistence or recurrence of urinary incontinence
can be undertaken as soon as any oedema, inflammation, tissue necrosis, and in-
fection have resolved. (GoR B) • Persistence of lower urinary tract symptoms or occurrence of new lower urinary
There are no high quality data to indicate greater cure rates for any one technique tract symptoms, including overactive bladder
as compared to others; level 3 evidence indicates similar success rates for vaginal • Urinary tract infections
and abdominal, and for transvesical and transperitoneal approaches. (GoR C)
• Upper urinary tract symptoms, including loin pain
A variety of interpositional grafts can be used in either abdominal or vaginal pro-
cedures, although there is little evidence to support their use in any specific setting. • Dyspareunia and sexual dysfunction
(GoR C)
• Infertility
Conventional and robotically-assisted laparoscopic approaches have both been
shown to be feasible in selected cases; the indications for, or optimal patient for • Neurological symptoms
these techniques is not yet clear. (GoR C) • Psychological problems and mental illness

2573
 MANAGEMENT OF VESICOVAGINAL FISTULA

2574
Leakage of urine from vagina / perineum
HISTORY

• Clinical examination
CLINICAL • Urethro-cystoscopy
ASSESSMENT • Imaging (X-ray/CT/MRI, US)
• Evaluate upper urinary tract

Recent VVF Established VVF

PRESUMED
DIAGNOSIS
Consider Catheter, evaluate weekly

Healed Persistant leakage

Primary simple Primary complex Recurrence Post-irradiation

MANAGEMENT*

Vaginal repair Surgical repair If small, consider Surgical repair

Consider timing Consider timing catheter, evaluate weekly 6-12 months
Consider interposition Consider interposition
material material
Surgical repair
Consider timing
Consider interposition
material

Assess fistula closure & assess continence status

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

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ICS Standards 2019

• Most upper urinary tract fistulae should be initially managed by conservative or
1. MANAGEMENT OF FISTULAE INVOLVING BOWEL endoluminal techniques where such expertise and facilities exist. ( GoR B)
• Persistent ureterovaginal fistulae should be repaired by an abdominal ap-
• There is limited evidence to support a non-surgical or conservative surgical
proach using open, laparoscopic or robotic techniques according to availability
approach in colo-vesical fistulae where there are minimal symptoms or evi-
and competence. (GoR D)
dence of limited bowel involvement. (GoR C)
• For patients with ureteric fistulae associated with advanced pelvic cancer and
• A one-stage approach to surgery for intestino-vesical fistulae is appropriate in
poor performance status, palliation by nephrostomy tube diversion and endo-
many cases, but should be limited to those patients whose nutritional state is
luminal distal ureteric occlusion is an option. (GoR C)
good, and where there is no evidence of additional intra-abdominal pathology
(e.g. severe inflammation, radiation injury, advanced malignancy, intestinal ob-
struction) or major co-morbidity. (GoR B) 3. MANAGEMENT OF URETHRO-VAGINAL FISTULAE
• A laparoscopic/robotic approach to one-stage management is feasible, alt-
hough there is no high level evidence to allow comparison of outcomes with Recommendations

3. The International Consultation on Incontinence Algorithms

open surgery. (GoR D) • Urethrovaginal fistulae are preferably treated by a vaginal approach. (GoR C)

2. MANAGEMENT OF URETERIC FISTULAE • A variety of autologous tissue interposition techniques have been described,
but their value remains uncertain. (GoR C)

• Surgeons undertaking complex pelvic surgery should be competent at identi- • Urethrovaginal fistulae repair may be complicated by stress incontinence, ure-
fying, preserving and repairing the ureter. (GoR D) thral stricture and urethral shortening necessitating long-term follow-up. (GoR
C)
• Ureteric stents are not required as prophylaxis against injury during routine
gynaecological surgery, while their role in more extensive surgery remains to
be established. (GoR B)

2575
 MANAGEMENT OF IATROGENIC URETERIC FISTULAE

2576
Extra-urethral vaginal urinary leakage and/or signs of ureteric obstruction
HISTORY

CLINICAL Clinical examination Urethro-cystoscopy Imaging (Xray/CT/ MRI, US)

ASSESSMENT Evaluate upper urinary tract obstruction

Ureterovaginal fistula
PRESUMED
DIAGNOSIS

Endoluminal technique (stenting, Unable to stent (initially)...

MANAGEMENT* nephrostomy) for at least 6 weeks

Re-evaluate for fistula closure, ureteric obstruction

Persisting fistula
or ureteric obstruction

Healed Ureteric reimplantation (open, laparoscopic or robotic)

Long-term follow-up for stricture and hydropephrosis

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

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ICS Standards 2019

V. PELVIC ORGAN PROLAPSE
When examination findings of the extent of the prolapse are not consistent with the
1. INTRODUCTION history the examination can be repeated in a few weeks’ time. (GoR C).
Post void residual should be measured; while most elevated post-void residual
Pelvic organ prolapse includes vaginal and rectal prolapse. Treatment of pelvic or-
urines (150mls) resolve with treatment of the prolapse, a specialist consulation is
gan prolapse is generally reserved for symptomatic prolapse. Clinicians should rec-
required.
ognise that coexistent pelvic floor symptoms are frequently present and that these
symptoms may or may not be related to the prolapse. Women with prolapse require
a careful and detailed initial assessment not only of the prolapse but associated 3. MANAGEMENT
bladder, bowel and sexual function.
Observation is appropriate when medically safe (GoR C).
2. ASSESSMENT Lifestyle interventions include weight loss, treating constipation, avoiding straining

3. The International Consultation on Incontinence Algorithms

at stool and heavy lifting (GoR C).
Symptom assessment preferably with a validated pelvic floor questionnaire that as- Pelvic floor muscle training:
sesses bladder, bowel, vaginal and sexual function and bothersomeness is re-
• Reduces associated pelvic floor symptoms (GoR A).
quired. (Grade C).
• May reduce the symptom of vaginal bulge (GoR C).
Physical examination should:
• Does not reduce extent of prolapse on examination based on POP-Q stage
• Report the most distal site of vaginal descent in relation to a fixed point such (GoR B).
as the hymen and include an assessment of the anterior posterior and apical
vagina. While standardised reporting utilising tools such as the Pelvic Organ Vaginal Pessary: when successfully fitted
Prolapse Quantification (POP-Q) are encouraged. The system used to meas- • May reduce prolapse symptoms (GoR B)
ure the extent of the prolapse should be documented. • Need to be regularly reviewed (GoR C)
• Be undertaken in the standing position to evaluate the full extent of the pro- • Have high rates of discontinuation (GoR C)
lapse.
Local Oestrogens are recommended in those with hypo-oestrogenic symptoms and
• Determine if coexistent pelvic pathology is present on careful bimanual exam- in those with urethral prolapse or vaginal ulceration (GoR B)
ination. Cytological screening of the cervix should be undertaken if required. Reconstructive surgery is reserved for those with symptomatic prolapse and is
• The prolapse should be reduced to document the presence of occult stress aimed at correcting the vaginal topography and functional pathology. Please see
urinary incontinence (see chapter for prolapse and urinary incontinence path- text for full recommendations.
way). Obliterative surgery is an important and effective treatment option in those who are
• Assess pelvic floor muscle function (see chapter for full review). happy to sacrifice coital activity. (GoR C)
• Determine if epithelial/ mucosal ulceration is present.
• Evaluate anal sphincter tone and or the presence of rectal prolapse in those
with bowel symptoms (refer to chapter for pelvic organ prolapse and bowel
symptom pathway).

2577
 MANAGEMENT OF PELVIC ORGAN PROLAPSE

2578
(INCLUDING UROGENITAL PROLAPSE AND RECTAL PROLAPSE)

Bothersome pelvic organ prolapse Complex or recurrent prolapse

HISTORY

CLINICAL Symptoms Screening: assess bothersomeness, frequency and severity of urinary,

ano-rectal, genital and sexual symptoms Investigation by specialist
ASSESSMENT
• Urinary: PVR, cough stress test, urinalysis.
• Physical Examination: Sufficient to determine the site and severity of prolapse
and detect other significant findings
o Selective use of urodynamics when results would alter planned treatment.
o Selective use of upper tract imaging when observation is planned
• Ano-Rectal: Endoscopy, lower GI tract imaging

UROGENITAL PROLAPSE WITH OR RECTAL PROLAPSE WITH OR

DIAGNOSIS WITHOUT OTHER PELVIC SYMPTOMS WITHOUT OTHER PELVIC SYMPTOMS

• Observation • Observation Specialist management

MANAGEMENT* • Lifestyle interventions • Lifestyle interventions
• Pelvic floor muscle training • Transperineal surgery
• Pessary • Transabdominal surgery
• Reconstructive surgery
• Obliterative surgery

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

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ICS Standards 2019

PATHWAY FOR THE SURGICAL MANAGEMENT OF PELVIC ORGAN PROLAPSE
The pelvic organ prolapse (POP) surgery pathway was designed to provide an ev- equally effective vaginal options (LoE 1) and utilisation of transvaginal permanent
idence based guide for both clinicians and women for the surgical management of mesh apical support is not supported by the data (LoE1).
pelvic organ prolapse. Within the pathway green lines highlight the preferred option
and yellow lines indicate reasonable options. When performing sacral colpopexy the laparoscopic approach is preferred with re-
duced peri-operative morbidity and cost when compared to both the open or robotic
An early option in the treatment pathway for women not wanting to preserve sexual approach (LoE 2). The yellow reasonable option pathway exists for both open and
function is obliterative surgery (colpocleisis) which is an efficacious intervention that robotic options in recognition of the longer learning curve associated with the lapa-
has low morbidity (LoE 3). roscopic approach (LoE3).
The majority of women will enter the reconstructive pathway. Apical suspension Apical support in those with uterine prolapse can be performed abdominally or vag-
procedures should be considered in all cases with 10-year re-operation rates for inally and includes options for both uterine preservation (hysteropexy) and hyster-
prolapse being significantly reduced if apical suspensions are performed concomi- ectomy, with not insignificant relative contraindications for uterine preservation

3. The International Consultation on Incontinence Algorithms

tantly with both anterior and posterior colporrhaphy as compared to those per- listed in Table 6. In post-menopausal women undergoing hysterectomy, bilateral
formed without apical support. salpingo-oopherectomy (BSO) significantly reduces the rate of ovarian cancer with-
out increased morbidity. In those retaining ovaries at hysterectomy, bilateral salpin-
In those undergoing anterior and posterior colporrhaphy the evidence is supportive gectomy also reduces rate of subsequent ovarian cancer.
of traditional native tissue suture plications (LoE 1). In the anterior compartment
permanent mesh could be considered for recurrent cases when the patient under- Vaginal hysteropexy is equally effective as vaginal hysterectomy with apical sus-
stands the risk benefit profile for these interventions and that the data for their use pension and is associated with reduced blood loss and operating time as compared
is scant. Evidence is not supportive of biological grafts in the anterior compartment to hysterectomy (LoE 1). Vaginal hysterectomy with apical support has a lower re-
(LoE 2). operation for prolapse than abdominal sacrohysteropexy (LoE1). Sacrohysteropexy
has a higher re-operation for prolapse than sacral colpopexy with hysterectomy
In the posterior compartment, fascial plication is superior to site specific native tis- however sacral colpopexy with hysterectomy is not recommended due to the high
sue repair (LoE 2) and levatorplasty should be avoided due to higher rates of rate of mesh exposure (LoE2). Supra-cervical hysterectomy at sacral colpopexy
dyspareunia (LoE3). Data are not supportive of biological or permanent mesh reduces the rate of mesh exposure associated with hysterectomy and sacral col-
grafts. Posterior colporrhaphy is superior to transanal repair of rectocele (LoE 1) popexy however in a single retrospective study, recurrent prolapse was more com-
and there is no data to support ventral rectopexy with or without vaginal graft for mon in the supracervical hysterectomy group. Although those data is not complete,
rectocele. vaginal based hysterectomy and hysteropexy with apical support should generally
With recognition of the importance of apical vaginal support in minimising the risk be considered as preferred options for uterine prolapse with sacral colpopexy re-
of subsequent recurrence, the pathway separates those with post-hysterectomy served for vault prolapse.
(vault) prolapse from those with uterine prolapse. Those undergoing prolapse surgery with stress urinary incontinence (SUI) and oc-
Data are supportive of sacral colpopexy as the preferred intervention for vault pro- cult SUI should generally have continence surgery performed at the time of pro-
lapse with superior anatomical and functional outcomes when compared to a vari- lapse surgery (LoE1). Those with prolapse without SUI or occult SUI should not
ety of vaginal based interventions with and without transvaginal mesh (LoE1). This undergo continence surgery at time of prolapse surgery (LoE1).
preference is highlighted by a green preferred option arrow in the management Based largely upon expert opinion (LoE3) those with prolapse without bowel symp-
pathway. In recognition that not all patients are suitable for sacral colpopexy, a toms and those with impaired defaecation with rectocele should undergo prolapse
yellow reasonable option is included for vaginal based apical support (uterosacral surgery as per the above pathway. Those with POP and impaired defaecation with-
or sacrospinous colpopexy). Both uterosacral and sacrospinous colpopexy are out rectocele, and those with faecal incontinence require colorectal assessment. If

2579
 rectal prolapse exists, these patients may benefit from combined colorectal and Those undergoing POP surgery generally have improved sexual function post-op-
gynaecological interventions. Those with significant constipation and prolapse eratively but a small number undergoing any POP surgery will experience painful

2580
should be approached cautiously and may benefit from gastroenterology assess- intercourse post-operatively that may require subsequent intervention (LoE 1).
ment prior to entering the POP surgery pathway.

Management Conseneue Stements

383
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ICS Standards 2019

PATHWAY FOR THE SURGICAL MANAGEMENT OF PELVIC ORGAN PROLAPSE

Sexual Function

Bladder POP Bowel Function

Function SUGERY

Reconstructive Obliterative
surgery surgery

3. The International Consultation on Incontinence Algorithms

Apical Isolated cystocele Isolated rectocele

Vault Uterine

Hysterectomy ± Hysteropexy
BSO

Vaginal Sub-total ASC + Vaginal SS Sacral

hysterectomy hysterectomy hysterectomy hysteropexy hysteropexy
ASC

LSC ± repair Sacrospinous Uterosacral

colpopexy colpopexy

Consider CONTINENCE PRODUCTS for temporary support during treatment

2581
 VI. URINARY INCONTINENCE IN NEUROLOGICAL PATIENTS

2582
A. INITIAL MANAGEMENT

o peripheral lesions (as after major pelvic surgery) including those with le-
1. STRONG GENERAL RECOMMENDATIONS sions of the cauda equina (eg.lumbar disc prolapse);
o sacral spinal cord lesions involving the sacral micturition centre
• Patients with known neurological disease often need evaluation to exclude
bladder dysfunction, not only if symptoms occur, but as a standard assessment o suprasacral spinal cord lesions (suprasacral infrapontine spinal cord le-
as neurogenic bladder has a high prevalence in the particular disease (for prev- sions);
alence figures see chapter) o central lesions of the brain or brain stem (stroke, Parkinson’s disease).
• A possible neurological cause of “idiopathic”incontinence should always be • Assessment should be made using Questionnaires, urinalysis, bladder diary,
considered. Diagnostic steps to evaluate this include basic assessments, such uroflowmetry with assessment of PVR, and imaging of the urinary tract (ultra-
as history and physical examination, urodynamics and specialised tests. sonography); all provide basic data for the initial assessment of the NLUTD.
• Incontinence in neurological patients does not necessarily relate to the neuro- • Invasive urodynamics should be used as part of the initial assessment in select
logic pathology. Other diseases such as prostate pathology, pelvic organ pro- patient populations (SCI, meningomyelocele)
lapse, might have an influence. These factors should be evaluated as potential
primary or contributory causes. • Due to increasing data on organ cross-sensitisation and the debilitating effect
of faecal incontinence on QOL, a history of bowel function should be also in-
• Extensive diagnostic evaluation is often useful and necessary to tailor an indi- cluded
vidual treatment based on complete neurofunctional data. This may not be
needed in every patient e.g. patients with suprapontine lesions or in patients
where treatment will consist merely of bladder drainage when the person is frail 3. INITIAL TREATMENT
or has limited life expectancy.
• There is often a need to manage both bladder and bowel dysfunction simulta- • Patients with peripheral nerve lesions (e.g. denervation after pelvic surgery)
neously and patients with spinal cord lesions (e.g. traumatic spinal cord lesions) should
receive specialised urological management (GoR A).
2. INITIAL ASSESSMENT • Initial treatment for patients with incontinence due to suprapontine pathology,
like stroke; need to be assessed for degree of mobility and ability to cooperate.
Initial recommended treatments are behavioural therapy (GoR C) and anti-
• The management of neurological urinary incontinence depends on an under- muscarinic drugs for presumed detrusor overactivity (GoR A). If incontinence
standing of the likely mechanisms producing incontinence. This can in turn de- persists and if operative procedures are not indicated then continence products
pend on the site and extent of the nervous system abnormality. (GoR B) or catheters (GoR C) may be necessary on a long-term basis. These
• Under current classifications, neurogenic incontinence patients can be divided can also be necessary in non-cooperative or less mobile patients.
into four groups. History and physical examination are important in helping Pharmacological detrusor relaxation and/or antibiotics may be useful in cases of
distinguish these groups: persistent bypass leakage and/or recurrent UTI (patients with continuous drainage)
In all cases, bowel management should complement management of NLUTD

Management Conseneue Stements

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ICS Standards 2019

INITIAL MANAGEMENT OF NEUROGENIC URINARY INCONTINENCE
Peripheral nerve lesion Suprasacral infrapon- Suprapontine cerebral
HISTORY, LEVEL (e.g. radical pelvic surgery). tine and pontine lesions lesion (e.g. Parkinson’s disease,
OF LESION Sacral cord/cauda equina lesion (e.g. (e.g. trauma, multiple system atrophy) stroke, multiple sclerosis)
lumbar disc prolapse)

• Further history (bowel. sexual function, fertility issues)

CLINICAL • General assessment including of home circumstances
ASSESSMENT • Urinary diary and symptom score
• Assessment of functional ability, quality of life and desire for treatment
• Physical examination: assessment of sensation in lumbosacral dermatomes, anal tone and voluntary contraction of anal sphincter,
bulbocavernosus and anal reflexes, gait, mobility, contractures, hand fuction.

3. The International Consultation on Incontinence Algorithms

• Urine analysis + culture (if infected: treat as necessary)
• Urinary tract imaging, serum creatinine : if abnormal to specialised management
• Post void residual (PVR) assessment by abdominal examination or optional by ultrasound
• Invasive UDS in select patient populations (eg. spinal cord injury, meningomeylocele)

This assessment will give basic information, but does not yield precise neurourological diagnosis

Stress urinary incontinence due to Urinary incontinence due to detrusor overactivity

PRESUMED sphincter incompetence with
DIAGNOSIS negligible PVR
Urinary incontinence associated with With negligible PVR
poor bladder emptying (significant PVR)

• Behavioural modification (C) • Intermittent catheterisation ** with or Depending on co-operation and mobility:
MANAGEMENT* • External appliances (B) without antimuscarinics (A) • Behavioural modification, (C)
• Antimuscarinics (A) /beta 3 agonists (D)
• Continence products (B)
• Indwelling catheter (C)

Failure Failure

SPECIALISED MANAGEMENT

* Consider CONTINENCE PRODUCTS for temporary support during treatment

** Some patients omit IC through personal choice or inability to self catheterise
***Add complimentary bowel management in all cases

2583
 VI. URINARY INCONTINENCE IN NEUROLOGICAL PATIENTS

2584
B. SPECIALISED MANAGEMENT

1. ASSESSMENT 3. TREATMENT MODALITIES (OFTEN IN COMBINATION)

 Conservative
• Most patients with neurogenic urinary incontinence require specialised assess-
ment: Invasive urodynamic studies should be used with videourodynamics if • Intermittent catheterisation (GoR A)
available when surgical interventions are planned or when the “bladder may
be unsafe”. • Behavioural treatment (GoR C)

• Upper tract imaging is needed in some patients and more detailed renal func- • Timed voiding (GoR C)
tion studies will be desirable if the upper tract is considered in danger: high
• Continence products (GoR B)
bladder pressure, upper urinary tract dilation, recurrent or chronic upper tract
infection, (major) stones, (major) reflux. • Antimuscarinics (GoR A)
• In patients with peripheral lesions, clinical neurophysiological testing may be • Alpha-1-adrenergic blockers (GoR C)
helpful for better definition of the lesion
• Oral cannabinoid agonists (MS) (GoR C)
2. TREATMENT • Beta-3-agonist alone or as an add-on to AM (GoR D)
• Bladder expression (GoR B)
For specialised management, conservative treatment is the mainstay (GoR A).
Management of neurogenic urinary incontinence has several options. The algorithm • Triggered voiding (GoR C)
details the recommended options for different types of neurological dysfunction of
the lower urinary tract. The dysfunction does not necessarily correspond to one • Indwelling catheter (GoR C)
type/level of neurological lesion and is defined best by urodynamic studies. One
should always ascertain that the management ensures a safe lower urinary tract  Minimally invasive treatments
(storage at low pressure and complete emptying)
• Botulinum toxin for: sphincter (C) detrusor (A)
Both urinary and bowel function should be assessed together if both systems are
affected, as symptoms and treatment of one system can influence the other, and • Intravesical electrical stimulation (C)
vice versa (GoR A).
• PTNS/TTNS (C)
As therapeutic approaches can differ in various neurological diseases, the most • SNM (stable disease only) (C)
prevalent diseases are discussed separately in the chapter

Management Conseneue Stements

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 Surgical treatment • Stents intraurethral (B)

• TUI sphincter (B)
• Artificial sphincter (A)

ICS Standards 2019

• Sacral deafferentation (B)
• Bladder neck sling (B)
• Sacral anterior root stimulator (B)
• Sub-urethral tapes (D)
• Enterocystoplasty (B)
• Bulking agents (D)
• Bladder neck closure (D)

3. The International Consultation on Incontinence Algorithms

2585
 SPECIALISED MANAGEMENT OF NEUROGENIC URINARY INCONTINENCE

2586
Peripheral nerve lesion (e.g. radical Suprasacral infrapontine and pontine Suprapontine cerebral lesion (e.g.
LEVEL AND EXTENT lesion (e.g. trauma, multiple sclerosis) Parkinson’s disease, stroke, multiple
pelvic surgery) conus cauda equina
OF LESION, HISTORY lesion (e.g. lumbar disc prolapse) sclerosis)
AND CLINICAL
ASSESSMENT

• Urodynamic testing (preferably videourodynamics).

SPECIALISED • Urinary tract imaging
ASSESSMENT

Urodynamic Stress Incontinence due Incontinence associated with poor UI due to detrusor overactivity
DIAGNOSIS to sphincter incompetence bladder emptying due to detrusor
underactivity / sphincter overactivity
With DSD No DSD

CONSERVATIVE • Timed voiding (C) • IC (A) • IC + AM (A) • Behavioural (C)

• External appliance (B) • α-1 blockers (C) • IDC + AM (C) • IC + AM (A)
TREATMENT • Straining* (B) • Triggered voiding (C)
• Indwelling cath. + AM (C)
• Continence products + AM (B)
MINIMALLY • Artificial sphincter (A)
• Bladder neck (autologous) • Stents intraurethral (B)
INVASIVE/SURGICAL sling (B) • TUI sphincter (B)
TREATMENT • Bulking agents (D) • BTX-A to sphincter ** (C)
• BTX-A to detrusor + IC (A) • BTX-A to detrusor ± IC
• Bladder neck closure (D) • IVES (C)
• SDAF + IC (B) • PTNS/TTNS/SNM
(Synthetic midurethral tapes
AM antimuscarinics • SDAF +/- SaRS (B) • Enterocystoplasty
D)**
SDAF sacral deafferentation
SARS sacral anterior root
stimulation
IC intermittent catheterisation
PVR postvoid residual STOMA/DIVERSION MAY BE AN OPTION IN SELECTED CASES
TUI transurethral incision
DSD Detrusor-sphincter
dyssynergia
IDC indwelling catheter ** if urethral hypermobility is the cause of USI; the long-term risks of tapes in the neurogenic population are undefined
BTX-A Botulinum toxin A * If IC not possible or after sphincter relaxation procedures and with adequate UDS control
**Intravesical botulinum injections undertaken according to national licensing. Sphincteric botulinum injections are not currently licensed.
IVES intravesical electrical
stimulation * Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

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ICS Standards 2019

VII. BLADDER PAIN SYNDROME
Definition pain worsening with bladder filling and day-time and/or night-time urinary fre-
quency. There is no proven infection or other obvious local pathology. Bladder pain
Bladder Pain Syndrome (BPS): in the absence of a universally agreed definition, syndrome is often associated with negative cognitive, and behavioural, sexual, or
the International Society for the Study of Interstitial Cystitis – ESSIC definition is emotional consequences, as well as with symptoms suggestive of lower urinary
given (1). tract and sexual dysfunction.
ESSIC: Chronic pelvic pain, pressure or discomfort of greater than 6 months dura- The Consultation believes that, based on the pathology and endoscopic finding
tion perceived to be related to the urinary bladder accompanied by at least one characteristics of the Hunner lesion, the epidemiological pattern that distinguishes
other urinary symptom like persistent desire to void or urinary frequency. Confus- it from bladder pain syndrome, the clinical response to local treatment of the lesion
able diseases as the cause of the symptoms must be excluded. by resection, fulguration, or steroid injection, the response to cyclosporine, and the
There are no published data as to what duration of symptoms indicates that early
spontaneous resolution of symptoms is unlikely. While ESSIC arbitrarily uses a 6

3. The International Consultation on Incontinence Algorithms

month duration, the American Urological Association Guideline suggests that a 6
week history is long enough to initiate diagnosis and treatment of BPS (2). Without
further data, the Consultation cannot make a recommendation and believes that it
is up to the discretion of the physician and patient as to the proper interval between
symptom onset and evaluation and diagnosis of a chronic condition.

1. NOMENCLATURE

The scientific committee of the International Consultation voted to use the term
“bladder pain syndrome” for the disorder that has been commonly referred to as
interstitial cystitis (IC). The term painful bladder syndrome was dropped from the
lexicon. The term IC implies an inflammation within the wall of the urinary bladder,
involving gaps or spaces in the bladder tissue. This does not accurately describe
the majority of patients with this syndrome. Painful Bladder Syndrome, as defined
by the International Continence Society, is too restrictive for the clinical syndrome.
Properly defined, the term Bladder Pain Syndrome appears to fit in well with the
taxonomy of the International Association for the Study of Pain (IASP) (see below),
and focuses on the actual symptom complex rather than what appears to be long-
held misconception of the underlying pathology.
Bladder Pain Syndrome (XXIII-2) (per IASP)
Bladder pain syndrome is the occurrence of persistent or recurrent pain perceived
in the urinary bladder region, accompanied by at least one other symptom, such as Figure 1

2587
 absence of reports in the literature that non-Hunner patients go on to develop Hun-
ner lesions (ie, the finding of a Hunner lesion does not represent a continuum in the 3. INITIAL TREATMENT

2588
natural history of bladder pain syndrome), that the presence of a Hunner lesion
should be considered a distinct disease. It therefore should drop out of the bladder • Patient education, (GoR B)
pain syndrome construct, much like we do not consider other painful conditions like
radiation cystitis, ketamine cystitis, or urinary tract infection a part of bladder pain • Dietary manipulation, (GoR B)
syndrome.
• Nonprescription analgesics,
The Consultation concludes that it would be reasonable to designate the Hunner
lesion in symptomatic patients with the term “interstitial cystitis”, thus indicating a • Stress reduction,
true interstitial inflammation. It would be defined much as Hunner defined it 100 • Pelvic floor relaxation techniques comprise the initial treatment of BPS. In the
years ago, and harmonise the largely Asian, European, and North American con- patient with findings suggesting pelvic floor dysfunction, pelvic floor physical
cepts of interstitial cystitis. The Consultation will continue to refer to the symptom therapy with myofascial trigger point release and intravaginal Thiele massage
complex as “bladder pain syndrome”. Hunner lesion will be considered a distinct is often an effective therapeutic intervention. The treatment of pain needs to
phenotype, but in the future may be classified as a separate disorder entirely, albeit be addressed directly, and in some instances referral to an anesthesia/pain
with local symptoms that are difficult to differentiate from bladder pain syndrome in centre can be an appropriate early step in conjunction with ongoing treatment
the absence of endoscopy. In other words, we may be coming full circle in the of the syndrome. (GoR A)
historical perspective Figure 1.
When conservative therapy fails or symptoms are severe and conservative man-
2. HISTORY / INITIAL ASSESSMENT agement is unlikely to succeed,
• Oral medication (GoR B) or
Males or females whose symptoms meet the requirements of the definition of blad-
• Intravesical treatment can be prescribed. It is recommended to initiate a single
der pain syndrome should be evaluated. The presence of commonly associated
form of therapy and observe results, adding other modalities or substituting
disorders including irritable bowel syndrome, chronic fatigue syndrome, and fibrom-
other modalities as indicated by the degree of response or lack of response to
yalgia in the presence of the cardinal symptoms of bladder pain syndrome also
treatment. (GoR B)
suggests the diagnosis. Abnormal gynaecological findings in women and well-char-
acterised, confusable diseases that may explain the symptoms must be ruled out.
4. SECONDARY ASSESSMENT
The initial assessment consists of a bladder diary or frequency/volume chart, fo-
cused physical examination, urinalysis, and urine culture. In the absence of con-
fusable disorders (uncomplicated disease), a diagnosis can be made and treatment If initial oral or intravesical therapy fails, or before beginning such therapy based on
instituted. Urine cytology, cystoscopy, and urodynamic evaluation are recom- clinician judgment, it is reasonable to consider further evaluation which can include
mended if clinically indicated and/or the diagnosis is in doubt (complicated disease). urodynamics, pelvic imaging, and cystoscopy with bladder distention and possible
Patients with urinary infection should be treated and reassessed. Those with re- bladder biopsy under anaesthesia.
current urinary infection, abnormal urinary cytology, and microscopic or gross hae- • Findings of detrusor overactivity suggest a trial of antimuscarinic or beta-3-
maturia are evaluated with appropriate imaging and endoscopic procedures, and agonist therapy.
only if the findings are unable to explain the symptoms, are they diagnosed with
BPS. GoR C • The presence of a Hunner lesion suggests therapy with transurethral resection,
fulguration of the lesion, or direct steroid injection into the lesion. (GoR B)

Management Conseneue Stements

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ICS Standards 2019

• Bladder distention itself can have therapeutic benefit in 30-50% of patients, • Oral cyclosporine A (GoR C), or
though benefits rarely persist for longer than a few months. (GoR C)
• Clinical trials of newly described pharmacological management techniques. At
this point, most patients will benefit from the expertise of an anaesthesia pain
5. REFRACTORY BPS clinic.
The last step in treatment is usually some type of surgical intervention aimed at
Those patients with persistent, unacceptable symptoms despite oral and/or in-
increasing the functional capacity of the bladder or diverting the urinary stream.
travesical therapy are candidates for more aggressive treatment modalities. Many
of these are best administered within the context of a clinical trial if possible. These • Urinary diversion with or without cystectomy has been used as a last resort
may include with good results in selected patients. Cystectomy and urethrectomy do not
appear to add any additional efficacy to diversion alone.
• Sacral nerve stimulation, (GoR B)
Augmentation or substitution cystoplasty seems less effective and more prone to
• Intradetrusor botulinum toxin, (GoR B)
recurrence of chronic pain in small reported series (GoR C)

3. The International Consultation on Incontinence Algorithms

2589
 BLADDER PAIN SYNDROME

2590
Pain, pressure or discomfort perceived “Complicated” BPS:
SYMPTOMS to be related to the bladder with at • Incontinence
least one other urinary symptom (e.g. • Urinary infection
frequency, nocturia) • Haematuria
• Gynaecologic signs/symptoms

History Consider:
BASIC • Bladder diary or frequency/volume • Urine cytology
ASSESSMENT chart • Further imaging
• Focused physical examination • Endoscopy
• Urinalysis, culture • Urodynamics
• Laparoscopy
URINARY INFECTION

Test and reassess

“Uncomplicated BPS” Normal Abnormal

1ST LINE RX Conservative Therapy
Stress reduction (B)
Patient education (B)
Dietary manipulation (B)
Nonprescription analgesics
Pelvic floor relaxation
Pelvic floor physical therapy (A)
Consult if associated disease

TREAT AS INDICATED

Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

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ICS Standards 2019

BPS REQUIRING MORE ACTIVE INTERVENTION
Consider oral and or intravesical therapies; (B)
2ND LINE Consider physical therapy; (A)
TREATMENT Consider cystoscopy with hydrodistention under anaesthesia and treatment of any
Hunner lesion (B)
(no hierarchy implied)

3RD LINE Consider, if not done previously:

Cystoscopy under anaesthesia with bladder hydrodistension fulguration, resection or
TREATMENT steroid injection of Hunner lesion (B)

3. The International Consultation on Incontinence Algorithms

Sacral Nerve stimulation (B)
4TH LINE Intra-detrusor botulinum toxin (B)
TREATMENT Cyclosporine A (C)
Consider new treatment trials
(no hierarchy implied)

Consider: Improved with acceptable

5TH LINE Diversion with or without cystectomy (C) quality of life:
TREATMENT Substitution cystoplasty Follow and support

Note: The only FDA approved therapies are DMSO and pentosan polysulfate.
Consider CONTINENCE PRODUCTS for temporary support during treatment.

• Pain management is a primary consideration at every step of the algorithm

• Patient enrollment in appropriate research trial is a reasonable option at any point

• Evidence supportingSNS, cyclosporine A, and botulinum toxin for BPS remains limited. These interventions are appropriate only for practitioners with
experience in treating BPS and who are willing to provide long-term care post-intervention

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 VIII. FAECAL INCONTINENCE IN ADULT PATIENTS

2592
ASSESSMENT AND MANAGEMENT

• Physical examination will include anal inspection, abdominal palpitation, a brief

1. INITIAL CLINICAL ASSESSMENT neurological examination, digital rectal examination and usually procto-sig-
moidoscopy or colonoscopy.
Adult patients with faecal incontinence present with a variety of symptom com-
plexes. As many people are reluctant to admit to having faecal incontinence, it is • Further diagnostic testing needs to be considered if the patient has symptoms
important to proactively enquire about it, especially in known high risk groups (such such as an unexplained change in bowel habit, weight loss, anaemia, rectal
as older community-living individuals, post partum women who might have had an bleeding, severe or nocturnal diarrhoea, or an abdominal or pelvic mass and
obstetric injury and patients with loose stools). bowel pathology when organic conditions such as cancer, inflammatory bowel
disease (IBD), a recto-vaginal fistula, full thickness rectal prolapse, or cloacal
History will include symptoms such as loose stools and urgency, the type and se- deformity are suspected. Condition specific management is indicated for these
verity of bowel incontinence, systemic disorders, neurological disorders, and ano- patients.
rectal surgeries (e.g., haemorrhoidectomy), obstetric history for women, medica-
tions, diet, chronic straining, cognitive status, and effects of symptoms on quality of • Reversible factors (such as inadequate access to toilets and side effects of
life. medications resulting in loose stools) should be assessed and addressed at
the outset.
2. INITIAL INTERVENTIONS  Some initial management can often be performed in primary care. After envi-
ronmental factors and local or systemic pathology have been excluded, initial
• Assessing the type of bowel incontinence may help identify an aetiology. Types interventions include:
of bowel incontinence: Anal incontinence is the involuntary loss of faeces
and/or flatus and/or mucus). Faecal incontinence is the involuntary loss of fae- • Discussion of options and goals of management with the patient
ces. Flatus incontinence is the involuntary loss of rectal gas, which may indi-
cate rectal sensory impairment and/or anal sphincter dysfunction. Mucus in- • Provision of patient or caregiver information and education (GoR A)
continence is the involuntary loss of mucus only (See Figure 1). • Adjustment of diet and fluid advice, fibre intake (GoR A)
o Some subtypes of faecal incontinence are urgency faecal incontinence, • Establishing a regular bowel habit (GoR C) or urgency training if relevant (GoR
which is the involuntary loss of faeces due to an inability to defer defaeca- C)
tion, once the desire is perceived, for long enough to reach a toilet. Ur-
gency faecal incontinence is often a symptom of external anal sphincter • Anti-diarrhoeal medication can help if stools are loose (GoR B)
dysfunction. The symptom of urgency does not necessarily result in ur-
gency faecal incontinence. Functional faecal incontinence is due to limita- • Use of continence products including various types and sizes of absorbent
tions in mobility or toileting ability or delayed assistance. Passive faecal pads, briefs, etc., to contain leaked faeces and prevent skin damage
incontinence, incontinence without forewarning, is typically related to in-
• Provide advice on practical coping skills when incontinence occurs (GoR C)
ternal anal sphincter dysfunction or poor closure of the external sphincter
due to rectal prolapse or stage III/IV haemorrhoids.

Management Conseneue Stements

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ICS Standards 2019

3. SECONDARY INTERVENTIONS 4. SECONDARY ASSESSMENT

• If initial interventions fail to improve symptoms after 8-12 weeks, consideration • A variety of anorectal investigations, including manometry, anal ultrasound,
should be given to referral to an incontinence specialist (e.g., gastroenterolo- and possibly MRI, defaecography, and neurophysiological testing can help to
gist, continence nurse, advisor physiotherapist, or colorectal surgeon) for other define structural or functional abnormalities of anorectal function and guide
interventions or further assessment. management if initial and/or secondary interventions are ineffective
• Pelvic floor muscle training (PFMT) – contraction of pelvic floor muscles, mul-
tiple times per day to improve strength of contraction and increase awareness 5. TERTIARY REFERRAL, SURGICAL OR MULTI-
of anorectal muscle function. (GoR C) DISCIPLINARY CONSULTATION
• Biofeedback therapy – behavioural treatment designed to enhance the
strength of sphincter contraction and improve rectal sensation using special- • Faecal incontinence that fails to respond to initial and secondary management
ised equipment. Biofeedback therapy can be combined with PFMT to improve requires specialised consultation by a gastroenterologist, colorectal surgeon,

3. The International Consultation on Incontinence Algorithms

strength. (GoR B) urogynaecologist, and/or a multi-disciplinary team
• Transanal Irrigation to maximise bowel emptying and minimise faecal inconti-
nence primarily in patients with incomplete elimination, passive faecal inconti-
nence, or faecal incontinence with defaecation difficulty, (GoR C)

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 ASSESSMENT AND CONSERVATIVE MANAGEMENT OF FAECAL INCONTINENCE

2594
Identification
Active case finding or patient presents
with faecal incontinence (C)

Initial Clinical Assessment Address Reversible Factors

• History (C) Toilet access, medication side effects, loose stools, etc. (C)
• Physical exam (C)
• Medication and diet review (C)
• Assessment of impact on quality of life
(C)
• Proctosigmoid-oscopy and/or Initial Interventions
colonoscopy as needed (C) • Discussion of options and patient’s goals of management (B/C)
• Education of patient and/or caregiver (B/C)
• Diet and eating pattern modifications (B), and dietary fibre supplements (A)
• Medications (loperamide) (B)
Condition Specific • Bowel habit training (C)
• Transanal irrigation (C)
Assessment and • Incontinence products such as pads for containment (B)
Management • Practical advice for coping (locating toilets, carrying cleansing kits, etc.) (C)
For cancer, IBD, impaction, full
thickness rectal prolapse, recto-
vaginal fistula, cloacal deformity (C)
Incontinence Specialist (C)

Secondary Interventions Secondary Assessment

• PFMT +/ (B) • Manometry and/or Ultrasound (B/C)
• Biofeedback (A) • Possible additional test
• Incontinence products such as an anal • MRI (C)
plug or insert (B) • Defaecography (B/C)
• Neuro-physiology testing (C/D)

Tertiary
Referral, surgical and/or multi-discipline consult (C)

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

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ICS Standards 2019

VIII. FAECAL INCONTINENCE IN ADULT PATIENTS

SURGERY FOR FAECAL INCONTINENCE

• Patients with sphincter defects of greater than 180° or major perineal tissue
1. PATIENT ASSESSMENT loss require individualised treatment. In some cases, initial reconstruction can
be performed. Should incontinence persist, alternatives include stimulated
• The reader is referred to the relevant chapter sections in “Dynamic Testing” muscle transposition (usually gracilloplasty) artificial anal sphincter implanta-
and “Conservative Treatment for Faecal Incontinence.” In general, patients re- tion, or SNS. (GoR C)
ferred for surgical management of faecal incontinence must either have failed
conservative therapy or not be candidates for conservative therapy due to se- 3. SALVAGE MANAGEMENT
vere anatomic or neurological dysfunction.

3. The International Consultation on Incontinence Algorithms

• Prior to surgical management of faecal incontinence, the integrity of the anal • For patients who remain incontinent following sphincteroplasty, repeat endo-
sphincter complex should be assessed. This assessment is best performed anal ultrasound should be undertaken to reassess the status of the repair. If
with endoanal ultrasound, though pelvic MRI may also be useful. Ancillary tests no defect is present, or if the sphincter defect is minimal, options include SNS
include anal manometry, electromyography, and defaecography. and biomaterial injection therapy. If there is a large persisting sphincter defect,
repeat sphincteroplasty can be considered. (GoR C)
• If the patient has persisting faecal incontinence, he or she should undergo re-
peat assessment, including endoanal ultrasound. • Patients who have failed SNS can be considered for biomaterial injection ther-
apy or sphincteroplasty if a sphincter defect is present. Other alternatives in-
clude stimulated graciloplasty and implantation of an artificial anal sphincter.
2. SPECIALISED MANAGEMENT (GoR C)
• Patients who fail surgical therapy for faecal incontinence, or who do not wish
• The surgical approach is influenced by the presence and magnitude of an an- to undergo extensive pelvic reconstruction, should consider placement of an
atomical anal sphincter defect. If no defect is present, or if the sphincter defect end sigmoid colostomy. (GoR C) While this procedure does not restore conti-
is minimal, options include SNS and biomaterial injection therapy. nence, it does restore substantial bowel control and appears to improve social
function and quality of life. Novel therapies can also be considered under pro-
• Acute anal sphincter repair is usually required following obstetric or direct
trauma. End to end or overlapping repair may be performed. When possible tocol: PTNS, the magnetic anal sphincter, SECCATM, vaginal pessary (Eclip-
seTM) and sling procedures. (GoR D)
the internal anal sphincter should be separately repaired. (GoR C)
• Patients with rectal prolapse, rectovaginal fistula or cloacal deformity often 4. SPECIAL SITUATIONS
have associated faecal incontinence. Initial therapy should be directed at cor-
rection of the anatomical abnormality. (GoR C)
• Individuals with congenital abnormalities may be amenable to surgical repair.
• For patients with moderate sphincter defects, sphincteroplasty, SNS or bio- Often this will involve both laparoscopic abdominal and perineal approached.
material injection therapy can each be considered. For patients with large Poor functional outcomes may be treated by an Antegrade Continence Enema
sphincter defects (>120 degrees), sphincteroplasty is likely to be the best op- (ACE) procedure or colostomy. Patients with cauda equina type neurological
tion, though a PNE trial for SNS can be considered. (GoR C) disorders, either congenital or acquired, should be considered for an ACE pro-
cedure or colostomy. (GoR C)

2595
 SURGICAL MANAGEMENT OF FAECAL INCONTINENCE

2596
MDT-REVIEW: Repeat evaluation
CLINICAL, RADIOLOGICAL AND
PHYSIOLOGICAL DATA

ACE Colostomy Severe spinal cord Rectal prolapse Correction of anatomic

impairment Rectovaginal fistula abnormality
Cloacal deformity

Rectal evacuation Sphincter defect > 180o Sphincter defect Sphincter defect No sphincter defect
disorder or significant perineal 120o-180o < 120o
tissue loss

• Rectocele repair • Sphincteroplasty +/- • Sphincteroplasty • SNS • SNS

• Ventral rectopexy vaginal and perineal • SNS • Sphincteroplasty • BI
reconstruction • Colostomy • BI • Colostomy
• Stimulated graciloplasty • Colostomy
• Artificial anal sphincter
• SNS
• Colostomy

Yes No
Symptom improvement

Follow up Novel therapies:

• Magnetic anal sphincter
• Puborectal sling
• Radiofrequency energy treatment
• Stem cell therapy
ACE Antegrade Continence Enema • Vaginal pessary - Eclipse™
BI Biomaterial Injection
MDT Multi-Disciplinary Team
SNS Sacral Nerve Stimulation * Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

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IX. FAECAL INCONTINENCE IN NEUROLOGICAL PATIENTS

A. INITIAL MANAGEMENT

 Patients with known neurological disease may present with symptoms related  Functional assessment:
to neurological bowel dysfunction, such as; difficulty in defaecation, constipa-
tion and faecal incontinence which disturb their activities of daily living and im- • Hand and arm use, fine hand use, mobility – maintaining body position, transfer
pair quality of life. Many have permanent impairments and functional limitations and walking ability.
and disabilities, which are due to neurological deficits and complications  Environmental factors assessment:

1. INITIAL ASSESSMENT • toilet accessibility; devices for bowel care and mobility; caregiver support and
attitude;

3. The International Consultation on Incontinence Algorithms

 The history should include:
2. BASIC INVESTIGATIONS
• Neurological diagnosis and functional level
• Previous and present lower gastrointestinal (LGIT) function and disorders Stool examination, plain abdominal X-Ray

• Severity of neurogenic bowel dysfunction 3. INITIAL TREATMENTS

• Current bowel care and management including diet, fluid intake, medications
affecting bowel functions • Patient education and goals-setting to achieve complete defaecation on a reg-
ular basis and faecal continence based on right time, right place, right trigger
• Co-morbidity / complication e.g., urinary incontinence, autonomic dysreflexia, and right consistency
pressure ulcers, sexual dysfunction
• Adequate fibre diet and fluid intake; appropriate trigger according to preserva-
• Patient’s satisfaction, needs, restrictions and quality of life tion of sacral (anorectal) reflex – digital rectal stimulation (GoR C); suppository
• Environmental factors and barriers and facilitators to independent bowel man- and enema (GoR B); if no anorectal reflex, manual evacuation (GoR B); ab-
agement. dominal massage (GoR C) can also be helpful

 Physical examination: • Prescribe medications – stool softener, laxative, prokinetic agents, anti-diar-
rhoeal drugs as neccessary
 Cognitive function; motor, sensory and sacral reflexes – voluntary anal sphinc-
ter contraction, deep perianal sensation, anal tone, anal and bulbo- cavernosus • Assistive techniques may be necessary for
reflexes o Defaecation – transanal irrigation (GoR A)
o For incontinence – anal plug (GoR C)
 Spasticity of the lower limbs
The algorithm does not apply to management in acute neurological patients that
 Abdominal palpation for faecal loading and rectal examination need regular bowel emptying.

2597
 INITIAL MANAGEMENT OF NEUROGENIC FAECAL INCONTINENCE

2598
Sacral cord/cauda equina lesion (e.g. Suprasacral infrapontine and pontine Suprapontine lesions
HISTORY, LEVEL lumbar disc prolapse). Peripheral lesion (e.g. trauma, multiple sclerosis) (e.g. Parkinson’s)
OF LESION nerve lesion (e.g. radical pelvic
surgery)

• History taking including diagnosis, pre-morbid bowel function and sensation and their disorders, current bowel and bladder
CLINICAL programme, co-morbid diseases/disorders, QOL and needs
ASSESSMENT • Physical & neurological examination including cognitive function, voluntary anal contraction, perianal sensation, sacral reflexes,
digital rectal examination, abdominal palpation for faecal impaction
• Functional assessment including hand and arm use, fine hand use, balance, transfer and walking
• Environmental factors assessment including toilet accessibility, assistive device, caregivers’ support and attitude
• Basic investigation: stool exam, plain film abdomen in selected patients (diarrhoea, impaction not felt on rectal examination)
This assessment will give basic information but does not permit a precise diagnosis of neurogenic bowel dysfunction

Incontinence due to sphincter Incontinence due to lack of cognitive "false incontinence" due to faecal
PRESUMED incompetence function, sensory awareness impaction
DIAGNOSIS disorders, unable to control by vol-
untary anal contraction

• Manual evacuation • Digital rectal stimulation • Faecal disimpaction:

TREATMENT* • Assistive device – anal plug • Chemical stimulant, • Oral PEG plus enemas or transanal
• Mini-enema, transanal irrigation suppository,mini-enema, stool irrigation
• Suppository softener, laxative, prokinetics, and
• Biofeedback • Transanal irrigation could be given
by patient/caregiver; biofeedback
by patient

NECESSARY IN Patient education, adequate fibre diet and fluid intake; regular bowel care, preferably ± 3 times a week
ALL

SPECIALISED MANAGEMENT PREFERABLE FOR MORE " TAILORED " TREATMENT

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

401
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ICS Standards 2019

IX. FAECAL INCONTINENCE IN NEUROLOGICAL PATIENTS
B. SPECIALISED MANAGEMENT

• Electrical stimulation sphincter, (GoR C).

1. ASSESSMENT
• Percutaneous neuromodulation and sacral nerve stimulation : further research
is required (GoR D).
• Some patients with neurogenic faecal incontinence will need specialised as-
sessment, especially if initial management is unsuccesful to look for comorbid-  Surgical management of neurogenic faecal incontinence has different options
ity and certainly before performing invasive treatment which need a very strict patient selection
• Do not assume that all symptoms are due to neuropathy, e.g. women with neu- • Antegrade Continence Enema ACE (GoR C).
rological pathology might have had childbirth injury to the sphincter

3. The International Consultation on Incontinence Algorithms

• Artificial bowel sphincter or FENIX procedure (GoR C).
• Special investigations: manometry, endoanal ultrasound, (dynamic) MRI, (nee-
dle) EMG. These specific bowel functional tests and electro-diagnostic tests • Sacral Anterior Root Stimulation SARS (GoR C).
must be considered optional, as their value in neurological pathology is not
• Botulinum Toxin (GoR C).
sufficiently demonstrated so far.
• Neuromodulation (GoR C).
2. TREATMENTS  It is recommended that urinary and bowel function are assessed simultane-
ously if both systems are affected, as symptoms and treatment of one system
can influence the other and vice versa (GoR A).
 As the therapeutic approach can differ in different neurological diseases, the
 Conservative treatment for neurological faecal incontinence is also the main-
most prevalent diseases are discussed separately in the chapter.
stay for specialised management, (GoR C).

 Management of neurological incontinence does not include very extensive

treatment modalities and many conservative interventions are still empirical.
• Transanal irrigation (GoR B).

2599
 SPECIALISED MANAGEMENT OF NEUROGENIC FAECAL INCONTINENCE

2600
PRIMARY ASSESSMENT, Sacral cord/cauda equina lesion (e.g. Suprasacral infrapontine and pontine Suprapontine lesions
HISTORY, LEVEL AND lumbar disc prolapse). Peripheral lesion (e.g. trauma, multiple sclerosis) (e.g. Parkinson’s)
nerve lesion (e.g. radical pelvic
EXTENT OF LESION, surgery)
CLINICAL ASSESSMENT

• Functional bowel testing / functional imaging

SPECIALISED
ASSESSMENT • Consider neurophysiological testing and anorectal manometry.

Faecal Incontinence through loss of bowel sensation, sphincter deficiency Faecal impaction
DIAGNOSIS or severe rectal prolapse

Faecal disimpaction

• Transanal irrigation (B) Failure

CONSERVATIVE • Electrical stimulation of sphincter (C), consider
TREATMENT • Percutaneous neuromodulation: further studies

Failure consider

• ACE (C)
SURGICAL • Artificial bowel sphincter or FENIX procedure (C)
TREATMENT • SARS (C)
• Botulinum Toxin for anal sphincter spasticity (C) ACE Antegrade Continence Enema
• Neuromodulation (C) SARS Sacral Anterior Root Stimulation

STOMA/DIVERSION MAY BE AN OPTION IN SELECTED CASES

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

403
 404

ICS Standards 2019

X. URINARY AND FAECAL INCONTINENCE IN FRAIL OLDER MEN AND WOMEN
• There is no reason to suspect why interventions which have proven efficacy in faecal incontinence care (dryness, decrease in specific symptoms, quality of
the community dwelling elderly should not also be effective in frail older people. life, reduction of comorbidity, lesser care burden) (GoR B); and likely coopera-
Clinicians should, however, take due regard of the practicality, potential bene- tion with management (GoR C).
fits and dangers of employing any single intervention in this population.
• Evaluation for bowel “alarm” symptoms (rectal bleeding, positive blood screen-
• Frail older people do require a different approach addressing the potential role ing from stool studies, obstructive symptoms, recent onset of constipation,
of co-morbid disease, current medications (prescribed, over the counter and/or weight loss, and a change in stool calibre) will need more extensive evaluation
naturopathic), and functional and cognitive impairment in urinary and faecal (GoR A)
incontinence.
• Urinalysis is recommended for all patients, primarily to screen for haematuria
• The extent of the investigation and management should take into account the (GoR C).
degree of bother to the older person and/or caregiver, the goals for care, the
•

3. The International Consultation on Incontinence Algorithms

degree that the older person is able to undertake any intervention and the over- Treatment of otherwise asymptomatic bacteriuria/pyuria is not beneficial (GoR
all prognosis and life expectancy. C), and it may cause harm by increasing the risk of antibiotic resistance and
severe adverse effects. e.g., Clostridium difficile colitis (GoR C).
• Effective management to meet the goals of care should be possible for most
frail older people. • Stool studies may not be needed in all patients with faecal incontinence. Pa-
tients with diarrhoea, especially those with more acute onset diarrhoea, may
need to be tested for infectious causes of their diarrhoea. Other stool studies
1. HISTORY AND SYMPTOM ASSESSMENT could involve testing for malabsorption syndromes.
• The utility of the Clinical Stress test in this population is uncertain (GoR D).
• Active case finding for urinary and faecal incontinence should be done in all
frail older people (GoR A). • Wet checks can assess urinary incontinence frequency in long-term care resi-
dents (GoR C).
• History should include comorbid conditions and medications that could cause
or worsen incontinence. • A post voiding residual volume (PVR) test is impractical in many care settings
and there is no consensus for the definition of what constitutes a “high” PVR in
• Physical examination should include a rectal examination for faecal loading or
any population. A PVR measurement is not recommended in the routine initial
impaction (GoR C), functional assessment (mobility, transfers, manual dexter-
assessment of frail older people with urinary incontinence.
ity, dressing and undressing ability, ability to toilet) (GoR A), a screening test
for depression (GoR B), and cognitive assessment (to assist in planning and • However, there is compelling clinical experiential evidence for PVR testing in
management, (GoR C)). selected frail older people with: diabetes mellitus (especially long standing);
prior urinary retention or high PVR; recurrent UTIs; medications that impair
• The mnemonic DIPPERS (see urinary and faecal incontinence algorithms) co-
bladder emptying (e.g., opiates); severe constipation; persistent or worsening
vers some of these comorbid conditions. Note that urogenital atrophy does not,
urgency urinary incontinence despite antimuscarinic/beta-3-agonist treatment;
in itself, cause urinary incontinence and should not be treated for this purpose
or prior urodynamics showing detrusor underactivity and/or bladder outlet ob-
(GoR B).
struction (GoR C). Treatment of contributing comorbidity may reduce PVR.
• The patient and / or caregiver should be asked about the degree of bother of Trial with catheter may be considered for PVR > 200-500 ml if the PVR is felt
urinary incontinence and/or faecal incontinence(GoR B); goals for urinary and to contribute to UI or urinary frequency (GoR C).

2601
 • Nocturia Assessment of frail elders with bothersome nocturia should identify may be added to conservative therapy of urgency UI (GoR A-C, depending on
potential underlying causes including nocturnal polyuria (by bladder diary/fre- agent).

2602
quency- volume chart or wet checks; oedema on examination) (GoR C),pri-
mary sleep problems (e.g., sleep apnoea); and low voided volumes (e.g., from • For the select cognitively intact older with FI, biofeedback may be considered,
high PVR). but few studies exist among frail older adults.

• Stool impaction/loading. If suspected on digital rectal examination, an ab- • Alpha-blockers may be cautiously considered in frail men with suspected pros-
dominal x-ray may be necessary to further evaluate the degree and location of tatic obstruction (GoR C). All drugs should be started at the lowest dose and
impaction/loading in frail older adults. titrated with regular review until either care goals are met or adverse effects
are intolerable.
2. CLINICAL DIAGNOSIS • DDAVP (vasopressin) has a high risk of severe hyponatraemia in frail older
persons and should not be used outside specialist centres .or without very
careful monitoring and long term followup (GoR A).
The most common types of Urinary Incontinence in frail older people are urgency,
stress, and mixed urinary incontinence. Frail older people with urgency urinary in- • Improving stool consistency can be done with dietary fibre and supplem.entary
continence also may have detrusor underactivity during voiding with a high PVR fibre in older adults (GoR C). In older adults with diarrhoea, loperamide may
but without outlet obstruction. There is no evidence that antimuscarnincs are less be considered at low doses to improve stool consistency. However, close mon-
effective or cause retention in this situation (GoR D). itoring for constipation and impaction is needed.
The most common types of faecal incontinence in frail older people are related to
urgency and passive leakage. Passive leakage can refer to leakage, seepage and 4. ONGOING MANAGEMENT AND REASSESSMENT
staining following bowel movements that are not associated with faecal urgency
and may also occur with faecal impaction. Because constipation and impaction of- Optimal urinary and faecal incontinence management is usually possible with the
ten contribute to faecal incontinence in older adults, these are considered sepa- above approaches. If initial management fails to achieve the desired goals, the next
rately in the algorithm. steps are reassessment and treatment of contributing comorbidity and/or functional
impairment.
3. INITIAL MANAGEMENT
5. SPECIALISED MANAGEMENT
• Initial treatment should be individualised and influenced by goals of care, treat-
ment preferences and estimated remaining life expectancy, as well as the most If frail older people have either other significant factors (e.g., pain, haematuria,
likely clinical diagnosis (GoR C). In some frail older persons the only possible bowel “alarm” symptoms), UI or FI symptoms that cannot be classified as urgency,
outcome may be containment; management with continence products, espe- stress, or mixed or overflow or other complicated comorbidity which the primary
cially for people with minimal mobility (require assistance of > 2 people to trans- clinician cannot address (e.g. dementia, functional impairment), then specialist re-
fer), advanced dementia (unable to state their name), and /or nocturnal urinary ferral should be considered. Referral may also be appropriate when there is been
and faecal incontinence. insufficient response to initial management. The type of specialist will depend on
• Conservative and behavioural therapy for UI includes lifestyle changes (GoR local resources and the reason for referral: surgical specialists (urologists, gynecol-
C), bladder training for more fit alert persons (GoR B), and prompted voiding ogists, colorectal surgeons), gastroenterologists, geriatricians or physical therapist
for frailer, more impaired older people (GoR A). (functional and cognitive impairment); or continence nurse specialists (homebound
patients). Referral decisions should consider goals of care, patient/caregiver desire
• For the select cognitively intact older person with UI or FI, pelvic floor muscle for invasive therapy and estimated remaining life expectancy.
therapy can be considered, but there are few studies (GoR C). Antimuscarinics

Management Conseneue Stements

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ICS Standards 2019

Age per se is not a contraindication to UI or FI surgery (GoR C), but before sur- • Discussion (including the caregiver) to ensure that the anticipated surgical out-
gery is considered, all patients should have: come is consistent with goals of care in the context of the patient’s remaining
life expectancy (GoR C).
• Evaluation and treatment for any comorbidity, medications, and cognitive or
functional impairments contributing to UI that could compromise surgical out- • Urodynamic testing or anorectal manometry, because clinical diagnosis may
come (e.g., dementia that precludes patient ability to use artificial sphincter) be inaccurate (GoR B).
(GoR C).
• Preoperative assessment and perioperative care to establish risk of, and to
• Adequate trial of conservative therapy, including pharmacological therapies minimise the risk of common geriatric post-operative complications such as
where relevant (GoR C). delirium and infection (GoR A), dehydration and falls (GoR C).

3. The International Consultation on Incontinence Algorithms

2603
 MANAGEMENT OF URINARY INCONTINENCE IN FRAIL OLDER MEN & WOMEN

2604
Active case finding in all frail elderly people (A) UI associated with:
HISTORY/ SYMPTOM • Pain
ASSESSMENT • Haematuria
• Recurrent symptomatic UTI
• Delirium • Pelvic mass
• Assess, treat and reassess potentially treatable conditions,
CLINICAL • Infection including relevant comorbidities and ADLs (see text) (A-C) • Pelvic irradiation
ASSESSMENT • Pharmaceuticals • Assess Qol, desire for Rx, goals for Rx, patient & caregiver • Pelvic / LUT surgery
• Psychological preferences (C) • Prolapse beyond introitus
• Excess urine output • Targeted physical examination (cognition, mobility, (women)
• Reduced mobility neurological and digital rectal examination) (A-C) • Suspected fistula
• Stool impaction (and their • Urinalysis (C)
factors) • Consider bladder diary or wet checks, especially if nocturia is
(avoid overtreatment of present. PVR in specific patients (see text) (C)
asymptomatic bacteriura (C))

These diagnoses may overlap URGENCY UI* SIGNIFICANT PVR* STRESS UI*
CLINICAL DIAGNOSIS in various combinations, e.g.,
Mixed UI, DHIC (see text)

(If Mixed UI, initially treat most • Lifestyle interventions • Treat constipation (C) • Lifestyle interventions
INITIAL bothersome symptoms) (B-C) • Review medications (B-C)
MANAGEMENT* • Behavioural therapies (B) • Consider trial of alpha- • Behavioural therapies (B)
• Consider trial of blocker (men) (C) (See text)
antimuscarinic drugs / • Catheter drainage if PVR
beta 3 agonist (A-C) 200-500 ml, then reassess
(see text) (C)

If insufficient improvement, reassess for and treat contributing comorbidity ± functional

ONGOING impairment
REASSESSMENT AND
MANAGEMENT
If continued insufficient improvement, or severe associated symptoms are present, consider
specialist referral as appropriate per patient preferences and comorbidity (see text)

* Consider CONTINENCE PRODUCTS for temporary support during treatment

Management Conseneue Stements

407
 408

ICS Standards 2019

MANAGEMENT OF FAECAL INCONTINENCE IN FRAIL OLDER MEN & WOMEN
Active case finding in all frail elderly people (A) FI associated with:
HISTORY/ SYMPTOM • Pain
ASSESSMENT • Rectal bleeding
• Change in stool calibre
Rx reversible causes: • Weight loss
CLINICAL • Delirium • Assess, treat and reassess potentially treatable conditions, • Chronic diarrhoea
• Infection including relevant comorbidities and ADLs (see text) (A-C) • Faecal impaction
ASSESSMENT • Assess Qol, desire for Rx, goals for Rx, pt & caregiver
• Pharmaceuticals • Inflammatory bowel disease
preferences (C)
• Psychological • Pelvic irradiation
• Targeted physical examination (cognition, mobility,
• Excess stool output • Malabsorption syndromes
neurological and digital rectal examination) (A-C)
(diarrhoea)
• Urinalysis (C) • Prolapse beyond introitus
• Reduced mobility
• Consider bowel diary and clean checks (C) (women)

3. The International Consultation on Incontinence Algorithms

• Stool impaction (and their
factors) • Suspected fistula

** These diagnoses may overlap Urge Fl** Constipation/ faecal Passive Fl*
CLINICAL DIAGNOSIS in various combinations, e.g., Impaction*
Urgency-related,passive/seepage,
and impaction (see text)

• Lifestyle interventions • Treat constipation (osmotic • Lifestyle interventions

INITIAL (B-C) laxatives) If impacted, (B-C)
MANAGEMENT* • Behavioural therapies (B) glycerine or Bisacodyl sup- • Behavioural therapies (B)
• Biofeedback (C) positories. Phospate enemas if • Biofeedback (C)
• Improve stool consistency severe. (B-C) • Improve stool consistency
(C) • Review medications that may (C)
contribute to constipation (C)
• Consider biofeedback if
dyssynergic defaecation is
suspected (C)

If insufficient improvement, reassess for and treatment of contributing comorbidity ±

ONGOING functional impairment
REASSESSMENT AND
MANAGEMENT
If continued insufficient improvement, or severe associated symptoms are present, consider
specialist referral as appropriate per patient preferences and comorbidity (see text)

* Consider CONTINENCE PRODUCTS for temporary support during treatment

2605
 409

4. RECOMMENDATIONS FOR
FURTHER RESEARCH IN
EPIDEMIOLOGY

1. Longitudinal study designs are needed to: (i) es- 4. There should be more emphasis on the associa-
timate the incidence and remission rates of uri- tions between UI, AI and POP and specific dis-
nary incontinence (UI) anal incontinence (AI) and eases like stroke, diabetes, and psychiatric dis-
pelvic organ prolapse (POP) and to (ii) describe eases.
the natural course of these conditions and (iii) to
investigate risk factors and possible protective 5. The variation of disease occurrence in groups of
factors. In addition, similar studies regarding different racial origin yet similar environmental
other lower urinary tract symptoms (LUTS) exposures, lend support to the presumed genetic
should be initiated. influence on the causation of UI, AI and POP.
This again provides circumstantial evidence for a
2. Although there is now more information regard- genetic contribution to pelvic floor muscle disor-
ing prevalence, incidence, and other epidemio- ders since most of these studies have been una-
logical data in developing countries, further infor- ble to control for heritability in relation to the com-
mation is still needed. It is recommended that plex interaction of environmental factors.
fundamental research regarding prevalence, in-
cidence and other epidemiological data in devel- The aetiology of UI, AI and POP is widely recog-
oping countries should be encouraged, and tai- nised to be multifactorial, yet the complex inter-
lored to the cultural, economic and social envi- action between genetic predisposition and envi-
ronment of the population under study. ronmental influences is poorly understood. Ge-
netic components require further investigation.
3. Some potential risk and protective factors de- Twin studies provide a possible means of study-
serve more attention. For example, the role of ing the relative importance of genetic predisposi-
pregnancy and childbirth in the development of tion and environmental factors. By comparing
UI, AI and POP must be studied in a fashion that monozygotic female twins with identical geno-
links population-based methods to clinical as- type, and dizogytic female twins who, on aver-
sessment of pregnancy, delivery and birth age, share 50 percent of their segregating
trauma and follows women over many years. genes, the relative proportions of phenotypic var-
Such a design is necessary because the effect of iance resulting from genetic and environmental
pregnancy and childbirth may become clear only factors can be estimated. A genetic influence is
years later when the woman is older and be- suggested if monzygotic twins are more concord-
cause the woman will not then be able to report ant for the disease than dizygotic twins whereas
the exact nature of the tear, episiotomy, etc. evidence for environmental effects comes from
monozygotic twins who are discordant for the
disease.

2606 RECOMMENDATIONS OF THE INTERNATIONAL SCIENTIFIC COMMITTEE

Recommendations for Further Research in Epidemiology

410

5. RECOMMENDATIONS FOR
FURTHER BASIC SCIENCE
RESEARCH

The following proposals for research come from the o Develop inter-institutional research-training
Committees’ work in reviewing the current literature programmes to allow new researchers the
on Basic Science: opportunity to better interact and exchange
ideas.
1. Integrate data from reductionist experiments to
inform the formulation of better systems-based 7. Bring about a greater emphasis on the im-
approaches in the investigation of the pathology portance of research to medical trainees and sci-
of the lower urinary tract (LUT), the genital tract ence graduates through:
(GT) and the lower gastro-intestinal tract (LGIT).
o Establishing research training as a core
2. Encourage greater emphasis on basic research component of postgraduate clinical develop-
to characterise tissues receiving relatively little ment
attention: ie the lower gastrointestinal tract; the
bladder neck and urethra; the ureter, pelvic floor o Increased access to support funds, espe-
musculature. cially scholarships and personal awards

3. Generate research programmes for fetal and ne- o Organisation of focused multidisciplinary re-
onatal research in LUT and LGIT function. search meetings, either stand-alone or as
dedicated sessions during national and in-
4. Use genome-wide bioinformatic and population ternational conferences
health surveys to generate testable hypotheses
regarding the physiological and pathophysiologi- o Greater interaction between medical centres
cal functions of the LUT, GT and LGIT. and Higher Education Institutions (HEIs).

5. Generate improved experimental approaches to o Allowing researchers-in-training better ac-

investigate the pathophysiology of the LUT and cess to international meetings through re-
LGIT by: duced registration charges and improved
travel grants.
o The development of animal models that ac-
curately describe human pathological condi- o Inclusion in clinical meetings of point-coun-
tions, including the greater use of large-ani- terpoint session(s) with both basic science
mal models and clinical viewpoints.

o The better use of reverse translational ap- o Development of research forums for ex-
proaches for linking animal models to the change of ideas between active researchers
human disease. and industry.

o The use of human tissue from well-charac- o Lobbying research-funding organisations

terised patient groups. about the medical and social importance of
LUT and LGIT disorders.
o The development of emerging areas such
as: tissue engineering; proteomics and 8. Increase emphasis on research into LUT and
metabolomics LGIT in HEIs through:

o Increased collaborations between biologi- o Greater representation on grant-funding

cal, physical and mathematical sciences. agencies

6. Develop centres of excellence or consortia of ex- o Encouragement of submission to high im-

cellence in LUT, GT and GIT research pact factor journals and recognition of re-
search published in specialty journals
o Integrate expertise from university depart-
ments, academic medical units and industry o More integrated teaching and training op-
portunities
o Encourage translational approaches to re-
search.

RECOMMENDATIONS FOR FURTHER BASIC SCIENCE RESEARCH 2607

ICS Standards 2019

3. The International Consultation on Incontinence Algorithms
 411

6. RECOMMENDATIONS FOR
PRIMARY PREVENTION,
CONTINENCE PROMOTION,
MODELS OF CARE AND
EDUCATION

Primary prevention, continence promotion and advo- • Strategies to promote awareness about inconti-
cacy, models of care and education involves inform- nence and its treatment can be strengthened by
ing and educating the public and health care profes- the use of evidence based theories and methods
sionals that UI and FI are not inevitable, but are treat- from the field of health promotion, including the
able or at least manageable. Other bladder disorders social determinants of health (GoR D)
such as BPS/IC and POP can also be treated suc-
cessfully. The committee found information about re- • The Internet represents an important source of
cent practice and research initiatives in all of these information about incontinence, however the
areas but evidence-based research only on primary quality of information is variable (GoR C)
prevention of UI. Continence promotion and advo- • For help-seeking behaviour, no RCTs or case-
cacy, and professional and non-professional educa- control studies were located (Level of Evidence
tion, require prioritisation by public health profession- 4)
als, educationalists, clinicians and researchers to re-
duce the burden that UI, FI, BPS/IC and POP places • Continence promotion programmes need to ac-
on society, healthcare systems, caregivers, and commodate varying levels of health literacy and
above all, affected adults. As to models of care, the access to health information in different popula-
evidence supports nurse-led community services as tions (Level of Evidence: 4)
leading to higher health-related QoL and in some in-
stances, higher cure rates. The multidisciplinary re- • Public health campaigns about incontinence and
ferral settings are also reporting favourable out- other pelvic floor disorders need to use terminol-
comes. ogy targeted to consumers’ understandings
(Level of Evidence: 4)
1. PRIMARY PREVENTION • Satisfaction surveys about continence care could
yield relevant and detailed information by using
• Pelvic floor muscle exercises can prevent UI in open-ended, rather than closed-ended questions
pregnant and postpartum women. (Level of Evi- (Level of Evidence: 1)
dence: 1) • Evidence for the use of leaflets or brochures in
• Education designed for community-dwelling raising awareness about UI and different treat-
older women can prevent UI. (Level of Evidence: ment options is inconclusive (Level of Evidence:
1) 1).

• No recent RCTs or case-control studies were lo- • Evidence for the impact of continence advocacy
cated for prevention of FI. (Level of Evidence: 4) worldwide was based on opinion (Level of Evi-
dence: 1)
• Pelvic floor muscle exercises should be provided
for pregnant women. (GoR A) • Recommendation for help-seeking behaviour:
No recommendation was possible based on the
• Education of older women to prevent UI should level of evidence provided by the available re-
be provided. (GoR A) search.
• Continence promotion is required to address • Worldwide Advocacy (GoR D)
broad gaps in knowledge about incontinence
(GoR C)

2608 RECOMMENDATIONS OF THE INTERNATIONAL SCIENTIFIC COMMITTEE

Recommendations for Primary Prevention, Continence Promotion, Models of Care and Education
412

• Effectiveness of guidelines in clinical practice

2. MODELS OF CARE has not been determined. (Levels of evidence: 3
to 4).
• Effectiveness of service delivery models. (Level
• There is a continued need for evaluation re-
of Evidence: 4)
search to explore impact of guidelines on clinical
• A care delivery model should be based on the care both at individual and population levels.
principles as described in the Optimum Conti- This evaluation strategy needs to include impact
nence Service Specification. (GoR C) on a wide range of outcomes, including inci-
dence and prevalence of disease, treatment out-
• Increased emphasis is needed on non-physician comes, prevention efforts, costs, and health care
models of care. (GoR C) policy. (GoR: C)
• Despite the proliferation of guidelines, there is in- • Effectiveness of public education efforts through
creasing evidence that practicing clinicians and various channels including education, public me-
nurses are not consistently following them. Im- dia and mass communications (Levels of Evi-
plementation models should be developed on dence 3-4)
how to translate guidelines into practice. (GoR C)
• There is a need for additional focused research
on methods to enhance patient and public about
3. EDUCATION pelvic disorders, both at an individual and
broader public level. (GoR C)
• Professional education of UI, FI, BPS/IC, and
POP is not evident as determined by materials • The role of technology in public education for
reviewed. (Levels of Evidence: 3-4) continence promotion should be examined in
more depth. (GoR C)

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7. RECOMMENDATIONS FOR
TRANSLATIONAL AND CLINICAL
RESEARCH

Report details of ability to perform correct contraction,

A. RECOMMENDATIONS ON dose-response issues and adherence. (GoR A)
STUDY CONDUCT AND Use recommended outcome measures with high re-
sponsiveness, reliability and validity. (GoR A)
STATISTICAL METHODS
Compare new methods with the best available inter-
The role of quality RCTs as providing the strongest vention. (GoR A)
level of evidence in incontinence research should be
fully acknowledged by researchers, journal review- Use power calculation in planning of the study. Avoid
ers, and editors. (GoR A) large sample sizes and weak (ineffective dosages) in-
terventions. (GoR A)
Careful attention to the planning and design of all re-
search, especially RCTs, is of the utmost importance. For long-term follow-up studies report cross-over, co-
(GoR A) interventions, recurrent and competing events, ad-
herence in the follow-up period and loss to follow- up.
Appropriate expertise in biostatistics and clinical trial (GoR A)
design should be employed at the design phase of a
RCT and thereafter on an ongoing basis. For Phase
4, phase 5, and implementation trials, health eono- 2. RECOMMENDATIONS FOR
mists should be included in trial design to support SURGICAL AND DEVICE TRIALS
questions of value (cost-effectiveness). (GoR A)
The design, conduct, analysis and presentation of • The safety and serious side effects of new oper-
RCTs must be fully in accordance with the ations must be completely defined with adequate
CONSORT Statement. (GoR A) follow-up so that risks can be weighed against
efficacy. At a minimum, this requires more use of
The design, conduct, analysis and presentation of ob-
large scale, independent, prospective, multicen-
servational studies should follow STROBE guide-
tre cohort studies when RCTs are not practical.
lines. (GoR A)
(GoR A)
The design, conduct, analysis and presentation of
• Safety and serious side effects of incontinence
meta-analyses should follow QUORUM guidelines.
devices must be completely defined with ade-
(GoR A)
quate follow-up, especially for use of implantable
Reporting studies of diagnostic tests, including urody- devices and biological materials, so that risks
namics, should follow the STARD statement guide- can be weighed against efficacy. (GoR A)
lines. (GoR A)
• Valid informed research consent is required in all
trials of surgical interventions, which is separate
B. RECOMMENDATIONS ON from the consent for surgery. (GoR A)
RESEARCH CONDUCT • We recommend ongoing research into the use-
fulness of pre- and post-operative predictive test-
ing (such as urodynamics, ultrasound, MRI, etc)
1. RECOMMENDATIONS FOR in surgical trials. (GoR A)
CONSERVATIVE TREATMENT • Reports of successful treatment should be lim-
TRIALS ited to subjects with a minimum (not mean) of
one-year follow-up and should include a patient
perspective measure. Specific assumptions
Use correct terminology to describe the intervention. about subjects lost to follow-up should be stated.
(GoR A) (GoR A)

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Recommendations for Translational and Clinical REsearch

414

• Randomisation for surgical trials should occur at research where prolapse and continence out-
the time of surgery to minimise drop-outs and comes are being assessed. (GoR A)
switch of procedure (GoR A)
• Criteria for cure/improvement/failure from incon-
• Long-term follow-up of RCT cohorts in an obser- tinence treatment should be defined in the proto-
vational cohort is recommended (GoR A) col based on patient perception as well as objec-
tive and semi-objective instruments such as val-
3. RECOMMENDATIONS ON COST idated questionnaires, diaries and pad tests.
(GoR A)
ANALYSIS IN INCONTINENCE
• Assessment of the impact of treatment on sexual
function should be performed with other outcome
• Cost analysis should be incorporated into clinical assessment when appropriate. (GoR B)
studies whenever possible (137). (GoR A)
• Cost analysis should describe the perspective of 2. CHILDREN
the analysis and analyses using the societal per-
spective and the payer perspective are useful. • Long-term follow-up is of critical importance in
(GoR A) the paediatric population in order to ascertain the
effect of a treatment on normal growth and de-
C. RECOMMENDATIONS FOR velopment. (GoR A)
SPECIFIC PATIENT GROUPS • Research is needed to develop standardised
outcome measures including validated, age-
specific symptom and disease-specific quality of
1. MEN AND WOMEN WITH LUTS life outcome measures. (GoR B)

1.1. Men with LUTS 3. NEUROGENIC POPULATIONS

• Measurement of prostate size should be per-
• Detailed urodynamic studies are recommended
formed before and after treatment (at the same
for classification of neurogenic lower urinary
time as continence outcome measures where
tract disorders in research studies because the
possible) whenever prostate size is considered
nature of the lower tract dysfunction cannot be
to be a variable, or to change during the interven-
accurately predicted from clinical data. Videouro-
tion and follow up. (GoR A)
dynamic studies are preferred but are not man-
• Maximum free flow rate and measurement of datory. (GoR C)
post- void residual urine should be recorded pre-
• An area of high priority for research is the devel-
treatment and the effect of therapy on these pa-
opment of a classification system to define neu-
rameters should be documented simultaneously
rogenic disorders. Relevant features could in-
with assessment of the primary outcome varia-
clude the underlying diagnosis, the symptoms, a
bles. (GoR A)
precise documentation of the neuromuscular le-
• Participants should be stratified by prostate size sion by clinical neurophysiologic testing, and the
at randomisation when size is considered to be a nature of the urodynamic abnormality. (GoR C)
potentially important determinant of treatment
outcome. (GoR C) 4. POPULATIONS AFFECTED BY
1.2. Women with LUTS BLADDER PAIN SYNDROME
• Specific information about menopausal status, (INCLUDING INTERSTITIAL
hysterectomy, parity/obstetric history, and hor-
monal status should be included in baseline clin- CYSTITIS)
ical trial data and controlled for in specified anal-
yses in the research protocol. (GoR A) • Broader entry criteria should be used to reflect
the full spectrum of the BPS/IC patient popula-
• High quality, symptom and bother scores
tion. (GoR B)
(e.g.,ICIQ-FLUTS, ICIQ-SF, ICIQ-QoL(KHQ) ,
PISQ, ICIQ- FLUTSsex) validated in women • The primary endpoint of BPS/IC trials should be
should be employed when assessing outcomes. patient driven and the Global Response Assess-
(GoR A) ment is recommended. A wide spectrum of sec-
ondary endpoints will be useful in defining the ef-
• Standardised assessment of pelvic organ pro-
fect of treatments. (GoR B)
lapse should be performed before treatment and
at the time of other outcome assessments in all

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Submitted to Biomedical Journals, from the Interna-

5. POPULATIONS AFFECTED BY tional Committee of Medical Journal Editors should
PELVIC ORGAN PROLAPSE be followed. Authorship requires:
• Substantial contributions to conception and de-
• A validated standardised assessment of pro- sign or acquisition of data or analysis and inter-
lapse (eg POP-Q) should be used for baseline pretation of data,
and outcome assessments. (GoR A)
o Drafting the article or revising it critically for
• Complete reporting of outcomes including a vali- important intellectual content,
dated assessment of anatomy, functional status, o Final approval of the version to be published
and complications is essential. (GoR A)
• Authors should provide a description of what
• Complications/adverse events (especially for each contributed and editors should publish that
mesh) must be explicitly and completely reported information.
in any research. (GoR A)
• Authors should have access to all raw data from
• Long term outcomes (> 2 years) of intervention clinical trials, not simply selected tables
studies are needed. (GoR A)
Clinical trial results should be published regardless of
D. RECOMMENDATIONS FOR outcome. The sponsor should have the right to review
manuscripts for a limited period of time prior to publi-
ETHICS IN RESEARCH cation but the manuscript is the intellectual property
of its authors, not the sponsor.
The GoR for this section is A. • All authors should be able to accept responsibil-
Continuity in clinical direction from design through au- ity for the published work and all potential con-
thorship is mandatory. Investigators should be in- flicts of interest should be fully disclosed
volved in the planning stage and a publications com-
mittee should be named at the beginning of the clini-
cal trial. The Uniform Requirements for Manuscripts

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8. INTERNATIONAL
CONSULTATION ON
INCONTINENCE MODULAR
QUESTIONNAIRE (ICIQ):
QUESTIONNAIRES AND
BLADDER DIARY

Given the intention to produce an internationally ap-

A. INTERNATIONAL plicable questionnaire, requests were made for trans-
CONSULTATION ON lations of the ICIQ-UI Short Form at an early stage,
for which the Advisory Board developed a protocol for
INCONTINENCE MODULAR the production of translations of its modules. The ICIQ
modules have been translated into over 40 languages
QUESTIONNAIRE (ICIQ) to date across the various modules.

The scientific committee which met at the end of the Since the fifth consultation a further two modules
1st ICI in 1998 supported the idea that a universally have been published and are available for use: the
applicable questionnaire should be developed, that ICIQ Bladder Diary (3,4) and ICIQ-LTCqol(5). The
could be widely applied both in clinical practice and bladder diary is the first fully validated bladder diary,
research and should reflect the patients’ perspective which notably incorporated patient and clinician input
of their situation. during its development. The ICIQ-LTCqol question-
naire provides an assessment of symptoms, impact
The hope was expressed that such a questionnaire and bother associated with indwelling catheter use.
would be used in different settings and studies and This brings the total number of available modules to
would allow cross-comparisons, for example, be- sixteen.
tween a drug and an operation used for the same
condition, in the same way that the IPSS (Interna- With increasing demand for electronic versions of
tional Prostate Symptoms Score) has been used. questionnaires, a study has been conducted by the
ICIQ group to evaluate the equivalence of the ICIQ’s
An ICIQ Advisory Board was formed to steer the de- psychometric properties in alternative formats (6).
velopment of the ICIQ and met for the first time in With equivalence demonstrated, app development for
1999. The project’s early progress was discussed the eICIQ is underway.
with the Board and a decision made to extend the
concept further and to develop the ICIQ Modular www.ICIQ.net provides details of the validation status
Questionnaire to include assessment of urinary, of the modules under development for urinary symp-
bowel and vaginal symptoms(1). The first module to toms, bowel symptoms and vaginal symptoms and
be developed was the ICIQ Short Form Question- provides information regarding the content of existing
naire for urinary incontinence: the ICIQ-UI Short Form modules. Information regarding production of transla-
(2) (Fig 1). The ICIQ-UI Short Form is now widely tions and the ICIQ development protocol is also avail-
used globally and since 2004 its use or further devel- able for those interested in potential collaborations to
opment has been reported in almost 100 publications. continue development of the project.

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Figure 1: ICIQ-UI Short Form

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418

Table 1: Fully validated ICIQ modules and derivation

MODULES AVAILABLE FOR USE

ICIQ-MLUTS(7) Urinary symptoms (male)

(ICSmale Short Form)
ICIQ-FLUTS(8) Urinary symptoms (female)
(BFLUTS Short Form)
ICIQ-VS(9) Vaginal symptoms and quality of life

ICIQ-B(10,11) Bowel symptoms and quality of life

ICIQ-UI Short Form(2) Urinary incontinence short form

ICIQ Bladder diary(3,4) Bladder events and fluid intake

ICIQ-N(12,13) Nocturia symptoms
(ICSmale/BFLUTS)

ICIQ-OAB(12,13) Overactive bladder symptoms

(ICSmale/BFLUTS)

ICIQ-MLUTS Long Form(12) Urinary symptoms long form (male)

(ICSmale)

ICIQ-FLUTS Long Form(13) Urinary symptoms long form (female)

(BFLUTS)
ICIQ-LUTSqol(14) Urinary symptoms quality of life
(KHQ)
ICIQ-Nqol(15) Nocturia quality of life
(N-QoL)

ICIQ-OABqol(16) Overactive bladder quality of life

(OABq)
ICIQ-LTCqol(5) Long term catheter symptoms and quality of life

ICIQ-MLUTSsex(12) Sexual matters related to urinary symptoms (male)

(ICSmale)
ICIQ-FLUTSsex(13) Sexual matters related to urinary symptoms (female)
(BFLUTS)

BLADDER DIARIES
B. ANNEX 1 BLADDER CHARTS
• the information above, but also
AND DIARIES
• assessments of urgency,
The ICS defines three types of Bladder Charts and • degree of leakage (slight, moderate or large) and
Diaries which can be used to collect data: descriptions of factors leading to symptoms such
MICTURITION TIME CHART as stress leakage, eg. running to catch a bus. It
is important to assess the individual’s fluid in-
• times of voiding and take, remembering that fluid intake includes flu-
ids drunk plus the water content of foods eaten.
• incontinence episodes It is often necessary to explain to a patient with
FREQUENCY VOLUME CHART LUTS that it may be important to change the tim-
ing of a meal and the type of food eaten, particu-
• times of voiding with voided volumes measured, larly in the evenings, in order to avoid trouble-
some nocturia.
• incontinence episodes and number of changes
of incontinence pads or clothing The recent development and publication of the ICIQ
Bladder Diary provides the first fully validated bladder
. diary that incorporated patient, clinician and statistical

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input during its development (3,4). This rigorous de- 11. The time you pass your urine, eg. 7.30am. Do
velopment methodology has ensured the provision of this every time you pass urine throughout the day
a psychometrically robust tool that reflects the key is- and night.
sues from a patient’s and clinical perspective to ena-
ble the gathering of required information to treat pa- 12. Each time you pass urine, collect the urine in a
tients with LUTS (Fig 1). The diary is intended to be a measuring jug and record the amount (in mls or
standalone tool that provides instructions and an ex- fluid ozs) next to the time you passed the urine,
ample to guide completion. The diary is intended for eg. 1.30pm/320ml.
completion over three days and fits onto two sides of 13. Each time you pass your urine, please write
A4 to optimise administration and completion. Data down how urgent was the need to pass urine:
collected are:
‘O’ means it was not urgent.
• Fluid intake
+ means I had to go within 10 minutes.
• Urine output
++ means I had to stop what I was doing and go
• Leakage episodes to the toilet.
• Time of sleep and waking 14. If you leak urine, show this by writing an ‘W’ on
the diary at the time you leaked.
• Pads used
15. If you have a leak, please add ‘P’ if you have to
• Optional bladder sensation scale change a pad and ‘C’ if you have to change your
The bladder sensation scale is intended to be an in- underclothes or even outer clothes. So if you leak
terchangeable variable that can be replaced with a and need to change a pad, please write ‘WP’ at
more pertinent measure for an intended use, for ex- the time you leaked.
ample, a pain scale. It is advised that any scale used 16. If you have a leakage please write in the column
in this manner should be validated. called ‘Comments’ whether you leaked a small
INSTRUCTIONS FOR USING THE BLADDER amount or a large amount and what you were do-
DIARY ing when you leaked, eg. ‘leaked small amount
when I sneezed three times’.
This diary helps you and us to understand why you
get trouble with your bladder. The diary is a very im- 17. Each time you change a pad or change clothes,
portant part of the tests we do, so that we can try to please write in the ‘Comments’ column.
improve you symptoms. On the chart you need to rec- 18. When you go to bed at the end of the day show
ord: it on the diary - write ‘Went to Bed’.
9. When you get out of bed in the morning, show
this on the diary by writing ‘GOT OUT OF BED’.
10. During the day please enter at the correct time
the drinks you have during the day, eg. 8.00am
– two cups of coffee (total 400 ml).

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Figure 2: ICIQ-Bladder Diary (page 1)

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Figure 3: ICIQ-Bladder Diary (page 2)

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422

11. Cotterill N, Norton C, Avery KNL, Abrams P,

REFERENCES Donovan JL. Psychometric evaluation of a new
patient-completed questionnaire for evaluating
1. Abrams P, Avery K, Gardener N, Donovan J, anal incontinence symptoms and impact on
ICIQ Advisory Board. The International Consul- quality of life: the ICIQ-B. Dis Colon Rectum.
tation on Incontinence Modular Questionnaire: 2011 Oct;54(10):1235–50.
www.iciq.net. J Urol. 2006 Mar;175(3 Pt
12. Donovan JL, Abrams P, Peters TJ, Kay HE,
1):1063–6; discussion 1066.
Reynard J, Chapple C, et al. The ICS-’BPH’
2. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh Study: the psychometric validity and reliability
M, Abrams P. ICIQ: a brief and robust measure of the ICSmale questionnaire. Br J Urol. 1996
for evaluating the symptoms and impact of uri- Apr;77(4):554–62.
nary incontinence. Neurourol Urodyn.
13. Jackson S, Donovan J, Brookes S, Eckford S,
2004;23(4):322–30.
Swithinbank L, Abrams P. The Bristol Female
3. Bright E, Cotterill N, Drake M, Abrams P. De- Lower Urinary Tract Symptoms questionnaire:
veloping and validating the International Con- development and psychometric testing. Br J
sultation on Incontinence Questionnaire blad- Urol. 1996 Jun;77(6):805–12.
der diary. Eur Urol. 2014 Aug;66(2):294–300.
14. Kelleher CJ, Cardozo LD, Khullar V, Salvatore
4. Bright E, Cotterill N, Drake M, Abrams P. De- S. A new questionnaire to assess the quality of
veloping a validated urinary diary: phase 1. life of urinary incontinent women. Br J Obstet
Neurourol Urodyn. 2012 Jun;31(5):625–33. Gynaecol. 1997 Dec;104(12):1374–9.

5. Cotterill N, Fowler S, Avery M, Cottenden AM, 15. Abraham L, Hareendran A, Mills IW, Martin ML,
Wilde M, Long A, et al. Development and psy- Abrams P, Drake MJ, et al. Development and
chometric evaluation of the ICIQ-LTCqol: A validation of a quality-of-life measure for men
self-report quality of life questionnaire for long- with nocturia. Urology. 2004 Mar;63(3):481–6.
term indwelling catheter users. Neurourol Uro-
16. Coyne K, Revicki D, Hunt T, Corey R, Stewart
dyn. 2016 Mar;35(3):423–8.
W, Bentkover J, et al. Psychometric validation
6. Uren AD, Cotterill N, Parke SE, Abrams P. Psy- of an overactive bladder symptom and health-
chometric equivalence of electronic and tele- related quality of life questionnaire: the OAB-q.
phone completion of the ICIQ modules. Neu- Qual Life Res Int J Qual Life Asp Treat Care
rourol Urodyn. 2016 Aug 11; Rehabil. 2002 Sep;11(6):563–74.

7. Donovan JL, Peters TJ, Abrams P, Brookes

ST, de aa Rosette JJ, Schäfer W. Scoring the
short form ICSmaleSF questionnaire. Interna-
tional Continence Society. J Urol. 2000
Dec;164(6):1948–55.
8. Brookes ST, Donovan JL, Wright M, Jackson S,
Abrams P. A scored form of the Bristol Female
Lower Urinary Tract Symptoms questionnaire:
data from a randomized controlled trial of sur-
gery for women with stress incontinence. Am J
Obstet Gynecol. 2004 Jul;191(1):73–82.
9. Price N, Jackson SR, Avery K, Brookes ST,
Abrams P. Development and psychometric
evaluation of the ICIQ Vaginal Symptoms
Questionnaire: the ICIQ-VS. BJOG Int J Obstet
Gynaecol. 2006 Jun;113(6):700–12.
10. Cotterill N, Norton C, Avery KNL, Abrams P,
Donovan JL. A patient-centered approach to
developing a comprehensive symptom and
quality of life assessment of anal incontinence.
Dis Colon Rectum. 2008 Jan;51(1):82–7.

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4. ICS CONSENSUS DOCUMENTS

A ‘medical consensus’ is defined by the Council of Europe as “a public statement on a particular aspect of
medical knowledge that is generally agreed upon as an evidence-based, state-of the-art knowledge by
a representative group of experts in that area”.

The document is usually developed by a multidisciplinary independent panel of experts convened either
by a medical association or by a governmental authority to review and summarise the scientific literature
in order to:

1. Advance the understanding of an issue, procedure, or method;

2. Outline standards of care and good practice;

3. Provide guidance to health care professionals, especially on controversial or poorly understood

aspects of care;

4. Support and promote good clinical practice in the best interest of the patient;

5. Improve the quality and effectiveness of health care.

The consensus documents by summarising the published literature on a specific topic should be con-
sidered as a comprehensive summary of the opinions and the expression of the general opinion of the
panel of experts that does not necessarily imply unanimity. Since they provide a “snapshot in time” they
must be re-evaluated periodically.

There are different ways of producing a consensus document. The Delphi method is a useful process that
involves sending out questionnaires of statements; collating and anonymizing feedback; sharing them
in a number of cycles within the experts who can adjust their answers in subsequent rounds. It allows
to avoid bringing experts together for a physical meeting, to facilitate interaction between experts and
to reduce individual bias. However, consensus documents do not provide algorithms or guidelines for
practice that are usually issued by any organization for healthcare providers and commissioners to pro-
mote best care for patients.

In this e-book we will describe how the International Continence Society consensus documents are de-
veloped. These are usually commissioned by the Board of Trustees or by ICS committees and aim to set
out the organisation’s position or philosophy about a specific topic.

We will also describe the criteria that Working /Committee groups which wish to produce a consensus
document for the ICS should adhere to.

Finally, we will discuss the Standard Operating Procedure that has been compiled by the International
Continence Society. This includes a Proposal Stage, a Preparatory Stage, a Review Stage, a Publication
Stage and a Implementation Stage. A set of step-by-step instructions for the creation of the consensus
documents will be described in detail including: creation of a working group and appointment of a chair;
submission of the proposal sent to ICS Office; review and approval of the proposal by Board of Trustees
and Editor of NeuroUrology & Urodynamics Journasl (NUUJ); preparation of the consensus document;
review of the content by relevant committees and Board of Trustees; submission of the consensus docu-
ment NUUJ; publication of the consensus document on the ICS website and advertised.”

Alex Digesu
ICS Trustee
424

Neurourology and Urodynamics 35:S5–S7 (2016)

Artificial Urinary Sphincter:

Executive Summary of the 2015 Consensus Conference
X. Biardeau, S. Aharony, the AUS Consensus Group, L. Campeau, and J. Corcos**
Department of Urology, Jewish General Hospital, McGill University, Montreal, Qu�
ebec, Canada

INTRODUCTION participants. The co-chairs distributed topics randomly (except

for one) to all participants. Each participant had to propose a
The AMS800TM device, by far the most frequently implanted
statement on their topic(s) for approval by the conference after
artificial urinary sphincter (AUS) worldwide, is considered to be
a short evidence-based presentation, when possible.
the ‘‘gold-standard’’ when male incontinence surgical treat-
ment is contemplated. Despite 40 years of experience, it is still a
specialized procedure with a number of challenges. Here, we RESULTS
present the recommendations issued from the 2015 ICS AUS A total of 25 urologists were invited to participate, 19 able to
Consensus Group, regarding indications, management, and attend the conference. The present recommendations, based on
follow-up AMS800TM implantation or revision. the most recent and relevant data available in the literature as
well as expert opinions, successively address multiple specific
MATERIALS AND METHODS and problematic issues associated with the AMS800TM trough a
eight-chapter structure: pre-operative assessment, pre-opera-
Under ICS auspices, an expert panel met on July 10, 2015 in tive challenges, implantation technique, post-operative care,
Chicago, IL, in an attempt to reach a consensus on diverse issues trouble-shooting, outcomes, special populations, and the future
related to the AMS800TM device. Participants have been of AUSs.
selected on the basis of their practice in a University hospital
and their number of implanted AUSs according to AMS
Preoperative Assessment
(American Medical System Holdings Inc., Minnetonka, MN)
records and/or major published articles. Listed topics were The AUS should be offered to individuals with stress urinary
selected by a pre-meeting email brainstorming by all incontinence (SUI) due to intrinsic sphincter deficiency (ISD),

Conflict of Interest: Dr. Morey has received honraria from Coloplast and American Medical Systems outside the submitted work. Dr. Mourtzinos has served as a
consultant for Boston Scientific, Medtronic, Allergan, and Astellas outside of the submitted work. Dr. Peterson has received grants from American Medical Systems and
Coloplast during the conduct of the study, as well as grants from American Medical Systems outside of the submitted work. Dr. Chartier-Kastler reports personal fees
from American Medical Systems and personal fees from Uromedica outside of the submitted work. Dr. Sandhu reports personal fees from Boston Scientific outside the
submitted work. Dr. Corcos reports grants from Pfizer, Astellas, and Allergan outside the submitted work. Dr. Angermeier reports grants and personal fees from
American Medical Systems (now Boston Scientific) outside the submitted work. Dr. McCammon has received honoraria from American Medical Systems and has been a
consultant for American Medical Systems outside the submitted work. Dr. Drake reports grants, personal fees and non-financial support from Allergan, grants and
personal fees from Ferring, grants, personal fees and non-financial support from Astellas, outside the submitted work. Dr. Westney reports grants from American
Medical Systems, outside the submitted work. Dr. Herschorn reports personal fees from Boston Scientific, during the conduct of the study; grants and personal fees from
Astellas, grants and personal fees from Allergan, personal fees from Pfier, personal fees from Merus, personal fees from Lilly, personal fees from Promedon, outside the
submitted work. Dr. Boone has served on advisory boards and acted as a speaker for Astellas and Allergan outside of the submitted work. Dr. Nitti has served as an
investigator for Allergan, Astellas, and Cook MyoSite outside of the submitted work. Dr. Brant reports grants and personal fees from Boston Scientific, during the
conduct of the study. Dr. Hellstrom reports personal fees from American Medical Systems, during the conduct of the study; personal fees from Abbvie, Allergan, Antares,
Astellas, Coloplast, Endo, Pfizer, Repros, Lipocine, other from Coloplast, Endo, NERI, personal fees from Endo, Menarini, other from NIH, Theralogix, outside the submitted
work. The other authors have no conflicts to disclose.

The AUS Consensus Group: KW Angermeier1, TB Boone2, WO Brant3, E Chartier-Kastler4, DS Elliott5, M Drake6, WJ Hellstrom7, S Herschorn8, JS Sandhu9,
KA McCammon10, AF Morey11, A Mourtzinos12, VW Nitti13, AC Peterson14, OL Westney15, FA Yafi7
1
Glickman Urologic and Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
2
Department of Urology, Houston Methodist Hospital, Houston, TX, USA
3
Division of Urology, Center for Reconstructive Urology and Men’s Health, University of Utah, Salt Lake City, UT, USA
4
Piti�e-Salp^etri�ere Academic Hospital, Department of Urology, Assistance Publique-H^ opitaux de Paris, Pierre and Marie Curie Medical School, Paris, France
5
Department of Urology, Section of Pelvic and Reconstructive Surgery, Mayo Clinic, Rochester, MN, USA
6
Bristol Urological Institute, University of Bristol, Bristol, UK
7
Department of Urology, Tulane University Health Sciences Center, New Orleans, LA 70112, USA
8
Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada
9
Division of Urology, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA
10
Department of Urology, Eastern Virginia Medical School, Norfolk, VA, USA
11
Department of Urology, University of Texas Southwestern, Dallas, TX, USA
12
Institute of Urology, Lahey Clinic Medical Center, Tufts University School of Medicine, Burlington, MA 01805, USA
13
Department of Urology, New York University Langone Medical Center, New York, New York, USA
14
Division of Urologic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA
15
Division of Urology, Department of Surgery, University of Texas-Houston Medical School, Houston, TX 77030, USA

Correspondence to: Jacques Corcos, M.D., Department of Urology, Jewish General Hospital, 3755 chemin de la C^ ote Sainte-Catherine, Montreal, Quebec, Canada H3T 1E2.
E-mail: jcorcos@uro.jgh.mcgill.ca
Published online in Wiley Online Library
(wileyonlinelibrary.com).
DOI 10.1002/nau.23001

# 2016 Wiley Periodicals, Inc.

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4. ICS Consensus Documents
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S6 Biardeau et al.
having failed conservative management. It should be consid- Post-Operative Care
ered no earlier than 6 months after prostatectomy in patients
A14 French urethral catheter should be left in place and
presenting with sufficient dexterity and cognitive function to
removed after a brief period (usually overnight). Post-
operate the device.
operative prescriptions should consist of oral analgesia
SUI should be evaluated and verified by careful history and
and stool softener, if indicated by patient history, while
physical examination. UDS should be carried out at the
no evidence currently supports the standard administration
discretion of clinicians in cases where it will help with
of post-operative antibiotics. Patients should be advised
diagnosis or counseling and follow-up, while pre-operative
to limit physical activity during the 6-week post-operative
endoscopic evaluation of the lower urinary tract is highly
period.
recommended prior to AUS placement.
Although a virgin AUS should be activated at 4–6 weeks post-
Pre-operative teaching must deliver a full explanation of
implantation, activation times after device replacement or
device function. Furthermore, patients must be fully informed
revision may be adjusted on the basis of clinical situation and
about expected rates of mechanical failure, erosion, and
patient comfort.
infection.
Patients must be informed to forewarn healthcare profes-
sionals in the event of catheterization. They should avoid
Preoperative Challenge perineal pressure and be instructed to wear a MedicAlert type of
bracelet.
Clinicians must manage bladder neck or vesico-urethral
Physical long-term follow-up should be ensured between 3
anastomotic stricture prior to AUS placement. Surgeon must
and 6 months post-operatively. Subsequently, yearly follow-up
treat clinically relevant bladder neck or vesico-urethral
may be undertaken in person or by mailed questionnaire.
anastomotic stricture either prior to or during AUS
implantation.
Radiated patients should be informed that they constitute a Trouble Shooting
high-risk population with increased adverse outcomes and
Patients who complain of leakage problems after AUS
associated complications, including cuff erosion as well as re-
placement may have technical issues with the device, another
operation. When AUS implantation is considered in males
urodynamic factor or a combination of the two. Therefore,
presenting with post-prostatectomy incontinence, the poten-
assessment of men with unsatisfactory outcomes after AUS
tial indication for adjuvant radiation therapy should be taken
requires a systematic evaluation to determine if AUS malfunc-
into account, and risks and benefits of cancer control versus
tion, urodynamic changes, or other influences occur.
urinary outcome need to be weighed.
Sub-cuff urethral atrophy is defined as progressive loss of
Detrusor overactivity should be treated before surgery, but
initial continence after AUS implantation in the absence of
does not constitute a contraindication for AUS implantation.
erosion, mechanical malfunction or leak, and/or bladder-
related causes of worsening urinary continence. In AUS
Implantation Technique patients presenting with recurrent or gradual worsening of
incontinence, sub-cuff urethral atrophy should be considered as
Surgery for AUS implantation may be performed either in
diagnosis of exclusion, after dismissing erosion on cysto-
lithotomy or supine position. Surgeons should be permitted
urethroscopy and mechanical failure by other modalities.
their choice of razors or clippers for pre-operative preparation of
Treatment should first take the most conservative revision
the male genitalia. A 5-min pre-operative topical antimicrobial
approach, followed by procedures for cuff revision requiring
scrub is recommended and Chlorexidine-alcohol skin prepara-
complex surgery or additional hardware.
tion should be performed.
If AUS infection is suspected, cysto-urethroscopy should be
Pre-operative prophylactic antibiotics should be adminis-
undertaken to evaluate the urethra for cuff erosion. In gross or
tered for all AUS procedures within 60 min of the incision and
persistent infections, the entire device should be explanted as
all efforts should be made to ensure low bacterial counts at the
soon as it is clinically safe, and reimplantation should be
time of AUS placement.
delayed.
The perineal approach should be preferred for AUS cuff
In case of urethral cuff exposure or erosion, the decision to
placement while trans-scrotal approach may represent a useful
remove the cuff exclusively or the device entirely will mainly
alternative in some select instances. The peri-urethral cuff
depend on time since AUS implantation, The decision to
placement should be favored while the trans-corporal implan-
perform concomitant urethroplasty should be based on the
tation may be considered under certain circumstances.
extent of urethral loss at the time of cuff explantation. Eroded
Prosthesis may be filled with either sterile saline or contrast
cuffs should be replaced at different urethral locations or
filling solution, at the surgeon’s discretion. A 61–70 cmH2O
even through a trans-coporal approach, depending on local
pressure-regulating balloon should be used for most patients
conditions.
implanted with bulbar urethral cuff and filling volume range
Definitive diagnosis of mechanical AUS failure is demon-
with empty cuff should be 22–27 cc, depending on cuff size and
strated by decreased fluid in the system, either by intra-
number of cuffs. It must be placed under the abdominal wall
operative aspiration or pre-operative radiologic evidence of
fascia and may be inserted into the retro-pubic space or into a
diminished fluid in the pressure-regulating balloon. In case of
space created between the abdominal musculature and the
mechanical failure, whole system replacement is generally
transversalis fascia. The pump should be placed in the
preferred at the time of AUS revision.
dependent portion of the scrotum, anterior to the testicle, to
ensure that patients can access it post-operatively.
At the end of the procedure, urethral injury should
Special Populations
systematically be ruled out and proper functioning should
be confirmed by device cycling. Closure should finally be Inflated penile prosthesis placement after trans-corporal AUS
done multi-layered with absorbable sutures after copious cuff insertion should be considered a high risk and the
irrigation. procedure should be done in specialized, high-volume centers.

Neurourology and Urodynamics DOI 10.1002/nau

Artificial Urinary Sphincter: Executive Summary of the 2015 Consensus Conference

426

Artificial Urinary Sphincter S7

It should be noted that trans-corporal AUS could have a considered as a salvage technique in bothered patients after
potentially negative impact on erectile dysfunction. mid-urethral sling failure in the absence of urethral mobility.
AUSs can successfully manage urinary incontinence in AUSs in women should be contra-indicated after pelvic
neurogenic bladder patients. However, it is associated with a radiotherapy.
higher numerical complication rate versus post-prostatectomy The retro-pubic approach is recommended over the vaginal
patients. Erosion is frequent in this specific population and all approach because of a lower infection rate.
effort should be made to prevent its occurrence. Furthermore,
long-term follow-up with bladder and upper urinary tract
Future of AUS
monitoring is essential.
Placement of indwelling urethral catheters in patients with The ‘‘ideal’’ AUS should be easily manipulated and inacti-
AUSs is the most common cause of erosion and should be vated, modify cuff pressure after implantation, be able to adapt
avoided at all costs. When catheters are absolutely required occlusive cuff pressure in a real-time manner, have a simple
the device must be inactivated in the open position, and the and robust design, be safely implanted via a minimally
smallest size urethral catheter should be used for the shortest invasive procedure, and be as cost effective as possible.
time period (less than 48 hr). When fluid monitoring in
obtunded patients is required, the device should be deactivated
CONCLUSION
and an externally secured collection method, such as a condom
catheter, should be attempted. In cases that require prolonged The present guidelines are issued from brainstorming by 19
drainage (>48 hr), a supra-pubic tube should be considered, urological surgeons, all considered expert in the use of the
with imaging guidance. AMS800TM. The most recent and relevant data available in the
In females, AUSs are indicated in cases of pure SUI or mixed literature as well as expert opinions were taken into account to
UI in female patients if ISD is present and is the main reason for reach a consensus on each of the presented statements. These
SUI. They have never been compared in this population with recommendations will undoubtedly help urologists in their
any technique, especially slings, and they should, therefore, be daily practice with the AMS800TM.

Neurourology and Urodynamics DOI 10.1002/nau

ICS Standards 2019

4. ICS Consensus Documents
 427

Received: 19 September 2018 | Revised: 21 November 2018 | Accepted: 3 December 2018

DOI: 10.1002/nau.23939

TERMINOLOGY, CONSENSUS ARTICLE,

BEST PRACTICE POLICIES

International Continence Society consensus on the

diagnosis and treatment of nocturia

Karel Everaert1 | Francois Hervé1 | Ruud Bosch2 | Roger Dmochowski3 |

Marcus Drake4 | Hashim Hashim4 | Christopher Chapple5 |
Philip Van Kerrebroeck6 | Sherif Mourad7 | Paul Abrams4 | Alan Wein8

1
Urology Department, Ghent University
Hospital, Ghent, Belgium Abstract
2
Urology Department, UMC Utrecht, Introduction: Patients with nocturia have to face many hurdles before being
Utrecht, The Netherlands diagnosed and treated properly. The aim of this paper is to: summarize the
3
Urology Department, Vanderbilt nocturia patient pathway, explore how nocturia is diagnosed and treated in the
University Medical Center, Nashville,
Tennessee
real world and use the Delphi method to develop a practical algorithm with a
4
Bristol Urological Institute, University of focus on what steps need to be taken before prescribing desmopressin.
Bristol, Bristol, United Kingdom Methods: Evidence comes from existing guidelines (Google, PubMed),
5
Department of Urology, Sheffield International Consultation on Incontinence‐Research Society (ICI‐RS) 2017,
Teaching Hospitals NHS Foundation
prescribing information and a Delphi panel (3 rounds). The International
Trust, University of Sheffield, Sheffield,
United Kingdom Continence Society initiated this study, the authors represent the ICI‐RS,
6
Urology Department, Maastricht European Association of Urology, and Society of Urodynamics, Female Pelvic
University Medical Center, Maastricht, Medicine and Urogenital Reconstruction (SUFU).
The Netherlands
7
Results: Diagnostic packages: there is a consensus on history taking for all
Urology Department, Ain Shams
University, Cairo, Egypt causalities, intake diary (fluid, food) and bladder diary, not for its duration. Pelvic
8
Urology Department, University of (women) or rectal (men) examination, prostate‐specific antigen, serum sodium check
Philadelphia, Philadelphia, Pennsylvania (SSC), renal function, endocrine screening: when judged necessary. Timing or empty
Correspondence
stomach when SSC is not important. Therapeutic packages: the safe candidates for
Karel Everaert, Department of Urology, desmopressin can be phenotyped as no polydipsia, heart/kidney failure, severe leg
Ghent University, Ghent, Belgium. edema or obstructive sleep apnea syndrome. Lifestyle interventions may be useful.
Email: karel.everaert@uzgent.be
Initiating desmopressin: risk management consensus on three clinical pictures.
Follow‐up of desmopressin therapy: there was consensus on SSC day 3 to 7, and
at 1 month. Stop therapy if SSC is <130 mmol/L regardless of symptoms. Stop if
SSC is 130 to 135 mmol/L with symptoms of hyponatremia.
Conclusion: A summary of the nocturia patient pathway across different
medical specialists is useful in the visualization and phenotyping of patients for
diagnosis and therapy. By summarizing basic knowledge of desmopressin, we
aim to ease its initiation and shorten the patient journey for nocturia.

Karel Everaert and Francois Hervé contributed equally to this study.

Editorial assistance was provided by Caroline Loat, PhD.

478 | © 2019 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2019;38:478-498.

International Continence Society consensus on the diagnosis and treatment of nocturia

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EVERAERT ET AL. | 479

KEYWORDS
Delphi technique, desmopressin, expert opinion, guideline, interdisciplinary research, nocturia,
nocturnal polyuria

1 | IN TROD UC T I ON using their own guidelines and recommendations based

on levels of evidence available from prior research and
Nocturia was defined in 2002 as a complaint that the literature. Diagnostic and therapeutic “packages” from
individual has to wake at night one or more times to each discipline are helpful to visualize the approach to
void.*1 It affects a high proportion of adults.2 Never- nocturia that is taken in clinical practice.
theless, for a long time, the symptom received very little No single treatment can effectively treat nocturia in all
specific research attention as it was considered just one of contexts. However, desmopressin is the only evidence‐
a number of lower urinary tract symptoms (LUTS) based pharmaceutical therapy for nocturia.7 Despite this,
indicating overactive bladder (OAB) or benign prostatic the breadth of its use in clinical practice is limited.6,8
obstruction (BPO). In recent years, however, there has Patients with nocturia have to face many hurdles before
been growing recognition that it is a specific symptom in being diagnosed properly and treated with desmopressin,
its own right, with wide‐ranging pathophysiology (in- instead of OAB/BPO medication.6 Potential reasons for
cluding blood pressure changes, cardiac dysfunction, this, besides side effects, are the limited knowledge of
fluid shift into the lower limbs, polyuria, sleep apnea, clinicians regarding the drug and how to use it, and
insomnia, pharmacotherapy, and polypharmacy). anxiety about safety, regardless of the evidence that with
Furthermore, it is associated with significant negative the available low‐dose formulations, hyponatremia is
outcomes in terms of patient health, sleep, and quality of extremely rare, even in older patients.9,10 There is a clear
life. Yet there is no consensus on how to identify and need for a summary of the available information and a
manage nocturia patients for the best possible outcomes. simple algorithm on how desmopressin should be used in
During the 2017 meeting of the International Con- adults with nocturia.
sultation on Incontinence‐Research Society (ICI‐RS) in The aim of this paper, based on the International
Bristol, a nocturia think‐tank discussed how to study the Continence Society’s (ICS) 2002 document,1 is to:
gaps in our knowledge to develop a practical patient‐
oriented diagnostic and therapeutic algorithm for noctur- 1) Summarize the nocturia patient pathway.
ia.3 It was obvious that the many and varied causes of the 2) Explore how nocturia is diagnosed and treated in the
condition are underdiagnosed and that many clinicians of real world.
different disciplines see patients with nocturia without 3) Use the Delphi method to develop a practical
paying specific attention to diagnosing and treating their algorithm based on the ICS’s 2002 standardization of
excessive nocturnal voiding. terminology in nocturia,1 with a focus on what steps
Nocturia guidelines are mainly hidden within broader need to be taken before prescribing desmopressin.
LUTS guidelines because nocturia has historically been
linked primarily to OAB and BPO, even though its main
cause is nocturnal polyuria (NP).5 A one‐year delay
between onset of LUTS symptoms and consultation of a 2 | METHO DS
medical professional has been reported.6 Patients with
nocturia are treated by healthcare providers from An initial consultation between 12 urologists was held
numerous different disciplines because nocturia is pre- during the ICS 2017 meeting in Florence, with participants
valent in many other conditions, such as cardiovascular representing the ICS, ICI‐RS, European Association of
disease, diabetes, and OAB. However, the specific Urology (EAU), and Society of Urodynamics, Female Pelvic
condition of nocturia is ignored by most specialities, Medicine and Urogenital Reconstruction (SUFU). Follow-
and only rarely does it improve with treatment of other ing the meeting, a nonsystematic keyword‐based literature
underlying conditions. Different medical disciplines search was performed using Google (search on “guidelines
diagnose and treat nocturia or its underlying diseases 2010‐2017” + symptom/sign/disease terms [edema, hyper-
tension, heart failure, diet, menopause, male LUTS, OAB,
*The nocturia definition was recently updated by the International Continence Society (see the
prolapse, renal failure, diabetes insipidus, and diabetes
article by Hashim et al4) as: The number of times urine is passed during the main sleep period. mellitus]). All expert panel members were also invited to
Having woken to pass urine for the first time, each urination must be followed by sleep or the
intention to sleep. This should be quantified using a bladder diary.
add any additional important guidelines from the different

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480 | EVERAERT ET AL.

medical disciplines relevant to the diagnosis and treatment confined to two or more voids per night, or include any
of nocturia and its underlying causes. Some of these level of nocturia. There was a consensus that nonbother-
guidelines specifically target nocturia, and others aspire to some nocturia, or convenient voids, should not be treated
target the underlying cause. with desmopressin.
In areas where there was an absence of evidence and
consistency between guidelines, the Delphi method was
used to obtain an expert consensus—see Figure 1 for
3.1 | Diagnostic packages
details. After the ICS 2017 meeting, a survey to gain views The diagnostic packages in each subdiscipline dealing
regarding the format, content, and additional panel with nocturia patients are summarized below with
members needed for the consensus report was distributed reference to guidelines, prescribing information and the
among nine of the urologists who agreed to participate as Delphi consensus—see Table 1 for an overview. History‐
authors of the report, using the www.surveymonkey.com taking, physical examination, and clinical assessment
platform (round 1); 75% agreement was needed to reach a including disease‐specific questionnaires (DSQ) are
consensus. As part of this round, it was decided that a recommended diagnostic tools. The EAU 2018 guidelines
broader range of experts should be included in the panel suggest the severity and bother of individual LUTS
for round 2 to provide a multidisciplinary perspective. (nocturia) should be identified with a symptom score,
The initial Delphi panel for round 2 comprised of 20 supplemented by directed questioning if needed. Exam-
clinicians, but 1 invitee did not respond to any of the ples of nocturia‐specific questionnaires are the interna-
rounds, and so the consensus was reached based on the tional consultation on incontinence questionnaire—
views of the remaining 19 who participated. These 19 nocturia; nocturia quality of life questionnaire, and the
included 11 urologists (9 from the original group), 1 nocturia impact diary. In line with the diagnostic
gynecologist, 1 epidemiologist/physiotherapist, 1 sleep considerations from each of the relevant therapeutic
specialist, 1 nephrologist, 1 geriatrician, 1 general areas, a questionnaire has recently been developed to
practitioner, 1 neurologist, and 1 pharmacist. The Delphi help to unify approaches to nocturia diagnosis.11 The
panel members were asked to indicate whether they TANGO questionnaire is a short patient‐administered
agree or disagree with statements about the diagnosis and screening metric designed to help the clinician assess
treatment of nocturia patients. Again, 75% of the panel nocturia and diagnose these different contributory
had to agree to achieve a consensus. If there was a mechanisms. Although some further validation is
criticism of the statement/question, it was reformulated needed, the tool is available for clinical use in English
for an additional subround, of which there were 2 in and Dutch, and validation in French and Spanish is
round 2 (Figure 1). In round 3, a different set of ongoing.
statements were presented to the multidisciplinary
Delphi panel, and the same level of agreement was
needed (ie, ≥75%) for a consensus, but panel members
3.1.1 | The lower urinary tract package
were also asked to rate appropriateness of the statement History‐taking with or without the use of validated
on a scale of 1 to 9 (1‐3 inappropriate; 4‐6 uncertain; 7‐9 questionnaires is structured based on symptoms of the
appropriate). From the panel responses, a median filling phase and the emptying phase of the bladder.4,12
appropriateness score was derived. As in round 2, if Physical examination focusses mainly on assessment of
there was a criticism of the statement/question proposed, the prostate, vaginal examination for pelvic organ
it was reformulated for an additional subround. prolapse, and any urethral pathology, according to the
This consensus report on the diagnosis and treatment relevant guidelines.
of nocturia is therefore based on real‐life clinical practice, The 2018 EAU male LUTS guidelines4 recommend to
guideline/literature reviews, and where needed, an expert add urine analysis, serum prostate‐specific antigen (PSA)
consensus obtained using the Delphi method. test (if a diagnosis of prostate cancer will change the
management), and to measure postvoid residual urine
volumes.
3 | RESUL T S Three‐day bladder diaries, including sleep and wake
up time, as well as the next morning’s first void, have
The real‐life diagnostic and therapeutic pathways for been recommended as giving the optimal balance
nocturia patients, based on the underlying causes of between compliance and reliability.13 The Delphi panel
nocturia,6 are summarized in Figure 2. There was a agreed (15/19) that it is necessary to demonstrate the
consensus that we should treat bothersome nocturia but presence of NP using a bladder diary before prescribing
there was no consensus on whether this should be desmopressin. There was no consensus on the duration of

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EVERAERT ET AL. | 481

FIGURE 1 Summary of the Delphi process [Color figure can be viewed at wileyonlinelibrary.com]

bladder diary required, including on whether patients nocturia is predictable, with some safety margin (noctur-
with cognitive impairment or impaired executive func- ia index of >1.3 is generally accepted as a reliable cut‐
tion warrant the use of a shorter duration of bladder off).15 The frequent causes of reduced voided volumes
diary. Approximately half of the panel (9/17) believe that include an OAB and residual urine (secondary to
all patients need to complete a 3‐day diary; while the obstruction or detrusor underactivity). A residual urine
remainder (8/17) believe that the diary period can be measurement is, therefore, part of the initial assessment
shortened if the patient had his/her symptoms during the of nocturia.4 When reduced voided volumes are seen,
observation day. In the latter case, it would be necessary imaging, urodynamics, and occasionally cystoscopy are
to include a question in the bladder diary regarding performed, as appropriate.
whether this was a typical night for LUTS, or if it was Excessive nocturnal or 24‐hour urine output is
better or worse than usual, for example, to give an diagnosed using a bladder diary. According to the ICS
indication of whether the case night was indicative of the definition, NP is diagnosed if more than one‐third (>33%)
patient’s condition. Even if there was an accurate of the 24‐hour urine volume is produced during the night
questionnaire (>95% accuracy) that could predict NP, in patients over 65 years, and after excluding patients
13/18 (no consensus, 72%) would still ask patients to with 24‐hour polyuria (>40 mL/kg/d). In the United
complete a bladder diary. This perseverance with the use States, the FDA’s regulatory decision‐making regarding
of a bladder diary may reflect an underlying lack of desmopressin use has been based on these definitions. In
conviction amongst the panel that such a questionnaire younger people (21‐35 years) the cut‐off for NP is >20% of
could feasibly be developed. 24‐hour urine.1 No definition of NP between these age
The maximum voided volume, void frequency, and categories has been established. The “one‐third” defini-
the ratio of nocturnal to 24‐hour urine production are the tion in older people is the most widely used definition
most used diary parameters to study and assess and has a high sensitivity but low specificity. Other
nocturia.14 A maximum voided volume of 350 mL is definitions are available,16 but the most appropriate
generally considered as reduced without real evidence to definition of NP is still the subject of much discus-
support this criterion. When the nocturnal urine sion.17,18 However, the definition of NP is not the scope of
production exceeds the maximum voided volume, then this document.

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482 | EVERAERT ET AL.

F I G U R E 2 Summary of the nocturia patient diagnosis and treatment pathways. Note that obesity can be indicative of excess caloric
intake but is also associated with metabolic syndrome and is therefore also relevant to the cardiovascular pathway. Clinical specialities that
deal with specific conditions may vary by country—for example, OSAS patients may be treated by a variety of specialists (including sleep, ear
nose, and throat). BOO, bladder outlet obstruction; OAB, overactive bladder; OSAS, obstructive sleep apnea syndrome; RLS, restless legs
syndrome [Color figure can be viewed at wileyonlinelibrary.com]

The Delphi panel considered that, in women, a pelvic 3.1.2 | Nephrological causes of nocturia
examination is necessary before starting desmopressin and their diagnosis
either in all cases (7/19) or in those women with daytime
Renal causes of polyuria include renal diseases such as
symptoms (8/19)—an overall consensus of 15/19 in favor
nephrogenic diabetes insipidus and loss of different
of pelvic examination.
circadian rhythms of the kidney, for example through
There was a consensus from the panel that a PSA
aging of the kidney.19,20 Nephrogenic diabetes insipidus
check need not be standard in all older men before
can also be caused by some medications, including
starting desmopressin (0/18); 7/18 answered that
lithium. Renal failure can also lead to leg edema with NP
there is no need to check PSA and 11/18 agreed that
as a consequence.
PSA measurement is only appropriate when consid-
When (nocturnal) polyuria is found, it is possible to
ered necessary for other reasons. LUTS have no
diagnose the cause of the excess in urine output using
relation to PSA except in advanced prostate cancer
renal function profiles.19 These renal function profiles
(owing to the associated bladder outlet obstruction),
help in distinguishing whether the excess in urine
and NP specifically is not associated with prostate
production is due to an increase in free water clearance
cancer.
(vasopressin‐related), osmotic diuresis (mainly salt, but
There was a consensus that older men with nocturia
can be urea [protein], glucose [diabetes], calcium
should complete a DSQ (13/17, median 7.4), post‐void
[hypercalciuria], or lithium), or a combination. However,
residual (14/17, median 7.4), bladder diary is manda-
renal function profiles are only advised after the failure of
tory (14/17, median 8.7), and there was no consensus
desmopressin therapy, and for research purposes. In
on the need for a digital rectal examination (10/17,
clinical practice, elevated free water clearance is the most
median 7).

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EVERAERT ET AL. | 483

FIGURE 3 Phenotyping nocturia for uncontrolled causalities when prescribing desmopressin, based on guidelines, prescribing information
or Delphi panel. *Based on evidence and guidelines to use CPAP for sleep apnea and the high levels of ANP and nocturnal salt loss. Conc,
concentration; CV, cardiovascular; DI diabetes insipidus; DM, diabetes mellitus; Est, estrogen; E, efficacy; LUT, lower urinary tract; OSAS,
obstructive sleep apnea syndrome; RLS, restless legs; S, safety; T, testosterone [Color figure can be viewed at wileyonlinelibrary.com]

frequent cause of NP throughout the lifespan and by Graugaard et al,24 and levels are even lower in the
increases with age. The second most frequent etiology elderly, as described by Asplund. There is further
is an increased sodium clearance (eg, due to excess evidence of an effect of the menstrual cycle in women,25
intake, leg edema, heart failure, hypertension, obstructive which may also increase female sensitivity to desmo-
sleep apnea syndrome [OSAS], and medication), and this pressin. If doses are given in identical strengths in men
also increases with age. In summary, at first assessment, and women (not measuring the dynamic endpoint of
phenotyping (Figures 2 and 3) based on history taking, NP), we would expect more safety concerns in women,
concomitant medication and a general physical examina- especially elderly women. Vasopressin itself is difficult to
tion help the clinician to implement lifestyle interven- measure as a routine test; copeptin is a by‐product of
tions and therapies such as desmopressin (assuming vasopressin and is being explored as a biomarker of
minimum glomerular filtration rate [GFR] of vasopressin levels.
50 mL/kg/min). The sex hormones are also involved in regulation of
diuresis.26 Deficiency in sex hormones (estrogen, testos-
terone) is diagnosed based on history taking and physical
3.1.3 | Hormones and nocturia examination and can be confirmed with blood analysis.
Vasopressin is the main water‐regulating hormone in our Some validated questionnaires are available for diagnos-
body. Vasopressin deficiency and vasopressin resistance ing menopause. Nocturia is not discussed in these
of nephrogenic (receptor) origin are the main mechan- guidelines.27
isms leading to a lack of antidiuretic response within the
body. The result is 24‐hour polyuria and polydipsia,
3.1.4 | Sleep and the central nervous
known as diabetes insipidus, which is a rare condition
system (CNS) as a cause of nocturia
diagnosed via a bladder diary and a low morning (fasting)
serum and urine osmolality. An abnormal circadian Sleep pathology, insomnia, and sleep disruption are well‐
rhythm of vasopressin is the main mechanism for NP.21,22 known causes of NP and nocturia,28,29 and as such, they
Asplund described a lack of circadian rhythm in patients need to be diagnosed, especially as they are associated
with NP and nocturia in both men and women,23 but with morbidity and mortality.30–32 In epidemiological
plasma levels in adults without nocturia peak at around studies, nocturia is associated with restless legs syn-
8 pg/mL in men and 4 pg/mL in women—both with a drome.33 History taking and physical examination can be
circadian rhythm.24 These levels fall and a gender complemented with questionnaires including the Pitts-
difference becomes more obvious in adults, as described burgh Sleep Quality Index,34 which screens for both

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|

T A B L E 1 Summary of diagnostic and therapeutic packages

Diagnostic Therapeutic

Guidelines (see the

Supporting Prescribing
Information information for
Diagnostic test Materials for refs.) dDAVP Delphi panel Lifestyle Pharmacological
Lower urinary tract Nocturia within other Nocturia, nocturia Bladder training OAB/BOO medication
guidelines due to nocturnal (level 2
(OAB, LUTS) polyuria evidence)
History and physical + − Consensus Pelvic floor dDAVP
examination, DSQ training (level 2
evidence)
Pelvic—digital rectal + − If judged necessary Consider combination therapy
examination for refractory nocturia
(Delphi consensus)
PSA + − If judged necessary Botulinum toxin, sacral
neuromodulation
PVR + (weak) − Consensus Prostatic and urethral surgery,
prolapse correction
Kidney Nocturia within other Nocturia, nocturia Salt, protein and No dDAVP if eGFR <50
urological guidelines due to nocturnal calorie (Delphi consensus)
polyuria restriction
History and physical + − Consider dDAVP in low/
examination, DSQ moderate renal failure
Need/use for/off − − No consensus Antihypertensive medication
questionnaire for
screening NP
Bladder diary +3d + 1. Consensus on the use of a Dialysis
diary, no consensus on
duration (50/50)
2. No consensus on the
definition, NPI33 is widely
used and practical but too
sensitive. Use the right
definition for the right
population
(Continues)
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T A B L E 1 (Continued)
EVERAERT

Diagnostic Therapeutic

4. ICS Consensus Documents

ET AL.

Guidelines (see the

Supporting Prescribing
Information information for
Diagnostic test Materials for refs.) dDAVP Delphi panel Lifestyle Pharmacological
Baseline GFR estimation + + 1. No consensus, as by PI Kidney transplantation
2. Consensus no desmopressin
below 50 mL/kg/min
Baseline serum sodium + + 1. Age cutoff as by PI, consensus, Nephrectomy
but not stringent
2. Consensus <130 mmol/L is
contraindication for
desmopressin; majority (66%)
prefers >135
3. Timing and having an empty
stomach or not are of no
importance to the timing of test,
consensus
Hormones Nocturia not − Sleep hygiene Menopause‐related nocturia
mentioned should be treated with
lifestyle interventions and
HRT (Delphi consensus)
History and physical + − Limit drinking dDAVP for patients with
examination, DSQ blunted AVP secretion at
night
Serum LH, FSH, + − Bladder/pelvic
testosterone, estrogen floor training
Sleep Nocturia not − Sleep hygiene CPAP in patients with OSAS
mentioned (level 1a evidence)
History and physical + − Weight loss Sleep clinic/dDAVP in
examination, DSQ patients with insomnia,
nocturia, and NP (consensus)
Polysomnography + − RLS: no consensus to refer/diagnose Physical activity Pramipexol, sleep aids
Cardiovascular and Nocturia not − Physical activity, Antihypertensive medication,
edema mentioned weight loss timed diuretics
|

(Continues)
485
 486

T A B L E 1 (Continued)
|

Diagnostic Therapeutic

Guidelines (see the

Supporting Prescribing
Information information for
Diagnostic test Materials for refs.) dDAVP Delphi panel Lifestyle Pharmacological
History and physical + − Salt restriction dDAVP with caution only in
examination and assess those with Class I mild
leg edema, DSQ congestive heart failure and
no severe leg edema
BNP + (excludes heart − Postural Varicose vein surgery
failure if suspected) drainage
stockings
Intake Nocturia not + Fluid restriction Consider dDAVP
mentioned
History and physical + + (limited to fluid Consensus useful (fluid, food, and Salt, protein, and Bariatric surgery
examination, DSQ, intake) calories) calorie
Intake diary restriction –
balanced diet
Abbreviations: AVP, arginine vasopressin; BNP, brain natriuretic peptide; BOO, bladder outlet obstruction; CPAP, continuous positive airway pressure; dDAVP, desmopressin; DSQ, disease‐specific questionnaire;
FSH, follicle stimulating hormone; GFR, glomerular filtration rate; HRT, hormone replacement therapy; LH, luteinising hormone; LUTS, lower urinary tract symptoms; NP, nocturnal polyuria; NPI33, nocturnal
polyuria index >33%; OAB, overactive bladder syndrome; OSAS, obstructive sleep apnea syndrome; PI, prescribing information; PSA, prostate‐specific antigen; PVR, post‐void residual urine; RLS, restless legs
syndrome.
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nocturnal and diurnal symptoms related to sleep sodium) or as overfilling (hyponatremia). Both conditions
disorders. The Berlin questionnaire35 and the STOP coincide with an elevated creatinine, a bad estimator of
questionnaire36 are screening tools for OSAS. Polysom- GFR in these patients, and demand referral before
nography is performed when a diagnosis of sleep initiation of desmopressin or timed diuretic therapy.58
disorders is suspected. Right‐sided heart failure, in particular, is
Parkinson’s disease and restless legs syndrome are characterized by fluid retention and swelling of the
conditions characterized by a dopamine deficiency.37,38 abdomen, legs, and feet (https://www.mayoclinic.org/
Sleep disruption and deprivation are associated with low diseases‐conditions/heart‐failure/symptoms‐causes/syc‐
dopamine levels in the central nervous system.39 Both 20373142). Edema, and especially leg edema, causes NP and
Parkinson’s disease and restless legs syndrome are nocturia through resorption of fluid when supine,59,60
associated with NP and a reduced bladder capacity due resulting in an immediate excess in urine output and a
to OAB and sphincter dysfunction.40–42 However, a delayed increase in ANP‐related salt diuresis. Leg edema is
recent study suggested that the prevalence of NP in seen with liver, heart or kidney disease or following varices
Parkinson’s disease is no higher when compared with a of the legs, lack of physical activity or muscle paralysis.
control population, indicating some uncertainty in this Concomitant medications that can cause edema are listed
regard.43 The diagnosis of a brain‐ or sleep‐related cause in the section below on concomitant medication. Diagnosis
of nocturia is made clinically, and when suspected, of edema is based on expert opinion rather than empirical
patients need to be referred to neurologists or sleep evidence, and the available guideline documents for edema
specialists. do not mention nocturia.48,49
Evidence‐based medicine6 supports the need to refer As mentioned above, there was a consensus that older
and diagnose nocturia patients with suspected obstruc- men with edema and nocturia should complete a DSQ
tive sleep apnea. Among the Delphi panel, there was no (13/17), have a postvoid residual measurement (14/17),
consensus whether suspected restless legs syndrome and a clinical evaluation of cardiovascular and leg edema
required a referral (9/17 [6 would treat NP simulta- (13/17); a bladder diary is mandatory (17/17). There was
neously with referral]) or simply initiation of treatment no consensus on a digital rectal examination (10/17).
for NP (8/17). There was a consensus that older people with nocturia
should have their blood pressure measured (13/17,
median appropriateness 8). Older people with leg edema
3.1.5 | Cardiovascular causes of nocturia
and nocturia were considered likely candidates for
Hypertension is associated with nocturia and NP.22 cardiovascular aetiological factors (13/17, median appro-
Nondipping hypertensive patients are a subgroup who do priateness 7), and it was agreed that clinical examination
not exhibit a nocturnal reduction in blood pressure. There is should focus on this pathophysiology (13/17, median 7).
an association between nondipping hypertension and
nocturia,44 and a specific association has been reported
3.1.6 | Fluid and food intake as a cause
between NP and nondipping hypertension.45 Children with
of nocturia
enuresis have also been found to have higher nocturnal
blood pressure than controls.46 Nondipping hypertension is High intake of water, salt, or protein results in an
associated with increased morbidity.47 In addition, postural increased excretion by the kidney and can result in NP
hypotension with low blood pressures when standing and nocturia. An excess intake of osmoles leads to thirst,
results in higher blood pressures when supine. Diagnosis and increased fluid intake—a second reason for NP. An
is simply made by measuring the blood pressure as part of excess intake of calories results in obesity which may,
the general clinical examination. Available guidelines in even without the presence of the metabolic syndrome,
this area do not discuss nocturia.48–53 result in NP due to the higher intra‐abdominal pressure,
The metabolic syndrome is strongly associated with mainly when supine, as a result of obstruction of the
nocturia and many conditions predisposing to NP,54,55 and respiratory tract.61 History taking, physical examination,
it is an important burden for healthcare systems worldwide. recording of fluid and food intake on a bladder diary, and
The condition needs to be diagnosed when clinically hypothetically renal function profiles can diagnose the
suspected in patients with nocturia. Again, available excess of intake of sodium (salt) and ureum (protein).62,63
guidelines in this area do not mention nocturia.56,57 Dietary guidelines discuss the treatment of obesity56,64
Heart failure often coincides with renal failure but nocturia‐related recommendations are not available.
(30%‐40%) and correlates with increased mortality. This The consensus panel agreed that it is appropriate (13/17,
cardio‐renal syndrome presents as elevated brain na- median appropriateness 7) to investigate caloric intake and
triuretic peptide (BNP) with hypovolemia (normal serum physical activity through history taking and/or diaries.

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488 | EVERAERT ET AL.

3.1.7 | Concomitant medication leading • Consensus for bladder diary, but not for its duration
to nocturia (3 days suggested).
• Consensus for diaries on sleep, intake (fluid and food),
Concomitant medication is often difficult to interrupt or and physical activity.
change but might have an important impact on nocturia • Consensus for postvoid residual measurements.
through increasing or decreasing diuresis, changing bladder • PSA, serum sodium check (SSC), renal/heart function,
function, or through interfering with sleep. Other factors and endocrine screening when judged necessary.
that will influence the impact of concomitant medication • Timing or empty stomach when SSC performed is not
are the timing of administration, mode of administration, important.
formulation (long‐ vs short‐acting), and so on. Most of these
factors have not been well studied.3,14
For many medications, the net result on diuresis 3.2 | Therapeutic packages
(water and osmotic diuresis) is unknown and insuffi- Lifestyle interventions targeted towards the aetiology of
ciently studied, and many medications have contra- nocturia may be useful in some patients (Figure 4).
dictory effects on water and osmotic diuresis. Even
desmopressin, known to solely impact on free water
excretion, can cause water retention resulting in renin‐ 3.2.1 | Lower urinary tract therapy
angiotensin‐aldosterone system suppression, ANP, re- There is level two evidence that treating dysfunctions of
lease and osmotic diuresis. the bladder and the prostate (eg, OAB and BPO) with
Another example of the contradictory effects of con- lifestyle interventions such as bladder training and pelvic
comitant medication is calcium channel blockers—these floor training, or evening exercise (eg, walking the dog),
increase salt excretion65 to lower blood pressure, but side as well as medication or surgery, improve nocturia.6
effects include leg edema, which can potentially worsen There was a consensus from the panel that combina-
nocturia when the edema fluid is resorbed during the night. tion therapy should be considered for nocturia that is
Medications that typically increase diuresis are refractory to initial treatment (18/19).
diuretics, all antihypertensive medication, progesterone,
melatonin, lithium, and SECT‐2‐inhibitors (antidiabetic
patients).6 Other medications decrease diuresis, such as 3.2.2 | Nephrological causes of nocturia
the older antidiabetic patients, antidepressants, antiepi- and their therapy
leptics, estrogens, testosterone, corticoids, and nonster-
Lifestyle interventions aim to prevent rather than treat
oidal anti‐inflammatory drugs (NSAIDs).
renal disorders, for example by avoiding obesity, hyper-
Medications that typically cause leg edema are anti-
tension, and diabetes. Salt, protein, and caloric restriction
depressants (monoamine oxidase inhibitors, trazodone),
are advised in patients with renal failure but there is no
antihypertensives (beta‐blockers, clonidine, hydralazine,
evidence of its effect on nocturia. Desmopressin can have
methyldopa, minoxidil and so on), antivirals (acyclovir),
some effect in partial nephrogenic diabetes insipidus but
hormones (sex hormones), NSAIDs (celecoxib, ibuprofen),
is not the primary choice in patients with severe renal
and some chemotherapeutics and cytokines.6
failure as the risk of hyponatremia is much higher
There is a consensus that the following conditions are
(Table 3). For those undergoing an investigation of renal
a contraindication for desmopressin: congestive heart
function, there was a consensus that desmopressin
failure (16/19), polydipsia (15/19), and concomitant
should not be prescribed if eGFR is <50, and that higher
medication with a high risk of hyponatremia (16/19).66
limits are dependent on local prescribing information. In
There was no consensus for peripheral edema (12/19),
patients with low to moderate renal failure, as is seen in
uncontrolled hypertension (13/19), uncontrolled diabetes
most of the older population, a loss of circadian rhythms
(11/19), and oral steroids (6/19). For nasal/inhalation
in diuresis is found and these patients are potentially
steroids there was a reversed consensus (0/19).
good candidates for desmopressin therapy.
Diagnostic packages:
3.2.3 | Hormones and nocturia therapy
• Consensus on history taking or questionnaires for all
In the 2002 standardization document,1 low estrogen and
causalities.
menopause are recognized as a cause of nocturia,
• Pelvic (women) or rectal (men) examination when
and androgen deprivation is also associated with
judged necessary.
LUTS and nocturia. There is no evidence‐based
• Blood pressure and edema check is necessary.
medicine to demonstrate that hormonal substitution in

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EVERAERT ET AL. | 489

menopause is asymptomatic, except for nocturia (5/18).

Desmopressin should not be given during the first
treatment consultation in the presence of menopausal
symptoms (1/18 if menopausal symptoms), but when
there is nocturia without menopausal symptoms, there
was nearly a consensus that desmopressin can be given
(13/18 [74%]).
Patients with NP due to a blunted increase in AVP
secretion at night, leading to an increase in free water
clearance, are good candidates for desmopressin ther-
apy.67 Patients with 24‐hour polyuria due to central
diabetes insipidus (in which production of AVP is
compromised) are also effectively treated with desmo-
pressin,68 which is in these cases a type of hormone
replacement therapy.

F I G U R E 4 Lifestyle interventions in nocturia according to 3.2.4 | Sleep and the CNS in nocturia
pathophysiology. DM, diabetes mellitus [Color figure can be viewed
therapy
at wileyonlinelibrary.com]
There is level 1a evidence for the use of CPAP in patients
postmenopausal women is an effective treatment of with OSAS. There is only low level 2 or lower level
nocturia (ICI‐RS 2017).26 The 2015 NICE guidelines evidence that sleep aids, treatment of low dopamine and
(https://www.nice.org.uk/guidance/ng23) state that there treatment of restless legs syndrome have an impact on
is a good evidence that hormonal substitution is helpful nocturia (ICI‐RS 2015).42
for vasomotor symptoms (hot flushes) and for vaginal There was a lack of consensus from the panel
atrophy and its consequences, but do not mention regarding the treatment of patients with insomnia,
nocturia. nocturia, NP, and a diagnosis of RLS. There was no
There was a consensus that menopause‐related consensus (10/17) whether patients with insomnia and
nocturia and hot flushes should be treated with lifestyle NP should be treated for insomnia and with desmopres-
interventions and hormone replacement therapy (17/18). sin at the same time (median appropriateness was 7).
These approaches were not considered useful when There was no consensus on treating RLS, insomnia,

T A B L E 2 Prescribing information for different desmopressin formulations indicated for nocturia, which is likely to influence clinician
judgments

Desmopressin 0.2 mg, Nasal spray 0.83‐1.66 µg/ Sublingual wafers 25‐50 µg,
tablets 0.1 mL (Noctiva) (Nocdurna)
Age for baseline sodium 65 65 65
checks and follow up
Fluid restriction Restrict Moderation advised (do not Restrict 1 h before to 8 h after
drink large amounts close to administration
bedtime)
GFR (lower limit for 50 or 60a 50 50‐60a
prescribing)
Sodium checks after baseline 3 d + after uptitration Within 7 d + after uptitration 4‐8 d + 1 mo or 4‐8 d, 1 mo, every 3
(≥65 y) to 6 months, depending on
clinical need
Cardiovascular Cardiac insufficiency or NYHA class II or higher CHF Heart failure, edema
contraindication conditions requiring Diuretic use
diuretics
Frail elderly Not mentioned Not mentioned Contraindicated
CHF, congestive heart failure; GFR, glomerular filtration rate; NYHA, New York Heart Association
a
Moderate to severe renal failure or <50‐60 mL/min depending on the formula used and cut‐off used.

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T A B L E 3 Consensus summary of risk management for hyponatremia when considering desmopressin administration

Standard vigilance to hyponatremia

Standard vigilance to symptoms + serum sodium
Risk management hyponatremia symptoms check (SSC) Contraindication
< 65 y 65 y or older Frail older people
Baseline sodium > 135 Baseline sodium 130‐135 Baseline sodium below 130
eGFR > 50‐60 eGFR 50‐60 eGFR <50
No concomitant medication that Concomitant medication weakly or Concomitant medication strongly
can cause hyponatremia moderately related to hyponatremia related to hyponatremia
No leg edema Low to moderate leg edema Important leg oedema
No heart failure Heart failure (NYHA class I) Heart failure (NYHA class II or
higher)
No diabetes mellitus or Controlled diabetes mellitus or Uncontrolled diabetes mellitus or
hypertension hypertension hypertension
Need for a higher dose, up‐titration Psychogenic polydipsia (>3 L/d)
Higher risk in women Higher risk in women
Formulation Any desmopressin formulation Low dose desmopressin Treat condition if possible and wait
with desmopressin
SSC No consensus on SSC Consensus on SSC –

insomnia with RLS, or NP with RLS and insomnia in any In people with moderate cardiac failure, there was a
combination. consensus that this condition should be treated before
In patients with insomnia, nocturia, and NP any attempt to address nocturia specifically (16/17,
without a diagnosis of RLS, there was a consensus to median 9). Use of desmopressin in such cases is
treat NP (14/17) but this was split across treatment of completely inappropriate (16/17, median 2). There was
NP per se (8/17), referral to a sleep clinic (3/17), or no consensus concerning the use of daytime furosemide
both (6/17). Reasons for this lack of agreement across (4/17, median appropriateness 5).
the panel on the appropriate steps may relate to a lack In older people with NP, nocturia, and hypertension,
of evidence on which to base treatment of insomnia there was no consensus as to whether hypertension should
with nocturia/NP, or perhaps to the range of special- be treated first (11/18, median appropriateness 7). Treat-
isms in the group with inconsistent views on the ment of NP first was considered inappropriate by 8/17
role of other disciplines, e.g., for example, sleep (median 4). The treatment of hypertension and NP
medicine. simultaneously also had no consensus (5/17 inappropriate,
6/17 uncertain, and 6/17 appropriate; median appropriate-
ness 5). The Delphi panel did not consider it useful to
3.2.5 | Cardiovascular causes of nocturia change antihypertensive drugs or their timing (other than
and their therapy diuretics) (8/17, median 6) to address nocturia.
There is ample evidence that treating heart conditions, In patients with varicose veins but no cardiac failure,
increasing physical activity, salt restriction, losing weight, there was no consensus on treating veins first (9/18,
and preventing edema treats nocturia.6 median 6) nor on using desmopressin first (10/17
Desmopressin for nocturia is contraindicated in inappropriate, 3/17 uncertain, and 4/17 appropriate;
patients with mild (class II) to severe (class IV) median 4).
congestive heart failure (New York Heart Association
Class II to IV) or uncontrolled hypertension, and should
3.2.6 | Intake as a target of nocturia
be used with caution (eg, monitoring of volume status) in
therapy
patients with New York Heart Association Class I mild
congestive heart failure because of the risk of fluid Limiting excess fluid intake and changing the type of
overload and electrolyte abnormalities. Patients with fluid is advised in most LUTS guidelines.70 Less is known
heart failure may also be at increased risk for low sodium about the effect of diet and weight loss.6 Weight loss will
concentrations.69 decrease hyperfiltration and diuresis. Low protein intake

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EVERAERT ET AL. | 491

will decrease salt and ureum output and osmotic diuresis. should be checked before desmopressin treatment. This
Salt restriction might decrease osmotic diuresis. Low was also true for renal function (eGFR). This lack of
carbohydrate intake will not change diuresis directly. consensus is likely affected by differences in prescribing
Low fat intake will not directly affect diuresis. During information and recommendations between countries.
most diets, an increase in water intake is advised, However, there was a consensus that any age limit should
increasing water diuresis. In conclusion, from a theore- not be treated too stringently, and patients who are near
tical, nonevidence‐based viewpoint, a protein‐rich and the limit may also be checked before treatment (17/19).
fat/carbohydrate‐restricted diet might increase urine The Delphi consensus was that patients with a
output as well as reduce it in the longer‐term via weight baseline serum sodium of ≤130 mmol/L should not be
loss. A well‐balanced calorie‐restricted diet seems the prescribed desmopressin (18/19), with the panel split
most logical approach to avoid high excretion of ureum between a cut‐off of >130 mmol/L (6/19) and
and salt in patients with nocturia. In general, guidelines >135 mmol/L (12/19) for treatment. Again, the panel’s
suggest caloric restriction and summarize that a high views on this issue might be influenced by regional
protein intake results in more efficient weight loss.56,57 regulatory rules and prescribing information.
There was no consensus from the Delphi panel on Dilutional hyponatremia takes several days of positive
appropriate therapeutic options for patients with high water balance to build up. To decrease by 5 mmol/L a
BMI and nocturia (including losing weight [no consensus positive water balance of 2 L is needed. There was a
9/18, median appropriateness 6]; weight loss with consensus (15/17) that SSCs can be performed at any time
desmopressin [5/18, median 5]; desmopressin alone of day and are not affected by whether or not the stomach is
[6/18, median 5]; and adapting diet when there is a high empty (although note that polydipsia is a contraindication
osmotic load [6/18, median 5]). of the drug). There is sufficient literature to support that a
sodium check can be done at any time of the day.71
Therapeutic packages: The following conditions are agreed to be contra-
indications for desmopressin use: congestive heart failure
• There is only good evidence for desmopressin and (16/19), polydipsia (15/19), and concomitant medication
for CPAP. with a high risk of hyponatremia (16/19). Concomitant
• For all other therapies, the evidence is moderate medication with low risk for hyponatremia (5/19),
(furosemide, OAB‐BPH medication) or weak for most peripheral edema (12/19), uncontrolled hypertension
causalities. (13/19) or diabetes (11/19), oral steroids (6/19), and
• The safe candidates for desmopressin can be pheno- nasal steroids (0/16) did not reach consensus.
typed as no polydipsia, heart/kidney failure, severe leg The panel agreed that women are more prone to
edema, or OSAS. hyponatremia and that this should have implications for
desmopressin therapy and its follow‐up (16/19). There is
a consensus that some form of fluid restriction is needed
3.3 | Initiating desmopressin treatment
by patients prescribed desmopressin (18/19)—either
NP due to reduced nocturnal vasopressin is the primary following thirst (14/19) or strict fluid restriction (4/19).
target for desmopressin. Salt‐related NP is associated with With earlier formulations of desmopressin (0.2 mg
other causes such as sleep apnea (the primary target for tablets), hyponatremia was seen mainly in older popula-
CPAP), edema, obesity, hypertension, heart failure, and tions, leading to a restriction in use to those below 65 years
high salt intake. There is level 1a evidence that of age. Lowering the dose to provide an antidiuretic effect of
desmopressin and CPAP treat nocturia.4,7 A summary 6 to 8 hours was the logical way to treat the older (especially
of the prescribing information for available desmopressin female) population. Low dose therapy is not a well‐defined
formulations for nocturia from the United States, term but is today the best way to describe the newer
Australia, and Europe is given in Table 2. formulations in the market, which have both been tested in
The panel agreed that bothersome nocturia should be an older population. Low dose therapy is advisable in older
treated (17/19); however, there was no consensus (but not frail) patients and serum sodium monitoring is
regarding what level of severity warrants treatment (≥2 needed; such monitoring can be individualized depending
voids/night [5/19], or any nocturia [12/19]). It was agreed on patient‐specific factors (eg, age, concomitant medication)
that nonbothersome nocturia or convenience voids (ie, and comorbidities (16/19). Frail older patients with bother-
secondary to waking for a different reason) should not be some nocturia and comorbidities or other risk factors
treated with desmopressin (1 and 0/19). should first be treated for other issues and comorbidities
There was no consensus among the Delphi panel as to and then, if still required, desmopressin should be initiated
an appropriate age limit above which serum sodium with careful monitoring (15/18).

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Young healthy patients can be treated with any regarding exactly when in the first week this should
licensed desmopressin formulation (15/18). occur (Day 3 [7/19] or Day 5‐7 [9/19]). Weekly blood
samples were not deemed necessary (1/18); 4/18
Initiating desmopressin: preferred 2‐weekly and 13/18 (or 72%; no consensus)
agreed that samples should be taken at the discretion
• Risk management consensus on classification into of the physician. There was a consensus to perform an
three clinical pictures: (1) standard vigilance to SSC as judged by the clinician at 1 month (17/18).
symptoms of hyponatremia, (2) SSC, and (3) contra- Beyond 1 year, there is no consensus on follow up
indications. required—10/18 agree that monitoring should be
• Decision‐based on age, renal function, heart failure, performed when the patient’s medical condition (eg,
frailness, edema, baseline serum sodium, drinking hospitalization, fever) or concomitant medication
habits, and medication. changes; 8/18 agreed with annual checks.
• Low‐dose formulations preferred in patients need- In young healthy patients, there was no consensus on
ing SSC. SSC needed—the majority believed no checks were neces-
sary (11/18), assuming no underlying medical conditions.
3.4 | Follow‐up of desmopressin therapy There was a consensus that some form of fluid
restriction should be advised for all patients (only 1/18
Critical to the appropriate use of desmopressin and its found it unnecessary)—the consensus was split between
analogs is an established schema for monitoring of advising patients to follow their own thirst (14/18) and
sodium homeostasis in the acute and chronic phase of strict fluid restriction (4/18).
therapy. Contingent on stable dosing and otherwise If the response to desmopressin is insufficient at a
unchanging comorbidities is the realization that shifts low dose, there was a consensus that dose should be
in fluid ingestion may potentiate the risk of hypona- up‐titrated (18/19), depending upon the frailty of the
tremia in an otherwise stable patient. Therefore, an patient (11/19). An SSC should be carried out before
informed and the engaged patient is critical to up‐titration, depending on the patient (17/19). If the
desmopressin safety. In addition, acute alterations in dose is up‐titrated and further sodium checks are
concomitant comorbidities should be assessed for appropriate (15/19), these should be carried out
their potential to impact sodium levels. within 7 days.
There are various approaches to sodium monitor- If hyponatremia is found after initiating desmopressin
ing in the literature. Before starting therapy, baseline therapy, there is a consensus (15/19) that treatment
sodium levels must be obtained in patients at risk for should be discontinued when an SSC is below 130
hyponatremia. Bioavailability and formulation deliv- regardless of the presence of symptoms. If sodium check
ery appear to have an impact on desmopressin half‐ is between 130 and 135 and the patient is asymptomatic,
life and the area under the curve (indicative of drug treatment need not be discontinued (only 1/19 would
exposure), both of which impact the risk of hypona- stop the therapy), but further checks (8/19) or drug‐free
tremia. 17 There is some evidence from analysis of a intervals (3/19) or lowering the dose (7/19) should be
merged database 17 that a sodium monitoring plan performed. See Figure 5 for a summary.
should begin with a baseline sodium ≥135 mmol/L
with additional SSC at week 1 and month 1 after Follow‐up of desmopressin therapy:
initiation of desmopressin in patients who are at
increased risk (eg, due to older age, or concomitant • If SSCs are necessary, follow‐up on day 3 to 7 and 1
medications). This conclusion is based on the fact that month.
most clinically significant cases of hyponatremia were • Further checks at clinician discretion.
seen within 2 to 3 weeks of treatment initiation. A • Stop therapy if serum sodium is <130 mmol/L regard-
noteworthy observation is that time to return to less of hyponatremia symptoms, and if serum sodium is
normal after cessation of treatment was a median of 130 to 135 mmol/L with symptoms.
17 days (range 8‐28).
As the optimal monitoring schedule is often
debated, the Delphi panel was consulted. When
baseline serum sodium levels were judged necessary, 3.5 | Patient‐oriented nocturia
there was a consensus that serum sodium should be care path
checked on a fixed schedule, beginning within 7 days Based on existing guidelines, evidenced‐based medicine,
of desmopressin initiation, but with no consensus and the Delphi panel, we developed a patient‐oriented

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EVERAERT ET AL. | 493

multidisciplinary diagnostic and therapeutic algorithm for fluid intake, which could decrease the voiding frequency,
bothersome nocturia, aiming for a more holistic approach urgency, and volume is mentioned with a Grade B
to nocturia from a multidisciplinary angle (Figure 6). The recommendation. For nocturia specifically, no such high
aim of this algorithm is to ease the work of clinicians and levels of evidence exist, with the exception of fluid restriction
shorten the time to treatment. (Level 1b). In contrast, expert opinion supports weight loss,
diet, foods, salt restriction, and protein restriction in the
therapy of nocturia.6 This shows an important scientific
4 | DIS C USSI ON knowledge gap in our understanding of approaches to the
reduction of LUTS and nocturia.
Diagnostic and treatment packages (Figure 2) are helpful in There are a number of strategies to manage the risk
the visualization of the pathway of nocturia patients. We associated with desmopressin therapy (namely hypona-
believe they could be a useful educational tool for training tremia risk). In young healthy people with nocturia, it is
of healthcare professionals to improve patient care for advised that any desmopressin formulation can be used,
nocturia, to limit the hurdles a patient has to get over to and dose can be up‐ or down‐titrated when needed. In
receive appropriate care and decrease the time to treatment. older people, the factors summarized in Table 3 should be
The lifestyle interventions that are recommended in all checked, and a low dose formulation should be used or
LUTS guidelines are a good case in point. There is a growing the patient should be excluded from desmopressin
interest globally in lifestyle interventions as a possible therapy. It is safer to start with a lower dose and to
treatment for LUTS and, therefore, also for nocturia. The lower the threshold to perform SSC in women compared
International Consultation on Incontinence summarized the with men as women have a higher sensitivity to
need for research on conservative management of incon- desmopressin and are more prone to hyponatremia. This
tinence,72 and the possible lifestyle interventions that can be gender difference in antidiuretic response has been found
relevant in nocturia are weight loss, diet change, fluid intake in animal studies73 and in clinical studies.74,75 In female
modification, and exercise. Of these, weight loss and fluid rats, it was shown that this gender difference is explained
management have a fair amount of scientific data to support by a significantly higher expression of the V2 receptor in
their impact. Weight loss (Level 1 evidence) is mentioned as females.73 It was suggested that this was caused by escape
a first‐line treatment to reduce the prevalence of urinary from X‐chromosome inactivation by the X‐linked V2R
incontinence with a Grade A recommendation. Restricted gene, causing increased V2R dosage in females.76

F I G U R E 5 Follow‐up after
desmopressin prescription when serum
sodium checks wanted or needed.
Symptoms of hyponatremia include:
nausea and vomiting, headache,
confusion, loss of energy, drowsiness,
and fatigue, restlessness and irritability,
muscle weakness, spasms or cramps,
seizures, and coma. FU, follow up;
SSC, serum sodium check [Color figure
can be viewed at wileyonlinelibrary.com]

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494 | EVERAERT ET AL.

FIGURE 6 Continued.

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EVERAERT ET AL. | 495

High‐risk medications for hyponatremia are thiazide protocol will be difficult. It is likely that complex statistical
diuretics, lithium, valproate, and carbamazepine66 and use studies on merged databases may be a promising strategy
of these should be considered as a contraindication for for the future and could help to produce a personalized
desmopressin therapy. Low‐to‐moderate risk medications for medicine algorithm for serum sodium monitoring after
hyponatremia are loop diuretics, antidepressants, ACE‐ desmopressin initiation. In the meantime, clinicians should
inhibitors, and angiotensin‐II‐receptor blockers. These can err on the side of caution, even if it means more SSC.
be used concomitantly with desmopressin after consideration From a clinical scientific perspective, when looking at
of the other factors from Table 3; concomitant use Table 2, it would be interesting to demonstrate the actual
necessitates follow‐up and sodium monitoring. Based on plasma levels of desmopressin following the use of the
studies with loop diuretics,6 it is wise not to start both three different formulations, as this explains better the
medications at the same time, but to allow an interval of 2 to rationale for the dose differentiation. We would suggest
3 weeks between their initiation to help the kidney in focussing on pharmacodynamic studies combined with
resetting its salt gradient before administering the sec- pharmacokinetic studies to evaluate the strength and
ond drug. duration of the antidiuretic effect, and the effect on
Since it is important to consider the frail elderly as serum sodium levels. These studies would ideally be
distinct from other older persons for the purpose of performed in nocturia patients during an overnight
desmopressin therapy, a definition of what is meant by evaluation, as performed by Goessaert et al.79
frailty would be helpful. Perhaps the combination of a It is clear from this Delphi panel experience that items
clinical frailty scale and a Timed Up and Go test (to assess a which suffer from a lack of evidence in the literature are
person’s mobility using static and dynamic balance) would difficult to form a consensus on with a multidisciplinary
capture enough about frailty for most clinicians. The panel. This demonstrates the need for more studies on some
modified frailty index is an 11 item frailty index described of the smallest steps in the care path of nocturia patients.
for noncancer gynecological patients which captures enough However, the performance of studies that are crucial to our
information to detect adverse outcomes and this might be understanding, but do not attract funding from the
useful.77 There is also the G8 survey, which captures pharmaceutical industry (eg, effects of lifestyle interven-
“frailty.”78 Regarding comorbid conditions, a Charleston tions), will be challenging, as will be the study of low‐
comorbidity index would be of use, although it is somewhat frequency events and patient risk factors. There is also a
limited in older people by a lack of variability. difficulty in reaching consensus in relation to diagnostic
In the consideration of heart failure and its diagnosis tests such as serum PSA or clinical prolapse evaluation as
in nocturia patients, heart failure should be suspected the guidelines in these areas originated from urological or
when there is a history of heart disease, when edema gynecological organizations (and indirectly from studies on
and/or weight gain with rapid onset is found and/or a urological and gynecological patients), whereas the Delphi
patient complains of exertional dyspnea or orthopnea. A panel is multidisciplinary and clearly votes from this
normal serum BNP concentration rules out uncontrolled broader perspective. Our algorithm needs more research
heart failure. It is clear that when this condition is mainly in relation to the causalities of the cardiovascular
suspected, even in mild form, clinicians should be careful system and intake‐related aetiologies. Even in urogynecol-
with prescribing desmopressin and it is better to refer the ogy, many questions remain unanswered such as the
patient to a cardiologist and await instructions. efficacy of medication in nocturia patients with a reduced
The monitoring of serum sodium in nocturia patients bladder capacity. For sleep disorders, little research has
treated with desmopressin lacks sufficient evidence to been done on restless legs syndrome and insomnia as a
produce good guidelines. As hyponatremia is rare in well‐ cause of nocturia. Finally, there is a need to study nocturia
selected patients with the currently available low‐dose based on this multicausal origin, as well as from a
formulations, producing strong evidence for a safety diagnostic and a therapeutic angle. Development of a

FIGURE 6 A patient‐oriented multidisciplinary diagnostic and therapeutic algorithm for nocturia. *If desmopressin, consider Figure 3
and Table 3 before initiating, and consider Figure 5 for follow‐up. BD, bladder diary; BNP, brain‐derived natriuretic peptide; BOO, bladder
outlet obstruction; BPS, bladder pain syndrome; Con Med, concomitant medication; CPAP, continuous positive airway pressure;
CV, cardiovascular; DI, diabetes insipidus; DM, diabetes mellitus; DSQ, disease‐specific questionnaires; DVT, deep venous thrombosis;
ECG, electrocardiogram; GFR, glomerular filtration rate; HRT, hormone replacement therapy; LUT(S), lower urinary tract (symptoms);
MS, multiple sclerosis; OAB, overactive bladder; OSAS, obstructive sleep apnoea syndrome; PSA, prostate‐specific antigen; PSG,
polysomnography; PVR, post void residual; RLS, restless legs syndrome. consensus, consensus “when judged necessary by the
clinician,” “combinations possible” [Color figure can be viewed at wileyonlinelibrary.com]

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standalone evidence‐based nocturia guideline will probably Department, Maastricht University Medical Center, Maas-
originate from a multidisciplinary organization, and in the tricht, The Netherlands; Adrian Wagg: Division of Geriatric
future, we envisage that the nocturia care path will move Medicine, University of Alberta, Edmonton, Canada; Alan
away from the disciplines of urology and gynecology Wein: Urology Department, University of Philadelphia,
towards less narrowly focused specialisms such as internal Philadelphia, Pennsylvania; Jeff Weiss: Department of
medicine, geriatrics, and general practice. Urology, SUNY Downstate College of Medicine, New York
City, New York.
We would also like to thank Caroline Loat, PhD for
5 | C ON C LU S I O N editorial assistance.

A summary of the nocturia patient pathway across different

ORCID
medical specialisms is useful in the visualization and
phenotyping of patients for diagnosis and therapy. It also Francois Hervé http://orcid.org/0000-0002-9079-251X
highlights that nocturia is in general not a urological Marcus Drake http://orcid.org/0000-0002-6230-2552
symptom, but predominantly a symptom of a wide variety Hashim Hashim http://orcid.org/0000-0003-2467-407X
of causalities, many of which are easy to screen for with Chris Chapple http://orcid.org/0000-0002-2960-9931
history taking, questionnaires, and physical examination.
By providing some basic knowledge of desmopressin, its
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Additional supporting information may be found online
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polyuria is related to 24‐hour diuresis and osmotic excretion in article.
an enuresis population referred to a tertiary center. J Urol.
2007;178(6):2630‐2634.
64. DeSalvo KB, Olson R, Casavale KO. Dietary guidelines for How to cite this article: Everaert K, Hervé F,
Americans. JAMA. 2016;315(5):457-458. http://jama.jamanetwork.
Bosch R, et al. International Continence Society
com/article.aspx?doi=10.1001/jama.2015.18396
consensus on the diagnosis and treatment of
65. Luft FC. Calcium‐channel‐blocking drugs and renal sodium
excretion. Am J Nephrol. 1987;7(Suppl. 1):39‐43. nocturia. Neurourology and Urodynamics. 2019;38:
66. Liamis G, Milionis H, Elisaf M. A review of drug‐induced 478‐498. https://doi.org/10.1002/nau.23939
hyponatremia. Am J Kidney Dis. 2008;52(1):144‐153.

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Received: 25 November 2018

DOI: 10.1002/nau.23923
| Accepted: 28 November 2018

SOUNDING BOARD

International continence society white paper regarding female

genital mutilation/cutting

Christopher K. Payne MD1 | Jasmine Abdulcadir MD, PD, FECSM2 |

Charlemagne Ouedraogo MD3 | Sebastien Madzou MD4 |
Fasnéwindé Aristide Kabore MD5 | Elise JB De MD6 |
Ethics Committee if the International Continence Society

1 Department of Urology, Stanford

University Medical School, Stanford, Female genital mutilation/cutting (FGM/C)—also known as Female Genital Cutting
California or Mutilation—is defined as the partial or total removal of the female external
2 Department of Gynecology and Obstetrics,
genitalia for non-therapeutic reasons. This White Paper, prepared under the auspices
Geneva University Hospitals, Faculty of
Médicine, UNIGE, Geneva, Switzerland
of the International Continence Society (ICS), is intended by the ICS as a statement
3 Department of Obstetrics and Gynecology, promoting the abandonment of this practice. The ICS also supports the respectful and
Centre Hospitalier Universitaire de evidence-based care or treatment of women and girls already affected by FGM/C, in
Bogodogo, Ouagadougou, Burkina Faso
keeping with the World Health Organization (WHO) Guidelines on the Management
4 Department of Obstetrics and Gynecology,
of Health Complications from Female Genital Mutilation.1 Our members specialize
Pole Femme Mere Enfants, Angers, France
5 Department of Urology, Universite de in pelvic floor disorders from perspectives within a range of specialties; we encounter
Ouagadougou, Centre Region, Burkina Faso and treat women living with FGM/C and its consequences—particularly inconti-
6 Department of Urology, Massachusetts nence, infections, voiding dysfunction, sexual dysfunction, chronic pelvic pain, and
General Hospital, Boston, Massachusetts
obstetric trauma. Understanding the ethical, sociocultural, medical and surgical
Correspondence factors surrounding FGM/C is central to caring for women and girls with a history of
Elise JB De, MD, Massachusetts General FGM/C. The ICS voices herein state strong opposition to FGM/C. We encourage
Hospital—Harvard Medical School,
members to apply their skills to improve prevention strategies and the management of
Department of Urology, 55 Fruit Street,
Boston MA 02114. those affected.
Email: ede@mgh.harvard.edu
KEYWORDS
circumcision, complications, cutting, defibulation, female genital mutilation, public health

1 | INTRODUCTION reasons.”1 FGM/C is distinguished from female genital

cosmetic surgery by consensual and other factors, as
Female Genital Mutilation (FGM/C), in its official World discussed below. This paper specifically addresses non-
Health Organization Definition, “comprises all procedures consensual procedures, which are for the most part performed
that involve the partial or total removal of external genitalia or on minors. There are no health benefits to FGM/C. FGM/C
other injury to the female genital organs for non-medical violates basic human rights. In addition there are significant
immediate and long-term risks associated with FGM/C
including obstetric, neonatal, urologic, gynecologic, infec-
Institutions: The writing was performed at all of the above institutions as tious, sexual, and psychological health consequences as
well as Albany Medical Center. outlined below. FGM/C is a deeply ingrained sociocultural
Funding: None. practice in many countries. The practice is seen within a range
Neurourology and Urodynamics. 2019;1–11. wileyonlinelibrary.com/journal/nau © 2019 Wiley Periodicals, Inc. | 1

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of cultures and ethnicities, and within Muslim, Animist, and comprise a wide range of practices from the excision of the
Christian societies. However, it predates the Islamic and labia with or without the external part of the clitoris, with or
Christian religions and mention is absent from both the Koran without covering/narrowing the introitus, to performing
and the Bible. Explanations for the practice may include genital piercing, pricking or stretching. Research shows
safeguarding virginity, aesthetics, prevention of rape, ensur- that women can accurately answer whether they have
ing fidelity—and therefore social acceptance, family honor undergone FGM/C; therefore, simple surveys can provide
and marriageability—and establishing ethnic identity.1 reasonable estimates of prevalence.4,5 For the most part,
The ICS position is that: women who have undergone FGM/C cannot correctly
identify specifically what was done to them; this is not at
1. FGM/C should be prevented and progressively eradicated. all surprising as in many countries the majority of girls are cut
2. Healthcare professionals should not perform FGM/C, as before age five. Accurate classification requires examination
medicalization1 of the practice does not prevent many of by a trained observer (a visual reference and learning tool
the complications. Healthcare professionals should be describing the WHO classification, including a video, has
trusted promoters of prevention/abandonment of the been published6). Proper classification, recording, and coding
practice and care of already affected women and girls. may have value clinically to individuals living with FGM/C
3. FGM/C complications should be screened, recognized, as well as in research efforts to understand risks associated
treated, and recorded appropriately and ultimately prevented. with the condition, optimal treatments, and in communication
for academic and clinical endeavors. Classification is
important for epidemiological and statistical purposes, for
1.1 | Status of FGM/C
example, to study changing trends of the practice and the
FGM/C is in fact illegal in many countries (Figure 1). quality of care provided to patients. For example, following
However, FGM/C is still practiced in approximately 30 campaigns aimed at abandoning FGM/C, there is evidence
countries around the world,2 including many where out- that FGM/C may be performed at an earlier age and/or in a
lawed.3 An estimated 200 million women have undergone milder form.3,7
FGM/C to date.3 A 2013 UNICEF report estimated another 30
million girls are at risk in the coming decade.3 The vast
1.2 | FGM/C should be prevented and
majority of FGM/C occurs in children prior to the age of 15.3
ultimately eradicated
Cultural factors continuing the practice of FGM/C are not
simple to change and will be explored below. It is the position of the ICS that FGM/C should be prevented
The WHO classification distinguishes four basic types of and thereby eradicated. There are no studies showing any
FGM/C with subclassifications (See Figure 2). These medical benefit to any form of FGM/C. FGM/C causes

FIGURE 1 Prevalence of Female Genital Mutilation in the world. Courtesy of GAMS, based on DHS, MICS March 2016 and other
nationally representative surveys, ©GAMS Belgium http://gams.be

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FIGURE 2 Classification of FGM/C. Photos courtesy Jasmine Abdulcadir. Drawings reprinted from World Health Organization. WHO
guidelines on the management of health complications from female genital mutilation. https://www.who.int/reproductivehealth/topics/fgm/
management-health-complications-fgm/en/ Geneva (Switzerland): World Health Organization; 2016. Box 1.1 pages 2, 3, 4 (drawings of FGM
types). (A) FGM Type Ia. (B) FGM Type Ib. (C) FGM Type IIa. (D) FGM Type IIb. (E) FGM Type IIc. (F) FGM Type IIIa. (G) FGM Type
IIIb. (H) FGM Type IV.

significant immediate and long term complications. Most 1.2.2 | Immediate morbidity and mortality of
importantly, FGM/C is a violation of basic human rights. FGM/C
There are no reliable estimates of the morbidity and mortality
attributable to FGM/C. Only a portion of the most serious
1.2.1 | FGM/C violates human rights
complications ever reach medical attention. Nevertheless, given
As the WHO Guidelines state, “FGM/C violates a series of that the procedures are performed forcibly on young girls who
well-established human rights principles, including the are generally unaware of what will happen, and (the vast
principles of equality and non-discrimination on the basis of majority of the time) without the benefit of anesthesia, it is
sex, the right to life when the procedure results in death, and the reasonable to assume that nearly all suffer pain and
right to freedom from torture or cruel, inhuman or degrading psychological trauma and that all are at risk of serious adverse
treatment or punishment, as well as the rights of the child.” events. Most subjects will experience bleeding. In many this will
Many other international human rights organizations have be physically and/or emotionally significant; hemorrhage and
called for an end to the practice, including the United Nations death can occur.11 In a large majority of countries traditional
Populations Fund (UNFPA)/United Nations International practitioners without medical training do the cutting, typically
Children's Emergency Fund (UNICEF),8 the United Nations using crude instruments (Figure 3). The lack of sterile
Convention on the Elimination of all Forms of Discrimination environment and proper antiseptics leads to a risk of tissue
Against Women (CEDAW), the United Nations Convention infection, sepsis, and even death from infectionxi. Tetanus is a
on the Rights of the Child (CRC), and the Protocol on the particular risk given the circumstances and the lack of uniform
Rights of Women in Africa (“the Maputo Protocol”), and the national vaccination programs. Urinary tract infections also
Pan African Parliament (PAP)9 among others.10 occur. There can be inadvertent injury to the urethra or even the

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published a detailed handbook “Care of Girls and Women

Living with Female Genital Mutilation” (http://www.who.int/
reproductivehealth/publications/health-care-girls-women-
living-with-FGM/en/) which covers each of these topics as
well as the general approach to these patients.

1. Obstetric and Neonatal complications: FGM/C, particularly

type III, includes an increased rate of adverse obstetric13 and
neonatal14 outcomes including hemorrhage, obstructed
labor, perineal tears and stillbirth.15 FGM/C may contribute
to the obstetric factors leading to fistula. A 2006 multicenter
study by the WHO showed increased relative risks for:
cesarean delivery (RR 1.31), postpartum hemorrhage (RR
1.69), extended maternal hospital stay (RR 1.98), infant
FIGURE 3 Representative instruments used for typical FGM/C. resuscitation (RR 1.66), and stillbirth or early neonatal death
Courtesy Charlemagne Ouedraogo
(RR1.55).16 A secondary analysis of such data showed that
women with FGM/C had an increased risk of C-section
rectum. Swelling and pain can produce acute urinary retention.
performed for unclear indications, probably due to a lack of
Although unquantified, these risks are potentially serious and
training of providers in performing defibulation or in
substantial. They are not offset by any type of benefit.
managing FGM/C.17 A large systematic review and meta-
analysis written in the USA and Europe in 201414 as well as
1.2.3 | Long-term consequences of FGM/C a prior review from 200512 corroborated these findings.
Damage caused by FGM/C can have a domino effect leading Several studies performed on obstetric outcome after FGM/
to many long-term consequences as presented in Figure 4. In C in high income countries show that with trained and
2005, a systematic review regarding the health consequences appropriate management, such risks can be significantly
of FGM/C was published, noting difficulty in study design reduced and controlled.18–20 Educational material on
and capturing the data.12 Observation itself is complex in deinfibulation has been published and is available online.21
limited health delivery systems; reporting may not be accurate A great concern in managing a pregnant woman with
(observers or subjects may not identify the FGM/C type FGM/C, particularly Type II and III, is perineal tearing.
correctly); sampling bias is present on multiple levels More recent studies and secondary analysis of the 2006
(incidence of complications, time of data collection, difficulty WHO paper showed that the high rate of C-section in
in finding comparison groups); and confounders abound FGM/C seems related to inappropriate indications for the
(FGM/C effect vs poor medical care). Regardless, ICS C-section. This probably relates to unfamiliarity of
specialists should be familiar with the spectrum of possible providers concerning defibulation during/outside preg-
complications following FGM/C, and be prepared to screen, nancy or in labor and a low threshold for Cesarean for
diagnose, record, code and manage them. The WHO has women with FGM/C. One study showed that there was no

FIGURE 4 Conceptual framework for long term consequences of FGM/C. Reproduced from Morison L, Scherf C, Ekpo G, Paine K, West
B, Coleman R, Walraven G. The long-term reproductive health consequences of female genital cutting in rural Gambia: a community-based
survey. Tropical Medicine and International Health 2001 6(8) 643–653

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difference in the incidence of strong medical indications 23.5%, and incomplete voiding in 22.7%, with all three
for C-section between women with and without FGM/C. reported in 11.6% of the women. Women with a history of
However, C-sections were performed more often on Type II and Type III FGM/C had a significantly higher risk of
women with FGM/C lacking a clear medical indication reporting all 3 LUTS than those with Type I.27
in relation to various maternal factors or arrest disorders.16 3. Infections: Infection is common in the short term after FGM/
Another study found that episiotomies were protective C.28 A Tetanus is a serious potential risk and can even cause
against anal sphincter tears and post-partum hemorrhage death after FGM/C in regions where no vaccination/
after Type III FGM/C, however in this study it is unclear if immunoglobulins are available. In the long term, as noted
an associated defibulation was also performed.22 Routine above, girls and women may be at increased risk of urinary
episiotomy is not currently recommended for women with tract infections after FGM/C. However, other serious
FGM/C in the 2016 WHO guidelines,i however a lower infections including HIV are also possible long-term
threshold for episiotomy is recommended in this group.23 sequalae as described in a 2013 systematic review.29 More
2. Urinary tract complications: Lower urinary tract complica- infections were identified in those with Type III FGM/C.29
tions are of special concern to ICS members and are prevalent 4. Mental health problems: Women living with FGM/C
following FGM/C.24 Damage to the urethra at the time of suffer from psychiatric disorders significantly more
FGM/C is common due to its intimate relation to the clitoris commonly than their peers without this history.30 A small
and labia25 (Figures 5 and 6)—the cephalad apex of the study of Senegalese women who had undergone FGM/C
clitoral hood is only 12 mm from the urethral orifice at age 0- found that over 90% of women recalled their cutting as
3 and 17 mm at age 4-8.26 Urethral injuries result in scarring/ “appalling and extremely traumatizing” with 30% devel-
stricture/stenosis and subsequent lower urinary tract dys- oping posttraumatic stress disorder and another 47%
function. Unfortunately, good data on urinary complications suffering from other psychiatric disorders.31 Appreciation
is lacking. ICS membership could contribute in research of the potential psychiatric sequelae is vital to the approach
initiatives. A 2005 systematic review reported significant to many women with FGM/C. However, it is also
prevalence of dysuria (58-64%), urinary retention (12-70%), important for ICS specialists to consider that many women
urinary tract infection including recurrent UTI (2-38%), are capable of coping with the impediments and may
incontinence (6%) and unspecified urinary symptoms (15- regard the ritual as “normal” or even enhancing their
25%).12 Another group recruited 251 patients specifically to gender identity or body image rather than a sickness. The
investigate lower urinary tract symptoms (LUTS). They experience and memories of FGM/C as well as coping
found at least one LUT symptom was present in 38.8% of strategies can differ according to the age, conditions, type
women. Nocturia was reported in 38.6%, intermittency in and consequences of the practice. Diversity in interpreting

FIGURE 5 Observed clitoral anatomy in the pediatric population. Observed clitoral hood shapes: a) horseshoe; b) trumpet; c) coffee bean; d)
tent; and examples of convergence of labia minora under glans and intersection with clitoral hood (e, f, g). Reprinted with permission from
Journal of Pediatric Urology, 12/177.e1-177.e6. Brodie KE, Grantham EC, Huguelet PS, Caldwell BT, Westfall NJ, Wilcox DT. Study of the
clitoral hood anatomy in the pediatric population. pp e1-e6 (2016), with permission from Elsevier

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FIGURE 6 Percentage distribution of ages at which girls have undergone FGM (as reported by their mothers). United Nations Children's
Fund, Female Genital Mutilation/Cutting: A statistical overview and exploration of the dynamics of change, UNICEF, New York, 2013

events and the level of remembrance is crucial for experiencing experience sexual pleasure and orgasm, provided other
psychopathology.32 Migration and a different sociocultural physical or psychological effects do not interfere.37 The
setting can make women more aware of their FGM/C; a presence and severity of sexual dysfunction can vary greatly
woman previously well adapted to her experience may then and depends on the specific tissues involved, eventual
feel stigmatized, socially excluded or ashamed.33 To avoid complications, and on biopsychosocial factors that have to
contributing to these feelings, ICS specialists will benefit be addressed to treat sexual dysfunction after FGM/C.
women with FGM/C by approaching care in a neutral manner. Dyspareunia among women with FGM/C type III can often
Appropriate therapy interventions should be considered for be treated with defibulation. Clitoral pain and dyspareunia due
those who are experiencing symptoms consistent with anxiety to post-traumatic neuromas, cysts, adhesions/synechiae or
disorders, depression or post-traumatic stress disorder (PTSD). obstetric trauma can be approached surgically. Pelvic floor
5. Sexual Dysfunction:34 There are many research gaps regarding muscle dysfunction can be treated with pelvic floor physical
sexual function after FGM/C, especially with regards to type of therapy. Culturally sensitive sexual health counseling (includ-
FGM/C and the specific effects of clitoral involvement.35 A ing education on anatomy and the sexual response) is
systematic review of sexual consequences of FGM/C recommended for both those living with FGM/C and their
representing 12 671 women reported that those with a history partners.
of FGM/C were 52% more likely to have dyspareunia and 6. Other Gynecologic Problems: Dysmenorrhea can result
greater than twice as likely to lack desire versus women from obstructed drainage. Infertility can result from
without a history of FGM/C.36 Some forms of FGM/C involve ascending genital infection. Chronic vulvar pain can be
excision of the glans or the glans and part of the body of the a long-term outcome of FGM/C.
clitoris. However, the remaining tumescent sexual structures 7. Effects of FGM/C on Men: FGM/C can also affect men
(the body or part of the body; the crura of the clitoris and the negatively within a marriage, and thereby becomes an issue
vestibular bulbs and the corpus spongiosum of the urethra) are pertaining to them.38–40 A Sudanese study of married men
not involved by the cutting. Because of this, women may still (n = 59) found that most expressed difficulty with vaginal

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penetration, wounds or infections on the penis, and Sudan, only 7% of midwives could identify the four types of
psychosexual problems.39 The majority perceived their FGM/C correctly, whereas 81% had practiced the procedure,
wives’ suffering as their own problem, and most stated they and in Alexandria, only 7% of nurses could identify the types;
would have preferred to be married to “uncut” women. in both studies there was little knowledge among these
According to UNICEF, 67% of women in 29 countries and practitioners regarding the medical consequences of the
63% of men in 18 countries, all aged 15-49 and who are procedure and the majority planned to continue the
aware of FGM/C believe it should stop.41 Wahlberg and practice.44,45 Similar findings have been reported in diaspora
Johnsdotter demonstrated that most Somali immigrants, countries; therefore, it behooves ICS members to be aware of
including those newly arrived, opposed all forms of FGM/C the condition and to be prepared to identify and care for these
with increased opposition over time after migration.42 patients.46 As mentioned above, women who have experi-
O’Neill surveyed immigrants in three European countries enced FGM/C may not know what unaltered anatomy looks
and found that most men and women reported that FGM/C like, what type of FGM/C they have personally experienced,
affected their sex lives in a negative way.43 and the current symptoms may be so remote from the FGM/C
that they do not associate the cause and effect.47

1.3 | Healthcare professionals should not

perform FGM/C 1.4.2 | Treatment of FGM/C
The ICS stands firmly against all forms of FGM/C as defined The WHO Handbook “Care of Girls and Women Living with
at the outset—those non-consensual procedures mostly Female Genital Mutilation” (http://www.who.int/
performed on minors (and less commonly unconsenting reproductivehealth/publications/health-care-girls-women-
adults). This extends to medicalization1 of FGM/C where living-with-FGM/en/) provides excellent advice to the
such procedures may be performed by professionals with clinician managing FGM/C patients. However, there is a
varying degrees of surgical training, with clean instruments relative paucity of information in many areas. A primary role
and in safer settings. While is it probable that medicalization for the ICS lies in improving training of its members and in
can reduce some FGM/C complications such as acute sharing research and expertise, workforce, and resources to
infection, it does not prevent the long-term complications. improve the care of women with FGM/C. We envision:
Most importantly, healthcare professionals should be the
trusted promoters of prevention/abandonment of the practice � Working with providers in high prevalence areas and
and of sexual and reproductive health literacy as well as the diaspora countries to design prospective clinical trials that
healthcare of women and girls already affected by FGM/C. will inform future care.
The aim of the paper does not extend to address the complex � Supporting high quality training for front-line ob-gyn,
and sometimes controversial issues surrounding adult women urologists, pediatricians, general practitioners, infectious
who request various forms of genital surgery, including disease specialists and surgeons in managing complica-
reinfibulation and female genital cosmetic surgery. Several tions of FGM/C, offering defibulation and reconstructive
researchers are addressing these topics from a legal, medical, techniques.
social and ethical perspective. Conflicts between the important � Sharing knowledge through regional meetings and via on-
principle of autonomy and concerns about coercion or social line educational resources.
pressure are not easily resolved. The long-term consequences of � For those who wish to submit educational material for ICS
such surgery are not easily identified and become more nuanced online content are invited to submit according to the
when taken in a sociocultural context. Male circumcision and the Standard Operating Procedures for format: https://www.
concept of “genital autonomy” in intersex conditions are ics.org/committees/education/icssops
similarly complex issues—the ICS recognizes these as
important discussions but beyond the scope of this work.

1.4 | FGM/C complications should be screened 1.4.3 | Prevention of FGM/C

and recognized, treated appropriately and
We need to understand the socio-cultural milieu that
ultimately prevented
supports the practice of FGM/C if we are to prevent it. The
most effective and durable change will arise from within
1.4.1 | Screening for FGM/C
the practicing societies rather than being imposed upon
The first step in management is to screen and recognize the them. FGM/C stems from long-standing socio-cultural
FGM/C and its eventual complications. In a study in Eastern mores; therefore, efforts toward eradication must align

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with cultural factors perpetuating the practice. The updated their bodies and their rights are very rare.56 According to
2013 UNICEF statistical overview emphasizes the chal- UN estimates, most young people lack access to education
lenging dynamics of cultural change, noting according to about their bodies and the impact of FGM/C.57 WHO
social science research it “is difficult for individual recommends that to have the most responsible impact,
families to stop the practice on their own. There is a preventing unintended alienation and retraumatization,
social obligation to conform to the practice and a educational interventions should be evidence-informed
widespread belief that if they do not, they are likely to and scientifically accurate, non-prejudicial, non-judgmen-
pay a price that could include social exclusion, criticism, tal, sensitive and respectful, non-stereotypical, and when
ridicule, stigma or the inability to find their daughters involving adolescents, geared toward their evolving
suitable marriage partners.”3 According to Mpofu and capacities. A culturally integrated educational approach
colleagues, the practice of FGM/C is deeply embedded in will favor these goals. Mpofu highlights select programs
social and cultural traditions dating back generations. Over that emphasize the healthy portions of the coming-of-age
time, interventions have failed to understand the complex- rituals associated with FGM/C, teaching girls about the
ities surrounding the practice.48 “Most campaigns against responsibilities associated with adult and married life,
FGM/C have come about from a viewpoint of outrage, while omitting the FGM/C itself.
disgust and condemnation, and therefore are seen as a The fundamental question at hand remains: how can
direct and aggressive attack on a people's core values, FGM/C be most effectively prevented? Although in decline,
beliefs and traditions which have been a part of their very it remains distressingly prevalent. The Pan African
existence for generations49–51” and can lead to further Parliament (PAP) has recently joined the U.N. Population
stigmatization of girls and women who have already Fund (UNFPA) in an action plan to ban FGM/C for the
undergone FGM/C. “FGM/C is said to enhance marriage- whole continent. This is a promising legal and cultural
ability, fertility, and to promote purity or virginity of a statement on the part of the Parliament. The initiative
womanl,52–54 and is also said to “. . .temper female sexual includes legislation, community mobilization, advocacy,
urges thereby preserving a girl's virginity for mar- and recruitment of men to speak out against FGM/C.9 There
riage.”50,55...The belief in the protection of female virtue is some evidence that changing hearts and minds at the
goes hand in hand with upholding family status and community level will ultimately be the most effective
dignityl When one is [circumcised], it is a symbol of entry strategy.58
into womanhood and marks that one fully belongs to a Looking more closely at specific countries country will
community.” Marriage and reproduction are essential to highlight the complexity of changing the practice of FGM/
the long term economic and social security of most C. The prevalence in Kenya decreased from 41% in 1984 to
women, and FGM/C is regarded in many communities as a 11% in 2014 (however, these numbers differ from those in
normal and acceptable part of raising the girl child. Mpofu's study). In 2001, the Kenyan government outlawed
Programs aimed at preventing FGM/C and its conse- the practice, passing the Children's Act.59 Further, in 2011 it
quences must therefore: passed the Prohibition of Female Genital Mutilation Act.
Lastly, successful public education campaigns have led to
� Be strongly based on facts and evidence as opposed to relief of social pressures—for example, young men have
aversion and disgust had an impact by publicly declaring their preference to
� Evolve from cultural understanding within the society marry a woman who has not undergone FGM/C.60 In 1990
rather than being imposed from outside. Burkina Faso formed the Committee to Fight the Practice of
� Avoid stigmatizing the girls and women who have already Excision (Comité National de lutte contre la Pratique De
undergone FGM/C. l'excision, CNLPE). In November 1996 a penal code was
adopted forbidding female genital mutilation, threatening
The evidence discussed above regarding the effects of imprisonment of 6 months to 3 years and large fine for all
FGM/C on men and the changing attitudes of many forms of FGM/C. In addition, special emphasis is placed on
immigrants are promising, as they may allow strategies to education of the girl so that in adulthood, she does not seek
lift the social obligation of FGM/C, once proper dialogue FGM/C for her daughters. The CNLPE instituted campaigns
between genders and within community hierarchies can of sensitization regarding FGM/C; policemen were trained
occur. UNICEF3 has been developing programs in to intervene in keeping with the law; the subject of FGM/C
consultation with communities. These participatory pro- became part of scholastic programs; and women who had
grams have a greater impact as individuals within the endured complications linked to FGM/C were treated free
community state publicly they will not practice FGM/C, of charge in certain health initiatives identified by CNLPE,
and they then educate others. According to WHO, in line with WHO Guidelines. A free telephone line called
however, programs that educate women and girls about “SOS Excision” (SOS Female genital cutting), was set up to

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gather real-time information on the acts of mutilation. The International Continence Society is uniquely positioned
According to UNICEFxli, the prevalence of FGM/C in to promote the care for women and girls living with FGM/C.
Burkina Faso declined from 89% in 1980 to 58% in 2010 Although a smaller percentage of our members have significant
(however, not unlike Kenya, according to internal statistics, experience in managing patients with FGM/C, as a multidisci-
the prevalence of FGM/C may remain significant: 76 % plinary, international society, we have significant reach with
[EDSBF-MICS IV 2010]).61 The persistent high prevalence, educational needs around the world. We can lend our expertise
although decreasing and lower than some surrounding to many of the preventative and cure needs such as obstetric
countries, is likely multifactorial—including the low level trauma, urogynecological and psychosexual consequences. Our
of population education (30% literacy), the persistence of expertise in education, research methodology, complex recon-
traditional practices impacting the health of women overall structive surgery, nursing, physiotherapy, psychosexual issues
(eg, beliefs impacting nutrition during pregnancy), and can be of great value. We will start by providing educational
inadequate funding for the permanent implementation of the opportunities to our members so that they can develop
national strategy against FGM/C. The continued high appropriate sociocultural, rehabilitative (including physiother-
incidence of FGM/C in Burkina Faso, Kenya, and other apy), medical and surgical knowledge of the topic.
countries also calls into view the complexity of criminali- ICS and its Members will lend support and act to:
zation. It is possible that this strategy may have a
diminished effect by driving the practice underground 1) Educate:
instead of into the light. It is certain that work across health � Support the work of practitioners treating high volumes
care disciplines in cooperation with government and non- of patients with FGM/C throughout the world through
government organizations engaging community leadership assistance in creating, presenting, filming and distribut-
will be required for optimal results. ing educational material (See www.ics.org/tv, https://
Medical professionals can help prevent FGM/C by www.ics.org/committees/education/icssops).
providing healthy, non-judgmental messages in every � Educate health care workers, patients, and communities
interaction. For example: regarding FGM/C—raising awareness, exploring med-
ical, ethical and cultural issues, consequences of FGM/
� offer health education on FGM/C during pregnancy C, and management.
(preparing for the issue to arise if the future child is a girl), � Work within communities to engage women and men
� primary doctors must build trusting relationships, includ- regarding the medical risks of FGM/C and to lift the
ing the father or other important family elders and myths perpetuating this practice.
exploring the beliefs of the family, 2) Research:
� pediatricians must discuss this issue with parents over time, � Lend our expertise to define the benefits and risks of
� doctors can provide safeguarding/protection measures post-FGM/C intervention, and to further characterize
according to the local laws in case of real and immediate the health consequences.
risks. � Support and/or conduct studies to define optimal care of
those with FGM/C.
3) Provide Care:
� Provide neutral, clear, non-alienating information to
2 | CONCLUSION women and girls who have experienced FGM/C regarding
its meaning to her individual situation, and options for care.
FGM/C is relevant to all who practice pelvic medicine, as � To provide holistic care always, high quality recon-
understanding the unique health issues significantly impacts structive surgery where appropriate, and to support
care for this population. The ICS position on FGM/C is that colleagues in high prevalence areas of the world when
it should never be performed in any form on a girl or non- opportunities arise.
consenting woman. ICS members can educate themselves 4) Advocate:
and others on the practice. Those with significant experi- � Partner with affected women and girls and other
ence in caring for women with FGM/C can offer associations regarding FGM/C.
information, health education, reconstructive and rehabili- � Promote government support for medical care of
tative services to women and girls with a history of FGM/C women who have had FGM/C, including culturally
experiencing urogynecological, infectious, obstetric, sexual fluent psychological care.
and functional pelvic floor consequences. A respectful, � Work within communities to promote the healthy
neutral, non-judgmental, non-stigmatizing and trained coming-of-age rituals associated with FGM/C while
approach should be the tone of the individual patient removing the permanently damaging risks associated
interaction. with FGM/C.

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10
| PAYNE ET AL.

CONFLICTS OF INTEREST consequences of female genital mutilation/cutting. Obstet Gynecol

Int. 2014;542859.
No conflicts of interest. 15. http://www.who.int/mediacentre/factsheets/fs241/en/
16. Banks E, Meirik O, Farley T, Akande O, Bathija H, Ali M. WHO
studygroup on female genital mutilation and obstetric outcome Female
ORCID genital mutilation and obstetric outcome; WHO collaborative prospec-
Elise JB De http://orcid.org/0000-0003-0730-9038 tive study in six African countries. Lancet. 2006;367:1835–1841.
17. Rodriguez MI, Say L, Abdulcadir J, Hindin MJ. Clinical indications
for cesarean delivery among women living with female genital
mutilation. Int J Gynaecol Obstet. 2017;139:21–27.
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Available from: http://www.ncbi.nlm.nih.gov/books/NBK368483/ care of women with female genital mutilation attending a
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5. Bjalkander O, Grant DS, Berggren V, Bathija H, Almroth L. Female 23. Royal College of Obstetricians and Gynecologists, Green-top
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to Help Women Thrive. New York: Population Council. Wilcox DT. Study of the clitoral hood anatomy in the pediatric
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9. http://www.ipsnews.net/2016/08/pan-african-parliament-endorses- 28. Bjälkander O, Bangura L, Leigh B, Berggren V, Bergström S,
ban-on-fgm/ Almroth L. Health complications of female genital mutilation in
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Charter on Human and Peoples’ Rights on the Rights of Women in 29. Iavazzo C, Sardi TA, Gkegkes ID. Female genital mutilation and
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2003 (http://www.achpr.org/files/instruments/women-protocol/ Gynecol Obstet. 2013;287:1137–1149.
achpr_instr_proto_women_eng.pdf, accessed 4 April 2016). 30. Ahmed MR, Shaaban MM, Meky HK, et al. Psychological impact
11. https://www.irishtimes.com/news/world/africa/we-ve-seen-too- of female genital mutilation among adolescent Egyptian girls: a
many-girls-bleed-to-death-eradicating-fgm-in-uganda-1.3382 765 cross-sectional study. Eur J Contracept Reprod Health Care.
12. Obermeyer CM. The consequences of female circumcision for 2017;22:280–285.
health and sexuality: an update on the evidence. Cult Health Sex. 31. Behrendt A, Moritz S. Posttraumatic stress disorder and memory
2005;7:443–461. problems after female genital mutilation. Am J Psychiatry.
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outcome, Banks E, Meirik O, et al. Female genital mutilation and 32. Knipscheer J, Vloeberghs E, van der Kwaak A, van den
obstetric outcome: wHO collaborative prospective study in six Muijsenbergh M. Mental health problems associated with female
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14. Berg RC, Odgaard-Jensen J, Fretheim A, Underland V, Vist G. An 33. Vloeberghs E, van der Kwaak A, Knipscheer J, van den
updated systematic review and meta-analysis of the obstetric Muijsenbergh M. Coping and chronic psychosocial consequences

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of female genital mutilation in The Netherlands. Ethn Health. Female Circumcision and the Politics of Knowledge: African
2012;17:677–695. Women in Imperialist Discourses, ed. Obioma Nnaemeka. West-
34. Berg RC, Denison E, Fretheim A. Psychological, social and sexual port, Connecticut: Praeger 2005. 288 pages.
consequences of female genital mutilation/cutting (FGM/C): a 50. Van Rossem R, Gage AJ. The effects of female genital mutilation
systematic review on quantitative studies. Report from Kunnskaps- on the onset of sexual activity and marriage in Guinea. Arch Sex
senteret nr 13-2010. Oslo: Nasjonalt kunnskapssenter for helsetje- Behav. 2009;38:178–185.
nesten; 2010. 51. Gruenbaum E. Sociocultural dynamics of female genital cutting:
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with female genital mutilation: an analysis. BJOG. 2015;122:294–303. 2005;7:429–441.
36. Berg RC, Denison E. Does female genital mutilation/cutting (FGM/C) 52. Sipsma HL, Chen PG, Ofori-Atta A, llozumba UO, Karfo K,
affect women's sexual functioning? A systematic review of the sexual Bradley EH. Female genital cutting: current practices and beliefs in
consequences of FGM/C. Sex Res Social Policy. 2012;9:41–56. Western Africa. Bull World Health Organ. 2012;90:120–127.
37. Abdulcadir J, Botsikas D, Bolmont M, et al. Sexual anatomy and 53. Ondiek CA. The persistence of female genital mutilation (FGM)
function in women with and without genital mutilation: a cross- and its impact on women's access to education and empowerment:
Sectional study. J Sex Med. 2016;13:226–237. A Study of Kuria District, Nyanza Province, Kenya. Thesis, 2010.
38. Varol N, Turkmani S, Black K, Hall J, Dawson A. The role of men Institutional Repository. University of South Africa http://uir.unisa.
in abandonment of female genital mutilation: a systematic review. ac.za/handle/10500/4121
BMC Public Health 2015;15:1034. 54. Odimegwu C, Okemgbo CN. Female circumcision and sexual activity:
39. Almroth L, Almroth-Berggren V, Hassanein OM, et al. Male Any Relationship. Unilag Sociological Review, 2000 (1), pp 159–176.
complications of female genital mutilation. Soc Sci Med. 55. Afifi M. Egyptian ever-married women's attitude towards female
2001;53:1455–1460. genital cutting. Singapore Med J. 2010;51:15–20.
40. Berggren V, Ahmed SM, Hernlund Y, Johansson E, Habbani B, 56. Realizing sexual and reproductive rights: a human rights framework.
Edberg A-K. Being victims or beneficiaries? Perspectives on London: Amnesty International; 2012 (http://www.amnesty.ca/sites/
female genital cutting and reinfibulation in Sudan. Afr J Reprod amnesty/files/act_350062012_english.pdf, accessed 27 April 2016).
Health. 2006;10:24–36. 57. Monitoring of population programmes, focusing on adolescents and
41. United Nations Children's Fund, Female Genital Mutilation/ youth. Report of the Secretary-General. Commission on Population
Cutting: A global concern, UNICEF, New York, 2016. https:// and Development, Forty-fifth session, 23–27 April 2012. New York
www.unicef.org/media/files/ (NY): United Nations Economic and Social Council; 2012 (E/
FGMC_2016_brochure_final_UNICEF_SPREAD.pdf CN.9/2012/5; http://www.un.org/esa/population/cpd/cpd2012/E.
42. Wahlberg A, Johnsdotter S, Selling KE, Källestål C, Essén B. CN.9.2012-5_UNFPAPopulation-programmes-report_Advance%
Baseline data from a planned RCT on attitudes to female genital 20 Unedited%20Copy.pdf, accessed 4 April 2016).
cutting after migration: when are interventions justified? BMJ 58. Diop NJ, Askew I. The effectiveness of a community-based
Open. 2017;7:e017506. education program on abandoning female genital mutilation/cutting
43. O’Neill S, Dubourg D, Florquin S, Bos M, Zewolde S, Richard F. A in Senegal. Stud Fam Plann. 2009;40:307–318.
59. Livermore L, Monteiro R, Rymer J. Attitudes and awareness of
mixed methods study exploring men's involvement in Female Genital
female genital mutilation: a questionnaire-based study in a Kenyan
Mutilation in Belgium, the Netherlands and the United Kingdom:
hospital. J Obstet Gynaecol. 2007;27:816–818.
Preliminary results. Men Speak Out Project, Brussels, 2016.
60. UNIFPA-UNICEF Annual Report 2011: Joint Programme on Female
44. Ali AA. Knowledge and attitudes of female genital mutilation
Genital Mutilation/Cutting: Accelerating Change. http://www.unfpa.
among midwives in Eastern Sudan. Reprod Health. 2012;9:23.
org/publications/accelerating-change-2011-annual-report
45. Ragheb SS, Smith E, Mekhemer SA. Study of knowledge and
61. Enquête Démographique et de Santé et à Indicateurs Multiples
attitudes of nurses in Alexandria towards female genital circumci-
(EDSBF-MICS IV). Institut National de la Statistique et de la
sion. Bull High Inst Public Health. 1979;8:293–306.
Démographie (INSD). Ministère de l’Économie et des Finances.
46. Abdulcadir J, Dugerdil A, Boulvain M, et al. Missed opportunities
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USA Avril 2012. https://www.unicef.org/bfa/french/bf_eds_2010.pdf
2014;125:256–260.
47. Clarke E. Female genital mutilation: a urology focus. Br J Nurs.
2016;25:1022–1028.
48. Mpofu S. Female genital cutting and sexual behavior in Kenya and How to cite this article: Payne CK, Abdulcadir J,
Nigeria. Research Report Submitted to the School of Social Ouedraogo C, Madzou S, Kabore FA, De EJ, Ethics
Science, University of the Witwatersrand, Student Number Committee if the International Continence Society.
0610960A Department of Demography and Population Studies. International continence society white paper
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sexual_behaviour_in_kenya_and_nig.pdf
49. Nnaemeka, O. African women, colonial discourses, and imperialist
https://doi.org/10.1002/nau.23923
interventions: female circumcision as impetus. pp 27–46. In:

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International Continence Society

Best Practice Statement for Use of Sacral
Neuromodulation

Howard B. Goldman, Jessica C. Lloyd, Karen L. Noblett, Marcus P. Carey, Juan Carlos Castaño-Botero,
Jerzy B. Gajewski, Paul A. Lehur, Magdy M. Hassouna, Klaus E. Matzel, Ian M. Paquette, Stefan G. de
Wachter, Michael J. Ehlert, Emmanuel Chartier-Kastler, Steven W. Siegel

Corresponding Author:
Howard B. Goldman, MD

Glickman Urological and Kidney Institute

Lerner College of Medicine

Cleveland Clinic

9500 Euclid Ave, Q10-1

Cleveland, OH 44195

Phone: (216) 445-5121

Fax: (216) 636-4492

goldmah@ccf.org

International Continence Society Best Practice Statement for Use of Sacral Neuromodulation
460

Disclosures

Marcus Carey —No disclosures

Juan Carlos Castaño Botero—Consultant: Medtronic, Finetech. Proctor – Medtronic, Boston Scientific,
Finetech

Emmanuel Chartier-Kastler—Teaching Activities: Allergan, Astellas, Pfizer, B. Braun, Coloplast;

Consultant: Allergan, Astellas, Axonics, Medtronic, Pfizer, Coloplast, Lilly, Promedon, Uromems, Pierre
Fabre Médicaments; Invited Speaker: Uromedica, Pierre Fabre Médicaments

Stefan deWachter – Consultant: Medtronic, Allergan, Astellas. Research grant Medtronic

Michael Ehlert—Consultant: Nuvectra; Clinical Investigator: Ipsen Pharmaceuticals

Jerzy Gajewski—Speaker: Astellas, Pfizer, Laborie; Consultant: Astellas, Medtronic; Advisory Board:
Pfizer, Medtronic, Duchesnay

Howard Goldman—Consultant: Medtronic, Allergan, Axonics, Nuvectra, NewUro. Study support:

Medtronic. Investigator: Cook, Bioness, Ipsen

Magdy Hassouna— Medtronic, Axonics

Paul Lehur—Consultant: Torax Medical, Medtronic, B.Braun

Jessica Lloyd—No disclosures

Klaus Matzel— Consultant: Medtronic

Karen Noblett— Chief Medical Officer, Axonics; Research Support Medtronic

Ian Paquette—Medtronic

Steven Siegel— Consultant: Nuvectra, Medtronic, Allergan. Study: Ipsen, Medtronic, Allergan

Funding for this project: Supported by an ICS-initiated grant from Medtronic

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SACRAL NEUROMODULATION CONSENSUS STATEMENT

INTRODUCTION
Sacral neuromodulation (SNM) is an accepted therapy for refractory urinary urgency and
frequency, urgency urinary incontinence (UI), non-obstructive urinary retention (NOR), and
fecal incontinence (FI).
● These indications for SNM are approved by the FDA in the United States. In other parts of the
world there are some other approved indications for various pelvic floor conditions.
● A need was identified for a comprehensive document reflecting best practices across indications
related to SNM
A panel of experts from the fields of urology, gynecology, and colorectal surgery was convened
to determine best practices for use of this therapy.
● Eight urologists, three colorectal surgeons and two urogynecologists, covering a wide breadth of
geographic and specialty interest representation, met for two days in Chicago, Illinois, USA on
January 19-20, 2017 to discuss best practices for neuromodulation. Suggestions for statements
were submitted in advance and specific topics were assigned to committee members. Committee
members prepared each assigned topic and presented supporting data to the group at which time
each topic was discussed in depth. Best practice statements were formulated based on available
data and expert opinion and then each member prepared a discussion section for each particular
topic which reflected the current literature and expert opinion. Another urologist was added to
the group during the initial writing process. After multiple rounds of editing within the group the
highlights of the statements were presented at the ICS meeting in Florence, Italy in September
2017. This document was then circulated to multiple external reviewers after which final edits
were made and approved by the group.
● The meeting and editing expenses were supported by the ICS. Funding to support this project
was based on an unrestricted society-initiated grant made by Medtronic to the ICS.
● As many of the recommendations herein are based on expert panel consensus, the
recommendations in this document, while meant to aid clinical decision-making, do not pre-empt
physician judgment in individual cases.
The statements and recommendations included in this document pertain to SNM in its present
form (Interstim, Medtronic) They may or may not have relevance for future SNM products or
therapies which become available for clinical use.
● At the time this document was created, the only sacral neuromodulation device commercially
available was the Medtronic Interstim (Minneapolis, MN). Thus, the data and statements
discussed pertain to this device. However, it is clear that other sacral neuromodulation devices
will be available in the near future. Accordingly, many of the concepts contained within this
document will likely apply to newer devices as well.

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● The panel used the International Consultation on Urological Diseases (ICUD) method when
determining levels of evidence and grades of recommendation. Table 1 summarizes the criteria
used for determining levels of evidence and grades of recommendation.1

DEFINITIONS
SNM: a technique that electrically stimulates a sacral spinal nerve root to modulate a neural
pathway with the aim of treating bladder and/or bowel dysfunction.
● The term neuromodulation vs. neurostimulation was preferred by the committee since SNM,
through electrically stimulating nerves, effectively functions by modulating the lower urinary tract
or bowels.
Neurogenic lower urinary tract dysfunction (NLUTD): includes all bladder/urinary sphincter
dysfunction related to any relevant neurological disease
Peripheral nerve evaluation (PNE) lead: a monopolar, temporary lead which is always removed
after an SNM test period and is not designed for long-term therapy.
Staged (tined) lead: a quadripolar lead which is designed for potential long-term use after a
successful test period.

BACKGROUND
SNM is not indicated as a first line therapy for either urinary or bowel disorders.
● Typically, conservative measures (behavioral, physical therapy) and medical treatment are
recommended prior to treatment with SNM.
In the absence of a comparative study with recommended doses of onabotulinum toxin A (BTX-
A) and contemporary SNM tined leads, no recommendations can be made as to whether BTX-
A or SNM should be used over the other for the management of refractory overactive bladder
(OAB).
● The Rosetta trial is a prospective randomized trial that compared SNM to Botulinum toxin.2 It
showed a slight short-term advantage to Botulinum toxin, however, it did not utilize currently
recommended doses of Botulinum toxin (200u as opposed to the recommend 100u dose) or the
currently available SNM lead technology and thus no conclusions can be drawn relative to
contemporary practice.
SNM is a minimally invasive technique with good long-term outcomes. SNM can be offered to
patients with OAB with or without incontinence who fail to respond to or are intolerant of
conservative and medical therapies. (Level of Evidence: I; Grade of Recommendation: A)
OAB Without Incontinence
The initial SNM prospective, randomized, 12 center study enrolled 51 patients for severe urgency-
frequency syndrome. This group reflects the present definition of OAB “dry” (urinary urgency and
frequency without urinary urgency incontinence). Subjects who demonstrated a satisfactory
response to PNE were randomly assigned either to immediate treatment or implant following a 6-
month delay (control group). At 6 months, voiding diary results demonstrated statistically significant
4

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improvements in the immediate implant group in comparison to the control group with respect to the
number of daily voids, volume per void and degree of urgency. 3 At 2 years follow-up, 29 urgency-
frequency patients showed significant reduction in the number of voids per day, with 56% of patients
showing 50% or greater reduction in the average voids per day, including 32% who returned to a
normal range of 4 to 7 voids per day.4
OAB With Incontinence
The initial prospective, randomized, multicenter trial included 34 patients with severe urgency
incontinence (OAB “wet”) who underwent immediate implantation of SNM after a positive trial test
and 42 patients (delayed group) who received standard medical therapy (SMT) for 6 months and then
were offered implantation. At 6 months, the number of daily incontinence episodes, severity of
episodes and absorbent pads or diapers replaced daily due to incontinence were significantly reduced
in the early stimulation compared to the delayed group. In the early stimulation group, 16 patients
(47%) were completely dry and an additional 10 (29%) demonstrated a greater than 50% reduction in
incontinence episodes 6 months after implantation. Efficacy appeared to be sustained for 18 months.
Surgical revision was required in 32.5% of patients.5
In this cohort, the long-term efficacy of SNM for refractory urinary urge incontinence remained high.
At 3 years, leaking was significantly reduced, with 59% of patients reporting 50% or greater reduction
in leaks per day and 46% of patients reporting that they were completely dry. 2 As compared to
baseline, the group of 96 implanted patients demonstrated significant reductions in urge incontinence
symptoms at an average of 30.8 (range 12-60) months with respect to the number of urge
incontinence episodes per day, severity of leaking, and the number of absorbent pads/diapers
replaced per day due to incontinence. About 10% of patients underwent device explant due to lack of
efficacy, pain or bowel dysfunction but no permanent injuries associated with the devices or therapy
were reported.3 Others demonstrate that after 3 years, 59% of urinary urgency incontinent patients
showed greater than 50% reduction in leaking episodes per day with 46% of patients being completely
dry.2 A single center study with median long-term follow-up of 50.7 months showed a success rate of
84.8% for urgency UI. Overall 39% of patients needed revision of the SNM neuromodulation implant. 6
SNM showed superior subjective and objective results compared to pharmacologic–SMT treatment
for OAB, at 6 months. SNM is shown to be a safe and effective treatment for OAB patients.7 Ultimately,
a 2009 Cochrane review concluded that implantable neurostimulators have benefits for some patients
with OAB symptoms, retention without organic obstruction, and in those for whom other methods of
treatment have failed.
SNM is an effective treatment for Fowler’s Syndrome, voiding dysfunction and NOR. (Level of
Evidence: I; Grade of Recommendation: A)
Non-Obstructive Urinary Retention (NOR)
The initial SNM prospective, randomized, 12 center study enrolled 177 patients for NOR. All patients
had PNE and 38.4% eventually received the implant. Of the 68 patients who qualified for implantation
37 were randomly assigned to an immediate treatment and 31 to a 6-month delayed implant (control
group). At 1.5-year follow-up 70% of 42 implanted patients (immediate or late) showed greater than
50% reduction in volume per catheterization.2 Further publication of 18-month follow-up showed that
of the patients treated with implants 69% eliminated catheterization at 6 months and an additional
14% had a 50% or greater reduction in volume per catheterization. Therefore, successful results were
achieved in 83% of the implant group with retention compared to 9% of the control group at 6 months.
5

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Temporary inactivation of SNM therapy resulted in a significant increase in residual volumes but
effectiveness of SNM was sustained through 18 months after implantation.8 Extension of this study
with 5-year follow-up showed significant reduction in the mean volume per catheterization and the
mean number of catheterizations. The clinical success rate of 71% was observed at 5 years after
implantation.9 In another single center study, out of 60 women implanted there was a spontaneous
voiding rate of 72% over a mean follow-up of 4 years. After surgery, of the 43 women who voided, 13
required the continued use of clean intermittent self-catheterization up to twice a day, but this was
less than before surgery. Women with abnormal EMG did better, with 76% of patients experiencing
restoration of voiding.10 Another study confirmed that the presence of Fowler's syndrome is a positive
predictive factor for SNM in female urinary retention.11 Several single center studies reported good
long-term outcomes between 73% 12 and 87%.5

SACRAL NEUROMODULATION FOR INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME

There is limited evidence supporting the role of SNM for patients with interstitial cystitis
(IC)/bladder pain syndrome (BPS).
SNM is an option for IC/BPS non-responsive to conservative therapies after appropriate assessment.
(Level of Evidence: III; Grade of Recommendation: C)
IC/BPS is a condition characterized by bladder, urethral and pelvic pain along with urinary frequency,
urgency and nocturia.13 SNM may be considered for patients with IC/BPS who do not sufficiently
respond to first, second or third-line treatments. However, SNM has approval for pelvic pain
conditions in only a few countries, and is not approved specifically for IC in any nation. There is limited
evidence supporting the role of SNM for patients with IC/BPS - typically small observational case series
all reporting different criteria for success. Based on these small observational studies, the success rate
for SNM for IC/BPS using intention to treat analysis was 48% to 72%. 14,15,16,17,18,19
Based on the available limited evidence, SNM may be an option for IC/BPS non-responsive to
conservative therapies after appropriate assessment and multidisciplinary team review. The AUA
IC/BPS Guidelines lists SNM as a 4th line therapy.20
There is a lack of evidence supporting SNM as a treatment option for patients with non-IC/BPS
chronic pelvic pain. (Level of Evidence: III; Grade of Recommendation: C)
Chronic pelvic pain is defined as “chronic or persistent pain perceived in structures related to the
pelvis of either men or women. It is often associated with negative cognitive, behavioral, sexual and
emotional consequences as well as with symptoms suggestive of lower urinary tract, sexual, bowel,
pelvic floor or gynecological dysfunction. Pain must have been continuous or recurrent for at least 6
months”.21
There is minimal evidence reporting the efficacy of SNM for chronic pelvic pain.22 Based on available
evidence, SNM cannot be recommended as a treatment option for patients with non-IC/BPS chronic
pelvic pain. However, pelvic pain is not necessarily a contraindication in patients with concomitant
voiding symptoms such as frequency and urgency, if those voiding symptoms improve during the trial
period and the patient endorses an associated improvement in quality of life.

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SACRAL NEUROMODULATION (SNM) FOR NEUROGENIC LOWER URINARY TRACT

DYSFUNCTION (NLUTD)
SNM is an option for symptom control in patients with NLUTD who are at low risk of upper
urinary tract deterioration. (Level of Evidence: III, Grade of Recommendation: C)
SNM for NLUTD is of growing interest, although it is still as an “off-label” indication. There have been
many reports of good outcomes in NLUTD but with a lack of standardized criteria in terms of patient
selection, success definition, etc. Most of the evidence is focused on incomplete SCI and multiple
sclerosis (MS) but patients with cerebrovascular accident, brain trauma, cerebral palsy, and
Parkinson’s disease have been implanted as well with similar outcomes as in patients with non-
neurogenic indications.23,24
SNM has been utilized in the treatment of detrusor overactivity (DO), NOR, detrusor sphincter
dyssynergia (DSD) and FI due to incomplete SCI. Although there are no clinical or urodynamic criteria
to select ideal candidates for SNM in SCI, in one study ASIA D (incomplete injury with some
preservation of motor function below the lesion) and E (normal sensory and motor functions below
the injury level) lesions and sensation of bladder filling were associated with higher success rate during
the test trial.25 We recommend that in SCI patients, SNM should be limited to ASIA D and E patients
with preserved bladder filling sensation.33
The success rate of SNM in patients with upper motor neuron injury may be higher than in patients
with lower motor neuron injury since the former preserves afferent integrity and contractility of the
detrusor. One study demonstrated an improvement in bladder emptying with SNM in patients with
acontractile or hypocontractile bladder, but the mechanism of action is unclear. 26
In patients with MS, SNM has demonstrated good results treating DO and NOR due to DSD but a low
success rate in treatment of NOR has been reported in those with an acontractile or hypocontractile
bladder.27 Patients with MS being considered for SNM should have stable disease without an expected
requirement for frequent or routine magnetic resonance imaging (MRI); patients with rapidly
progressive MS typically should not have SNM systems implanted.
The most recent studies in SNM for NLUTD utilize longer periods of the test trial than for patients with
idiopathic dysfunctions.28 Longer test periods might be more appropriate for more complex
conditions such as NOR29 as well as NLUTD.
Since SNM is used after all other therapies have failed and prior to more invasive procedures, a 50%
improvement during the trial period is adequate to define success. Most studies define success with
the same parameters as in non-neurogenic patients, such as reduction of urinary frequency, urgency
incontinence episodes, number of catheterizations, volume per catheterization and FI episodes.

NEED FOR URODYNAMIC TESTING PRIOR TO SNM

There is a lack of evidence to suggest that urodynamic testing can predict SNM outcomes. (Level
of Evidence III, Grade of Recommendation C).
Patient characteristics such as age, sex, comorbidities, duration and severity of symptoms, and results
of examination and testing such as cystoscopy, imaging and urodynamic studies (UDS) have shown
insignificant value in predicting which patients will respond to a trial of SNM. Indeed, in some parts of

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the world, UDS are commonly performed prior to SNM trial, whereas in other areas, they are not,
without an obvious difference in outcomes.
With regard to clinical studies, while some case series30 have shown that older patients and longer
duration of symptoms are less likely to respond, others31,32 have contradicted this. One study
suggested that combining traditional urodynamics and ambulatory monitoring might have additional
predictive value33 over conventional studies alone. None appear to be more sensitive, specific, or cost
effective for the prediction of response to SNM as the screening trial, consisting of a PNE or a staged
lead implant.34,35,36 There is however a single recent prospective study showing that children with
bowel and bladder dysfunction who had detrusor overactivity on videourodynamic testing had
significantly greater improvement in symptoms with 2 stage SNM implant.37

The trial phase of SNM is the single most valuable tool for predicting the potential
therapeutic success of SNM for urinary indications. (Level of Evidence II, Grade of
Recommendation B).
Several large, multicenter trials have shown that the PNE4 and the staged trial6 predict which
patients are likely to respond, and also which will likely have long term benefit from the
therapy.1.8,9,39 A unique advantage of SNM is this inherent ability to predict which patients are
likely to benefit with its own specific trial. UDS is unlikely to add significant diagnostic benefit in
the evaluation of routine idiopathic OAB.38
The index patient suffering from refractory OAB is female, has no neurologic disease, has not had
prior pelvic surgery, and has no or minimal SUI. On physical exam there is no significant pelvic
organ prolapse or urinary residual. She has failed first and second line options, and has significant
bothersome symptoms. In this scenario, the panel agreed that there is scant evidence that the
result of a UDS is likely to change the third line therapy options or outcomes. Patients with
neurologic disease, an unclear degree of SUI or bladder emptying symptoms, significant prolapse,
male patients, and prior pelvic surgeries including outlet reduction procedures (e.g. transurethral
resection of prostate) and slings are more likely to benefit from UDS to aid in the correct
differential diagnosis.
Pressure flow study or Video UDS may be valuable in the diagnosis of NOR. (Expert Opinion).
Urodynamics is particularly helpful to rule out obstruction when considering the diagnosis of NOR or
incomplete bladder evacuation.39,40 Another study showed that SNM treatment response in male
patients with impaired bladder emptying can be predicted with a bladder outlet obstruction (BOO)-
contractility nomogram.41 In this study of 18 men, the authors found that only 20% of patients below
the 10th percentile of contractility, but 86% of men between the 10 and 25th percentiles of the
Maastricht-Hannover nomogram were treated successfully with SNM. All successfully treated patients
voided without needing self-catheterization. Other studies have shown that EMG study of the external
urethral sphincter may be helpful in defining Fowlers syndrome. 42 In females, the combination of
video imaging and real time urodynamic data has been determined to be the best method of defining
BOO.43 Video studies in men may also be useful in determining the level of obstruction, for example
benign prostatic hypertrophy vs. pseudodyssynergia.44

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In cases where SNM has been tried and failed, UDS may be considered to further define the
underlying disorder. (Expert Opinion)
Considering that the PNE or staged lead placement have the best predictive value for determining
which patients will benefit from long term treatment with SNM, patients who fail screening, or those
who have declining efficacy over time may benefit the most from initial or repeat urodynamic
assessment, which may reveal bladder pathologies not amenable to SNM and direct another
therapeutic course.

FECAL INCONTINENCE (FI)

SNM should be considered as a second line treatment option for bothersome FI in patients who
have failed conservative measures. (Level of Evidence: 2, Grade of Recommendation: B)
Conservative medical measures are the first line treatment for FI, however, SNM should be considered
as the second line of treatment in most patients with FI.45,46,47 Physicians should consider SNM if the
patient has failed medical measures, as SNM has been shown to be superior to best medical
management in a randomized trial.13 Results of pooled analysis has suggested that 79% of patients
with permanent implant for chronic stimulation experience ≥ 50% improvement in incontinence
episodes in the short-term, while 84% achieve this endpoint with 3 years of follow-up.48 Comparative
studies are scarce. One study compared 23 patients randomized to SNM vs. 17 randomized to
percutaneous tibial nerve stimulation.49,50 Though short-term outcomes were acceptable in both
groups, the design of the study did not allow statistical comparison between groups. One study
compared 15 patients treated with SNM to 15 historical controls treated with the artificial bowel
sphincter. Postoperative incontinence scores were slightly better with the artificial sphincter, though
constipation scores were worse.51 Importantly, both the artificial bowel sphincter and the magnetic
sphincter, another recent option for FI, are currently unavailable. There are no comparative studies
of SNM vs. sphincteroplasty, the major competing procedure for FI.
An anal sphincter muscle defect is not a contraindication for SNM. (Level of Evidence: 3, Grade
of Recommendation: C)
There is a large and growing body of evidence that a defect of the internal or external sphincter is not
a contraindication for SNM for FI.50,52,53,54,55,56,57,58,59,60,61 Though clinical success has been reported in
patients with sphincter defects up to 180 degrees,13,57,62 most would agree that the size of the defect
does not matter and should not affect decision making.50,54 This is likely because the proposed
mechanism of action relies more on sensory nerve fibers and bowel motility than on muscular
contraction.63,64 Given the extent of the available evidence stating that a sphincter defect does not
impact the success of SNM, some authors have advocated using preoperative ultrasound only in
selected patients with FI.65
In a patient who is a good candidate for a sphincter reconstruction, typically in a younger woman with
relatively recent obstetric injury, it is appropriate to have a full discussion of risks and benefits of a
sphincteroplasty vs. SNM. Though there is no evidence to compare the outcomes of these two
techniques, many young women with new onset obstetric sphincter defect may be good candidates
for sphincter muscle repair.

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Other factors such as pudendal neuropathy and the presence of a prior sphincter repair do not predict
the outcome for SNM and should not be among the factors considered when deciding which patients
to test for SNM.45,65

Patients who have FI after Low Anterior Resection for rectal cancer may be a candidate for SNM
test lead implantation if conservative treatment fails. (Level of Evidence: 3, Grade of
Recommendation: D)
As treatment for rectal cancer has evolved and sphincter preservation strategies have emerged, many
of these patients are cured of their disease, but as many as 50-90% will suffer at least some degree of
bowel dysfunction.66 Many patients will suffer from debilitating low anterior resection syndrome
(LARS), a constellation of fecal urgency, clustering of bowel movements, and FI. As these patients have
altered anatomy after resection of the rectum, it is unclear how much benefit SNM may play in
achieving relief of symptoms. Two separate studies were conducted on the utility of SNS in LARS.67,68,69
Success was noted in 47-100% of patients subjected to a test implantation and QOL was generally
improved.67 The difficulty in interpreting this data is that the patient groups are heterogeneous. Some,
but not all, of the patients had radiation for rectal cancer, and the rectal resections were done for
different disease processes such as cancer or Crohn’s disease. Additionally, LARS is a constellation of
symptoms with many dimensions such as bowel movement clustering, urgency, and incontinence.
Though most studies report on improvement in continence, further research should use a more
comprehensive scoring system such as the LARS score70 to determine which elements of the overall
syndrome are improved by SNM. Though it is reasonable to consider SNM test stimulation in the
clinical setting of LARS, conservative treatment such as medical bowel management and lifestyle
modification should be attempted first.
SNM is the preferred therapy in an appropriate patient with combined urinary and bowel
symptoms. (Level of Evidence: III, Grade of Recommendation: C)
Combined Urinary and Bowel Symptoms
Early studies of 14 patents with FI and associated urinary disturbances showed encouraging results
with permanent SNM implant.71 A study of 24 female patients with combined FI and UI showed
improvement in both symptoms after SNM implant in 31.8% of patients with a mean follow-up of 28
months. SNM may be beneficial in selected patients with FI and UI.72 A recent study showed
improvement of bowel dysfunction in patients implanted with SNM for urinary urgency incontinence.
There was significant improvement in mean urinary and bowel symptom scores, though only urinary
quality of life (QOL) scores improved.73
SNM for combined urinary and fecal incontinence has been also explored in children with a positive
response. Based on prospective clinical data and patient-reported measures, 29 patients showed
between 55% and 91% improvement in both bowel and bladder dysfunction. 74
SNM should be considered for combined urinary and FI after the work-up for both conditions has been
completed.

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OTHER BOWEL CONDITIONS

SNM for constipation should only be considered for patients who have had symptoms for more
than one year and have failed conservative treatment, as results of clinical studies have been
disappointing. There should be no mechanically correctable cause. (Level of Evidence: 4, Grade
of Recommendation: D)
Reported outcomes of SNM in patients with constipation have been mixed,75,76,77,78,79,80 thus this
remains an area of considerable debate. Success rates with test lead implantation have been reported
at 42-100%, and extended testing periods of 2-3 weeks are often necessary.81 Contradictory studies
have emerged, suggesting much lower rates of clinical success. A study by Graf et al82 indicated that
only 11% of patients were improved at 24 months. A double-blind randomized trial of SNM vs. Sham
indicated that only 28% of SNM patients met the criteria for device implantation and there was no
benefit of this therapy over sham treatment. 83 Additionally, this therapy is not approved by the US
Food and Drug Administration, and is not universally covered by insurers in Europe. Best evidence
suggests that all less invasive medical and surgical measures should likely be taken prior to proceeding
with SNM in these patients.

NEED FOR BOWEL TESTING PRIOR TO SNM

A 2-3-week bowel diary is necessary prior to SNM test for bowel dysfunction. Anorectal
physiology testing (manometry, anorectal sensation, volume tolerance, compliance) can be
considered to help define the elements of dysfunction and guide management. (Level of
Evidence: 4, Grade of Recommendation: C)
It is difficult to identify from the literature the optimal work-up prior to SNM in bowel indications.
Some clinicians even consider the PNE test itself as a part of the pre-SNM work-up in FI patients, as
there is no known physiologic predictor of success of SNM in these patients. 84
However before embarking on an SNM trial, common bowel investigations are typically done to
identify those patients for whom such a test could be of greatest potential benefit. 85 Typically, the
patient proposed for SNM test has chronic, severe FI which is defined as more than “one leak per
week, over a 3 to 4-week period, lasting for more than 6 months” and that has failed conservative
measures. A 2-3-week bowel diary is the most important document prior to SNM test for bowel
dysfunction. The following is recorded and will be compared with a similar diary done during the test
phase: leaks (minor and major), normal evacuated stools, time to defer as a mean by day, and
medications taken. The Bristol stool chart is useful to characterize the bowel habits and to allow
exclusion of patients with diarrhea from SNM since a normalized stool pattern has not been reached.
Additional investigations may include the following:
● Anorectal physiology testing (manometry, anorectal sensation, rectal volume tolerance and
compliance) can be considered to help define the elements of dysfunction and guide
management. It is usually done before surgical decision-making, as part of the FI work-up and
plays a role to guide pelvic floor retraining.
● Endoanal ultrasound is the recommended tool to assess the anal sphincter complex and to
identify any sphincter defects. It would guide the discussion to proceed for repair vs. SNM trial
according to the different aspects of the defect.
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● Dynamic defecography, either standard or MRI, is nowadays also a test to consider prior to SNM
trial.86 This exam allows for identification of any posterior pelvic floor disorder including high-
grade rectal intussusception, which can be clinically difficult to identify and a potential cause of
FI. In such a case, many clinicians would first correct the rectal prolapse followed by an SNM trial
if FI persists.
● Neurophysiology testing may be performed in some neurologic conditions, but is not part of the
usual investigations.
● A/P and lateral views of the sacrum could exclude some abnormalities/malformations making the
needle and electrode placement difficult for instance in the case of sacral agenesis associated
with anorectal malformations.

SNM FOR THE PEDIATRIC POPULATION

SNM may be considered in children who have failed an extended period of behavioral
modification, biofeedback, and pharmacologic therapy and should be considered before
irreversible surgery.
Safety and effectiveness have not been established for pediatric indications. (Level of
Evidence: III, Grade of Recommendation: C)
Anatomical differences and somatic growth make implantation technically more
challenging (Level of Evidence: IV, Grade of Recommendation: D)
SNM has been reported to be effective in children in several single center pilot studies. In one, a
total of 23 patients, ranging from 6 to 15 years old with presenting symptoms of dysfunctional
voiding, enuresis, incontinence, urinary tract infections, bladder pain, urinary retention, urgency,
frequency, constipation and/or fecal soiling were followed for a mean of 13.3 months after SNM.
The overall patient satisfaction rate was 64%, while that of the caregiver was 67%. Explantation
rate was 10%.87 Another study with 30 children with refractory bowel and bladder dysfunction
showed significant improvements.37
There are only two prospective randomized trials utilizing SNM in children. The first study of 42
children with incontinence due to neurogenic LUTD showed subjective improvement in about half
of children undergoing SNM, including improved bowel function in 9 children, resolution of
urinary tract infections in 5 children, and improved bladder sensation in 6 children.88 The other
randomized study of 33 patients (24 boys) with mostly neurogenic LUTS and with a mean age of
12.2 years compared SNM to standard conservative treatment. Incontinence was mixed urinary
and fecal in 19 cases, urinary only in 9 and fecal only in 5. Overall positive response rate was more
than 75% for urinary and bowel dysfunction. 89
A study with longer follow-up (average 3.2 years) in consecutive children with UI, constipation,
frequency and/or urgency, and nocturnal enuresis from a single center showed that nearly all
children (99 of 105) experienced improvement of at least 1 symptom. Reoperations occurred in
56% of children, mainly for device malfunction. Explantation was performed in 35%, mainly for
complete symptom resolution.90 Of note, certain health preventive measures are of greater
importance in children, mainly reduced radiation exposure. Also, anatomical differences and
somatic growth must be considered with SNM implantation in the pediatric population.
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CONTRAINDICATIONS FOR SNM IMPLANTATION

Absolute contraindications for SNM includes: Inadequate clinical response to a therapeutic
trial, inability to operate the device with lack of supportive caregivers who could otherwise
offer assistance, and pregnant patients (Level of Evidence: IV, Grade of Recommendation: C).
Relative contraindications for SNM includes: patients with severe or rapidly progressive
neurologic disease, patients with established complete SCI, patients with known anticipated
need for MRI of body parts below the head and patients with abnormal sacral anatomy (Level
of Evidence: III, Grade of Recommendation: C).
The manufacturer of the currently most widely available system (InterStim II) has approved the safety
of the current device for 1.5 Tesla MRI of the head. See manufacturer’s website for further detail.91
Recent studies have shown that the risk of heating is low for clinical lumbar and pelvic MRI at 1.5-
Tesla, both in an intact SNM system and with a fractured lead.92
In pregnant women, no negative effects of SNS on the fetus, mother or device have been reported.
However, further studies are needed to conclude if it is a safe practice to implant or to leave a device
activated in a pregnant woman.93,94 Indeed, a recent review that included 16 Cesarean and 9 vaginal
deliveries, comprising 25 pregnancies with SNM devices in situ (8 with device left on during gestation,
18 with device deactivated, typically between 3-12 weeks gestation) reported that post-delivery SNM
dysfunction was present in 32%, with 3 after vaginal delivery and 5 after c-section. Ultimately, the
authors suggested that “within the current limited evidence, the decision regarding SNM activation
or deactivation should be individualized [in pregnancy].”93 Until more data is available, for example
from a patient registry, the panel recommends not implanting a SNM device in a pregnant woman
and deactivating the device when a patient already on SNM therapy becomes pregnant.

TIPS FOR INTRODUCTION OF SNM TO PATIENTS

SNM therapy should be discussed with all patients as part of their bowel or bladder control
treatment pathway. (Level of Evidence: IV, Grade of Recommendation: C)
Surgeons should review the need for life-long follow-up, eventual battery replacement,
complications, and expected symptom improvement. (Level of Evidence: IV, Grade of
Recommendation: C)
SNM is classified as a 3rd line option for treating OAB symptoms,95 and as a 2nd line therapy for FI.
Medications and non-invasive interventions comprise first line therapy. It is known that many patients
will not respond to initial therapies and will potentially be offered neuromodulation as an option.
There is no documented ‘best practice’ for introducing SNM to patients, however at least one study
showed that group-education visits made patients more informed and prepared for the test phase,
which translated into improved patient-reported outcomes compared to those undergoing standard
preoperative counseling, despite voiding diary outcomes being no different between the groups.96 As
no reliable predictor for patient response to more conservative therapies exists, it is our
recommendation that all patients be informed of this therapy as early as possible in the treatment
pathway. Similarly, for FI, where limited therapies exist beyond pelvic-floor therapy and modification
of stool consistency, patients should be alerted that SNM therapy exists.97 Patients with dual bladder
and bowel disorders stand to benefit with respect to both symptoms,73 which may direct the clinician
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to educate the patient about SNM almost at the first encounter. This is discussed in further detail
elsewhere in this consensus statement.
As patients are introduced to SNM is it important to review the limitations and implications of the
therapy. Currently, the InterStim II device is labeled for an expected battery life of 3-5 years, though
some have shown longer periods with lower energy settings. 5 Long-term follow-up, the need for
battery replacement, possible revision of the lead or programming changes are all important aspects
of SNM therapy,98 and should be communicated to the patient, in particular given that a recent study
using contemporary technology found a 32% rate of surgical intervention at 3 years following
implantation.31 Furthermore, while symptom improvement can be dramatic in some patients, the
target response of >50% improvement both objectively and subjectively as the implant threshold
indicates this is not a cure in most patients. Expectations for the patient are important and should be
balanced against the known response to trial and long-term implant success.

PREOPERATIVE COUNSELING - ADVERSE EVENTS

Preoperative counseling prior to SNM should include a discussion of risks including implant site
pain, infection, paresthesia, leg pain, and/or need for reprogramming or for device revision.
(Level of Evidence: 3, Grade of Recommendation: C)
Though SNM is a relatively safe surgical procedure, adverse events do occur. The most complete
report on adverse events comes from the North American Multi-Center trial, as investigators were
required to report all adverse events. The most common adverse events were implant site pain
(32.5%), paresthesia (19.2%), implant site infection (10%), leg pain (5.8%) or buttock pain (5.0%). 99
The 5-year clinical data on implants for bowel indications from Hull et al16 suggest that preoperative
counseling and long-term follow-up are necessary, as 24.4% required revision or replacement by 5
years, and 19% were permanently explanted by 5 years. Close follow-up with programming parameter
optimization, may increase clinical efficacy, while decreasing paresthesias and leg pain.100
In a recent multicenter trial, the infectious complication rate was 3.3%.101 It may be helpful to
distinguish between early (<1 month after implantation) vs. late (>1 month after implantation)
infections. Wexner et al102 reported that in colorectal patients, 5/7 early device infections resolved
with antibiotics, while all 4 late infections required device explantation. As testing strategies evolve
over time, there is increasing interest in the percutaneous office approach to testing, as at least one
publication suggested an overall infection incidence of 0% in patients tested via office PNE vs. 10.5%
in patients who received a staged approach in the operating room (OR). 103

RATIONALE for PNE vs STAGED PROCEDURE

Both PNE and staged trial play a role in SNM. The advantages and disadvantages of each must
be taken into consideration when selecting the approach. (Level of Evidence: II, Grade of
Recommendation: C)
One of the unique aspects of SNM is that patients are allowed to undergo a trial period to evaluate
whether the therapy is efficacious and provides adequate symptom relief.
Both PNE and the staged trial play a role in SNM. The advantages and disadvantages of each must be
taken into consideration when selecting the approach.2,6,104,105 An ideal candidate for PNE is one who
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is comfortable undergoing a procedure under local anesthesia (LA) and who is able to tolerate the
potential, mild discomfort related to the procedure. Patients with heightened levels of anxiety or a
low pain threshold may benefit from a staged procedure in the OR under monitored anesthesia care
(MAC) sedation /local or general anesthesia (GA).106
PNE is less invasive, less costly and can provide reliable sensory responses. (Level of Evidence:
III, Grade of Recommendation: C)
This form of test stimulation may be required by insurance carriers and may also act as a bridge
to therapy acceptance. However, PNE lead migration can be problematic, and there may be
limitations in pediatric populations and patients with NLUTD. (Level of Evidence: II, Grade of
Recommendation: C)
Overall, the PNE approach is less invasive, less costly if performed in an office setting, and can provide
reliable sensory as well as motor responses.107 As it is generally performed in the office setting, it may
also be more convenient for the patient as it has the potential to avoid one trip to the OR. This
advantage would reduce the risks associated with anesthesia and hospital admission by having only
one procedure in the hospital vs. two. Additionally, this form of test stimulation may be required by
insurance carriers as well as acting as a bridge to accepting therapy. However, there are issues with
PNE lead migration, and it may have limitations in a pediatric population and patients with neurogenic
voiding dysfunction.93
Staged implant is superior to PNE with regards to conversion rates to chronic therapeutic
stimulation in OAB and FI. (Level of Evidence: II, Grade of Recommendation: B)
This approach also has the advantage of a longer trial period.
However, this approach may be more costly, may require two trips to the OR and may
be associated with a greater rate of adverse events.
The advantage of the staged implant is that the there is a longer trial period, and the lead that is being
tested is the lead the patient will use long-term. The patient is also allowed to trial multiple programs
to achieve optimal outcomes. The conversion to permanent implant is consistently higher in the
staged vs. the PNE at rates of 80% vs. 44-52%, respectively.2,93,94,103, 108 Now with the use of fluoroscopy
at the time of PNE lead placement, the PNE conversion rate may be higher, however there is no
current data to support this supposition.

More data is needed to identify ideal candidates for PNE vs. staged implant. Reliable
predictors of test stimulation success are currently lacking in both bladder and bowel
dysfunction. (Level of Evidence: III, Grade of Recommendation: D)
For patients with FI who have continent periods of >5-7days punctuated by intermittent
episodes of FI, a staged implant may be preferable to ensure an adequate trial period.
(Level of Evidence: IV, Grade of Recommendation: D)
Since NLUTD is a complex condition and given the lower rate of positive tests using PNE,
a staged procedure should be considered for the majority of NLUTD patients. (Level of
Evidence: III, Grade of Recommendation: D)

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In patients with underlying neurological conditions, since NLUTD is a complex condition and given the
lower rate of positive tests using PNE, a staged procedure should be considered for the majority of
NLUTD patients. The majority of studies recently published in this area reported exclusively on the
use of tined lead electrodes for the test trial in NLUTD patients.36 Even though these studies do not
report comparative results between the two techniques it has been demonstrated that PNE testing
has disadvantages compared to the staged procedure such as lead migration 11-18%,2 lower rate of
positive tests 46% vs 88%109 (9) and different responses between temporal and definitive lead – up to
20%.

SCREENING FOR SUCCESS DURING THE TEST PERIOD

Patients who achieve ≥ 50% improvement in one or more of their bothersome urinary or bowel
parameters during PNE or Stage 1 test period may be offered a full system implantation.
For both PNE and stage 1 trials, both objective and subjective measures of improvement should be
assessed. Success during the SNM trial is defined as at least 50% improvement in one or more of the
bothersome parameters.9 Patients who achieve this benchmark should be offered full implantation.
PNE duration is typically 7 days for bladder indications. As the PNE leads are not anchored with tines,
there has historically been concern regarding lead migration causing an inconclusive trial; thus, PNE
trials are typically not done for more than about 7 days. However, some implanters do utilize longer
PNE trials with little ill effect (in particular European implanters for bowel indications).
PNE test stimulation period is typically 7 days for bladder and 10-21 days for bowel indications.
(Level of Evidence: III, Grade of Recommendation: 3)
PNE duration for urinary urgency/frequency and urgency incontinence is typically 7 days. This can be
extended in cases of NOR. The period for SNM trial recommended by the manufacturer is two-weeks
for bowel indications. It has been strictly applied in the US with a 10-14 day trial in the major published
studies.16 However, in Europe this is considered too short a duration as stated in the published
consensus statement based on a Delphi process in 2015.54 Assuming the lead remains viable without
significant migration, a 3-week trial period has been chosen as an empirical compromise.110
Thus, for bowel indications, it is suggested that SNM test duration last from 10 days to 4 weeks,
allowing for testing of various stimulation programs, which may be beneficial when a satisfactory
result is not immediately achieved.111 Ultimately, the goal of any trial (whether PNE or staged), is to
provide an adequate duration to determine whether at least a 50% improvement in symptoms has
been achieved.
Stage 1 test period duration is typically 2-3 weeks.
Stage 1 testing can be attempted if PNE is inconclusive, particularly if a longer test period is
required for screening.
A repeat stage 1 test may be performed at the physician's discretion.
Stage 1 duration is typically 2-3 weeks. There are some experts who do utilize up to four weeks, in
part to avoid any possible placebo effect, or in instances when it is unclear if the patient has met the
50% improvement criterion, or for patients with incomplete emptying.112 Kessler and colleagues
followed a series of 44 patients who underwent prolonged tined lead testing for a median of 30 days,
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with 70% proceeding to full implantation. The complication rate was 5% during the prolonged tined
lead testing, but none of these were attributable to the extended testing itself.113
Patients should be encouraged to adjust the stimulation settings during their test period to optimize
the trial.2 If PNE testing is inconclusive, it is reasonable to consider a Stage 1 trial, in particular if a
longer duration of testing is required. Stage 1 trials are typically not repeated, but can be attempted
at the physician’s discretion in select circumstances.

REMOVAL OF SCREENING LEAD

PNE electrode(s) removal preferably occurs in the clinician’s office, but may be removed by
patient/family at home.
Stage 1 tined leads can be removed under local anesthetic (in the office or OR) with or without
sedation to ensure patient comfort during removal of all components.
There are no published studies regarding removal of the PNE lead at home by the patient versus in
the office by the clinician. Removal at home is convenient for patients, especially those who travel a
great distance to their clinician’s facility; however, removal in the office allows for both confirmation
that the lead was removed intact, as well as an opportunity to review outcomes of the trial (though
this could also be done via phone in conjunction with home lead removal). The panel agrees that
removal of a PNE lead can likely be safely performed in either setting
Stage 1 tined leads should be removed by a physician.114 These can be removed under local anesthetic
in the office or the OR setting, with or without sedation, as needed to ensure patient comfort.

PREVENTION OF SURGICAL SITE INFECTION (SSI)

A perioperative antibiotic aimed at coverage of skin flora should be given intravenously within
60 minutes of incision for both bowel and bladder indications.
The specific antibiotic of choice should be guided by the local antibiogram and the patient’s
allergy profile. (Level of Evidence: IV, Grade of Recommendation D)
The most significant complication after SNM device implantation is wound infection. Reported wound
infection rates range from 2–11% and are most commonly caused by Staphylococcus aureus. 115 A
recent large multicenter trial reported a wound infection rate of 3.3%.116
No defined perioperative or postoperative antibiotic protocol is uniformly agreed upon for
neurostimulator implantation; instead, this decision should be guided by the local antibiogram and
surgeon discretion. For the staged procedure, preoperative intravenous antibiotics should be given
within 60 minutes prior to the incision and aseptic techniques should be closely followed.
The AUA Best Practice Statement for perioperative antibiotic prophylaxis recommends the use of a
first-generation cephalosporin for open surgical procedures that do not involve entry into the urinary
tract and does not recommend prolonged antibiotic usage, since there is no evidence to support it. 101
Prostheses implantation surgeries are recommended to receive prophylaxis with an aminoglycoside
plus a first-/second-generation cephalosporin or vancomycin. It is debatable how to categorize the
SNM procedure because it is an open surgical procedure not entering the urinary tract as well as an
implanted procedure.
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In a study done by Haraway et al,104 the use of cefazolin as the preoperative antibiotic was the only
significant risk factor for subsequent infection and explanation of the SNM device. Indeed, cefazolin
was less effective than vancomycin with or without gentamicin in preventing infection in this study,
likely due to resistant organisms.
Antibiotic recommendations for bowel and bladder indications are similar. The European consensus
statement for sacral nerve stimulation for FI and constipation recommends a single dose of
prophylactic antibiotics before both the tined lead and the IPG implantation procedures, and suggests
that routine postoperative antibiotics are not required.54
Chlorhexidine-based skin prep is commonly used for perioperative cleansing of the patient’s back and
upper buttocks, but this varies between clinicians. Care should be taken in preparation of the buttocks
and anus. If the implanter chooses to visualize the anus during test stimulation to observe the anal
sphincter contraction, it should be covered with a separate plastic drape until visualization is required
during surgery.
Other investigators suggest minimizing the risk of SSI with a preoperative shower with antiseptic, as
well as allowing the dressing to remain in place for 48 hours postoperatively following stage 2
procedures.117

IDEAL ANESTHESIA
No data suggest superiority of local anesthesia (LA) with IV sedation vs. general anesthesia
(GA) for a successful staged neuromodulation trial.
Muscle relaxants with GA and regional anesthesia causing neuromuscular blockade must
be avoided.
LA is preferred for PNE, and LA with IV sedation for IPG implant. GA may be considered.
There are two current methods for trialing SNM to screen for efficacy.
The first is the PNE, which is generally done in the office under LA. There is the option to perform the
PNE in an ambulatory surgical center (ASC) or even in the hospital and provide monitored anesthesia
care (MAC) or GA. The second method is the staged approach, which is typically done in an ASC or
hospital setting under MAC or GA. When SNM was first approved, this involved a PNE screening trial,
and if the patient was determined to be a success, they then underwent implant of the long-term
device. This required a large cut-down to the posterior aspect of the sacrum and was routinely
performed under GA with high success rates. This suggests that the use of GA does not negatively
impact the success of SNM.
In general, LA is considered to be safer than MAC, which is itself considered safer than GA. There is
no current data that suggests any type of anesthesia is superior over another in terms of outcomes
for SNM. As one of the parameters for determining a successful implant is appropriate motor response
(bellows and great toe flexion), the use of a paralytic agent should be avoided if using GA. (Level of
Evidence: V, Grade of Recommendation: C)
LA is preferred for PNE if patients are able to tolerate it, and LA with IV sedation (MAC) for tined lead
and IPG implant. GA may be considered under certain circumstances according to physician discretion,

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however there is no evidence that the choice of anesthesia impacts outcomes (Level of Evidence: II,
Grade of Recommendation: B).9,97

IMPLANT TECHNIQUE
The clinician should strive to achieve appropriate motor and/or sensory responses on all 4
contacts at stimulus amplitudes of <2 volts. (Level of Evidence: II, Grade of Recommendation:
B)
The concept of “Optimal Lead Placement” derives from the notion that while the overall success of
SNM is excellent,118 there is a potential for an individual patient to experience an incomplete benefit,
or a “false negative” response due to technique and imprecise lead positioning 2. Although it remains
to be proven scientifically, logically it is hard to dispute that the quality of the interface between the
neuromodulation device and the nervous system is of general importance to the therapeutic outcome
of SNM. The current 3023 tined lead is an electrode array, consisting of four equally spaced contacts
in a flexible assembly. By taking readily reproducible steps to steer the lead into position it is often
possible to follow the course of the sacral nerve target, and achieve similar motor and sensory
responses at each individual contact.119,120,121 Some have demonstrated more accurate placement
with the curved lead.121 These electrode contacts may then be employed singly or in combination to
achieve neuromodulation for clinical benefit.
The closer the lead is to the intended target, the lesser is the amount of energy that will be
required to obtain a neuromodulation response. On one level, effective programing at lower
thresholds is more efficient, and is likely to result in longer lasting battery life and less frequent
need for replacement thus increasing the cost efficacy of the therapy and reducing risks related
to re-operation.122,123 On another, electrode placement near the nerve means that the chance of
stimulation of unwanted tissues (ie, the piriformis muscle), which may trigger uncomfortable
stimulation or paresthesias, will be minimized. In turn, the need for reprogramming or re-
operation to resolve uncomfortable stimulation should be lessened.
Leads that require higher thresholds or offer responses at fewer than 4 contacts can be
successful. (Level of Evidence: II, Grade of Recommendation: B)
Sub-optimal lead placement can be therapeutically beneficial. Initial techniques for chronic lead
placement were performed in a “blind” fashion, guided only by anatomical landmarks, without
the routine use of fluoroscopy.4 The depth of lead placement, lead direction, and even the final
sacral level of placement was not standardized. Many subsequent series have shown excellent
symptom benefit before the concept of lead optimization was widely suggested. However, it is
unknown if the overall degree of symptom relief could potentially have been greater, and the rate
of screen failure, re-operation, or eventual therapy abandonment might have been reduced
within these study populations, had lead optimization been a standard. 124,125 Another unknown is
whether the demands for precise lead placement may differ for various indications. An example
of this concept is the notion that the target for lead placement for the indication of FI seems to
be more robust, with a relatively large neuromodulation target (S3 or S4), while placement for
urinary frequency and urgency without urge incontinence, and with a component of pelvic pain,
may require hitting a narrower target (S3 or pudendal lead placement).

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S3 is the preferred target for SNM. Bellows and toe dorsiflexion are the motor responses
consistent with S3 placement. Thresholds for bellows should be lower than for toe. Leads placed
in S4 may be appropriate in some cases. S2 should be avoided due to the risk of aberrant
sensation and motor response in the leg. (Level of Evidence: 3, Grade of Recommendation: C)
From the initial studies on SNM, S3 is the preferred target for SNM. A typical S3-mediated response is
a contraction of the pelvic floor along with plantar flexion of the first and second toes, whereas S4
stimulation does not produce any toe response.126 There is individual variation in composition of the
sacral roots. A direct ventral sacral root electrical stimulation study measuring bladder contraction by
means of intravesical pressure showed that in 100% of the patients, bladder pressure increase was
measured upon stimulation of the S3 anterior sacral root, but also in 60%, upon stimulation of S4,
40% on S2 and around 15% at S5. There is an individual difference in distribution of bladder efferent
fibers.127 It is unknown if the distribution of motor nerves activated directly by neurostimulation is
similar to the distribution of the rootlets stimulated for the indirect neuromodulation effect.
In a retrospective study on patients with FI however, there was no difference in success rate upon S3
or S4 stimulation during a 3-week PNE test. 128 These findings are also supported by reports of
accidently or deliberately implanted leads in S4.
S2 stimulation produces outward rotation of the leg and sensation running down the leg.116 These
effects may bother the patient, and S2 stimulation should therefore be avoided.
The clinician should consider both sensory and motor responses important for success. (Level
of Evidence: IV, Grade of Recommendation: C)
The most readily quantifiable responses are motor (bellows and toe) with the patient under sedation.
It is easier to obtain sensory responses than motor during a PNE, when the patient may not be able
to relax and is fully conscious.116,129 A purported mechanism of action of SNM is sensory afferent
neuromodulation, so the sensory side of the response may be meaningful. Indeed, given that sensory
responses are used when reprogramming, having appropriate sensory responses during initial
placement may help guide successful reprogramming and eliminate the need for revisions.
Motor responses alone may be utilized in patients who undergo GA. (Level of Evidence: IV,
Grade of Recommendation: C)
With patients under heavy sedation or GA, sensory responses are unlikely to be elicited. The
pattern of motor responses can be helpful in predicting where paresthesias will be felt. For
example, all bellows and no toe, or toe only at a significantly higher threshold than bellows, is
likely to be associated with anal sensation, while bellows followed by toe response immediately
or at slightly higher thresholds is more likely to be associated with genital sensation. Toe
movement at a lower threshold than bellows is likely to be associated with uncomfortable
sensation down the leg.
Sensation down the leg or in the buttock and discomfort in the anal, perianal, or genital areas should
be avoided. (Level of Evidence: II, Grade of Recommendation: B)
Although sub-sensory thresholds are potentially associated with good patient outcomes,
generally patients tend to do better when the stimulation is comfortable. One of the most
common adverse events of SNM is uncomfortable stimulation. 105 Most patients find stimulation
in the buttocks or down the leg less comfortable, than in the anal, perineal, or genital areas. 116
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Patients are more likely to require reprogramming when stimulation is uncomfortable. 105 It is
unclear whether anal, perineal, or genital sensations are associated with higher success in
individual patients or between patient groups depending on diagnosis, ie, FI vs. urinary frequency
with or without a component of pelvic pain.
Standard frequency and pulse width settings of 10-20 Hz should be used. (Level of Evidence: II,
Grade of Recommendation: B)
Other frequencies and pulse widths can be used during troubleshooting procedures. (Level
of Evidence: IV, Grade of Recommendation: D)
There are no studies which show definitive advantages of specific programming settings over others
for a condition or indication. Low frequency stimulation of 10-20 Hz, with pulse width between 180-
210 μs, has been associated with therapeutic success for all the indications approved for SNM. These
settings should be used initially. If patient comfort or therapeutic efficacy is not achieved, it is
reasonable to experiment with alternative programming, though consistent success is anecdotal.

ROLE OF FLUOROSCOPY
Fluoroscopy is recommended for staged lead positioning to control depth of foramen puncture
and optimize placement of the lead. (Level of Evidence IV, Grade of Recommendation D)
Fluoroscopy may be used for PNE to confirm proper lead placement. Alternatively, use of bony
landmarks to determine lead placement is acceptable if fluoroscopy is not available. (Level of
Evidence III, Grade of Recommendation C)
Fluoroscopy is a key element underlying quality tined lead placement, allowing the surgeon to control
both depth of puncture and the placement of the lead. In many countries, labeling of the therapy
indicates that fluoroscopy must be used for tined lead placement. Fluoroscopy may also be used
during PNE, but not all clinicians do this during their office procedures.
Siegel and colleagues first described fluoroscopic lead placement in 1992.130 Their description is still
useful today, and very much in keeping with the modern technique; however, they described an open
surgical procedure, which contrasts with the modern, minimally-invasive approach to tined lead
placement. The role of fluoroscopy has become even more crucial following conversion to the
minimally-invasive placement technique, as it allows for consistent, reproducible and optimal
positioning of the lead in the foramen, as well as confirming curvature along the path of the S3 nerve,
plausibly avoiding multiple punctures, minimizing bleeding, infection risk, post-operative pain and
surgical time.
● Active lateral fluoroscopy should be used during final tined lead deployment.
● The distal end of the lead introducer should be placed only ½ to 2/3 through the sacral bone table.
● The motor and sensory responses and the stimulus amplitude at which they occur, along with AP
and lateral x-ray images associated with final deployment, should be recorded in the medical
record.
● Radiographic appearance consistent with ideal lead placement entails:

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● In the lateral view, the lead parallels the fusion plane between third and fourth sacral
segments, enters above the hillock, and curves caudally. Distal lead contacts appear to be
spaced more closely together than proximal contacts.
● In the AP view, the lead starts close to the medial edge of the foramen, and curves out
mediolaterally. Proximal contacts appear to be spaced more closely together than distal
contacts.
● The curved stylet may be able to increase the number of responding contacts at lower
stimulus amplitudes. (Level of Evidence IV, Grade of Recommendation C)
There remains debate regarding optimal lead placement, and no prospective studies exist to correlate
clinical response (in bowel or bladder conditions) with lead positioning. Jairam et al131 from Masstricht
retrospectively reviewed lead placement in 189 patients, and found no correlation between the position
of the tined lead in the Stage 1 trial, with regard to depth, angle, and deflection, and the number of active
electrodes, and the likelihood of a successful trial in either the OAB group or the NOR group. Nonetheless,
expert consensus dictates that placement close to the nerve may reduce voltage used and improve
programming options and long-term battery life.

Figure 1a: A/P image demonstrating medial placement in the S3 foramen (arrow)
Figure 1b: Lateral image demonstrating 3 contacts below the sacral plate

IPG PLACEMENT
IPG buttock placement in the lateral upper quadrant is preferred but abdominal placement may
be required in some cases. (Level of Evidence: 3, Grade of Recommendation: C)
IPG should be placed above the muscle layer, no deeper than 2.5 cm (1 in). (Level of Evidence:
3, Grade of Recommendation: C)
When SNM was first introduced, the IPG was placed in the anterior abdominal wall. This required
repositioning of the patient during surgery and prolonged the procedure, and, of note, the lead
extension required for this type of placement is no longer manufactured. Buttock placement of the
IPG was described by Scheepens et al132 in 2001. This technique simplified the procedure and reduced
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operative time in all 39 trial patients by approximately 1 hour, given that no repositioning of the
patient was required during surgery. Pain was reduced and there were no infections. 121 It is, however,
difficult to assess the true advantage of buttock vs. abdominal placement, since no direct randomized
trials have been published. In some patients with very limited fat, an abdominal placement might be
utilized.
Because of the distance limitation of the wireless communication with the programmer, the IPG
should be placed no deeper than 2.5 cm (1 in). [Product information data]

POST PROCEDURAL PATIENT RESTRICTIONS

PNE test stimulation is associated with a risk of lead migration. Limited physical activity during
the trial is advised to reduce this risk. (Level of Evidence: 3, Grade of Recommendation: C)
Risk of lead infection is greater with Stage 1 testing than with PNE. Operative dressings should
not be removed during the test period, unless permitted by the surgeon. (Level of Evidence: 3,
Grade of Recommendation: C)
Following Stage 1 and Stage 2 procedures, patients should be encouraged to minimize vigorous
activity for several weeks to allow the tined lead to scar in place and prevent lead migration.
(Level of Evidence: 3, Grade of Recommendation: C)
Besides the manufacturer's recommendations (Manual InterStim 3889, 3058, etc.) very limited data
has been published regarding specific post procedural patient restrictions. However, the two main
risks to the implants are infection and dislodgement.
For test stimulation with temporary leads, which are only secured by external dressing and not by
internal fixation like the tined lead, secure fixation with splash-resistant, transparent dressing allowing
for washing and showering after disconnection of the external pulse generator is advised.133 Patients
should be instructed to avoid strenuous physical activities, which result in tension on the electrode.
For test stimulation with a tined lead, the risk of dislodgement appears to be less;134 however, the risk
of infection becomes more relevant. In a retrospective review of 669 SNM procedures, one group did
find substantial decreases in infection rates after instituting an at-home chlorhexidine washing
protocol.135 The removal of the dressing throughout the test period should, however, still be avoided
unless the physician has concern upon inspection of the dressing for infection or bleeding. There is no
consensus on the use or efficacy of continued antibiotics during the trial period.
In one study136 of 235 patients, lead migration occurred 1 subject when using a tined lead. In another
study, with 2 years follow-up after tined lead implantation, there was a 10% rate of lead migration
following tined lead implantation.137 Regardless, after implantation, vigorous activity and excessive
bending or twisting at the waist should be avoided for sufficient time to allow scarring and fixation of
the implanted device.

POST-OPERATIVE AND FOLLOW-UP CARE

Routine follow up should include a clinical examination, symptom evaluation, system check of
the stimulation device and confirmation that it is functioning. (Level of Evidence: III, Grade of
Recommendation: C)
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In patients with urinary retention, a post-void residual should be assessed.

Suggested routine follow up consultations during the first year should occur at 1, 6 and 12
months postoperatively, then annually thereafter. (Level of Evidence: IV, Grade of
Recommendation: D)
Follow up consultations on demand should also be available. (Level of Evidence: IV, Grade
of Recommendation: C)
The purpose of post-operative follow-up care is to confirm adequate functioning of the therapy and
to address potential complications/side effects. Different patterns of follow up visits have been
described.100
It is recommended that the initial follow-up visits and subsequent follow-up visits should be spaced
at least 1 month apart because full evaluation of setting changes may not be meaningful if the interval
is less.138 Based on the experience that a proportion of patients requires reprogramming in the early
phase of follow-up, more than one follow-up visit in the first year is recommended.100,139
Subsequent yearly follow-up visits are advised by international expert groups,100,125 but no consensus
on the timing and interval of follow-up was determined on recent systematic review.54 Follow up visits
are uniformly recommended when problems occur.54,100,125 A clinical evaluation of the efficacy of SNM
(eg, bowel and bladder diaries, scoring of the severity of symptoms, measurement of the impact of
symptoms on QOL) and evaluation of the correct functioning of the neurostimulation device (eg,
stimulation settings, impedances and side effects) are considered minimum requirements of follow-
up.100
Radiological imaging of the tined lead is advised at final implantation, which allows for
comparison and evaluation of lead migration in case of dysfunction or unexpected loss of
efficacy. (Level of Evidence: 3, Grade of Recommendation: C)
Whether postoperative radiological imaging after temporary lead insertion may be helpful to confirm
the position remains controversial.54 Intraoperative fluoroscopic monitoring/documentation during
the implantation phase and/or postoperative documentation of the implanted hardware is
recommended to document positioning of the electrode in the sacral foramen. Post-implantation
radiological imaging at routine follow up is not required, unless there is loss of efficacy potentially due
to electrode dislodgement or breakage.140

SUCCESSFUL OUTCOME—BLADDER AND BOWEL

A patient who is satisfied with the treatment is considered to have a successful treatment
outcome. (Level of Evidence: III, Grade of Recommendation: C)
For SNM, the most commonly used criterion for successful test stimulation is an improvement in the
patient’s bothersome symptoms of ≥ 50% during the period of observation monitored by bladder or
bowel diaries.54,100 Some data suggest that greater improvement during test stimulation may predict
better long-term outcomes.141,142,143 Regardless, the symptom improvement should be associated
with concomitant patient satisfaction before pursuing full implantation.
For patients with voiding dysfunction or NLUTD, further evaluations may be necessary to ensure
long-term safety of the urologic tract. (Level of Evidence: III, Grade of Recommendation: C)
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Of note, in patients with voiding dysfunction in the setting of NLUTD, further evaluation may be
necessary to ensure the long-term safety of the upper urinary tract. The clinical evaluation of patients'
LUT symptoms often includes a bladder diary, uroflowmetry followed by measurement of post-void
residual urine volume in spontaneous voiders, urinalysis, renal-bladder ultrasonography, assessment
of renal function, quality-of-life measurements and sometimes urodynamic investigations and/or
cystoscopy.144 UDS, with or without fluoroscopy, can at times be essential in these patients as a means
to assess detrusor and bladder outlet function and give fundamental information about detrusor
pressure and thus the risk factor for upper tract damage.145 Additional interventions, ranging from
oral medication or intradetrusor BTX-A injections, to augmentation cystoplasty or even urinary
diversion, may be required and are not contraindicated in the setting of SNM.

SNM INFECTION
Explantation of the IPG and lead and debridement of the infected tissue is recommended in
instances of SNM infection. The wound should be irrigated and a course of oral antibiotics can
be considered. (Level of Evidence: III, Grade of Recommendation: C)
Infection rate of SNM is low at 2-11% for urinary indications,2 as well as for FI.102 In one large
investigational trial of SNM for FI, in which patients were followed for an average of 28 months (range
2.2-69.5), 10.8% of subjects reported infection with SNM implant. One infection spontaneously
resolved and five were successfully treated with antibiotics. Seven infections (5.8%) required surgical
intervention, with infections in six patients requiring full permanent device explanation. 102
A study of staged SNM implantation revealed lead infection in 12% and IPG infection in 11%. The only
significant difference in clinical/surgical characteristics between infected and non-infected patients
was a longer operative time for Stage 2 in infected patients. 146 A prolonged first stage implant trial
with permanent quadripolar electrode has shown colonization in 13/34 electrode extension leads
with the mean stage 1 SNM evaluation period of 52.3 (27–116) days but this was not associated with
an increased risk of wound infection. The most frequent colonization was with Staphylococcus
epidermidis, Staphylococcus capitis, Peptostreptococcus spp., Enterococcus faecalis and Micrococcus
luteus.101 In the urinary literature, one study demonstrated that Cefazolin alone was less effective in
preventing infection compared with the other antibiotic regimens, with 88% of infections that
required explantation stemming from Staphylococcus aureus species resistant to cephalosporins. 104
There are no specific published reports regarding treatment of SNM device infections. Based on
common general surgical principle, guidelines and expert opinion the infected device must be
removed in its entirety, the wound irrigated/drained and oral/systemic antibiotic therapy started. The
choice of the antibiotic should depend on local institutional guidelines. In very rare instances, removal
of only one component of SNM implant may be contemplated with adequate antibiotic coverage. The
choice to close the wound primarily or allow it to heal by secondary intention should be decided on a
case by case basis. Other techniques to combat infection can be considered. 147
A 3-month waiting period prior to reimplantation is advised and use of the contralateral side
for the IPG pocket should be considered. (Level of Evidence: IV, Grade of Recommendation: D)
There is no reliable data regarding the waiting period for reimplantation after removal of the infected
device. The recommendation of a 3-month waiting time is based on expert opinion.

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TROUBLESHOOTING DEVICE MALFUNCTION – LOSS OF EFFICACY & PAINFUL

STIMULATION
Patients with declining efficacy or painful stimulation should undergo device assessment.
Turning off the device will differentiate painful stimulation vs. local pain at site of IPG.
Changing program voltage or lead configuration may correct painful stimulation prior to
attempting lead revision. (Level of evidence III, Grade of Recommendation C)
After permanent implantation, patients should be followed considering their primary reason for implant
and clinical effect obtained at the time of their trial. Common complaints include discomfort at the site of
the IPG, painful stimulation, recurrence of symptoms, absent stimulation, and stimulation in non-target
areas.5,148
Such complications can be related either to the device, implantation technique, or parameters of
stimulation. The most recent prospective, controlled data with 3 year follow-up is now available,31
reporting a global device-related adverse event rate of 16%. Concerning the IPG, 47% of patients in the
series reported adverse events, of which 91% were resolved at the time of analysis. These included an
undesirable change in stimulation (49/272, 18%), implant site pain (34/272, 13%) and lack of efficacy
(16/272, 6%). Loss of efficacy may develop either due to failure of the therapy to achieve significant
clinical improvement of symptoms (> 50%) or due to a depleted battery.
Little has been published regarding the troubleshooting of sacral neuromodulation systems since the
description by the Cleveland Clinic in 2005. As such, the following algorithm is recommended:

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When a patient presents with a side-effect which may be related to stimulation, such as declining
efficacy, painful stimulation, or aberrant neurological stimulation, the first action by the clinician
should be to turn off the IPG. Should symptoms disappear, the IPG may be turned back on and
reprogrammed, trying to avoid return of the presenting symptom. Pain related to stimulation should
disappear when turning off the IPG and reprogramming, which may include decreasing voltage,
decreasing frequency and/or changing the lead configuration. This can be done by the physician, or
by a physician assistant or dedicated nurse if they are adequately trained in programming as well as
clinical analysis of patient complaints. If pain persists after the IPG is turned off, the pain is may be
due to the position of the IPG itself and IPG repositioning may be required, or it may be unrelated to
the device. At minimum, other etiologies should be considered.
Device programming should be performed by experienced clinicians targeting comfortable low
sensory thresholds to the perineum. (Level of Evidence IV, Grade of Recommendation C)
Follow-up of patients undergoing permanent SNM depends somewhat on the local health care
system. As most of the adverse events require the clinician to analyze symptoms and then try to
correlate those symptoms with any device malfunction, office evaluation (rather than a telemedicine
visit) is usually required.
Patients given a complement of programs should try a new program for at least 1 week, unless
it is not tolerable secondary to unpleasant stimulation or severe worsening of symptoms. (Level
of Evidence IV, Grade of Recommendation C)
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Since voiding and bowel disorders are not always constant over time, any new program should be tested
for at least one week unless the patient experiences side effects from the new program. In a recent
prospective trial118 22% of patients needed reprogramming due to an undesirable change in stimulation,
decrease in therapeutic efficacy, or pain, within 5 years of implantation.
If reprogramming does not improve the patient’s symptoms, radiographic imaging should be
performed to assess for lead breakage or migration. (Level of Evidence IV, Grade of
Recommendation C)
X-ray images can reveal lead fractures or migration of system components that subsequently necessitate
replacement of the system. Moreover, impedances > 4000 ohms are also diagnostic of a lead fracture or
microfracture (which may not be visible on imaging) and likely requires lead replacement, although
evidence from a large retrospective series shows many abnormal impedances can be programmed around
to salvage a lead.98

WHEN TO STOP SNM TESTING/THERAPY

SNM testing or therapy should be discontinued if the patient no longer wishes to proceed, or if
in the judgment of the clinician, further testing/lead revision will not lead to symptom
improvement. (Level of Evidence: III, Grade of Recommendation: C)
The only documented predictor for treatment success is the response to a trial of stimulation. Since
implanted patients may experience declining efficacy over time,39 therapy may need to be altered. As
outlined elsewhere in this text, patients may elect to undergo device interrogation, re-programming,
or surgical revision when symptoms are not well controlled with SNM. If at any time the patient does
not desire to continue with SNM, or would prefer to transition to other 3rd line treatments, then
therapy should be discontinued. Furthermore, once a patient has exhausted the possible revisions
and alterations of therapy (lead location and side, programming options) and the clinician determines
that no further benefit can be expected, then SNM should be discontinued.

DEPLETED IMPLANTABLE PULSE GENERATOR (IPG)

Exchange of IPG should occur when end of service is confirmed and the patient has maintained
a successful response to SNM prior to battery depletion.
Check the impedance of the lead and, if indicated, replace the lead when exchanging the IPG. (Level
of Evidence: III; Grade of Recommendation: C)
Patients with a depleted IPG battery (end of service) will usually present with loss of SNM stimulation
and/or loss of efficacy of SNM. Occasionally, increased stimulation may be experienced. When
patients present with a depleted IPG battery, confirm end of service by running a battery check with
a physician programmer. Exchange the IPG when the end of service is confirmed and the patient has
maintained a successful response to SNM prior to battery depletion. Check the impedance of the lead
and, if indicated, replace the lead when exchanging the IPG.

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NON-FUNCTIONING SYSTEM
When patients present with a non-functioning system, confirm impedances by checking all
combinations with a physician programmer. If all of the combinations are non-functional,
then the IPG should be turned off to conserve battery life and the lead replaced. The lead
should also be replaced if there is a therapy-limiting number of programming options.
(Level of Evidence: III; Grade of Recommendation: C)
Patients with a non-functioning lead will usually present with loss of SNM stimulation and/or loss of
efficacy of SNM. When patients present with a non-functioning lead, confirm by an impedance check
all combinations with a physician programmer. At least one functioning lead electrode is required for
a lead to operate unipolar and two functioning leads for bipolar stimulation. If all of the combinations
are non-functional, the IPG should be turned off and the lead replaced.
When assessing the lead with the physician programmer, run an impedance check at 2.0 volts to
deliver sufficient energy for a complete check and assess all the seven possible circuit combinations.
A non-functioning combination will return a reading above 4,000 ohms or 0 ohms. If all of the
combinations are non-functional, the IPG should be turned off and the lead replaced (consider a trial
of unipolar stimulation if only one electrode is functioning). If not all of the combinations are non-
functional then, by a process of elimination, the non-functioning electrode(s) can be identified and
not used in future programming. Many devices with non-functional electrodes can be salvaged and
used to provide continued therapy after programming around the broken lead. 98
Before replacing a non-functioning lead, the clinician should discuss the implications of lead removal,
including the risk of retained fragments. Confirmation of the lead site should be sought, in the form
of a sacral X-ray if the prior operative reports or intraoperative films are not available. It is
recommended that the lead be removed through the pre-sacral incision. When removing the lead
through the pre-sacral incision, use gentle traction in a straight-line direction with respect to the lead
tines. If too much resistance is encountered during lead removal, further dissection through
lumbosacral fascia and pre-sacral periosteum may be required. The prevalence of lead breakage
during lead removal is 1-3.6%.103,149,150 Of note, some anecdotally report successful lead removal
through the buttock incision using gentle traction on the lead. Nonetheless, leads left in for prolonged
periods of time may be more challenging to remove this way and strong consideration should be given
to midline removal.

RESIDUAL LEAD FRAGMENTS FOLLOWING LEAD REMOVAL

Patients with residual lead fragments should be advised of the presence, nature and safety of
the residual fragments. Current evidence suggests it may be safe for residual lead fragments to
remain long-term. (Level of Evidence: III, Grade of Recommendation: C)
Patients with residual lead fragments should be advised of the presence, nature and safety of the
residual fragments. This should include providing patients with information regarding composition,
size and location of residual lead fragments. Although not reported for SNM, migration, infection, and
injury to surrounding structures from residual lead fragments are theoretical risks. Current evidence
suggests it is generally safe, for residual lead fragments to remain in situ long-term, including in
patients undergoing MRI.85

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BILATERAL AND PUDENDAL LEADS

During PNE testing, bilateral temporary lead placement is recommended to reduce the risk of
test failure due to lead migration. (Level of Evidence: III, Grade of Recommendation: C)
There is no published evidence that bilateral tined lead placement is more efficacious than
unilateral placement. (Level of Evidence: 3, Grade of Recommendation: C)
For PNE test, a non-tined electrode is used. The currently available version is a thin wire without any
anchoring system and is prone to migration. The risk of migration is related to the duration of the
test and thus only a few days of reliable stimulation are possible. Placing bilateral PNE leads increases
the possibility of a correctly placed lead, and increases the possibility of a successful test. Tined leads
are more expensive than non-tined, and it may be difficult in some countries due to insurance to place
bilateral tined leads for testing. In a retrospective study of55 patients with unilateral tined leads and
69 with bilateral tined leads, 76% of patients with bilateral leads went on to full implantation, versus
only 58% of those trialed with a unilateral lead. It should be noted that in patients with bilateral leads,
both leads were consecutively stimulated—not simultaneously.151
Theoretically, bilateral stimulation may be more efficacious than unilateral. This hypothesis is
supported by animal experiments which demonstrate that with bilateral stimulation more nerve
fibers can be stimulated enhancing the neuromodulatory effects. 152 However, in a prospective
randomized trial on 25 patients, no beneficial effect was found with bilateral PNE lead stimulation
compared to unilateral stimulation.153 In patients with loss of efficacy, adding a contralateral PNE lead
to achieve bilateral stimulation resulted in a significant decrease in the number of voids and pads per
day. However, no benefit was found between bilateral or contralateral stimulation.154 In FI, a study
exploring the benefit of bilateral over unilateral sacral neuromodulation had to be discontinued
prematurely after an interim analysis of 20 patients demonstrated no additional benefit in symptom
score, quality-of-life score, or findings on anorectal manometry.
Placement of pudendal leads can be considered as an alternative option if SNM fails after sacral
lead positioning and programming has been optimized, especially if the IPG is already in place
or if the patient is refractory to other minimally-invasive treatments. (Level of Evidence: III,
Grade of Recommendation: Grade C)
The currently available system for SNM can be used off-label for pudendal stimulation. However no
long-term data are yet available. A retrospective study in a mixed patient group including OAB
wet/dry, NOR and painful bladder syndrome showed successful responses upon pudendal stimulation
in 93% of patients failing SNM.155 In two prospective studies, patients (OAB wet/dry; painful bladder)
were implanted with leads at both S3 and close to the pudendal nerve. Of the patients responding
successfully to the test, 78% subjectively favored the pudendal lead for chronic stimulation; however,
it should be noted that the pudendal leads were placed with EMG guidance, while the sacral leads
were not.156,157

MRI CONSENSUS STATEMENT

For current devices, manufacturer labeling should be followed for MRI imaging of the head or
extremities. (Level of evidence: Grade IV, Grade D)

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MRI imaging is used to diagnose and monitor an increasing number of conditions. There are three
magnetic fields during MRI that can react with implanted neuromodulation devices including
mechanical force and torque induced by a static magnetic field, induced voltages and current on leads
by a pulsed gradient field, and current induced into the generator body by the radiofrequency
magnetic field.158,159,160. These forces could potentially result in local tissue injury or damage to the
implanted devices. Until the development of MR conditional neuromodulation systems, it is necessary
to consider explantation of entire systems in order to perform MRI, exposing the patient to loss of
therapy benefit, additional surgical risks, and costs.
According to the manufacturer’s labeling (2012 manufacturer’s instructions for use [IFU]), non-clinical
testing has demonstrated that InterStim Therapy systems have been found to be MR Conditional. If a
patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of
an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator,
lead, and extension as applicable), MRI examinations of the head only may be safely performed under
the following conditions:
● 1.5-Tesla (T) horizontal closed bore
● Maximum spatial gradient of 19 T/m (1900 gauss/cm)
● RF transmit/receive head coil only (no RF transmit body coil)
● Gradient slew rate limited to 200 T/m/s
● Normal operating mode (Scanning frequency of approximately 64 MHz only)
● If possible, do not sedate the patient
● Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator off
● Eligible Model 3023 Neurostimulators only: Disable the magnet switch
According to the manufacturer, scanning under different conditions may result in severe patient injury
or device malfunction, and is currently not recommended by FDA labelling. As a matter of course,
implant surgeons and radiologists should recognize these guidelines.

There appears to be an increasing body of evidence that axial MRI imaging can be performed
safely with present devices under certain circumstances. (Level of Evidence: II, Grade of
Recommendation: B)
Two separate studies have shown that MRI studies of the extremities other than the head and body
MRI scanning including the lumbar spine and pelvis can be performed safely with earlier and current
InterStim devices. Elkelini147 as well as Chermanski161 reported the results from individual small series
of patients studied without event using the interstim I device, using 1.5 and 0.6 Tesla machines. In
one case, a generator (IPG) was found to be damaged after study due to leaving the magnet switch
on, and both studies recommended setting the amplitude to zero and turning the magnet switch off.
In an ex vivo phantom model simulator study of the contemporary InterStim II device,162 there was no
significant heating, defined as in increase in temperature of >1°C, found using an intact system or with
a 5cm distal lead fragment meant to simulate a retained lead fragment after partial extraction.
Significant heating was found when a full-length lead, not connected to an IPG, was evaluated. Based
on these findings, a prospective in vivo study was performed163 wherein a pelvic or lumbosacral MRI
was performed on a series of eleven patients with their devices in situ, and turned off (no magnet
switches as part of these devices). No serious adverse events were reported during the MRI study and
there were no changes in the devices after, though two patients did report a sensation of warmth at
the IPG site during the scan, which resolved afterward. A caveat is that the patients were studied on
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the same MRI machine used to study the phantom model, and they were not willing to generalize to
other machines and specific locations.
Alternative forms of imaging should be considered carefully before device removal for MRI
imaging. (Level of Evidence: IV, Grade of Recommendation: D)
Although it appears that less restrictive use of MRI may be safe in certain clinical settings, it is
recommended that implanting physicians and radiologists follow the manufacturer’s guidelines at the
present time. Thoughtful discussion and planning with radiologists may be helpful in obtaining MRI
imaging of extremities that are geographically separate from the pelvis, using the principles outlined
in the manufacturers’ IFU for study of the head only. It remains prudent to consider imaging
modalities that can serve as a substitute for MRI whenever appropriate; indeed, a study by Lloyd et al
suggests that up to 24% of patients who undergo SNM device removal for MRI ultimately do not go
on to receive an MRI study, and that only 56% of MRIs lead to a change in clinical management,
emphasizing that it is of paramount importance to confirm the necessity of MRI before removing a
functional SNM device.164 Clearly, full body MRI conditional safety will be a highly valuable feature if
and when it becomes available with future systems and devices.

FUTURE RESEARCH
Future research, including newer technologies, mechanisms for patient-response driven
programming, and techniques for optimal lead placement, is needed.
This research will be aided by a better understanding of the mechanism of action of SNM
Attention should also be directed toward the development of better composite measures of therapy
outcomes.
This consensus statement highlights the complex nature of neuromodulation therapy. Broadly, we
have a low level of evidence for many of our recommendations. Patient selection is based on
symptoms, not biochemical or functional testing. Pelvic floor, urinary and bowel studies have not
reliably predicted the best candidates for SNM, nor have patient symptoms.165 One study has shown
an association of treatment satisfaction with pudendal nerve terminal motor latency in FI128 and and
another suggests that strong toe responses at as many electrodes as possible intraoperatively may
reduce the risk of future lead revision,166 but only response to a trial of stimulation can currently
predict response to treatment. This opens the door to newer technologies which incorporate the lead
trial into long-term therapy, possibly with a one-step implant if costs can be contained. The current
IPG (InterStim, Medtronic) is costly which is the reasoning behind a staged-implant approach. Other
perceived weaknesses of this device, including lead fracture, battery life, clinician-dependent
programming, and MRI compatibility, need to be addressed, as does the long-term effect of SNM on
bladder and bowel physiology.
Surgical technique has not changed much since the introduction of the tined-electrode, which
eliminated the need to suture directly to the periosteum. There remains debate regarding how
precisely the lead must be positioned. Some studies suggest that only one active electrode is needed
for a clinical response114, though most advocate for 4-electrodes targeted at low voltages.167 CT
guidance has been used for those with complex anatomical findings,168 while others have shown intra-
operative EMG to be of help.169 Nevertheless, further outcomes-based research is needed to clarify
the best method for placing the lead. (Level of Evidence: III, Grade of Recommendation: C)
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Furthermore, there are no specific programming recommendations besides the 4-program settings
and patient selection based on perceived symptom improvement. More novel approaches may
incorporate a patient’s “vote” for a program or a setting based on bowel/bladder diaries kept in real
time. There are already available smart-phone applications for patients to track their symptoms which
may be utilized in device programming.170
Economic modeling suggests that SNM becomes cost-effective relative to intradetrusor botulinum
toxin injections for idiopathic OAB after about 5 years of treatment. 171 At 10 years, models suggest
that SNM is also cost-effective relative to oral medical therapy for OAB.172 There is little data on SNM
cost-effectiveness relative to other treatments for urinary retention and fecal incontinence. Such
studies would need to incorporate patient reported outcome measures to best characterize
therapeutic benefit versus the cost of therapy.

ACKNOWLEDGEMENTS
The following physicians reviewed the manuscript and made critical suggestions:
Riyad Al Mousa, Marcio Averbeck, Kevin Benson, Karel Everaert, Bradley Gill, Michael Guralnick,
Hashim Hashim, Kathleen Kobashi, Anders Mellgren, Javier Pizarro-Berdichevsky, Steven Wexner

TABLE: International Consultation on Urological Diseases (ICUD) modification of The Oxford Centre
for Evidence-Based Medicine guidelines on the levels of evidence that generate the subsequent
grades of recommendations

Level of Evidence Criteria Grade of Criteria

Recommendation
I Meta-analysis of RCTs or A Usually consistent with
high-quality RCT level I evidence
II Low-quality RCT or good- B Consistent level II or III
quality prospective evidence or “majority
cohort study evidence” from RCTs
III Good-quality C Level IV evidence or
retrospective case- “majority evidence” from
control study or cohort level II or III studies,
study Delphi processed expert
opinion
IV Expert opinion D No recommendation
possible because of
inadequate or conflicting
evidence

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Abrams P, Paty J, Martina R, Newgreen DT, van Maanen R, Paireddy A, Kuipers-deGroot T, Ridder A.
Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive
bladder. Neurourol Urodyn. 2016 Aug;35(6):743-9.
171
Leong RK, de Wachter SG, Joore MA, van Kerrebroeck PE. Cost-effectiveness analysis of sacral
neuromodulation and botulinum toxin A treatment for patients with idiopathic overactive bladder. BJU
Int. 2011 Aug;108(4):558-64.
172
Arlandis S, Castro D, Errando C, Fernandez E, Jimenez M, Gonzalez P, Cresp C, Staeuble F, Rodriguez J<
Brosa M. Cost-effectiveness of sacral neuromodulation compared to botulinum neurotoxin a or
continued medical management in refractory overactive bladder. Value Health. 2011 Mar-
Apr;14(2):219-28.

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Received: 30 November 2018

DOI: 10.1002/nau.23931
| Accepted: 3 January 2019

SOUNDING BOARD

The clinical role of LASER for vulvar and vaginal treatments in

gynecology and female urology: An ICS/ISSVD best practice
consensus document

Mario Preti MD1 | Pedro Vieira-Baptista MD2,3 |

Giuseppe Alessandro Digesu PhD4 | Carol Emi Bretschneider MD5 |
Margot Damaser PhD5,6,7 | Oktay Demirkesen MD8 | Debra S. Heller MD9 |
10,11
Naside Mangir MD | Claudia Marchitelli MD12 | Sherif Mourad MD13 |
Micheline Moyal-Barracco MD14 | Sol Peremateu MD12 | Visha Tailor MD4 |
Tufan Tarcan MD15 | Elise J.B. De MD16 | Colleen K. Stockdale MD, MS17
1 Department of Obstetrics and Gynecology, University of Torino, Torino, Italy
2 Hospital Lusíadas Porto, Porto, Portugal
3 Lower Genital Tract Unit, Centro Hospitalar de São João, Porto, Portugal
4 Department of Urogynaecology, Imperial College Healthcare, London, UK
5 Center for Urogynecology and Pelvic Reconstructive Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland,
Ohio
6 Glickman Urological and Kidney Institute and Department of Biomedical Engineering Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio
7 Advanced Platform Technology Center, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio
8 Faculty of Medicine, Department of Urology, Istanbul University Cerrahpaşa, Istanbul, Turkey
9 Department of Pathology and Laboratory Medicine, Rutgers-New Jersey Medical School, Newark, New Jersey
10 Kroto Research Institute, Department of Material Science and Engineering, University of Sheffield, Sheffield, UK
11 Department of Urology, Royal Hallamshire Hospital, Sheffield, UK
12 Department of Gynecology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
13 Department of Urology, Massachusetts General Hospital—Harvard Medical School Boston, Boston, Massachusetts
14 Department of Dermatology, Hôpital Tarnier-Cochin, Paris, France
15 Department of Urology, Ain Shams University, Cairo, Egypt
16 Department of Urology, Marmara University School of Medicine, Istanbul, Turkey
17 Department of Obstetrics and Gynecology, University of Iowa, Iowa City, Iowa

Correspondence BACKGROUND: The clinical role of LASER for vulvar and vaginal treatments in
Giuseppe Alessandro Digesu, Imperial
College Healthcare, Department of gynecology and female urology is controversial.
Urogynaecology, London, UK. AIMS: In this best practice document, we propose recommendations for the use of
Email: alex.digesu@nhs.net
LASER for gynecologic and urologic conditions such as vulvovaginal atrophy,
urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature
review.

Roger Dmochowski led the peer-review process as the Associate Editor responsible for the paper.

Neurourology and Urodynamics. 2018;1–15. wileyonlinelibrary.com/journal/nau © 2019 Wiley Periodicals, Inc. | 1

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MATERIALS & METHODS: This project was developed between January and
September 2018. The development of this document followed the ICS White Paper
Standard Operating Procedures.
RESULTS: Most of the available studies are limited by their design; for example they
lack a control group, patients are not randomized, follow up is short term, series are
small, LASER is not compared with standard treatments, and studies are industry
sponsored. Due to these limitations, the level of evidence for the use of LASER in the
treatment of these conditions remains low and does not allow for definitive
recommendations for its use in routine clinical practice. Histological evidence is
commonly reported as proof of tissue regeneration following LASER treatment.
However, the histological changes noted can also be consistent with reparative
changes after a thermal injury rather than necessarily representing regeneration or
restoration of function. The use of LASER in women with vulvodynia or lichen
sclerosus should not be recommended in routine clinical practice. There is no
biological plausibility or safety data on its use on this population of women.
DISCUSSION: The available clinical studies do not present convincing data
regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary
incontinence. Also, while short-term complications seem to be uncommon, data
concerning long-term outcomes are lacking.
CONCLUSION: At this point, LASER is not recommended for routine treatment of
the aforementioned conditions unless part of well-designed clinical trials or with
special arrangements for clinical governance, consent, and audit.

KEYWORDS
genitourinary syndrome of menopause, ICS, ISSVD, LASER, lichen sclerosus, urinary incontinence,
vulvovaginal atrophy, vaginal laxity

1 | INTRODUCTION Several published studies have suggested that fractional

microablative CO2 and Er:Yag LASER effectively treat not
“Light Amplification by Stimulated Emission of Radiation” only atrophic vaginal mucosa (2014)(3), but also improve
(LASER) has been widely used in gynecology and urology for urinary incontinence (2015).4 From the initial studies, the
more than 40 years. It is well established in the management of jump to aggressive marketing and widespread adoption of the
HPV-related genital lesions, prostate vaporization, and litho- LASER technology was quick. However, the studies failed to
tripsy.1,2 More recently the use of trans-vaginal or vulvar LASER provide definitive evidence of its safety and effectiveness.
has escalated to be used as a panacea for several urological and Flaws of these studies include short follow-up time, absence
gynecological conditions, such as: lichen sclerosus, vulvodynia, of control groups, lack of standardized outcome measures,
“vaginal laxity”, overactive bladder, and pelvic organ prolapse. and the involvement of industry sponsorship.
Limited ex-vivo studies have suggested that LASER has the Vaginal atrophy related to hypoestrogenism is recognized
potential to modify tissue characteristics. Clinically it has as a prevalent and significant cause of morbidity in the
already been adopted for tissue remodeling of non-mucosal postmenopausal population.5 In 2014 it was integrated into
scars and wrinkles with relative success. These findings have led the broader definition of “genitourinary syndrome of
to the concept that LASER technology could be used in the menopause” (GSM).6 GSM classifies an extensive list of
treatment of vaginal atrophy3 and has already been utilized and signs and symptoms common to the natural process of female
marketed as a “treatment” or therapy for vaginal “rejuvenation” menopause as a syndrome. This umbrella term also carries the
and “Designer LASER Vaginoplasty” by the aesthetics industry. risk of classifying true disease (ie, lichen sclerosus) as GSM.7

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Despite the lack of a true functional or anatomical 2 | MATERIAL AND METHODS

definition, the use of the term “vaginal laxity” has become
more widespread.8 The term has been defined by the The ISSVD and the ICS identified and invited members to
International Urogynecological Association (IUGA) and develop this project; participants were assigned a specific topic
the International Continence Society as a feeling of vaginal to be thoroughly researched and summarized in order to produce
looseness,9 a woman's subjective sensation of vaginal recommendations. The project was developed between January
“looseness.” “Vaginal rejuvenation” with LASER is targeted and September 2018. The development of this document
to women with “vaginal laxity” as a procedure to improve the followed the ICS White Paper Standard Operating Procedures.23
sensation of laxity and thus enhance sexual function in those Literature searches were performed using Pubmed,
with decreased vaginal sensation.10 Google Scholar, Ovid, Cochrane, and Embase to identify
In 2007 the American College of Obstetrics and relevant papers. Search results were limited to papers written
Gynecology (ACOG) included “vaginal rejuvenation” and in English and published prior to June 2018.
“designer vaginoplasty” in a list of procedures that were “not Search strings for each topic were:
medically indicated” due to a “lack of evidence confirming
safety and effectiveness.”11 However the US Food and Drug 1. Vaginal atrophy/”rejuvenation”:
Administration (FDA) licenced the CO2 LASER systems for a. “genitourinary syndrome of menopause,” “vulvovagi-
“incision, excision, ablation, vaporization, and coagulation of nal atrophy,” “atrophic vaginitis,” “vaginal atrophy,”
body soft tissues and was used by specialities such as “vaginal rejuvination,” “menopause” and “LASER.”
aesthetics (. . .), otolaryngology (. . .), gynecology, neurosur- 2. Urinary incontinence and/or pelvic organ prolapse:
gery, and genitourinary surgery” in 2010.12 Other LASER a. “urinary incontinence,” “incontinence,” “prolapse,”
manufacturers requested FDA approval in 2014, with similar “POP,” “pelvic organ prolapse,” “cystocele,” “recto-
licence terms approved.13 Er:YAG LASERs were licensed for cele,” “hysterocele,” and “LASER.”
dermatologic uses: coagulation, vaporization, ablation, or 3. Vaginal laxity:
cutting of skin in dermatology and plastic/aesthetic surgery a. “vaginal tightening,” “vaginal laxity syndrome,” and
(2011).14 The Nd:YAG had a similar approval in 2014.15 “LASER.”
Treatment of vaginal atrophy and other gynecological 4. Vulvodynia:
disorders with LASER devices gained popularity and was a. “vulvodynia,” “vestibulodynia,” and “LASER.”
marketed for this purpose. In response to this surge, ACOG 5. Lichen sclerosus:
issued a warning in 2016 clarifying that the FDA had not a. “lichen sclerosus” and “LASER.”
approved the use of these devices for the treatment of 6. Other possible uses of LASER:
vulvovaginal atrophy.16 Despite this announcement, claims a. “bleaching,” “whitening,” “brightening” “labiaplasty,”
that the devices had received FDA approval for such “labioplasty,” “nymphoplasty” and “LASER.”
conditions were circulated.17,18
Several authors19,20 and groups, such as the International Evidence was graded according to the Center of Evidence
Society for the Study of Vulvovaginal Disease (ISSVD)10 and Based-Medicine's “Levels of Evidence for Therapeutic Studies”
the Society of Obstetricians and Gynecologists of Canada and recommendations according to the American Society of
(SOGC),21 have raised concerns about the lack of evidence Plastic Surgeons’ “Grade Practice Recommendations.”24
sustaining the use of LASER technologies for these After discussion and consensus among all participants,
gynecological indications. Finally, on the July 30th, 2018, the final version of the text was approved by the Executive
the FDA issued a warning that the effectiveness and safety of Council of the ISSVD and the Board of Trustees of the ICS.
energy-based devices (LASER and radiofrequency) for
urinary incontinence, vaginal “rejuvenation” or cosmetic
3 | BASIC SCIENCE EVIDENCE
vaginal procedures has not been established.22
The executive council of the International Society for
3.1 | Proposed mechanism of action of LASER
the Society for the Study of Vulvovaginal Disease (ISSVD)
on skin and vaginal tissue
and the board of trustees of the International Continence
Society (ICS) acknowledge the need to establish scientifi- Human skin is comprised of three layers: the epidermis, the
cally based recommendations on the new uses of LASER in dermis, and the subcutaneous fat.25 Currently, the hypothe-
their fields. This best practice document has therefore been sized mechanism by which the LASER rejuvenates the
developed to provide guidance on the use of LASER for the vaginal mucosal epithelium has been developed based on the
treatment of gynecological and urogynecological conditions effects of LASER on epidermal skin epithelium. The LASER
and to educate providers about the weaknesses of the is believed to induce controlled injury to the epithelial layer of
available data. the skin, which stimulates tissue repair and remodeling.26

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Wound repair in skin epithelium is a well-defined process Current published literature on the specific use of LASER
characterized by inflammation, proliferation leading to tissue in the vagina for the treatment of GSM is limited in the basic
restoration, and tissue remodeling.27 LASER is believed to science results as well as clinical outcomes and the potential
normalize the cycle of collagenesis and collagenolysis28–30 by correlation to the histology findings (level of evidence 3b/4,
inducing break down of disorganized collagen fibrils,31 grade of recommendation C). Thus, clinical conclusions
creating more organized collagen bundles, and decreasing drawn from these studies are highly speculative (Table 1).
collagen bundle thickness and density.32
Similar to skin, the vaginal wall is composed of three
3.2 | Histological effects
histologically unique layers. The most superficial layer of the
vaginal mucosa is made up of stratified squamous epithelium There is little known about the histology of the vaginal
but, unlike the skin epidermis, is devoid of keratinocytes and mucosa after LASER therapy for vaginal rejuvenation or
is therefore non-keratinized. Also unlike skin, vaginal tissue functional remodeling. What is reported is based on small
undergoes a number of discrete histologic changes during studies of patients over a short period of time.
menopause. Thinning of the vaginal epithelium, reduced Salvatore et al37 described a single case, with a post-
vaginal blood flow, diminished lubrication, increased pH, and treatment biopsy performed 1 hour after the CO2 fractional
a change in the vaginal microbiome, as well as decreased LASER treatment. The biopsy showed superficial epithelial
elasticity of the vaginal wall can occur.33 desquamation. In comparison, animal skin burn studies report
Neocollagenesis and restoration of the trabecular archi- signs of injury to include desquamation. Desquamation
tecture of collagen is the proposed basis for vaginal therefore cannot be interpreted as beneficial remodeling.38
rejuvenation with CO2 LASER treatment. Investigators In a prospective study from the same group,35 the authors
have hypothesized that the molecular and histologic changes compared treated vaginal mucosa with mucosa out of the field
demonstrated in the skin in response to LASER treatment can of therapy from the same patient. They noted neovasculari-
be recreated in the vaginal wall. However, given the zation, neocollagenesis, and restoration of the trabecular
differences in anatomy as well as histologic changes in architecture of collagen in the treated mucosa, which was
response to hormone balance, such as those seen during interpreted as remodeling changes. These biopsies however
menopause, it is unclear whether the effects of the LASER on were taken at the time of the LASER procedure, which would
skin could be expected for the vaginal wall. have provided insufficient time for remodeling to occur. In
In 2011, Gaspar et al34 demonstrated that vaginal comparison, skin studies have shown changes of wound
fractional CO2 LASER treatment increased the thickness of healing in the first few days after LASER therapy, while
the vaginal epithelium and increased the fibrillary component restorative changes ensue weeks later.39 The histology images
of the extracellular matrix. In 2015, Salvatore et al35 in the paper mentioned show denuding of the epithelium and
described fibrillogenesis and neocollagenesis of vaginal different degrees of tissue coagulation, which are consistent
tissue following vaginal LASER treatment in postmenopausal with thermal injury.
women. Zerbinati et al36 in 2015 carried out a similar study Zerbinati et al36 biopsied five patients before vaginal
and examined the tissue of postmenopausal patients with treatment, and at 1 and 2 months after treatment, which would
severe symptoms of GSM following CO2 LASER treatment. allow early changes to be appreciated. At 1 and 2 months,
They concluded that the histological changes seen support the changes were similar, noting thickened epithelium with
theory that the LASER stimulates fibroblasts to produce superficial shedding, increased dermal papilla with elongated
collagen. It is unclear, however, if these histologic changes capillaries, giving the epidermal-dermal junction an undulating
following LASER treatment can be directly correlated with pattern, increased glycogen in the epithelial cells, and an
improvement of clinical symptoms, as no control group was increase in fibroblast activity. Increased collagen and ground
used (discussed in section 3.2). substance have also been described in existing studies.35,36 The
illustrations in Zerbinati's paper show epidermal thickening
TABLE 1 The use of LASER in the vagina for the treatment of with acanthosis, and some show parakeratosis and increase in
atrophy/rejuvenation dermal chronic inflammatory cells.36 These changes are
Level of Grade of consistent with repair, as might be seen in lichen simplex
evidence recommendation chronicus, and alone do not indicate functional remodeling.
The mechanism of action of 3b/4 C Histology changes to the vaginal muscosa following
LASER on vaginal tissue in intravaginal LASER therapy have also been compared to a
normal or diseased states is healing vaginal wound at the 2-month time point. A lack of
not known and cannot be significant capillary density and the increase in cellularity of
used to justify treatment connective tissue is consistent with this. It has not been
results
confirmed if these changes are favorable for functional

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TABLE 2 The histology of vaginal LASER “rejuvenation” TABLE 3 Impact on the vaginal microbiome
Level of Grade of Level of Grade of
evidence recommendation evidence recommendation
The histological changes 4 C LASER cannot be 2b B
present after LASER therapy recommended as a means to
are consistent with reparative improve the vaginal
changes after a thermal microbiome.
injury. They do not The use of CO2 LASER does 2b B
necessarily represent not negatively impact the
restoration of function, and vaginal microbiome.
cannot be used to justify
treatment results.

increase in the number of lactobacilli although the techniques

remodeling or if they would be sustained at the 6 and used to estimate the lactobacilli population are known to
12 month marks.21 produce an inaccurate estimation. Interestingly, with an
Interpretation of available studies overall is limited by the inclusion criteria of vaginal pH in the range 4.5-5 at baseline,
lack of long-term follow-up, and hence complications such as nearly half of the women had normal vaginal flora according
scarring may not have been detected.40 In addition, in a to Nugent and Ison-Hay scores. Following treatment and at
review of the literature on LASER therapy for treating GSM, the end of the study, this increased to approximately 90%.
the authors noted that in one pilot study, the maturation index Colonization by Candida was very low (1.9%) and remained
(a ratio obtained by performing a random cell count of the stable. The vaginal maturation index improved, but no
three major cell types shed from the vaginal squamous changes regarding the presence of leukocytes in the vagina
epithelium: parabasal, intermediate, and superficial cells) was were noted.
not considered.3,40 Becorpi at al47 studied the vaginal microbiome in 20
In summary, the histology of vaginal LASER “rejuvena- breast cancer survivors treated with two sessions of CO2
tion” is not well studied. Only small series have been LASER. The study reported an almost unchanged micro-
published, with short follow-up. The changes present after biome following treatment. The authors suggested that any
therapy are consistent with reparative changes after a thermal possible benefits would be derived from a possible anti-
injury. Whether they represent restoration of function has not inflammatory effect.
yet been demonstrated by the histology. Further study is While LASER cannot be recommended as a means to
needed (level of evidence 4, grade of recommendation C). improve the vaginal microbiome, it does not seem to have a
Further study is needed (Table 2). deleterious effect on it (level of evidence 2b, grade of
recommendation B) (Table 3).

3.3 | Impact on the vaginal microbiome

In postmenopausal women, lactobacilli concentration and 4 | “GENITOURINARY SYNDROME
diversity tend to be lower, while there is a higher diversity of OF MENOPAUSE” AND VAGINAL
other species.41–43 These changes have been correlated to the ATROPHY
severity of vulvovaginal atrophy symptoms with normaliza-
tion using hormonal replacement therapy (HRT) associated GSM and vulvovaginal atrophy (VVA) are commonly seen in
with symptom improvement.44 Based on the limited and women after menopause. Nearly 50% of postmenopausal
controversial evidence demonstrating that vaginal LASER women report a vaginal symptom.48 These symptoms have a
improves sexual health, vaginal glycogen, and vaginal significant impact on the quality of life, interfering with the
epithelial thickness, its impact on the vaginal microbiome ability to be intimate, and enjoy sexual intercourse in 60-70%
was evaluated in two studies. of sexually active postmenopausal women.49,50 However,
Athanasiou et al46 enrolled 53 women with at least one many women consider their symptoms to be a natural part of
moderate or severe symptom of GSM. The methodology is aging. A survey of American women with a median age of
insufficient as it assumes that one symptom can be used as a 58 years revealed that 81% did not think VVA was a medical
surrogate of an entire syndrome45 and does not describe condition, of whom 71% had never sought treatment.5
which scale of severity was used. A total of 2451–74 clinical studies were identified that
Following vaginal LASER treatment, the authors report a investigated transvaginal LASER in women with GSM/VVA.
significant decrease in vaginal pH, but only one third reached Two studies appeared to include the same study population
a pH lower than 4.5. This decrease was accompanied by an (separate analyses).55,67 The vast majority of the studies used

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either Er:YAG or fractional, micro ablative CO2 LASER. 5 | STRESS URINARY

Some studies used ablative Er:YAG LASER.62 All studies but INCONTINENCE AND/OR PELVIC
four were prospective or retrospective case series without a ORGAN PROLAPSE
control group. There was one randomized placebo/estriol
controlled study74 (level of evidence 2b) and three prospec- Some evidence on the role of vaginal LASER exists for its use
tive, non-randomized studies using estradiol gel (or lubricant) in urinary incontinence and pelvic organ prolapse.4,34,77,80–86
as the comparative arm (level of evidence 3b).51,53,69 The data on its use in stress urinary incontinence comprises
The clinical outcomes measured were inconsistent mainly short-term observational studies. Participants varied
throughout the studies. Both subjective non-validated from 19 to 205 women. Treatment response was usually
outcome measures and validated clinical outcomes scores assessed with validated questionnaires and showed favorable
were used to assess symptoms, quality of life impact, and outcomes in terms of improvement of symptoms, but only one
general health. Samples taken varied from vaginal punch study followed patients for 24 months. None of the studies
biopsy after treatment in one study,75 to cytology, and pH had a control or placebo group.4,34,80–83
evaluation66 in others. Most studies had a follow up period of There is minimal published data on the use of LASER in
less than 12 months, although three studies presented 18-24 treating female pelvic organ prolapse. Its use has been
month follow up data. In addition, conflicts of interest were described in women with grade II (prolapse to the hymen) to
not always clearly specified and adverse events were rarely IV (maximum descent) cystoceles and follow up at 12 months
specifically outlined. has demonstrated an improvement in prolapse grade, with
LASER treatment for women with a history of breast some patients sustaining the effect at 36 months.86
cancer and vaginal atrophy was investigated in one paper. In While the use of LASER to treat stress urinary inconti-
this group of women hormonal treatment is either contra- nence and/or pelvic organ prolapse may seem appealing, the
indicated or patients are reluctant to take low dose topical lack of good quality evidence in the form of multi-center
estrogens for symptoms of GSM. This limited study drew randomized placebo-controlled trials is concerning.
similar conclusions to those reached for other women and was Use of LASER may lead to serious adverse events such as
hindered by similar study design flaws.70,71,76 vaginal burns, scarring, dyspareunia, and chronic pain.
Recent developments for the use of LASER in women Although reports of adverse events in the literature is
with GSM/VVA include an international multicenter obser- minimal, the sample sizes are small hence minimal reassur-
vational study aiming to evaluate 1500 women treated with ance can be taken from this.87 The histological effects of
vaginal Er:YAG LASER.77 There is also an ongoing LASER to the vaginal wall remain unclear leaving further
randomized study comparing the effects of CO2 LASER to questions regarding the effect of LASER therapy on surgical
vaginal estrogen treatment. This study aims to enrol nearly dissection and outcomes in women who may eventually
200 patients and is expected to finish by the end of 2018.78 require reconstructive pelvic or anti-incontinence surgery.
However there is still a need for a prospective randomized A recent review article looking at the evidence relating to
controlled trial with a placebo or sham control arm to the risks and benefits of intravaginal LASER technology in
understand the differences. For example a recent meta- the management of stress urinary incontinence confirmed that
analysis demonstrated that 67.7% of the treatment effect for despite the short-term observational studies of small patient
female sexual dysfunction is accounted for by placebo.79 numbers demonstrating improvements, there is still insuffi-
The available studies on the use of LASER to treat vaginal cient evidence to offer it as an effective modality for the
atrophy have overall not provided sufficient evidence of treatment of stress urinary incontinence over alternative
efficacy and long term safety (level of evidence 2b/3b, grade managements, such as pelvic floor physiotherapy, inconti-
of recommendation C) (Table 4). nence pessaries, or continence surgery.21 Similarly there is
insufficient evidence to offer intravaginal LASER therapy for
vaginal prolapse (level of evidence 4, recommendation grade
D) (Table 5).
TABLE 4 “Genitourinary syndrome of menopause” and vaginal
atrophy
Level of Grade of 6 | VAGINAL LAXITY SYNDROME
evidence recommendation
There is currently not enough 2b/3b C Vaginal laxity as a subjective patient complaint has been
scientific data demonstrating described by IUGA and ICS as a feeling of vaginal
efficacy and safety of LASER looseness.9 Its anatomical definition, quality of life impact
for treating vulvovaginal and treatment are poorly understood88 and not widely
atrophy.
recognized. “Vaginal laxity syndrome” (VLS) or even

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TABLE 5 Stress urinary incontinence and/or pelvic organ prolapse TABLE 6 “Vaginal Laxity Syndrome”
Level of Grade of Level of Grade of
evidence recommendation evidence recommendation
There is limited evidence 4 D There are no data supporting the 4 D
supporting the use of LASER recommendation of
for stress urinary performing “vaginal rugation
incontinence rejuvenation” or showing its
There is limited data concerning 4 D safety
the safety of LASER for Er:YAG LASER for vaginal 4 D
stress urinary incontinence looseness or laxity has not
The evidence supporting the use 4 D been shown to be safe or
of LASER for pelvic organ efficacious
prolapse is limited
The data concerning the safety 4 D
of LASER for pelvic organ In total, two small studies on the use of LASER in vaginal
prolapse is limited relaxation syndrome comprising 51 women showed non-
validated patient-reported improvements in sexual experience
after LASER treatment but follow up was short term.84,85 We
“vaginal hyperlaxity syndrome” are concepts and marketing
could not find any study in the literature evaluating the role of
terminology with a lack of a standardized definition.
CO2 LASER for vaginal tightening specifically. Several
Some believe that VLS is an evolution of the aesthetic
studies have arisen using radiofrequency. The available data,
designation of “vaginal rejuvenation.”89 It is described as a
in comparison to that for LASER use, are more robust and
disorder derived from the excessive laxity of the vaginal
sustained by studies with a better design. So far, there has
walls, leading to a sensation of looseness, diminished
been no comparison between the different types of energy.
sensation of penile friction, and may be associated with
There are no data supporting the recommendation of
urinary incontinence (urgency or stress).61 VLS is considered
performing “vaginal rugation rejuvenation” or showing its
a consequence of aging and related to having had vaginal
safety (level of evidence 4, grade of recommendation D)
deliveries. The term VLS and therefore its therapy, vaginal
(Table 6).
rejuvenation, is not endorsed or formally defined by the
leading gynecological societies.11 However, management of
the symptoms have evolved from techniques involving 7 | VULVODYNIA
sutures and the adaptation of traditional urogynecological
procedures to the use of LASER61,90 and radiofrequency Vulvodynia is a chronic, complex pain disorder of multifac-
procedures.91–99 torial aetiology that can be difficult to manage. It is common,
In 2011, there was an attempt to restore the rugae of the affecting more than 4-16% of women and can occur at any
vagina in postmenopausal women (“vaginal rugation rejuve- age, including postmenopausal women, particularly among
nation”), by vaporization of the vaginal wall in order to create those who remain sexually active.100,101
parallel grooves. The procedure was performed in women In 2015, the ISSVD, the International Society for the
with a sensation of a loose or smooth vagina. In a small Study of Sexual Health of Women (ISSWSH) and the
observational trial (10 patients in each arm), there was an International Pelvic Pain Society (IPPS) adopted new
apparent improvement of sexual function and no complica- terminology for vulvar pain and vulvodynia.102 It is
tions. The design and small sample size did not allow the classified according to the site of pain (generalized or
authors to draw conclusions from the study.90 localized), the need of a stimulus (provoked, not provoked
In 2014, Lee evaluated two different protocols (15 [spontaneous], or mixed), and the onset (primary or
patients in each arm), using Er:YAG LASER. Women in both secondary). Treatment is difficult, and rapid resolution is
groups were evaluated 2 months after the procedure. There unusual even with proper treatment. Decrease in pain may
were no complications or adverse effects, although mild take weeks to months and may not be complete. No single
heating of the vagina and ecchymosis were reported. There treatment is successful in all women.103 The vulvodynia
was an objective (perineometer) and subjective improvement treatment algorithm includes vulvar skin care guidelines,
for 70% of the subjects with 76.6% of their partners reporting topical, oral, and injectable medications, pudendal nerve
an improvement in sexual function. No validated scales were block, biofeedback, physical therapy, dietary modifications,
used for evaluation of the sexual function. A histological cognitive behavioral therapy, sexual counseling and
improvement was also suggested, but no analysis was shown surgery, as well as alternative therapies such as acupuncture
in Ref.61 and hypnotherapy.104

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Few studies have been conducted evaluating the 8 | LICHEN SCLEROSUS

usefulness of LASER therapy in the treatment of
vulvodynia.59,105,106 Lichen sclerosus (LS) is a complex chronic inflammatory
A retrospective study indicated less pain with sexual autoimmune dermatosis that can be found in patients of any
intercourse among 24 of 37 women treated with LASER pulse age and race.108 It is 10 times more common in females.109
therapy for vestibulodynia. However, 35% of the patients in The incidence rate is around 10 per 100 000 woman-years,
the study required a vestibulectomy to control the rising to over 30 per 100 000 woman-years in women older
symptoms.105 than 55.110 The main symptoms are itching, burning, and
In 2016, in a study involving 70 patients who underwent dyspareunia, with impact on health-related quality of life.111
fractional micro-ablative CO2 LASER treatment for vestibu- Vulvar LS (VLS) clinical aspects can vary significantly.
lar pain plus vestibulodynia (n = 37) or menopausal patients Differentiated (dVIN), the HPV-independent pathway to
(age > 50 years) who presented with vulvar pain secondary to vulvar carcinoma, must be suspected and biopsied promptly
GSM/VVA (n = 33), showed statistically significant im- in treatment-resistant cases, and in the presence of erosion or
provement of dyspareunia and pain scores, with gradual hyperkeratotic plaques in a field of VLS.112 The risk of vulvar
improvement over each time point persisting through 4- cancer in VLS is estimated to be 2-5%, with higher risk in
month follow-up. Average overall vestibular health index older women and with longer duration of disease.110,113,114
score (a non-validated score, that intends to assess vestibular Long term therapy, however, seems to be protective.115,116
atrophy) improved significantly in the two groups after each Current guidelines recommend the use of super-potent topical
of the three individual treatments. There was no statistically corticosteroids as first-line. Both the risk of cancer and the
significant difference in outcomes between the two study need of long term follow up must be taken into account when
groups.59 new treatment options are presented for LS, given the proven
More recently, a placebo-controlled, double-blinded, efficacy of topical corticosteroids.117–120
randomized clinical trial involving 34 women aged 19-46 In 1991 a Canadian study reported seven women with LS
years old using low-level LASER therapy (LLLT) versus refractory to topical testosterone who became asymptomatic
placebo showed Clinical Pain Report improvement in 78% in following LASER ablation (600-900 W/cm2 depth of tissue
the LLLT group and 44% in the placebo group. Nevertheless, destruction 2 mm under general anesthesia). No biopsy after
other measurable parameters (Q-tip test, intercourse pain on treatment was performed to confirm histological changes.121
the Visual Analog Scale, and tampon tests before and after Similar results and depth of tissue vaporization was described
treatment, severity of discomfort in daily activities and/or in by Kartamaa and Reitamo122 in two patients with VLS. The
daily pain intensity) did not show a difference between aim to “remove the epithelium and papillary dermis involved
groups. Although none of the patients reported side effects in LS” for resolution of symptoms was reported in another
during the study, recurrence of pain was evidenced in 33% of two cases study in the absence of post treatment biopsies.123
the LLLT group.106 In a recent case series,124 five women underwent
Interestingly, LASER (pulse or scan), used to treat vulvar fractional CO2 LASER treatment for hyperkeratotic VLS
mucosa disease (warts or vulvar HSIL) has been shown to be a not responding to topical clobetasol. After 1-3 treatments with
possible cause of chronic vulvar pain.107 CO2 LASER, energy 140-170 MJ and treatment depth
The few available studies concerning the treatment of 150 µm, symptoms had complete resolution in three, partial
vulvodynia with LASER have not proven it to be efficacious in one, and one was asymptomatic before treatment. Median
or safe, therefore its use should not be considered in these follow up was 9 months (range 6-48). Re-epithelialization
patients (level of evidence 2b, grade of recommendation B) occurred in 3-4 weeks in all cases. Hyperkeratosis recurred
(Table 7). after 6-8 months. In all patients, maintenance treatment was
clobetasol. The objective to ablate the improper function of
dermal epidermal zone, creating a new zone with proper
function, is not supported by the published data.
TABLE 7 Vulvodynia All the papers considered are studies with very small
Level of Grade of series of patients, who did not undergo randomization, with
evidence recommendation short follow-up time. Neither visual acuity scale (VAS) for
LASER therapy cannot be 2b B symptoms, nor details of pre/post treatment vulvar lesions
recommended as a means to were reported. The lack of description of the corticosteroid
improve pain in vulvodynia. regimen utilized is another common weakness in the reported
The use of low-level LASER 2b B studies that prevent correct analysis of CO2 LASER-treated
does not negatively impact patients and interpretation of its true efficacy. Furthermore,
symptoms in vestibulodynia.
injuries (mechanical, chemical, burning, etc.) can be a cause

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TABLE 8 Lichen sclerosus TABLE 9 Other possible uses of LASER (vulvar bleaching/
Level of Grade of whitening /brightening, labiaplasty)
evidence recommendation Level of Grade of
There are no data supporting the 4 C evidence recommendation
use of CO2 LASER in VLS There is no medical indication 4 C
There are no data concerning 4 C for the use of LASER for
the long term safety of the vulvar bleaching
use of CO2 LASER in VLS There are no data concerning 4 C
treatment the safety of the use of
LASER for vulvar bleaching
Nd:YAG and CO2 LASER 3b C
of isomorphic or Koeber phenomenon in LS patients.125
appear to be safe options for
Currently, there is no evidence that fractional LASER is labiaplasty
exempt from this risk in LS patients. Up to now the
There is no data supporting the 4 C
description of CO2 LASER as a safe and effective therapy for use of LASER labiaplasty to
recalcitrant VLS has no evidence within the literature data enhance sexual function
(level of evidence 4, grade of recommendation C) (Table 8).

9 | OTHER POSSIBLE USES OF women who underwent reduction of the labia minora using
LASER (VULVAR BLEACHING/ CO2 LASER to make a lambda shaped incision, a 100%
WHITENING/BRIGHTENING, satisfaction rate was reported, along with a low complication
LABIAPLASTY) rate (11 wound dehiscence, 3 hematomas, 1 acute bleed
requiring return to the operating room); however, there is no
While the labia tend to be more pigmented than the surrounding reference to the duration of follow up.132 More recently, in a
structures, some women have the desire to whiten it. It can study involving 112 women aged 15-62 years old using CO2
represent up to 6.8% of the patients consulting a gynecological LASER, improvement in overall satisfaction and comfort
aesthetical unit.126 This procedure, using LASER, is com- during intercourse were reported. The rate of complications
monly offered, but there are no studies showing its efficacy or and the duration of follow-up were not mentioned.133
safety. We could only find reference to it in one study, but None of the studies have included a control group. In at
LASER was done in combination with other procedures, such least two of the studies children were enrolled. In at least one
as labiaplasty, augmentation of the labia majora, mons pubis study, women did not meet the (controversial) study
liposuction, or vaginal tightening.127 Of note, even the use of definition of hypertrophy of the labia minora. There appears
LASER for hair removal has been related to serious to be no sufficient good quality data showing the safety of or
urogynecologycal complications, such as labial adhesion justification of the use of LASER for cosmetic indications.
with cryptomenorrhea, and acute urinary retention.128 In one There is no universally accepted definition of hypertrophy
survey, 85.9% of physicians stated that there is no medical of the labia minora; some authors have described it as a width
indication for the performance of such procedures.129 superior to 4 or 5 cm, or protruding beyond the labia
Labiaplasty is one of the most performed female cosmetic majora133. There is no correlation between the size of the
genital procedures worldwide. There are several techniques labia minora and the ability to feel sexual pleasure or
described, some with the use of LASER. Despite the orgasm134. Brodie et al evaluated normal adolescents and
misleading anatomical description, the procedure coined pointed that there can be significant variance in the size of
“Designer LASER Vaginoplasty” is also a form of labia minora, according to being stretched or non-stretched
labiaplasty.130 Of note, this procedure has been considered (1-13 mm), that asymmetry is common (>50% of adolescent
unethical by the American College of Obstetricians and women), and that the mean width of labia minora was 10 mm
Gynecologists, due to the lack of supporting evidence.11 (3-70 mm) (unstretched) and 20.5 mm (5-62 mm) (stretched)
In 2006, the use of Nd:YAG LASER for the treatment of 135. If those definitions were applied to adolescents, a
hypertrophy of the labia minora was reported. In a series of 55 significant number would be considered “abnormal”!
women (including 4 children 10-15 years old), of whom 11 There appears to be no sufficient good quality data
(20%) lacked the authors’ established criteria of hypertrophy showing the safety of or justification of the use of LASER for
of the labia minora (>2 cm of width), there were no gynecological cosmetic indications in general (level of
intraoperative complications, dehiscence occurred in 5.4%, evidence 4, grade of recommendation C). It appears, however,
and there was no pain after 7 days. Satisfaction rates were to be safe for labiaplasty (level of evidence 3b grade of
very high (>90%).131 In another series, comprising 231 recommendation C) (Table 9).

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10 | CONCLUSIONS remain within the domain of clinical trials or with special

arrangements for clinical governance, consent, and audit.
Advances in science, including medicine, are often questioned.
However, as science evolves, we must remain committed to
11 | RECOMMENDATIONS
maintaining a high ethical standard. The four pillars of ethics—
autonomy, beneficence, non-maleficence, and justice134—
Based on the available scientific evidence, with no supporting
must guide medicine in both clinical practice and research.
long term follow-up data, the use of LASER should, at
The lack of quality studies regarding the use of trans-
present, not be recommended for the treatment of vaginal
vaginal and vulvar LASER for gynecology and urology raises
atrophy, vulvodynia, or lichen sclerosus. The data for the role
the question of whether such therapy provides beneficence
of LASER for stress urinary incontinence and vaginal laxity
and absence of maleficence; its use also hinders the patient's
are inadequate to draw any conclusions or safe practice
autonomy and choice. In order to give truly informed consent,
recommendations. Therefore based on the available scientific
there is need for clear and definitive information. Many
evidence and on the lack of long term follow-up, the use of
questions remain unanswered from the safety profile of the
LASER should, so far, not be recommended for the treatment
therapies, comparison to current treatments, and long-term
of vaginal atrophy, vulvodynia, lichen sclerosus, stress
effects on tissues. Interestingly, the majority of LASER
urinary incontinence, vaginal prolapse, or vaginal laxity.
research carried out so far has been industry-funded, leading
to significant risk of bias. There is an attraction to this office
procedure which is profitable to the individual provider, ACKNOWLEDGMENTS
however this should not drive un-guided practice. The authors thank Debbie Roepe and Dan Snowdon for
Controversial applications regarding the use of LASER that facilitating the development and publication of this best
have been promoted recently without rigid scientific validation, practice consensus document. No funds were received for the
regulation, or oversight include the reconstructive therapy for elaboration of this paper.
“vaginal rejuvenation,” and design LASER vaginoplasty.130
The deceptive marketing of unproven treatments may not only
cause injuries but may also keep patients from accessing CONFLICT OF INTEREST
appropriate and recognized therapies. It is imperative that No conflicts of interest to declare.
providers protect patients from potential unknown harm due to
the understudied clinical application of LASER technology and
ORCID
protect themselves from potentially indefensible lawsuits.
While there is potential for utilization of LASER to treat Giuseppe Alessandro Digesu http://orcid.org/0000-0002-
some proposed clinical conditions, most commonly vaginal 3914-8147
atrophy and stress urinary incontinence, the scientific evidence Margot Damaser http://orcid.org/0000-0003-4743-9283
remains exploratory. The existing literature is almost all post- Naside Mangir http://orcid.org/0000-0002-3062-6480
marketing, in the setting of daily practice, rather than within
controlled clinical trials. As with other innovations this is
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pubmed/28645122

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Received: 6 March 2018

DOI: 10.1002/nau.23701
| Accepted: 5 April 2018

SOUNDING BOARD

Terminology report from the International Continence Society

(ICS) Working Group on Underactive Bladder (UAB)

Christopher R. Chapple1 | Nadir I. Osman1 | Lori Birder2 |

Roger Dmochowski3 | Marcus J. Drake4 | Gommert van Koeveringe5 |
Victor W. Nitti6 | Matthias Oelke7 | Phillip P. Smith8 | Osamu Yamaguchi9 |
Alan Wein10 | Paul Abrams11
1 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
2 Pittsburgh University, Pittsburgh, Pennsylvania
3 Vanderbilt University Medical Center, Nashville, Tennessee
4 University of Bristol and Bristol Urological Institute, Bristol, United Kingdom
5 Maastricht University Medical Center, Maastricht, Netherlands
6 New York University, New York, New York
7 St. Antonius Hospital, Gronau, Germany
8 University of Connecticut, Farmington, Connecticut
9 Nihon University, Koriyama, Japan
10 University of Philadelphia, Philadelphia, Pennsylvania
11 Bristol Urological Institute, Bristol, United Kingdom

Correspondence
Christopher R. Chapple, Department of
Urology, Sheffield Teaching Hospitals
KEYWORDS
NHS Foundation Trust, Royal Hallamshire
Hospital, Glossop Road, Sheffield, S10 International Continence Society, lower urinary tract function, standardisation, terminology
2JF, United Kingdom.
Email: c.r.chapple@shef.ac.uk

1 | INTRODUCTION especially in later life. While DU is a urodynamic definition

describing the detrusor voiding contraction, the clinical
This report presents definitions of the symptoms, signs, component of the definition—reduced urinary flow rate
urodynamic observations, and conditions associated with and/or an increased post-void residual (PVR)—have often
detrusor underactivity (DU) and the potentially associated and imprecisely been described as “underactive bladder”
lower urinary tract symptom complex of the underactive (UAB).1,2 In contrast to overactive bladder (OAB) and
bladder (UAB), relating to DU in all patients groups from detrusor overactivity (DO), UAB and DU have remained
children to the elderly. It is important to emphasize that in the largely unrecognized and poorly researched.1,2 There is a
past the use of the term UAB has been used in an non paucity of data regarding the pathogenesis and treatment of
standardized and imprecise fashion. DU, and the definitions of DU and UAB remain imprecise,
Detrusor underactivity (DU) may be an aspect of (or with a variety of definitions and diagnostic criteria found
contributor to) lower urinary tract symptoms (LUTS), within contemporary literature.1,2 This lack of uniformity
creates difficulties in characterizing UAB, in researching its
John Heesakkers led the peer-review process as the Associate Editor effect on patient quality of life, and in evaluating possible
responsible for the paper. treatments.
2928 | © 2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2018;37:2928–2931.

Terminology report from the International Continence Society (ICS) Working Group on Underactive Bladder (UAB)
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The symptoms associated with UAB are common3 and LUTS are divided into three groups: storage, voiding, and
likely to impact on quality of life.4 In the absence of a specific post micturition symptoms.
consensus-based definition of UAB, the true burden cannot be LUTS are not disease specific. The symptoms of
fully appreciated, nor can appropriately robust clinical trials hesitancy, straining to void, and a slow urinary stream can
be conducted.1–4 In this report, we discuss a new definition for be characteristic of both bladder outflow obstruction (BOO)
UAB that could be used as a platform for future discussion and detrusor underactivity (DU).
and research.
Although DU is an increasingly recognized urodynamic Storage Symptoms are experienced during the storage
observation contributing to LUTS in both men and women, phase of the micturition cycle.
there has been a lack of research into all aspects of this
dysfunction, and as yet, no effective treatments exist. DU can � Increased daytime frequency is the complaint by the
be diagnosed only on the basis of an invasive urodynamic patient who considers that he/she voids too often by day.
study. An international consensus group met at the � Nocturia is the complaint that the individual has to wake at
International Consultation on Incontinence-Research Society night one or more times to void.
(ICI-RS) and International Continence Society (ICS) annual � Urgency is the complaint of a sudden compelling desire to
meetings in 2014 and again at these meetings in 2015 to pass urine which is difficult to defer.
consider the feasibility of developing a working definition of
a symptom complex associated with DU. Drawing an analogy Voiding Symptoms are experienced during the voiding
to detrusor overactivity (urodynamic observation) and phase. Since UAB is a disorder of emptying these seem to be
overactive bladder (clinical diagnosis based on a symptom the predominant ones but voiding symptoms may also be
complex), the aim of this document is to help identify affected associated with storage symptoms in case of incomplete
patients of all ages and to facilitate further clinical and bladder emptying.
epidemiological research.
� Slow stream is reported by the individual as his or her
perception of reduced urine flow, usually compared to
2 | METHODS
previous performance or in comparison to others.
� Intermittent stream (intermittency) is the term used
The definitions restate or update those presented in previous
when the individual describes urine flow which stops and
International Continence Society Standardisation of Termi-
starts, on one or more occasions, during micturition.
nology reports.5–14
� Hesitancy is the term used when an individual describes
As far as possible, the definitions are descriptive of
difficulty in initiating micturition resulting in a delay in
observations, without implying underlying assumptions that
the onset of voiding after the individual is ready to pass
may later prove to be incorrect or incomplete. By following
urine.
this principle, the ICS aims to facilitate comparison of results
� Straining to void describes the muscular effort used
and enable effective communication by investigators who use
to either initiate, maintain, or improve the urinary
urodynamic methods.
stream.
This document was developed according to the published
� Feeling of incomplete emptying of the bladder during
methodology of the ICS Standardization Steering Commit-
voiding
tee.5 The group commissioned for this report developed an
� Terminal dribble is the term used when an individual
outline of proposed content and revised this in the light of a
describes a prolonged final part of micturition, when the
workshop held at the 4th International Neuro-Urology
flow has slowed to a trickle/dribble.
Meeting in Zurich, Switzerland in August 2015. The
subsequent text was reviewed by the working group before
Post Micturition Symptoms are experienced immedi-
a final draft was discussed at a workshop during the ICS
ately after micturition.
meeting in Montreal in October 2015.
� Feeling of incomplete emptying is a self-explanatory term
3 | DEFINITIONS for a feeling experienced by the individual after passing
urine.
LUTS are defined from the individual's perspective who is � Post micturition dribble is the term used when an
usually, but not necessarily, a patient within the healthcare individual describes the involuntary loss of urine immedi-
system. Symptoms are either volunteered by, or elicited from, ately after he or she has finished passing urine, usually after
the individual or may be described by the individual's leaving the toilet in men, or after rising from the toilet in
caregiver. women.

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2930
| CHAPPLE ET AL.

Symptom syndromes suggestive of lower urinary tract Abnormal detrusor activity in the voiding phase does
dysfunction not exclude the presence of detrusor overactivity in the
In clinical practice, empirical diagnoses are often used as storage phase. This may then be described as, for example,
the basis for initial management after assessing the individu- storage phase detrusor overactivity combined with voiding
al's lower urinary tract symptoms, physical findings and the phase detrusor underactivity.
results of urinalysis and other indicated investigations.

� Urgency, with or without urgency incontinence, usually 5 | CONCLUSIONS

with frequency and nocturia, can be described as the
overactive bladder syndrome, urge syndrome, or urgency- DU is diagnosed urodynamically and has a pressure/flow-
frequency syndrome. based ICS definition, however, it is not feasible to utilize
These symptom combinations are suggestive of urody- urodynamics outside a secondary care centre. DU is
namically demonstrable detrusor overactivity but can be characterized by an absent or low-pressure, and/or poorly-
due to other forms of urethro-vesical dysfunction. These sustained detrusor contraction in combination with low
terms can be used if there is no proven infection or other urinary flow. In contrast, UAB has no ICS definition but we
obvious pathology. would propose UAB as the clinical syndrome that includes
� Lower urinary tract symptoms suggestive of bladder DU. Because UAB is largely undefined in the literature, there
outlet obstruction is a term used when a man complains is, in our view, the need for a new symptomatic definition.
predominately of voiding symptoms in the absence of For the sake of symptom quantification in much-needed
infection or obvious pathology other than possible causes research moving forward, it appears that a crystallized
of outlet obstruction definition of UAB would be of definite value. In properly
� Underactive bladder is characterized by a slow urinary defining UAB, it will be important to consider the entire
stream, hesitancy and straining to void,a with or without a symptom complex, describing the sensation of incomplete or
feeling of incomplete bladder emptying sometimes with impaired voiding that may include hesitancy, straining to
storage symptoms.b (NEW) void, incomplete bladder emptying, slow or prolonged
stream, or intermittent stream, without implying any specific
urodynamic/functional findings or causative physiology.
4 URODYNAMIC OBSERVATIONS Properly defined, UAB could be to DU as OAB is to DO,
AND CONDITIONS where treatment according to a symptom-based diagnosis
would be possible if the diagnosis was sufficiently robust.
In the context of urodynamics we would affirm the ICS Patient choice, practical, and cost reasons often necessitate
standardisation report definitions: treatment without a pressure/flow-based diagnosis
We propose that this definition should now be tested to
Detrusor function during voiding check its validity. In particular the factors to be considered
are the influence of gender, age, and origin (neurogenic
- Normal detrusor function versus non-neurogenic), combining the interpretation of
Normal voiding is achieved by a voluntarily initiated symptoms along with bladder diaries, flow rates, PVR
continuous detrusor contraction that leads to complete volumes, and urodynamic data. It is hoped that this suggested
bladder emptying within a normal time span, and in the definition may be used as a springboard for future UAB
absence of BOO. For a given detrusor contraction, the research and discussion, in terms of both qualitative research
magnitude of the recorded pressure rise will depend on the to look for characteristic symptoms, and quantitative
degree of outlet resistance.c research in urodynamically-defined DU patients.
- Abnormal detrusor activity can be subdivided:

CONFLICTS OF INTEREST
� Detrusor underactivity is defined as a contraction of
reduced strength and/or duration, resulting in prolonged CRC is a researcher, author, consultant and/or speaker for
bladder emptying and/or a failure to achieve complete Astellas, Boston Scientific, GlaxoSmithKline, and Pfizer. PA
bladder emptying within a normal time spand. is a consultant for Astellas, Ferring, and Ipsen, a researcher for
� Acontractile detrusor is one that cannot be demonstrated Astellas, and a speaker for Astellas, Pfizer, and Ferring, MO is
to contract during urodynamic studies. a researcher and/or speaker for Apogepha, Astellas, Bayer,
Duchesnay, Ferring, GlaxoSmithKline, Lilly, Pfizer and
- Post void residual (PVR) is defined as the volume of urine Recordati. MJD is a researcher and speaker for Allergan,
left in the bladder at the end of micturition.e Astellas and Ferring. GvK is a consultant and/or researcher for

Terminology report from the International Continence Society (ICS) Working Group on Underactive Bladder (UAB)
522

CHAPPLE ET AL.
| 2931

Astellas, Solace therapeutics, Boston Scientific, Allergan and 4. Chancellor MB, Diokno A. CURE-UAB: shedding light on the
Medtronic. NO has received speaker fees and travel grants underactive bladder syndrome. Int Urol Nephrol. 2014;46:S1.
5. Abrams P, Cardozo L, Fall M, et al. Standardisation Sub-
from Astellas. OY is a researcher and/or a speaker for
committee of the International Continence Society. The stand-
Astellas, Ferring, Pfizer, Hisamitsu and Asahikasei. AW is a
ardisation of terminology of lower urinary tract function: report
consultant/advisor to Avadel, Allergan, Axonics, Valencia, from the Standardisation Sub-committee of the International
Urovant, and Medtronic. VN is a researcher for Allergan, Continence Society. Neurourol Urodyn. 2002;21:167–178.
Astellas, and Medtronic. 6. Abrams P, Blaivas JG, Stanton SL, Andersen JT. The
standardisation of terminology of lower urinary tract
function. The International Continence Society Committee
ENDNOTES on Standardisation of Terminology. Scand J Urol Nephrol
a
Suppl. 1988;114:5–19.
FOOTNOTE a) Underactive bladder occurs in association with 7. Abrams P, Blaivas JG, Stanton SL, Andersen JT. ICS 6th Report
diverse pathophysiologies and based on current knowledge there is no on the Standardisation of Terminology of Lower Urinary Tract
single distinguishing symptom. Function. Neurourol Urodyn. 1992;11:593–603.
b
FOOTNOTE b) Storage symptoms are varied and may be highly 8. Andersen JT, Blaivas JG, Cardozo L, Thüroff J. Seventh report on
prevalent, including nocturia, increased daytime frequency, reduced the standardisation of terminology of lower urinary tract function:
sensation of filling and incontinence. Underlying mechanisms of lower urinary tract rehabilitation techniques. Scand J Urol
storage symptoms are diverse, and are often related to a significant Nephrol. 1992;26:99–106.
post voiding residual urine volume. 9. Bump RC, Mattiasson A, Bo K, et al. The standardisation of
c
FOOTNOTE c) In women voiding symptoms are usually less likely to terminology of female pelvic organ prolapse and pelvic floor
be caused by anatomical bladder outlet obstruction, therefore, dysfunction. Am J Obstet Gynecol. 1996;175:10–17.
detrusor underactivity and functional causes of outlet dysfunction 10. Griffiths D, Höfner K, van Mastrigt R, Rollema HJ, Spangberg A,
are more likely (such as dysfunctional voiding). Gleason D. Standardisation of terminology of lower urinary tract
d function: pressure-flow studies of voiding, urethral resistance, and
FOOTNOTE d) A urodynamic study is essential to differentiate
urethral obstruction. International Continence Society Subcom-
between Bladder outlet Obstruction and Detrusor Underactivity. A
mittee on Standardization of Terminology of Pressure-Flow
normal detrusor contraction will be recorded as: high pressure if there
Studies. Neurourol. Urodyn. 1997;16:1–18.
is high outlet resistance, normal pressure if there is normal outlet
11. Stöhrer M, Goepel M, Kondo A, et al. The standardisation of
resistance or low pressure if urethral resistance is low.
terminology in neurogenic lower urinary tract dysfunction: with
e
FOOTNOTE e) If after repeated free uroflowmetry no residual urine suggestions for diagnostic procedures. International Continence
is demonstrated, then the finding of residual urine during urodynamic Society Standardization Committee. Neurourol Urodyn. 1999;
studies should be considered an artefact, due to the circumstances of 18:139–158.
the test. 12. van Waalwijk van Doorn E, Anders K, Khullar V, et al.
Standardisation of ambulatory urodynamic monitoring: report of
the standardisation sub-committee of the international continence
ORCID society for ambulatory urodynamic studies. Neurourol. Urodyn.
Christopher R. Chapple http://orcid.org/0000-0002- 2000;19:113–125.
13. Lose G, Griffiths D, Hosker G, et al. Standardisation of urethral
2960-9931
pressure measurement: report from the Standardisation Sub-
Marcus J. Drake http://orcid.org/0000-0002-6230-2552
committee of the International Continence Society. Neurourol.
Phillip P. Smith http://orcid.org/0000-0003-0160-8387 Urodyn. 2002;21:258–260.
14. van Kerrebroeck P, Abrams P, Chaikin D, et al. The stand-
ardisation of terminology in nocturia: report from the Stand-
ardisation
REFERENCES
Sub-committee of the International Continence Society. Neuro-
1. Osman NI, Chapple CR, Abrams P, et al. Detrusor underactivity urol. Urodyn. 2002;21:179–183.
and the underactive bladder: a new clinical entity? a review of
current terminology, definitions, epidemiology, aetiology, and
diagnosis. Eur Urol. 2014;65:389–398. How to cite this article: Chapple CR, Osman NI,
2. van Koeveringe GA, Vahabi B, Andersson KE, Kirschner- Birder L, et al. Terminology report from the
Hermanns R, Oelke M. Detrusor underactivity: a plea for new
International Continence Society (ICS) Working
approaches to a common bladder dysfunction. Neurourol Urodyn.
Group on Underactive Bladder (UAB).
2011;30:723–728.
3. Valente S, DuBeau C, Chancellor D, et al. Epidemiology and Neurourology and Urodynamics. 2018;37:
demographics of the underactive bladder: a cross-sectional survey. 2928–2931. https://doi.org/10.1002/nau.23701
Int Urol Nephrol. 2014;46:S7–10.

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5. ICS EDUCATION MODULES

An ICS Education Module is an endorsed, evidence based, standardised module designed to teach best
practice in the clinical or basic science of urinary, bowel and pelvic floor disorders. The module repre-
sents the gold standard of education for the ICS and is proposed and planned according to ICS Standard
Operating Procedure.

The module includes a 3-part format:

• Official ICS-consensus PowerPoint available for download

• A studio-quality video (hosted on the ICS website) and

• A peer-reviewed published article published in NAU

These modules represent the highest level in the ICS educational mission: ICS seeks to develop and dis-
tribute high quality global health educational modules; define standards and competencies in health
education; and address the needs of students, educators, and trainees as they seek to gain the skills and
knowledge necessary to become healthcare leaders. All ICS modules are created to be used by educators
around the world who can download the ICS module and present this to their students/colleagues. It is
also expected that when an ICS speaker is invited to speak at an educational course or guest lecture the
educational modules are used to provide the standardised educational content. The outcome of these
modules is that educators around the world, and ICS faculty, can download the ICS module and present
this to their students/colleagues. Additionally, if people are unable to attend a course on the topic the
video can serve as an excellent educational tool.

All of the modules can be found on ICS TV: www.ics.org/tv

If one clicks on the module one will see the text below the video- click ‘show more’ and this will include
the PPT slide and publication.

ICS Education Module Standard Operating Procedure (SOP)

ICS Education Modules are created according to SOP:

www.ics.org/education/icsstandardoperatingprocedures/videosops/icseducation3partmodule

Elise De
ICS Education Committee Chair
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Neurourology and Urodynamics 36:364–367 (2017)

ICS Teaching Module: Ambulatory Urodynamic Monitoring

G. Alessandro Digesu,1* Clara Gargasole,1 Caroline Hendricken,1 Michelle Gore,1 Ervin Kocjancic,2
Vik Khullar,1 and Peter F. Rosier3
1
Department of Urogynaecology, Imperial College Healthcare NHS Trust, London, United Kingdom
2
Department of Urology, University of Illinois at Chicago, Chicago, Illinois
3
University Medical Centre Utrecht—Urology, The Netherlands

Aim: To present the ICS Teaching Module on ambulatory urodynamics monitoring (AUM). Methods: This teaching
module has been developed by the ICS Urodynamics Committee to assist ICS members in their routine clinical practice. A
detailed literature search on studies published on the clinical role of AUM as well as expert opinions have been considered.
A slide set on AUM has been developed, approved by all members of the ICS Urodynamics Committee and is available to
the ICS membership on the ICS website. The final approved teaching module has been presented at the ICS Annual
Scientific Meeting in Brazil 2014. Results: The scientific evidence on the clinical role of AUM in patients with lower
urinary tract symptoms is summarized. The catheters and recording systems used, the patient preparation for the test,
the technique, the instructions to the patient, the analysis, interpretation, and quality control assessment of AUM trace
as well as the contraindications for AUM are described. Conclusions: The clinical role of AUM is still controversial. The
scientific evidence on the usefulness of AUM is still limited but the ICS Urodynamics Committee recommends its use as a
second line diagnostic tool when office laboratory urodynamics have failed to achieve a diagnosis. AUM has been
showed to be more sensitive than laboratory urodynamics in diagnosing detrusor overactivity but the level of evidence for
this measurement is not high. This manuscript summarizes the evidence and provides practice recommendations on
AUM for teaching purposes in the framework of an ICS teaching module. Neurourol. Urodynam. 36:364–367, 2017.
# 2015 Wiley Periodicals, Inc.

Key words: ambulatory urodynamics; ICS teaching module; inconclusive urodynamics; lower urinary tract symptoms

INTRODUCTION a practice protocol for AUM including troubleshooting and

interpretation are presented.
Ambulatory Urodynamic Monitoring (AUM) has been men-
tioned in International Continence Society (ICS) standards.1–2
AUM may be considered a useful tool to investigate lower Evidence and Philosophy of AUM
urinary tract dysfunction (LUTD) in patients with lower urinary
Conventional urodynamics is the standard clinical tool to
tract symptoms (LUTS) and inconclusive results on laboratory
investigate LUTD.2,8 However, it has been reported that it can fail
urodynamic testing.3,4 The clinical sensitivity and specificity of
to precisely demonstrate the cause of (storage) LUTS in
AUM are not very well established and the specific technical
19–44% of the cases.2–4 This may be due to the shorter duration
demands and the technical reliability are deliberated.1–2,5 To
of the test, thus abnormalities are not detected before the end of
date there is no clear consensus about the role of AUM in the
recording. Lack of correlation between abnormalities detected and
assessment of LUTD.6,7 Although the here above mentioned
symptoms reported by patients may also play a role since it is well
standards suggest some practical aspects, they do not cover all
known that in LUTD, signs and symptoms are neither very specific
issues arising with clinical testing. The ICS Urodynamics
nor sensitive towards the dysfunction.9 When conventional
Committee presents the teaching module ‘‘Ambulatory Urody-
urodynamics is inconclusive, AUM may be helpful in diagnosing
namic Monitoring’’ to serve as a standard education of Good
the cause of the symptoms and guiding more appropriate
Urodynamic Practice for everyone involved in indicating,
management of patients. In particular, AUM has been observed
performing, and analyzing urodynamic testing in general and
to have an increased detection of detrusor overactivity.10–16
more specifically, performing AUM. The teaching module
However, the fact that AUM shows abnormalities, especially
consists of a PowerPoint presentation, in combination with
detrusor overactivity, in healthy volunteers may also be consid-
this manuscript. This manuscript serves as a scientific
ered a sign of lesser specificity, apart from the fact that a person’s
background review; the evidence base for the ICS PowerPoint
perception of LUT function may be ‘‘false negative.’’17–20 There is
presentation, which is available via http://www.icsoffice.org/
single center expert retrospective evidence that stress urinary
eLearning. The presentation explains testing requirements,
incontinence became detectable during AUM with a leakage
clinical workup, and analysis. The presentation and this
manuscript are based on the highest-level available published
evidence, graded according to the modification of the Oxford Prof. Christopher Chapple led the peer-review process as the Associate Editor
responsible for the paper.
Center for Evidence-Based Medicine levels of evidence as also
Potential conflicts of interest: Nothing to disclose.
used by the 5th International Consultation on Incontinence. 
Correspondence to: G. Alessandro Digesu, M.D., Ph.D., Department Of Urogynae-
Where evidence is unavailable, experts’ opinion has been used cology, St. Mary’s Hospital, Cambridge Wing, Praed Street, W2 1NY London, United
and the sentence is marked as ‘‘eo’’ (experts’ opinion). The aim Kingdom. E-mail: a.digesu@imperial.ac.uk
Received 3 November 2015; Accepted 5 November 2015
of this ICS Teaching Module is to provide a summary of the
Published online 23 November 2015 in Wiley Online Library
published literature on the role of AUM in clinical research (wileyonlinelibrary.com).
practice, including indications. Furthermore the technique and DOI 10.1002/nau.22933

# 2015 Wiley Periodicals, Inc.

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Ambulatory Urodynamics 365

detector15 (LE3). The sensitivity and or specificity of AUM towards instructions (described more in detail in the following section)
voiding dysfunction or abnormalities is at present unknown. and will be able to record on a diary all the (LUT) signs and
AUM is performed in a similar way to conventional symptoms perceived during the AUM test. Since symptoms are
cystometry but differs in some specific elements: It uses natural compared against the pressures recorded, an accurate recording
(orthograde) filling of the bladder (the patients are usually asked of symptoms and the times when they occur is essential for the
to drink extra) and testing lasts for approximately 2–4 hr. final AUM diagnosis.21–23
Patients are fully dressed after the initiation of the test and Similar to conventional cystometry the catheters are inserted
are able to leave the urodynamic room, which may reduce into the bladder and the rectal canal. Air-filled or microtip
embarrassment.11,12 Disadvantages of AUM may be that the test transducers catheters need to be zeroed prior to insertion at the
and analysis are time-consuming and require specialized atmospheric pressure by having the open end of three-way
equipment with trained and dedicated personnel. taps, attached to the catheters, at the level of the symphysis
pubis. Via these three-way taps some gentle fluid flush can
eliminate entrapped air and debris from the catheters and can
Catheters
also check them for leaks. Sufficient catheter length should be
The majority of the reported studies on AUM have used catheter- inserted into the bladder/rectum and the catheters must be
mounted microtip transducers since they allow greater patient securely taped adjacent to the anus and external urethral
mobility and have a lesser incidence of movement artifacts.(eo) meatus to reduce the risk of catheters falling out as well as to
Although it is possible to measure pressures during AUM with reduce movement artifacts. The patient can then dress and the
fluid-filled lines, with intravesical capsules or with air filled catheters can be connected to the AUM recording system.
catheters, the evidence of their usefulness has still to be proven.10 Prior to commencing recording the patient is asked to cough
to check the intravesical, abdominal, and subtracted detrusor
pressures. If there is a prompt and steep increase of the vesical
Recording Systems
and abdominal pressures during cough and the subtracted
The oldest systems (Gaeltec Devices Ltd, Isle of Skye, Scotland) detrusor pressure does not change then the test can be started.
are mostly known for their catheters, made of flexible silicone- Otherwise any problem must be rectified.
covered braided metal, with mounted electronic microtip The method of recording urine leakage has not yet been
transducers. The main disadvantage of this system is the large standardized. An electronic pad and/or the patient using a
recorder box which has been awkward to carry around. The remote control and pressing an event marker button and/or
newer systems (i.e., Goby, Laborie Medical, Canada or Luna, completing a urinary symptom diary are possibilities. No
Medical Measurement Systems, Mississauga, Canada) have evidence exists for any of the methods being more specific,
a smaller remote control attachment that also allows data predictive, or reliable.
capturing of the important physiological events. These newer
systems can also accommodate water filled, air filled, and
Instructions to the Patient and AUM Test
electronic (microtip) options. (Comparative) evidence about the
clinical or technical reliability of each system or combination is As stated above, during AUM the bladder filling is accom-
lacking. plished with the patient’s own urine production instead of
filling the bladder through a catheter. The test may last from
2 to 4 hr. Patients should receive instructions prior to leaving
Patient Preparation
the urodynamic room (See Table I) in an easy to understand
The patient is asked to come to the department with an manner. In order to maximize AUM diagnostic power, the use of
empty bowel if possible, with a comfortably full bladder and a detailed patient diary is strongly recommended to improve
wearing comfortable (not too tight) clothes. If the rectum is the analysis of events occurring during AUM.14,eo However the
loaded with feces at the start this may need to be sorted prior to availability of event markers on the newer AUM systems may
commencement to prevent ‘‘fecal urgency’’ during the test. replace the use of the diary allowing more freedom, ease, and
Active urinary tract infection must be excluded prior to flexibility for the patient.
commencing the test. There is no scientific evidence demon- Usually patients are instructed to drink extra during the test,
strating that routine antibiotics before and or after the test are to be able to record some storage to voiding cycles in a
needed nor evidence supporting the use of routine bowel reasonable amount of time. Forced diuresis may unmask/
evacuation agents before AUM. Furthermore, laxatives can provoke detrusor overactivity, however voiding an equivalent
cause rectal activity and/or abdominal discomfort and there- of 4 L/24 hr may be an unusual challenge for the LUT.20
fore hinder the representativeness of the test.eo The patient instruction includes advice to return to the
To record episodes of urgency, incontinence, pain, start and end urodynamic office in case of problems. If a catheter is displaced
of voluntary voids, time and volume of fluid intake, feeling of or evacuated, or the system is malfunctioning, the trace, the
catheter displacement as well any provocative manoeuvers recorded pressures, subtractions, and quality of the trace the
(running, washing hands, coughing, sneezing etc) a remote test duration may need to be reviewed. If a diagnosis has not
control might be useful. Information leaflets explaining the test be revealed, in case of malfunction and test prolongation the
should be made available for patients prior to their appointment pressure transducers would need to be re-zeroed, re-inserted,
to explain what the test involves and how they can cooperate with and the test re-started.
the test. Preferably a uroflow and post void residual urine test are
performed before AUM is started. If there are no signs of urinary
Quality Control Assessment
tract infection the AUM test can be performed.
There is risk of losing signal quality associated with AUM.
Therefore, there are a number of additional precautions to
Technique
consider while performing AUM compared to conventional
Before the test is started it is mandatory to ensure that the cystometry. Obviously it is relevant to ensure that all the
patient understands and is able to follow some important catheters are securely taped adjacent to the meatus and the

Neurourology and Urodynamics DOI 10.1002/nau

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366 Digesu et al.

TABLE I. Outline of Patient Instructions for Ambulatory Urodynamic Test
How to you use the event buttons on the AUM device
Drink about 200–400 ml per hour or a fluid load up to 1 L drunk over 30 min.
If a fluid load is contraindicated the AUM time would take longer.eo
Register urgency, incontinence, pain, start and end of voluntary voids, time and volume of fluid intake.
Register activity and maneuvers that (usually tends to) provoke symptoms like example drinking, running,
lifting weight, washing hands, coughing, sneezing etc.
Return to the urodynamic room every hour to allow to check the system is recording the pressures correctly.
Return to the urodynamic room whenever you need to void.
This may allow recording up to three pressure flow studies during the whole study.eo
Return to the urodynamic room when a catheter (or both) falls out, or is expelled during voiding (or defecation).

anus. The catheter’s length should be fixed to the lower diagnostic capability a standardized workup and systematic
abdomen (stay inside the pants) and the rest of the length to the analysis by a skilled physician is mandatory. Analysis should be
monitor box should be as short as possible and secured built on an as reliable as possible measurement including a
underneath the clothes to further avoid accidental displace- detailed record of lower urinary tract signs and symptoms. For
ment during the test. this reason, it is also very relevant to ensure patient cooperation.
To ensure good quality control it is important to check the We have presented an evidence based teaching module to
signal quality by setting each transducer to zero prior to support good clinical practice regarding AUM with recom-
commencing to record the pressures and to ensure that the mended elements of standardization for the physician as well as
intravesical and abdominal pressures are similar by asking the for the instructions to the patient.
patient to cough. Thus it can be checked that the subtracted
detrusor pressure is within the normal range prior to
commencing the test and this may be checked every hour to REFERENCES
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catheters are not displaced. The instructions should also ambulatory urodynamic monitoring: Report of the standardisation sub-
preferably ask the patient to cough before and after each committee of the International Continence Society for ambulatory urody-
void when pressure flow studies are recorded (LE 2a). namic studies. Neurourol Urodyn 2000;19:113–25.
2. Sch€ afer W, Abrams P, Liao L, et al. Good urodynamic practices: Uroflowmetry,
filling cystometry, and pressure-flow studies. Neurourol Urodyn
2002;21:261–74.
Analysis and Interpretation of AUM Trace
3. Salvatore S, Khullar V, Cardozo L, et al. Evaluating ambulatory urodynamics: A
The first step in the analysis of an AUM trace is the prospective study in asymptomatic women. BJOG 2001;108:107–11.
4. Radley SC, Rosario DJ, Chapple CR, et al. Conventional and ambulatory
assessment of the quality of data (signal) recorded and to judge urodynamic findings in women with symptoms suggestive of bladder
whether the trace appears ‘‘active’’ with clearly visible coughs overactivity. J Urol 2001;166:2253–8.
and pressure variations due to the movement of the patient. A 5. Bradshaw H, Radley SC, Rosario DJ, et al. Evaluating ambulatory
dead (flat) signal in one or both of the pressures indicates a urodynamics: A prospective study in asymptomatic women. BJOG
2003;110:83–4.
problem and depending on the duration the test may not be 6. Collins CW, Winters JC. AUA/SUFU adult urodynamics guideline: A clinical
evaluable. If both pressures have been recorded for a sufficient review. Urol Clin North Am 2014;41:353–62.
amount of time, the detrusor pressure should be evaluated. 7. Lucas MG, Bosch RJ, Burkhard FC, et al. EAU guidelines on assessment
Evaluation of detrusor pressure is possible for the period that and nonsurgical management of urinary incontinence. Eur Urol
2012;62:1130–42.
the movement and couch responses have been ‘‘balanced,’’ 8. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower
without causing significant positive or negative deflections in urinary tract function: Report from the standardisation sub-committee of the
this pressure; though inevitably rectal activity may play a role International Continence Society. Urology 2003;61:37–49.
in (negative) deflections of detrusor ‘‘pressure’’ and these must 9. Cardozo L, Stanton S, Williams JE. Detrusor instability following surgery for
genuine stress incontinence. Br J Urol 1979;51:204–7.
be recognized. 10. Jarvis GJ, Hall S, Stamp S, et al. An assessment of urodynamic examination in
Analysis and interpretation of the trace should be performed incontinent women. Br J Obstet Gynaecol 1980;87:893–6.
immediately following the test to allow discussion of the 11. Versi E, Cardozo L, Anand D, et al. Symptoms analysis for the diagnosis of
findings and management options with the patient, thus genuine stress incontinence. Br J Obstet Gynaecol 1991;98:815–9.
12. Wall L. Diagnosis and management of urinary incontinence due to detrusor
avoiding unnecessary repeat visits.eo instability. Obstet Gynecol Survey 1990;45:8S–11S.
13. Blaivas J. Diagnostic evaluation of urinary incontinence. Urology
1990;36:11–20.
Contraindications for AUM 14. Patravali N. Ambulatory urodynamic monitoring: Are we wasting our time?
J Obstet Gynaecol 2007;27:413–5.
Poor patient mobility, cognitive impairment, or inabilities to 15. Pannek J, Pieper P. Clinical usefulness of ambulatory urodynamics in the
follow instructions are relative contraindications for AUM. diagnosis and treatment of lower urinary tract dysfunction. Scand J Urol
Severe constipation and active urinary tract infection may need Nephrol 2008;42:428–32.
to be treated before the test. 16. Salvatore S, Khullar V, Cardozo L, et al. Evaluating ambulatory urodynamics: A
prospective study in asymptomatic women. BJOG 2001;108:107–11.
17. Heslington K, Hilton P. Ambulatory monitoring and conventional
cystometry in asymptomatic female volunteers. Br J Obstet Gynaecol
CONCLUSIONS 1996;103:434–41.
18. van Waalwijk van Doorn ES, Remmers A, Janknegt RA. Conventional and
AUM may be performed when conventional urodynamic tests extramural ambulatory urodynamic testing of the lower urinary tract in
have failed to detect any underlying cause of LUTS and/or may be female volunteers. J Urol 1992;147:1319–25.
useful when conventional cystometry diagnosis does not 19. Webb RJ, Ramsden PD, Neal DE. Ambulatory monitoring and electronic
measurement of urinary leakage in the diagnosis of detrusor instability and
explain the symptoms. AUM is a more time consuming test incontinence. Br J Urol 1991;68:148–52.
than conventional cystometry and requires expertise as well as 20. van Venrooij GE, Boon TA. Extensive urodynamic investigation: interac-
specialized equipment. In order to make the most of its tion among diuresis, detrusor instability, urethral relaxation,

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incontinence and complaints in women with a history of urge 22. Davila GW. Ambulatory urodynamics in urge incontinence evaluation. Int
incontinence. J Urol 1994;152:1535–8. Urogynecol J 1994;5:25–30.
21. Martens FM, van Kuppevelt HJ, Beekman JA, et al. No primary role of 23. Dokmeci F, Seval M, Gok H. Comparison of ambulatory versus conventional
ambulatory urodynamics for the management of spinal cord injury patients urodynamics in females with urinary incontinence. Neurourol Urodyn
compared to conventional urodynamics. Neurourol Urodyn 2010;29:1380–6. 2010;29:518–21.

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Neurourology and Urodynamics 35:36–38 (2016)

ICS Teaching Module: Analysis of Voiding, Pressure Flow

Analysis (Basic Module)
Peter F.W.M. Rosier,1* Ruth Kirschner-Hermanns,2 Jan Svihra,3 Yukio Homma,4 and Alan J. Wein5
1
University Medical Centre Utrecht - Urology, The Netherlands
2
University Clinic, Rheinisch Friedrich-Wilhelms University - Clinic of Urology/Neuro-Urology Bonn, Germany
3
School of Medicine - Department of Urology, Slovakia
4
University of Tokyo - Department of Urology, Bunkyoku, Tokyo, Japan
5
University of Pennsylvania Health System - Division of Urology, Philadelphia, Pennsylvania

Aims: To present the evidence background for an ICS teaching module for the urodynamic analysis of voiding.
Methods: Literature analysis and expert opinion are combined to collate an outline and explanation of a preferred and
good urodynamic practice. Result: Patient’s preparation, pathophysiology, technique and principles of pressure flow
analysis are summarized in this manuscript. Conclusions: This manuscript serves as scientific background for a slides
set, made available on the ICS website to teach the basic and practical elements of pressure flow analysis. Neurourol.
Urodynam. 35:36–38, 2016. # 2014 Wiley Periodicals, Inc.

Key words: bladder outlet obstruction; diagnosis; pressure flow analysis; review; teaching module; underactive
detrusor; voiding

INTRODUCTION patient prophylactic antibiotics is unnecessary.7,eo Laxatives

are also unnecessary and might cause unwanted bowel (over)
The ICS Urodynamics Committee presents the teaching module
activity and fecal urgency during the test, but is advantageous
Analysis of Voiding; Pressure Flow Analysis-basic module to
to ask the patient to arrive with an empty bowel if possible.eo If
serve as a standard education of Good Urodynamic Practice for
high incidences of urinary tract infections after urodynamic
everyone involved in indicating, performing, and analyzing
testing are observed in a given practice, the first step should be
urodynamic testing in general and more specifically, performing
that the procedures are changed so that strict antisepsis is
analysis of voiding. The teaching module consists of a presenta-
followed.eo Thin (6–8F) double lumen or micro tip with lumen
tion, in combination with this manuscript. This manuscript
catheters for intravesical filling and pressure recording are
serves as a scientific background review; the evidence base, for
advised2 with adequate fixation alongside the meatus over the
the ICS Power Point presentation; available via http://www.
penis or a labium.
icsoffice.org/eLearning/. The presentation explains normal
physiology, testing requirements, pressure flow analysis
methods, and introduces the nomograms. The presentation PATHOPHYSIOLOGY
and this manuscript uses experts opinion where evidence is,
Voiding is an autonomic reflex that is, in the normal
especially for the clinical practice aspects, unavailable and
situation, initiated through voluntary and conscious pelvic
is marked with:eo (experts’ opinion).
floor relaxation. The detrusor dome, when parasympatically
activated delivers the energy to void. The bladder outlet or
PREPARATION OF THE PATIENT
bladderneck (or autonomic sphincter) relaxes as a result of
Urodynamic testing requires an optimally informed patient, inhibition of sympathic input and allows emptying. The
after adequate relevant medical history, systematic symptoms normal outlet controls the flow by passive distension and
analysis, laboratory, and clinical (neuro-gyneco-urological) through its visco-elasticity. The outlet collapses when the
exam and, preferably, at least one, not-catheterized (free) intravesical pressure is too low to overcome the forces that
flowmetry with post-void residual determination.1–3 Pressure close the outlet.8 Typically, reduced patency of the bladder
flow analysis is the element of urodynamic testing to diagnose outlet through an enlarged prostate or a urethral stricture, is
voiding dysfunction. Although voiding is, plausibly, negatively limiting the (maximum) flowrate and driving the detrusor
influenced by the shift of the autonomic system to sympatical muscle to higher power contraction, thus higher intravesical
dominance in the situation of mental stress, there is not very pressures, during voiding.
much evidence, that voiding in laboratory circumstances is
unacceptably unrepresentative.eo Some indirect evidence exists
that differences between office and home are not large in Christopher Chapple led the peer-review process as the Associate Editor
(elderly) male,4,5 as long as the bladder is not uncomfortably responsible for the paper.
Potential conflicts of interest: Nothing to disclose.
full.6 Perceivably, it is patient friendly to ensure adequate 
Corresponding Author: Peter F.W.M. Rosier, University Medical Centre Utrecht -
draping, normal seating (or standing, if preferred by the –male Urology Hp C04 236, Heidelberglaan 100, P.O. Box 85500, Utrecht 3508 GA,
patient) and maximum possible privacy during voiding as well The Netherlands.
as quiet, relaxing circumstances with as little number as E-mail: PeterF.W.M.Rosier@umcutrecht.nl
Received 18 April 2014; Accepted 2 July 2014
possible persons involved during urodynamic testing.eo Published online 11 September 2014 in Wiley Online Library
Infection prophylaxis necessitates sterile catheterization but (wileyonlinelibrary.com).
for this short time catheterization in the noncompromised DOI 10.1002/nau.22660

# 2014 Wiley Periodicals, Inc.

Analysis of Voiding, Pressure Flow Analysis (Basic Module)

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Urodynamics, LUTS (Female), LUTS (Male) 37

Clinical nomograms to quantify pressure flow analysis results This grading number is presented, and subsequently adopted,
in a standard manner are available for symptomatic elderly as the ICS-obstruction number.22,23
male with an enlarged prostate.9–11 All of those methods give Likewise, maximum of detrusor contraction (or contractility)
very consistent results.12,13 Women (and young men) voiding can be calculated with the ICS contraction number.22 Detrusor
dynamics differs from elderly men because there is no prostate contraction power during voiding can also be calculated
to act as a stable nozzle and pressure flow nomograms are more throughout the entire voiding24 and relates to bladder outlet
difficult to construct. Time based pressure and flow graphs obstruction and affectivity of voiding.25 Both analysis methods
allow judgement of the voiding; post processing with pressure give similar results.26
and flow on an X-Y graph is possible on all contemporary Analysis of female micturition is less standardized but
urodynamic equipment, and allows precise appreciation of follows the principles as mentioned here above. There is usually
bladder outlet obstruction (BOO) and outlet dynamics through- more flowrate and pressure variation during the time of one
out voiding. Nevertheless, good quality and plausibility control female voiding. Most women however, empty with high peak
as well as an evaluation of clinical representativity are flowrates and because high flowrate rules out static outlet
necessary.2 obstruction, outlet dynamics is the cause of variation here.
Relatively high detrusor pressure during voiding is also in
women regarded as a sign of (static) bladder outlet obstruc-
TECHNIQUE AND INTERPRETATION
tion.27 This is captured in a nomogram that integrates
maximum of (not catheterized) free flowrate with a minimum
Technique cut-off pressure, to be observed during voiding cystometry or
with observations during radiography.28,29 Although freque-
Pressure flow starts after permission to void and hesitancy
ntly used, in variations of application, this nomogram has
can be recognized if that permission is precisely marked. More
never been ICS-standard. Pressure at maximum flow is at
important, permission to void indicates the end of storage
present accepted as the most relevant parameter.30
phase and differentiates between detrusor overactivity (DO)
Pressure flow voiding can occur in a manner that does not
and detrusor voiding contraction; DO to be diagnosed only in
represent the patients’ usual behaviour. Comparison with free
the storage phase.
flowmetry and asking the patients’ opinion in this regard are
Pressure flow analysis relies on the simultaneous recording
valuable.eo
of pressures and flow. Pressures in the storage phase are
Artefacts arise when the (intravesical pressure recording)
interpreted as pattern; DO or reduced compliance, and there is
catheter is slipping out during voiding. This can be suspected
no evidence that the absolute pressures play a role. In pressure
already from the pressure recording during voiding and also
flow analysis however, the absolute pressures, referred to
from the pressures response on cough testing after voiding.2
atmospheric pressure, are relevant for the clinical interpreta-
All artefacts that are known from uroflowmetry are to be
tion with the nomograms (v.i.).
expected, and should be controlled for, also in pressure flow
There is no specific evidence for the preferred position during
cystometry.2,31
pressure flow testing. Plausibly women shall perform best
Very low pressure-voiding, inability to void, or to inability to
while comfortably sitting, however, many women never really
initiate a full voiding reflex as usual, limits the applicability of
sit on the toilet, or are used to squat.14,15 Sitting uncomfortably
pressure flow analysis. Especially in shy voiders, it can become
and voiding in a manner that does not adequately represent the
a problem to objectively diagnose the bladder outlet properties,
usual way of voiding may likely occur on a videourodynamic
or the real ability of the detrusor muscle to generate sufficient
equipment, because of the restrictions of the equipment. More
pressure. However, if (little) fluid leaves the bladder during a
in general: in the semi recumbent, supine, or gynecological
weak or incomplete voiding reflex, serious bladder outlet
position, voiding can hardly be as usual, however, direct
obstruction is relatively unlikely when this happens with low
comparative evidence is lacking.eo As in adults, position is of
pressure, although the level of uncertainty of this diagnosis is
influence for storage phase results, but the relevance of voiding
high.
position seems not studied in children and is not mentioned in
the standard.16,17 Free flow in men is, in group-wise compar-
isons, influenced by position, however, individuals might have CONCLUSIONS
a preferred position and the possibility to allow the patient
Pressure flow analysis is the golden standard for the analysis
preferred position seems relevant.18–20 To include the lag-time
of voiding. For male patients, precise and clinically relevant
from meatus to flow recording is necessary in any way,21
limits for bladder outlet obstruction are available. For female
but a very short meatus to flowmeter distance is beneficial.eo
and children, the limits are less precisely defined however, on
If the patient’s position is changed during the test, external
the basis of what can be expected from normal lower urinary
pressure transducers (if used) must be adjusted to the height of
tract physiology, closely linked to the methods and nomograms
the symphysis pubis again.
that are calibrated for male patients. Strict adherence to
antisepsis and a patient-centred approach before, during and
Interpretation after testing limits unwanted effects and enhances representa-
tivity. Adherence to good urodynamic practice standards, with
Analysis of bladder outlet obstruction is done on the second, adequate reference to atmospheric pressure ensures optimal
passive phase of micturition, usually from the moment quality of analysis and diagnosis. This ICS educational module
maximum of flow when detrusor and outlet act in a steady provides the background for the basic education of the analysis
state and are in balance.9,10 Before maximum flow, pelvic floor of voiding in patient with lower urinary tract symptoms.
relaxation and outlet distension dynamics are predominant,
but after maximum flow, the true passive outlet resistance is
obtained. Pressure at maximum flow in combination with REFERENCES
corresponding maximum flow gives a clinically relevant 1. Rosier PFWM, Kuo HC, GennaroM de, et al. Urodynamic testing. In: Abrams P,
grading of bladder outlet obstruction when used in a formula.11 Cardozo L, Khoury, Wein A, Incontinence: International consultation

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incontinence 2012. Incontinence ICUD-EAU 2013 editors. 429–506. ISBN 978- 17. Neveus T, von Gontard A, Hoebeke P, et al. The standardization of terminology
9953-493-21-3. of lower urinary tract function in children and adolescents: Report from the
2. Sch€afer W, Abrams P, Liao L, et al. International Continence Society. Good Standardisation Committee of the International Children’s Continence
urodynamic practices: Uroflowmetry, filling cystometry, and pressure-flow Society J Urol 176: 2006; 314.
studies. Neurourol Urodyn 2002;21:261–74. 18. Unsal A, Cimentepe E. Voiding position does not affect uroflowmetric
3. Abrams P, Cardozo L, Fall M, et al. Standardisation Sub-committee of the parameters and post-void residual urine volume in healthy volunteers. Scand
International Continence Society. The standardisation of terminology of J Urol Nephrol 2004;38:469–71.
lower urinary tract function: report from the Standardisation Sub-committee 19. Unsal A, Cimentepe E. Effect of voiding position on uroflowmetric parameters
of the International Continence Society. Neurourol Urodyn 2002;21:167–78. and post-void residual urine volume in patients with benign prostatic
4. Boci R, Fall M, Wald� en M, et al. Home uroflowmetry: Improved accuracy in hyperplasia. Scand J Urol Nephrol 2004;38:240–2.
outflow assessment. Neurourol Urodyn 1999;18:25–32. 20. Choudhury S, Agarwal MM, Mandal AK, et al. Which voiding position is
5. Cohen DD, Steinberg JR, Rossignol M, et al. Normal variation and influence of associated with lowest flow rates in healthy adult men? Role of natural
stress, caffeine intake, and sexual activity on uroflowmetry parameters of a voiding position. Neurourol Urodyn 2010;29:413–7.
middle-aged asymptomatic cohort of volunteer male urologists. Neurourol 21. Kranse R, van Mastrigt R, Bosch R. Estimation of the lag time between
Urodyn 2002;21:491–4. detrusor pressure- and flow rate-signals. Neurourol Urodyn 1995;14:
6. Tong YC. The effect of psychological motivation on volumes voided during 217–29.
uroflowmetry in healthy aged male volunteers. Neurourol Urodyn 22. Abrams P. Bladder outlet, obstruction index and bladder contractility index
2006;25:8–12. and bladder voiding efficiency: Three simple indices to define bladder voiding
7. Porru D, Madeddu G, Campus G, et al. Evaluation of morbidity of multi- function. BJU Int 1999;84:14–5.
channel pressure-flow studies. Neurourol Urodyn 1999;18:647–52. 23. Nitti VW. Pressure flow urodynamic studies: The gold standard for
8. Griffiths D. The pressure within a collapsed tube, with special reference to diagnosing bladder outlet obstruction. Rev Urol 2005;7:S14–21.
urethral pressure. Phys Med Biol 1985;30:951–63. 24. van Mastrigt R, Griffiths DJ. An evaluation of contractility parameters
9. Sch€afer W. Analysis of bladder-outlet function with the linearized passive determined from isometric contractions and micturition studies. Urol Res
urethral resistance relation, linPURR, and a disease-specific approach for 1986;14:45–52.
grading obstruction: from complex to simple. World J Urol 1995;13:47–58. 25. Rosier PF, de Wildt MJ, de la Rosette JJ, et al. Analysis of maximum detrusor
10. Griffiths D, van Mastrigt R, Bosch R. Quantification of urethral resistance and contraction power in relation to bladder emptying in patients with lower
bladder function during voiding, with special reference to the effects of urinary tract symptoms and benign prostatic enlargement. J Urol
prostate size reduction on urethral obstruction due to benign prostatic 1995;154:2137–42.
hyperplasia. Neurourol. Urodyn 1989;8:17–27. 26. Rosier PF, de Wildt MJ, Debruyne FM, et al. Evaluation of detrusor activity
11. Lim CS, Abrams P. The Abrams-Griffiths nomogram. World J Urol 1995;13:34–9. during micturition in patients with benign prostatic enlargement with a
12. Rosier PF, de la Rosette JJ, de Wildt MJ, et al. Comparison of passive urethral clinical nomogram. J Urol 1996;156:473–8 discussion 478-9.
resistance relation and urethral resistance factor in analysis of bladder outlet 27. Haylen BT, de Ridder D, Freeman RM, et al. An international urogynecological
obstruction in patients with benign prostatic enlargement. Neurourol association (iuga)/international continence society (ics) joint report on the
Urodyn 1996;15:1–10 discussion 10-5. terminology for female pelvic floor dysfunction. Neurourol Urodyn 2010.
13. Ding YY, Lieu PK. Comparison of three methods of quantifying urethral 29:4–20.
resistance in men. Urology 1998;52:858–62. 28. Groutz A, Blaivas J, Chaikin D. Bladder outlet obstruction in women:
14. Moore KH, Richmond DH, Sutherst JR, et al. Crouching over the toilet seat: Definition and characteristics. Neurourol Urodyn 2000;19:213–20.
Prevalence among British gynaecological outpatients and its effect upon 29. Blaivas JG, Groutz A. Bladder outlet obstruction nomogram for women with
micturition. Br J Obstet Gynaecol 1991;98:569–72. lower urinary tract symptomatology. Neurourol Urodyn 2000;19:553–64.
15. Yang KN, Chen SC, Chen SY, et al. Female voiding postures and their effects on 30. Nitti VW, Tu LM, Gitlin J. Diagnosing bladder outlet obstruction in women.
micturition. Int Urogynecol J 2010;21:1371–6. J Urol 1999;161:1535–40.
16. Lorenzo AJ, Wallis MC, Cook A, et al. What is the variability in urodynamic 31. Addla SK, Marri RR, Daayana SL, et al. Avoid cruising on the uroflowmeter:
parameters with position change in children? Analysis of a prospectively Evaluation of cruising artifact on spinning disc flowmeters in an experimen-
enrolled cohort. J Urol 2007;178:2567–70. tal setup. Neurourol Urodyn 2010;29:1301–5.

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GUIDELINE FOR PREVENTION OF CATHETER-

ASSOCIATED URINARY TRACT INFECTIONS 2009
Carolyn V. Gould, MD, MSCR 1; Craig A. Umscheid, MD, MSCE 2; Rajender K. Agarwal,
MD, MPH 2; Gretchen Kuntz, MSW, MSLIS 2; David A. Pegues, MD 3 and the
Healthcare Infection Control Practices Advisory Committee (HICPAC) 4

1
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Atlanta, GA
2
Center for Evidence-based Practice
University of Pennsylvania Health System
Philadelphia, PA
3
Division of Infectious Diseases
David Geffen School of Medicine at UCLA
Los Angeles, CA

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4
Healthcare Infection Control Practices Advisory Committee
(HICPAC)
Chair Department of Pathology
University of Florida Health Science
BRENNAN, Patrick J., MD Center-Jacksonville
Chief Medical Officer
Division of Infectious Diseases
University of Pennsylvania Health System MURPHY, Denise M., MPH, RN, CIC
Vice President, Safety and Quality
Executive Secretary Barnes-Jewish Hospital at Washington
University Medical Center
BELL, Michael R., MD
Associate Director for Infection Control OLMSTED, Russell N., MPH
Division of Healthcare Quality Promotion Epidemiologist
National Center for Infectious Diseases Infection Control Services
Centers for Disease Control and St. Joseph Mercy Health System
Prevention
PEGUES, David Alexander, MD
Members Professor of Medicine, Hospital Epidemiologist
David Geffen School of Medicine at
BURNS, Lillian A., MPH UCLA
Infection Control Coordinator
Infectious Diseases Department, RAMSEY, Keith M., MD
Greenwich Hospital Professor of Medicine
Medical Director of Infection Control
ELWARD, Alexis, MD, MPH Pitt County Memorial
Medical Director of Infection Control
Assistant Professor, Pediatric Infectious SINGH, Nalini, MD, MPH
Diseases Professor of Pediatrics
Washington University School of Medicine Epidemiology and International Health
George Washington University
ENGEL, Jeffrey, MD Children’s National Medical Center
Chief, Epidemiology Section, North
Carolina Division of Public Health SOULE, Barbara M., RN, MPA, CIC
North Carolina State Epidemiologist Practice Leader
Infection Prevention Services
LUNDSTROM, Tammy, MD, JD Joint Commission Resources/Joint
Chief Medical Officer Commission International
Providence Hospital
SCHECTER, William, P., MD
GORDON, Steven M., MD Department of Surgery, Ward 3A 17
Chairman, Department of Infectious San Francisco General Hospital
Diseases
Hospital Epidemiologist STEVENSON, Kurt Brown, MD, MPH
Cleveland Clinic Foundation Division of Infectious Diseases
Department of Internal Medicine
MCCARTER, Yvette S., PhD The Ohio State University Medical Center
Director, Clinical Microbiology
Laboratory

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Ex-officio Members Infection Control Consultant

Infection Control Associates
Agency for Healthcare Research and Quality
Ex-Officio American Health Care Association
BAINE, William B., MD FITZLER, Sandra L., RN
Senior Medical Advisor Senior Director of Clinical Services
Center for Outcomes and Evidence American Health Care Association
Agency for Healthcare Research and Quality
American College of Occupational and
National Institute of Health Environmental Medicine
Ex-Officio RUSSI, Mark, MD, MPH
HENDERSON, David, MD American College of Occupational and
Deputy Director for Clinical Care Environmental Medicine
National Institute of Health
Advisory Council for the Elimination of
Health Resources and Services Tuberculosis STRICOF, Rachel L., MPH
Administration Ex-Officio New York State Department of Health
JAY, Lorine J., MPH, RN, CPHQ
Regional Coordinator American Hospital Association
SCHULMAN, Roslyne, MHA, MBA
Food and Drug Administration Senior Associate Director, Policy
Ex-Officio Development
MURPHEY, Sheila A., MD
Chief, Infection Control Devices Branch Association of periOperative Registered
Division of Anesthesiology, General Hospital Nurses
Infection Control and Dental Devices BLANCHARD, Joan C., RN, BSN,
Center for Devices and Radiology Health MSS, CNOR, CIC
Food and Drug Administration Association of periOperative Registered
Nurses
Center for Medicare & Medicaid Services
(CMS) Ex-Officio Society for Healthcare Epidemiology of America
MILLER, Jeannie RN, MPH MARAGAKIS, Lisa, MD
Deputy Director, Office of Clinical Assistant Professor of Medicine
Standards and Quality/ Clinical Standards Johns Hopkins Medical Institutions
Group
Joint Commission on Accreditation of
Department of Veterans Affairs (VA) Healthcare Organizations
ROSELLE, Gary A., MD WISE, Robert A., MD
National Program Director, Infectious Division of Standards & Survey
Diseases Methods
VA Central Office Joint Commission on Accreditation of
Cincinnati VA Medical Center Healthcare Organizations

Liaisons Consumers Union

Senior Policy Analyst on
Association of Professionals of Infection MCGIFFERT, Lisa
Control and Epidemiology, Inc. Health Issues, Project Director
BJERKE, Nancy BSN, RN, MPH, CIC Stop Hospital Infections Organization

Council of State and Territorial Epidemiologists

KAINER, Marion MD, MPH
Medical Epidemiologist/Infections
Diseases Physician Director, Hospital
Infections and Antimicrobial Resistance
Program, Tennessee Department of Health

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Acknowledgement
HICPAC thanks the following members who served on the HICPAC CAUTI Guideline
subcommittee during the guideline development process: Russell N. Olmsted, MPH, Yvette S.
McCarter, PhD, Barbara M. Soule, RN, MPA, CIC, and Nalini Singh, MD, MPH.

HICPAC thanks the following outside experts for reviewing a draft of this guideline: Edward S.
Wong, MD, Lindsay E. Nicolle, MD, Anthony J. Schaeffer, MD, and Harriett M. Pitt, RN, MS,
CIC. The opinions of the reviewers might not be reflected in all the recommendations contained
in this document.

HICPAC would also like to thank the many individuals and organizations who provided valuable
feedback on the guideline during the public comment period.

Disclosure of Financial Interests and Relationships

The authors C.V.G., C.A.U., R.K.A., and G.K. report no actual or potential conflicts of interest.
D.A.P. is on the Speakers Bureau of Merck, Pfizer, Schering, and Cubist and is a consultant for
Dow Pharmaceuticals, DaVita, and Vasonova. C.A.U. and R.K.A. received funding from the
CDC to support the guideline development process.

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Table of Contents
Abbreviations ............................................................................................................. 6
I. Executive Summary ................................................................................................... 8
II. Summary of Recommendations ............................................................................... 10
III. Implementation and Audit ........................................................................................ 18
IV. Recommendations for Further Research ................................................................. 20
V. Background.............................................................................................................. 22
VI. Scope and Purpose ................................................................................................. 25
VII. Methods ................................................................................................................... 26
VIII. Evidence Review ..................................................................................................... 34
References .................................................................................................................... 49

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Abbreviations
ADL Activities of daily living
APACHE II Acute Physiology and Chronic Health Evaluation II
ASA American Society of Anesthesiologists
ASB Asymptomatic bacteriuria
BUN Blood urea nitrogen
CAUTI Catheter-associated urinary tract infection
CDC Centers for Disease Control and Prevention
CFU Colony-forming units
CI Confidence interval
CIC Clean intermittent catheterization
CICU Coronary intensive care unit
COPD Chronic obstructive pulmonary disease
ED Emergency department
F/U Follow-up
GRADE Grading of Recommendations Assessment, Development, and Evaluation system
Hb Hemoglobin concentration
HICPAC Healthcare Infection Control Practices Advisory Committee
H/O History of
HPF High power field
HR Hazard ratio
ICU Intensive care unit
IDR Incidence-density ratio
LOS Length of stay
MDR Multi-drug resistant
MICU Medical intensive care unit
NHSN National Healthcare Safety Network
NIH National Institutes of Health
NS Not significant
OBS Observational controlled study
OR Odds ratio
P P value
PACU Post-anesthesia care unit
PVC Polyvinyl chloride

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RCT Randomized controlled trial

RD Risk difference
RH Relative hazard
RR Relative risk
SAPS II Simplified Acute Physiology Score II
SICU Surgical intensive care unit
SR Systematic review
SUTI Symptomatic urinary tract infection
TMP/SMX Trimethoprim/sulfamethoxazole
TURP Transurethral resection of prostate
UTI Urinary tract infection
VAS Visual analog scale
WMD Weighted mean difference

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I. Executive Summary

This guideline updates and expands the original Centers for Disease Control and Prevention
(CDC) Guideline for Prevention of Catheter-associated Urinary Tract Infections (CAUTI)
published in 1981. Several developments necessitated revision of the 1981 guideline, including
new research and technological advancements for preventing CAUTI, increasing need to
address patients in non-acute care settings and patients requiring long-term urinary
catheterization, and greater emphasis on prevention initiatives as well as better defined goals
and metrics for outcomes and process measures. In addition to updating the previous
guideline, this revised guideline reviews the available evidence on CAUTI prevention for
patients requiring chronic indwelling catheters and individuals who can be managed with
alternative methods of urinary drainage (e.g., intermittent catheterization). The revised guideline
also includes specific recommendations for implementation, performance measurement, and
surveillance. Although the general principles of CAUTI prevention have not changed from the
previous version, the revised guideline provides clarification and more specific guidance based
on a defined, systematic review of the literature through July 2007. For areas where knowledge
gaps exist, recommendations for further research are listed. Finally, the revised guideline
outlines high-priority recommendations for CAUTI prevention in order to offer guidance for
implementation.

This document is intended for use by infection prevention staff, healthcare epidemiologists,
healthcare administrators, nurses, other healthcare providers, and persons responsible for
developing, implementing, and evaluating infection prevention and control programs for
healthcare settings across the continuum of care. The guideline can also be used as a resource
for societies or organizations that wish to develop more detailed implementation guidance for
prevention of CAUTI.

Our goal was to develop a guideline based on a targeted systematic review of the best available
evidence, with explicit links between the evidence and recommendations. To accomplish this,
we used an adapted GRADE system approach for evaluating quality of evidence and
determining strength of recommendations. The methodology, structure, and components of this
guideline are approved by HICPAC and will be used for subsequent guidelines issued by
HICPAC. A more detailed description of our approach is available in the Methods section.

To evaluate the evidence on preventing CAUTI, we examined data addressing three key
questions and related subquestions:

1. Who should receive urinary catheters?

A. When is urinary catheterization necessary?
B. What are the risk factors for CAUTI?
C. What populations are at highest risk of mortality related to urinary catheters?
2. For those who may require urinary catheters, what are the best practices?
Specifically, what are the risks and benefits associated with:
A. Different approaches to catheterization?
B. Different catheters or collecting systems?
C. Different catheter management techniques?
D. Different systems interventions (i.e., quality improvement programs)?
3. What are the best practices for preventing CAUTI associated with obstructed urinary
catheters?

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Evidence addressing the key questions was used to formulate recommendations, and explicit
links between the evidence and recommendations are available in the Evidence Review in the
body of the guideline and Evidence Tables and GRADE Tables in the Appendices. It is
important to note that Category I recommendations are all considered strong
recommendations and should be equally implemented; it is only the quality of the evidence
underlying the recommendation that distinguishes between levels A and B. Category IC
recommendations are required by state or federal regulation and may have any level of
supporting evidence.

The categorization scheme used in this guideline is presented in Table 1 in the Summary of
Recommendations and described further in the Methods section.

The Summary of Recommendations is organized as follows: 1) recommendations for who

should receive indwelling urinary catheters (or, for certain populations, alternatives to indwelling
catheters); 2) recommendations for catheter insertion; 3) recommendations for catheter
maintenance; 4) quality improvement programs to achieve appropriate placement, care, and
removal of catheters; 5) administrative infrastructure required; and 6) surveillance strategies.

The Implementation and Audit section includes a prioritization of recommendations (i.e., high-
priority recommendations that are essential for every healthcare facility), organized by modules,
in order to provide facilities more guidance on implementation of these guidelines. A list of
recommended performance measures that can potentially be used for internal reporting
purposes is also included.

Areas in need of further research identified during the evidence review are outlined in the
Recommendations for Further Research. This section includes guidance for specific
methodological approaches that should be used in future studies.

Readers who wish to examine the primary evidence underlying the recommendations are
referred to the Evidence Review in the body of the guideline, and the Evidence Tables and
GRADE Tables in the Appendices. The Evidence Review includes narrative summaries of the
data presented in the Evidence Tables and GRADE Tables. The Evidence Tables include all
study-level data used in the guideline, and the GRADE Tables assess the overall quality of
evidence for each question. The Appendices also contain a clearly delineated search strategy
that will be used for periodic updates to ensure that the guideline remains a timely resource as
new information becomes available.

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II. Summary of Recommendations

Table 1. Modified HICPAC Categorization Scheme* for Recommendations
Category IA A strong recommendation supported by high to moderate quality† evidence
suggesting net clinical benefits or harms
Category IB A strong recommendation supported by low quality evidence suggesting
net clinical benefits or harms or an accepted practice (e.g., aseptic
technique) supported by low to very low quality evidence
Category IC A strong recommendation required by state or federal regulation.
Category II A weak recommendation supported by any quality evidence suggesting a
trade off between clinical benefits and harms
No recommendation/ Unresolved issue for which there is low to very low quality evidence with
unresolved issue uncertain trade offs between benefits and harms
* Please refer to Methods (p.32) for implications of Category designations
†Please refer to Methods (p. 29-30) for process used to grade quality of evidence

I. Appropriate Urinary Catheter Use

A. Insert catheters only for appropriate indications (see Table 2 for guidance), and leave in
place only as long as needed. (Category IB) (Key Questions 1B and 2C)

1. Minimize urinary catheter use and duration of use in all patients, particularly
those at higher risk for CAUTI or mortality from catheterization such as women,
the elderly, and patients with impaired immunity.(Category IB) (Key Questions
1B and 1C)

2. Avoid use of urinary catheters in patients and nursing home residents for
management of incontinence. (Category IB) (Key Question 1A)

a. Further research is needed on periodic (e.g., nighttime) use of

external catheters (e.g., condom catheters) in incontinent patients or
residents and the use of catheters to prevent skin breakdown. (No
recommendation/unresolved issue) (Key Question 1A)

3. Use urinary catheters in operative patients only as necessary, rather than

routinely. (Category IB) (Key Question 1A)

4. For operative patients who have an indication for an indwelling catheter, remove
the catheter as soon as possible postoperatively, preferably within 24 hours,
unless there are appropriate indications for continued use. (Category IB) (Key
Questions 2A and 2C)

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Table 2.
A. Examples of Appropriate Indications for Indwelling Urethral Catheter Use 1-4
Patient has acute urinary retention or bladder outlet obstruction
Need for accurate measurements of urinary output in critically ill patients
Perioperative use for selected surgical procedures:
• Patients undergoing urologic surgery or other surgery on contiguous structures of the
genitourinary tract
• Anticipated prolonged duration of surgery (catheters inserted for this reason should be
removed in PACU)
• Patients anticipated to receive large-volume infusions or diuretics during surgery
• Need for intraoperative monitoring of urinary output
To assist in healing of open sacral or perineal wounds in incontinent patients
Patient requires prolonged immobilization (e.g., potentially unstable thoracic or lumbar spine,
multiple traumatic injuries such as pelvic fractures)
To improve comfort for end of life care if needed
B. Examples of Inappropriate Uses of Indwelling Catheters
As a substitute for nursing care of the patient or resident with incontinence
As a means of obtaining urine for culture or other diagnostic tests when the patient can
voluntarily void
For prolonged postoperative duration without appropriate indications (e.g., structural repair of
urethra or contiguous structures, prolonged effect of epidural anaesthesia, etc.)
Note: These indications are based primarily on expert consensus.

B. Consider using alternatives to indwelling urethral catheterization in selected patients

when appropriate.

1. Consider using external catheters as an alternative to indwelling urethral

catheters in cooperative male patients without urinary retention or bladder outlet
obstruction. (Category II) (Key Question 2A)

2. Consider alternatives to chronic indwelling catheters, such as intermittent

catheterization, in spinal cord injury patients. (Category II) (Key Question 1A)

3. Intermittent catheterization is preferable to indwelling urethral or suprapubic

catheters in patients with bladder emptying dysfunction. (Category II) (Key
Question 2A)

4. Consider intermittent catheterization in children with myelomeningocele and

neurogenic bladder to reduce the risk of urinary tract deterioration. (Category II)
(Key Question 1A)

5. Further research is needed on the benefit of using a urethral stent as an

alternative to an indwelling catheter in selected patients with bladder outlet
obstruction. (No recommendation/unresolved issue) (Key Question 1A)

6. Further research is needed on the risks and benefits of suprapubic catheters as

an alternative to indwelling urethral catheters in selected patients requiring short-
or long-term catheterization, particularly with respect to complications related to
catheter insertion or the catheter site. (No recommendation/unresolved issue)
(Key Question 2A)

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II. Proper Techniques for Urinary Catheter Insertion

A. Perform hand hygiene immediately before and after insertion or any manipulation of the
catheter device or site. (Category IB) (Key Question 2D)

B. Ensure that only properly trained persons (e.g., hospital personnel, family members, or
patients themselves) who know the correct technique of aseptic catheter insertion and
maintenance are given this responsibility. (Category IB) (Key Question 1B)

C. In the acute care hospital setting, insert urinary catheters using aseptic technique and
sterile equipment. (Category IB)

1. Use sterile gloves, drape, sponges, an appropriate antiseptic or sterile solution

for periurethral cleaning, and a single-use packet of lubricant jelly for insertion.
(Category IB)

2. Routine use of antiseptic lubricants is not necessary. (Category II) (Key

Question 2C)

3. Further research is needed on the use of antiseptic solutions vs. sterile water or
saline for periurethral cleaning prior to catheter insertion. (No
recommendation/unresolved issue) (Key Question 2C)

D. In the non-acute care setting, clean (i.e., non-sterile) technique for intermittent
catheterization is an acceptable and more practical alternative to sterile technique for
patients requiring chronic intermittent catheterization. (Category IA) (Key Question 2A)

1. Further research is needed on optimal cleaning and storage methods for

catheters used for clean intermittent catheterization. (No
recommendation/unresolved issue) (Key Question 2C)

E. Properly secure indwelling catheters after insertion to prevent movement and urethral
traction. (Category IB)

F. Unless otherwise clinically indicated, consider using the smallest bore catheter possible,
consistent with good drainage, to minimize bladder neck and urethral trauma. (Category
II)

G. If intermittent catheterization is used, perform it at regular intervals to prevent bladder

overdistension. (Category IB) (Key Question 2A)

H. Consider using a portable ultrasound device to assess urine volume in patients

undergoing intermittent catheterization to assess urine volume and reduce unnecessary
catheter insertions. (Category II) (Key Question 2C)

1. If ultrasound bladder scanners are used, ensure that indications for use are
clearly stated, nursing staff are trained in their use, and equipment is adequately
cleaned and disinfected in between patients. (Category IB)

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III. Proper Techniques for Urinary Catheter Maintenance

A. Following aseptic insertion of the urinary catheter, maintain a closed drainage system
(Category IB) (Key Question 1B and 2B)

1. If breaks in aseptic technique, disconnection, or leakage occur, replace the

catheter and collecting system using aseptic technique and sterile equipment.
(Category IB)

2. Consider using urinary catheter systems with preconnected, sealed catheter-

tubing junctions. (Category II) (Key Question 2B)

B. Maintain unobstructed urine flow. (Category IB) (Key Questions 1B and 2D)

1. Keep the catheter and collecting tube free from kinking. (Category IB)

2. Keep the collecting bag below the level of the bladder at all times. Do not rest
the bag on the floor. (Category IB)

3. Empty the collecting bag regularly using a separate, clean collecting container for
each patient; avoid splashing, and prevent contact of the drainage spigot with the
nonsterile collecting container. (Category IB)

C. Use Standard Precautions, including the use of gloves and gown as appropriate, during
any manipulation of the catheter or collecting system. (Category IB)

D. Complex urinary drainage systems (utilizing mechanisms for reducing bacterial entry
such as antiseptic-release cartridges in the drain port) are not necessary for routine use.
(Category II) (Key Question 2B)

E. Changing indwelling catheters or drainage bags at routine, fixed intervals is not

recommended. Rather, it is suggested to change catheters and drainage bags based on
clinical indications such as infection, obstruction, or when the closed system is
compromised. (Category II) (Key Question 2C)

F. Unless clinical indications exist (e.g., in patients with bacteriuria upon catheter removal
post urologic surgery), do not use systemic antimicrobials routinely to prevent CAUTI in
patients requiring either short or long-term catheterization. (Category IB) (Key Question
2C)

1. Further research is needed on the use of urinary antiseptics (e.g., methenamine)

to prevent UTI in patients requiring short-term catheterization. (No
recommendation/unresolved issue) (Key Question 2C)

G. Do not clean the periurethral area with antiseptics to prevent CAUTI while the catheter is
in place. Routine hygiene (e.g., cleansing of the meatal surface during daily bathing or
showering) is appropriate. (Category IB) (Key Question 2C)

H. Unless obstruction is anticipated (e.g., as might occur with bleeding after prostatic or
bladder surgery) bladder irrigation is not recommended. (Category II) (Key Question 2C)

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1. If obstruction is anticipated, closed continuous irrigation is suggested to prevent

obstruction. (Category II)

I. Routine irrigation of the bladder with antimicrobials is not recommended. (Category II)
(Key Question 2C)

J. Routine instillation of antiseptic or antimicrobial solutions into urinary drainage bags is

not recommended. (Category II) (Key Question 2C)

K. Clamping indwelling catheters prior to removal is not necessary. (Category II) (Key
Question 2C)

L. Further research is needed on the use of bacterial interference (i.e., bladder inoculation
with a nonpathogenic bacterial strain) to prevent UTI in patients requiring chronic urinary
catheterization. (No recommendation/unresolved issue) (Key Question 2C)

Catheter Materials

M. If the CAUTI rate is not decreasing after implementing a comprehensive strategy to

reduce rates of CAUTI, consider using antimicrobial/antiseptic-impregnated catheters.
The comprehensive strategy should include, at a minimum, the high priority
recommendations for urinary catheter use, aseptic insertion, and maintenance (see
Section III. Implementation and Audit). (Category IB) (Key Question 2B)

1. Further research is needed on the effect of antimicrobial/antiseptic-impregnated

catheters in reducing the risk of symptomatic UTI, their inclusion among the
primary interventions, and the patient populations most likely to benefit from
these catheters. (No recommendation/unresolved issue) (Key Question 2B)

N. Hydrophilic catheters might be preferable to standard catheters for patients requiring

intermittent catheterization. (Category II) (Key Question 2B)

O. Silicone might be preferable to other catheter materials to reduce the risk of encrustation
in long-term catheterized patients who have frequent obstruction. (Category II) (Key
Question 3)

P. Further research is needed to clarify the benefit of catheter valves in reducing the risk of
CAUTI and other urinary complications. (No recommendation/unresolved issue) (Key
Question 2B)

Management of Obstruction

Q. If obstruction occurs and it is likely that the catheter material is contributing to

obstruction, change the catheter. (Category IB)

R. Further research is needed on the benefit of irrigating the catheter with acidifying
solutions or use of oral urease inhibitors in long-term catheterized patients who have
frequent catheter obstruction. (No recommendation/unresolved issue) (Key Question
3)

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S. Further research is needed on the use of a portable ultrasound device to evaluate for
obstruction in patients with indwelling catheters and low urine output. (No
recommendation/unresolved issue) (Key Question 2C)

T. Further research is needed on the use of methenamine to prevent encrustation in

patients requiring chronic indwelling catheters who are at high risk for obstruction. (No
recommendation/unresolved issue) (Key Question 2C)

Specimen Collection

U. Obtain urine samples aseptically. (Category IB)

1. If a small volume of fresh urine is needed for examination (i.e., urinalysis or

culture), aspirate the urine from the needleless sampling port with a sterile
syringe/cannula adapter after cleansing the port with a disinfectant. (Category
IB)

2. Obtain large volumes of urine for special analyses (not culture) aseptically from
the drainage bag. (Category IB)

Spatial Separation of Catheterized Patients

V. Further research is needed on the benefit of spatial separation of patients with urinary
catheters to prevent transmission of pathogens colonizing urinary drainage systems. (No
recommendation/unresolved issue) (Key Question 2D)

IV. Quality Improvement Programs

A. Implement quality improvement (QI) programs or strategies to enhance appropriate use

of indwelling catheters and to reduce the risk of CAUTI based on a facility risk
assessment. (Category IB) (Key Question 2D)

The purposes of QI programs should be: 1) to assure appropriate utilization of catheters

2) to identify and remove catheters that are no longer needed (e.g., daily review of their
continued need) and 3) to ensure adherence to hand hygiene and proper care of
catheters. Examples of programs that have been demonstrated to be effective include:

1. A system of alerts or reminders to identify all patients with urinary catheters and
assess the need for continued catheterization

2. Guidelines and protocols for nurse-directed removal of unnecessary urinary

catheters

3. Education and performance feedback regarding appropriate use, hand hygiene, and
catheter care

4. Guidelines and algorithms for appropriate peri-operative catheter management, such

as:

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a. Procedure-specific guidelines for catheter placement and postoperative catheter

removal

b. Protocols for management of postoperative urinary retention, such as nurse-

directed use of intermittent catheterization and use of bladder ultrasound
scanners

V. Administrative Infrastructure

A. Provision of guidelines

1. Provide and implement evidence-based guidelines that address catheter use,

insertion, and maintenance. (Category IB)

a. Consider monitoring adherence to facility-based criteria for acceptable

indications for indwelling urinary catheter use. (Category II)

B. Education and Training

1. Ensure that healthcare personnel and others who take care of catheters are given
periodic in-service training regarding techniques and procedures for urinary catheter
insertion, maintenance, and removal. Provide education about CAUTI, other
complications of urinary catheterization, and alternatives to indwelling catheters.
(Category IB)

2. When feasible, consider providing performance feedback to these personnel on what

proportion of catheters they have placed meet facility-based criteria and other
aspects related to catheter care and maintenance. (Category II)

C. Supplies

1. Ensure that supplies necessary for aseptic technique for catheter insertion are
readily available. (Category IB)

D. System of documentation

1. Consider implementing a system for documenting the following in the patient record:
indications for catheter insertion, date and time of catheter insertion, individual who
inserted catheter, and date and time of catheter removal. (Category II)

a. Ensuring that documentation is accessible in the patient record and recorded in a

standard format for data collection and quality improvement purposes is
suggested. Electronic documentation that is searchable is preferable. (Category
II)

E. Surveillance resources

1. If surveillance for CAUTI is performed, ensure that there are sufficient trained
personnel and technology resources to support surveillance for urinary catheter
use and outcomes. (Category IB)

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VI. Surveillance

A. Consider surveillance for CAUTI when indicated by facility-based risk assessment.

(Category II)

1. Identify the patient groups or units on which to conduct surveillance based on

frequency of catheter use and potential risk of CAUTI.

B. Use standardized methodology for performing CAUTI surveillance. (Category IB)

1. Examples of metrics that should be used for CAUTI surveillance include:

a. Number of CAUTI per 1000 catheter-days

b. Number of bloodstream infections secondary to CAUTI per 1000

catheter-days

c. Catheter utilization ratio: (urinary catheter days/patient days) x 100

2. Use CDC/NHSN criteria for identifying patients who have symptomatic UTI
(SUTI) (numerator data) (see NHSN Patient Safety Manual:
http://www.cdc.gov/nhsn/library.html).

3. For more information on metrics, please see the U.S. Department of Health &
Human Services (HHS) Action Plan to Prevent Healthcare-Associated Infections:
http://www.hhs.gov/ophs/initiatives/hai/infection.html.

C. Routine screening of catheterized patients for asymptomatic bacteriuria (ASB) is not

recommended. (Category II) (Key Question 2D)

D. When performing surveillance for CAUTI, consider providing regular (e.g., quarterly)
feedback of unit-specific CAUTI rates to nursing staff and other appropriate clinical care
staff. (Category II) (Key Question 2D)

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III. Implementation and Audit

Prioritization of Recommendations

In this section, the recommendations considered essential for all healthcare facilities caring for
patients requiring urinary catheterization are organized into modules in order to provide more
guidance to facilities on implementation of these guidelines. The high-priority recommendations
were chosen by a consensus of experts based on strength of recommendation as well as on the
likely impact of the strategy in preventing CAUTI. The administrative functions and infrastructure
listed above in the summary of recommendations are necessary to accomplish the high priority
recommendations and are therefore critical to the success of a prevention program. In addition,
quality improvement programs should be implemented as an active approach to accomplishing
these recommendations and when process and outcome measure goals are not being met
based on internal reporting.

Priority Recommendations for Appropriate Urinary Catheter Use (Module 1)

• Insert catheters only for appropriate indications (see Table 2), and leave in place only as
long as needed. (Category IB)
o Avoid use of urinary catheters in patients and nursing home residents for
management of incontinence. (Category IB)
o For operative patients who have an indication for an indwelling catheter, remove
the catheter as soon as possible postoperatively, preferably within 24 hours,
unless there are appropriate indications for continued use. (Category IB)

Priority Recommendations for Aseptic Insertion of Urinary Catheters (Module 2)

• Ensure that only properly trained persons (e.g., hospital personnel, family members, or
patients themselves) who know the correct technique of aseptic catheter insertion and
maintenance are given this responsibility. (Category IB)
• In the acute care hospital setting, insert catheters using aseptic technique and sterile
equipment. (Category IB)

Priority Recommendations for Proper Urinary Catheter Maintenance (Module 3)

• Following aseptic insertion of the urinary catheter, maintain a closed drainage system
(Category IB)
• Maintain unobstructed urine flow. (Category IB)

Performance Measures

A. Internal Reporting. Consider reporting both process and outcome measures to senior
administrative, medical, and nursing leadership and clinicians who care for patients
at risk for CAUTI. (Category II)
1. Examples of process measures:
a) Compliance with educational program: Calculate percent of personnel who
have proper training:
• Numerator: number of personnel who insert urinary catheters and
who have proper training
• Denominator: number of personnel who insert urinary catheters
• Standardization factor: 100 (i.e., multiply by 100 so that measure is
expressed as a percentage)

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b) Compliance with documentation of catheter insertion and removal dates:

Conduct random audits of selected units and calculate compliance rate:
• Numerator: number of patients on unit with catheters with proper
documentation of insertion and removal dates
• Denominator: number of patients on the unit with a catheter in place
at some point during admission
• Standardization factor: 100 (i.e., multiply by 100 so that measure is
expressed as a percentage)
c) Compliance with documentation of indication for catheter placement: Conduct
random audits of selected units and calculate compliance rate
• Numerator: number of patients on unit with catheters with proper
documentation of indication
• Denominator: number of patients on the unit with catheter in place
• Standardization factor: 100 (i.e., multiply by 100 so that measure is
expressed as a percentage)
2. Recommended outcome measures:
a) Rates of CAUTI: Use NHSN definitions (see
http://www.cdc.gov/nhsn/library.html). Measurement of rates allows an
individual facility to gauge the longitudinal impact of implementation of
prevention strategies:
• Numerator: number of CAUTIs in each location monitored
• Denominator: total number of urinary catheter-days for all patients
that have an indwelling urinary catheter in each location monitored
• Standardization factor: Multiply by 1000 so that the measure is
expressed as cases per 1000 catheter-days
b) Rate of bloodstream infections secondary to CAUTI: Use NHSN definitions
for laboratory-confirmed bloodstream infection, available at
http://www.cdc.gov/nhsn/library.html.
• Numerator: number of episodes of bloodstream infections
secondary to CAUTI
• Denominator: total number of urinary catheter-days for all patients
that have an indwelling urinary catheter in each location monitored
• Standardization factor: Multiply by 1000 so that the measure is
expressed as cases per 1000 catheter-days

B. External Reporting. Current NHSN definitions for CAUTI were developed for
monitoring of rates within a facility; however, reporting of CAUTI rates for facility-to-
facility comparison might be requested by state requirements and external quality
initiatives.

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IV. Recommendations for Further Research

Our literature review revealed that many of the studies addressing strategies to prevent CAUTI
were not of sufficient quality to allow firm conclusions regarding the benefit of certain
interventions. Future studies of CAUTI prevention should:
1) Be primary analytic research (i.e. systematic reviews, meta-analyses,
interventional studies, and observational studies [cohort, case-control, analytic
cross-sectional studies])
2) Evaluate clinically relevant outcomes (e.g., SUTI, bloodstream infections
secondary to CAUTI)
3) Adjust for confounders as needed using multivariable analyses
4) Stratify outcomes by patient populations at risk for CAUTI
5) Ensure adequate statistical power to detect differences

The following is a compilation of recommendations for further research:

1. Catheter materials
a. Antimicrobial and antiseptic-impregnated catheters
i. Effect of catheters on reducing the risk of SUTI and other clinically
significant outcomes
ii. Patient populations most likely to benefit
iii. Incidence of antimicrobial resistance in urinary pathogens
iv. Role of bacterial biofilms in the pathogenesis of CAUTI
b. Standard catheters
i. Optimal materials for reducing the risk of CAUTI and other urethral
complications

2. Appropriate urinary catheter use

a. Incontinent patients
i. Risks and benefits of periodic (e.g., nighttime) use of external catheters
ii. Risk of local complications (e.g., skin maceration, phimosis) with the use
of external catheters
iii. Appropriate use of urinary catheters to manage sacral or perineal wounds
b. Appropriate indications for continued use in postoperative patients and
associated risks

3. Antiseptics
a. Use of antiseptic vs. sterile solutions for periurethral cleaning prior to catheter
insertion
b. Use of antiseptics (e.g., methenamine) to prevent CAUTI

4. Alternatives to indwelling urethral catheters and bag drainage

a. Risks and benefits of suprapubic catheters as an alternative to chronic indwelling
urethral catheters
b. Use of a urethral stent as an alternative to an indwelling catheter in selected
patients with bladder outlet obstruction
c. Use of catheter valves in reducing the risk of CAUTI and other urinary
complications
d. Other alternative methods of urinary drainage

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5. Optimal methods for preventing encrustation in long-term catheterized patients who

have frequent obstruction
a. Optimal catheter materials
b. Irrigation with acidifying solutions or oral urease inhibitors
c. Use of methenamine

6. Other prevention measures

a. Use of portable ultrasound in patients with low-urine output to reduce
unnecessary catheter insertions or irrigations (in catheterized patients)
b. Use of new prevention strategies such as bacterial interference in patients
requiring chronic catheterization
c. Optimal cleaning and storage procedures (e.g., wet vs. dry storage) for catheters
used for clean intermittent catheterization

7. Prevention of transmission
a. Spatial separation of patients with urinary catheters (in the absence of epidemic
spread or frequent cross-infection) to prevent transmission of pathogens
colonizing urinary drainage systems

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V. Background

Urinary tract infections are the most common type of healthcare-associated infection,
accounting for more than 30% of infections reported by acute care hospitals.19 Virtually all
healthcare-associated UTIs are caused by instrumentation of the urinary tract. Catheter-
associated urinary tract infection (CAUTI) has been associated with increased morbidity,
mortality, hospital cost, and length of stay.6-9 In addition, bacteriuria commonly leads to
unnecessary antimicrobial use, and urinary drainage systems are often reservoirs for multidrug-
resistant bacteria and a source of transmission to other patients.10,11

Definitions

An indwelling urinary catheter is a drainage tube that is inserted into the urinary bladder through
the urethra, is left in place, and is connected to a closed collection system. Alternative methods
of urinary drainage may be employed in some patients. Intermittent (“in-and-out”)
catheterization involves brief insertion of a catheter into the bladder through the urethra to drain
urine at intervals. An external catheter is a urine containment device that fits over or adheres to
the genitalia and is attached to a urinary drainage bag. The most commonly used external
catheter is a soft flexible sheath that fits over the penis (“condom” catheter). A suprapubic
catheter is surgically inserted into the bladder through an incision above the pubis.

Although UTIs associated with alternative urinary drainage systems are considered device-
associated, CAUTI rates reported to the National Healthcare Safety Network (NHSN) only refer
to those associated with indwelling urinary catheters. NHSN has recently revised the UTI
surveillance definition criteria. Among the changes are removal of the asymptomatic bacteriuria
(ASB) criterion and refinement of the criteria for defining symptomatic UTI (SUTI). The time
period for follow-up surveillance after catheter removal also has been shortened from 7 days to
48 hours to align with other device-associated infections. The new UTI criteria, which took effect
in January 2009, can be found in the NHSN Patient Safety Manual
(http://www.cdc.gov/nhsn/library.html).

The limitations and heterogeneity of definitions of CAUTI used in various studies present major
challenges in appraising the quality of evidence in the CAUTI literature. Study investigators
have used numerous different definitions for CAUTI outcomes, ranging from simple bacteriuria
at a range of concentrations to, less commonly, symptomatic infection defined by combinations
of bacteriuria and various signs and symptoms. Futhermore, most studies that used CDC/NHSN
30
definitions for CAUTI did not distinguish between SUTI and ASB in their analyses. The
heterogeneity of definitions used for CAUTI may reduce the quality of evidence for a given
intervention and often precludes meta-analyses.

The clinical significance of ASB in catheterized patients is undefined. Approximately 75% to

90% of patients with ASB do not develop a systemic inflammatory response or other signs or
6,31
symptoms to suggest infection. Monitoring and treatment of ASB is also not an effective
prevention measure for SUTI, as most cases of SUTI are not preceded by bacteriuria for more
25
than a day. Treatment of ASB has not been shown to be clinically beneficial and is associated
with the selection of antimicrobial-resistant organisms.

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Epidemiology

Between 15% and 25% of hospitalized patients may receive short-term indwelling urinary
12,13
catheters. In many cases, catheters are placed for inappropriate indications, and healthcare
providers are often unaware that their patients have catheters, leading to prolonged,
14-16
unnecessary use. In acute care hospitals reporting to NHSN in 2006, pooled mean urinary
catheter utilization ratios in ICU and non-ICU areas ranged from 0.23-0.91 urinary catheter-
17
days/patient-days. While the numbers of units reporting were small, the highest ratios were in
trauma ICUs and the lowest in inpatient medical/surgical wards. The overall prevalence of long-
term indwelling urethral catheterization use is unknown. The prevalence of urinary catheter use
in residents in long-term care facilities in the United States is on the order of 5%, representing
18
approximately 50,000 residents with catheters at any given time. This number appears to be
declining over time, likely because of federally mandated nursing home quality measures.
However, the high prevalence of urinary catheters in patients transferred to skilled nursing
facilities suggests that acute care hospitals should focus more efforts on removing unnecessary
18
catheters prior to transfer.

Reported rates of UTI among patients with urinary catheters vary substantially. National data
from NHSN acute care hospitals in 2006 showed a range of pooled mean CAUTI rates of 3.1-
17
7.5 infections per 1000 catheter-days. The highest rates were in burn ICUs, followed by
inpatient medical wards and neurosurgical ICUs, although these sites also had the fewest
numbers of locations reporting. The lowest rates were in medical/surgical ICUs.

Although morbidity and mortality from CAUTI is considered to be relatively low compared to
other HAIs, the high prevalence of urinary catheter use leads to a large cumulative burden of
infections with resulting infectious complications and deaths. An estimate of annual incidence of
HAIs and mortality in 2002, based on a broad survey of US hospitals, found that urinary tract
infections made up the highest number of infections (> 560,000) compared to other HAIs, and
19
attributable deaths from UTI were estimated to be over 13,000 (mortality rate 2.3%). And while
fewer than 5% of bacteriuric cases develop bacteremia,6 CAUTI is the leading cause of
secondary nosocomial bloodstream infections; about 17% of hospital-acquired bacteremias are
20
from a urinary source, with an associated mortality of approximately 10%. In the nursing home
setting, bacteremias are most commonly caused by UTIs, the majority of which are catheter-
21
related.

An estimated 17% to 69% of CAUTI may be preventable with recommended infection control
measures, which means that up to 380,000 infections and 9000 deaths related to CAUTI per
22
year could be prevented.

Pathogenesis and Microbiology

The source of microorganisms causing CAUTI can be endogenous, typically via meatal, rectal,
or vaginal colonization, or exogenous, such as via contaminated hands of healthcare personnel
or equipment. Microbial pathogens can enter the urinary tract either by the extraluminal route,
via migration along the outside of the catheter in the periurethral mucous sheath, or by the
intraluminal route, via movement along the internal lumen of the catheter from a contaminated
collection bag or catheter-drainage tube junction. The relative contribution of each route in the
pathogenesis of CAUTI is not well known. The marked reduction in risk of bacteriuria with the
23
introduction of the sterile, closed urinary drainage system in the1960’s suggests the
importance of the intraluminal route. However, even with the closed drainage system,

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bacteriuria inevitably occurs over time either via breaks in the sterile system or via the
24 25,26
extraluminal route. The daily risk of bacteriuria with catheterization is 3% to 10%,
approaching 100% after 30 days, which is considered the delineation between short and long-
27
term catheterization.

Formation of biofilms by urinary pathogens on the surface of the catheter and drainage system
28
occurs universally with prolonged duration of catheterization. Over time, the urinary catheter
becomes colonized with microorganisms living in a sessile state within the biofilm, rendering
them resistant to antimicrobials and host defenses and virtually impossible to eradicate without
removing the catheter. The role of bacteria within biofilms in the pathogenesis of CAUTI is
unknown and is an area requiring further research.

The most frequent pathogens associated with CAUTI (combining both ASB and SUTI) in
hospitals reporting to NHSN between 2006-2007 were Escherichia coli (21.4%) and Candida
spp (21.0%), followed by Enterococcus spp (14.9%), Pseudomonas aeruginosa (10.0%),
Klebsiella pneumoniae (7.7%), and Enterobacter spp (4.1%). A smaller proportion was caused
by other gram-negative bacteria and Staphylococcus spp 5.

Antimicrobial resistance among urinary pathogens is an ever increasing problem. About a

quarter of E. coli isolates and one third of P. aeruginosa isolates from CAUTI cases were
fluoroquinolone-resistant. Resistance of gram-negative pathogens to other agents, including
third-generation cephalosporins and carbapenems, was also substantial 5. The proportion of
organisms that were multidrug-resistant, defined by non-susceptibility to all agents in 4 classes,
29
was 4% of P. aeruginosa, 9% of K. pneumoniae, and 21% of Acinetobacter baumannii.

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VI. Scope and Purpose

This guideline updates and expands the original CDC Guideline for Prevention of CAUTI
published in 1981. The revised guideline addresses the prevention of CAUTI for patients in
need of either short- or long-term (i.e., > 30 days) urinary catheterization in any type of
healthcare facility and evaluates evidence for alternative methods of urinary drainage, including
intermittent catheterization, external catheters, and suprapubic catheters. The guideline also
includes specific recommendations for implementation, performance measurement, and
surveillance. Recommendations for further research are also provided to address the
knowledge gaps in CAUTI prevention identified during the literature review.

To evaluate the evidence on preventing CAUTI, we examined data addressing three key
questions and related subquestions:

1. Who should receive urinary catheters?

A. When is urinary catheterization necessary?
B. What are the risk factors for CAUTI?
C. What populations are at highest risk of mortality from catheters?
2. For those who may require urinary catheters, what are the best practices?
Specifically, what are the risks and benefits associated with:
A. Different approaches to catheterization?
B. Different catheters or collecting systems?
C. Different catheter management techniques?
D. Different systems interventions (i.e., quality improvement programs)?
3. What are the best practices for preventing UTI associated with obstructed urinary
catheters?

This document is intended for use by infection prevention staff, healthcare epidemiologists,
healthcare administrators, nurses, other healthcare providers, and persons responsible for
developing, implementing, and evaluating infection prevention and control programs for
healthcare settings across the continuum of care. The guideline can also be used as a resource
for societies or organizations that wish to develop more detailed implementation guidance for
prevention of CAUTI.

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VII. Methods
This guideline was based on a targeted systematic review of the best available evidence on
CAUTI prevention. We used the Grading of Recommendations Assessment, Development and
Evaluation (GRADE) approach 32-34 to provide explicit links between the available evidence and
the resulting recommendations. Our guideline development process is outlined in Figure 1.

Figure 1. The Guideline Development Process

GUIDELINE SEARCH

DEVELOPMENT OF KEY QUESTIONS

Review of relevant guidelines to inform key questions

LITERATURE SEARCH
Databases identified; search strategy developed;
references stored; duplicates resolved

ABSTRACT AND FULL-TEXT SCREENING

To identify studies which were a) relevant to one or more
key questions b) primary analytic research, systematic
review or meta-analysis and c) written in English

DATA EXTRACTION AND SYNTHESIS

Data abstracted into evidence tables; study quality
assessed

DRAFT RECOMMENDATIONS
Strength of evidence graded; summaries and
recommendations drafted

FINALIZE RECOMMENDATIONS
Recommendations finalized; guideline published

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Development of Key Questions

We first conducted an electronic search of the National Guideline Clearinghouse® (Agency for
Healthcare Research and Quality), Medline® (National Library of Medicine) using the Ovid®
Platform (Ovid Technologies, Wolters Kluwer, New York, NY), the Cochrane® Health
Technology Assessment Database (Cochrane Collaboration, Oxford, UK), the NIH Consensus
Development Program, and the United States Preventive Services Task Force database for
existing national and international guidelines relevant to CAUTI. The strategy used for the
guideline search and the search results can be found in Appendix 1A. A preliminary list of key
questions was developed from a review of the relevant guidelines identified in the search.1,35,36
Key questions were finalized after vetting them with a panel of content experts and HICPAC
members.

Literature Search

Following the development of the key questions, search terms were developed for identifying
literature relevant to the key questions. For the purposes of quality assurance, we compared
these terms to those used in relevant seminal studies and guidelines. These search terms were
then incorporated into search strategies for the relevant electronic databases. Searches were
performed in Medline® (National Library of Medicine) using the Ovid® Platform (Ovid
Technologies, Wolters Kluwer, New York, NY), EMBASE® (Elsevier BV, Amsterdam,
Netherlands), CINAHL® (Ebsco Publishing, Ipswich, MA) and Cochrane® (Cochrane
Collaboration, Oxford, UK) (all databases were searched in July 2007), and the resulting
references were imported into a reference manager, where duplicates were resolved. For
Cochrane reviews ultimately included in our guideline, we checked for updates in July 2008.
The detailed search strategy used for identifying primary literature and the results of the search
can be found in Appendix 1B.

Study Selection

Titles and abstracts from references were screened by a single author (C.V.G, R.K.A., or
D.A.P.) and the full text articles were retrieved if they were 1) relevant to one or more key
questions, 2) primary analytic research, systematic reviews or meta-analyses, and 3) written in
English. Likewise, the full-text articles were screened by a single author (C.V.G. or D.A.P.) using
the same criteria, and included studies underwent a second review for inclusion by another
author (R.K.A.). Disagreements were resolved by the remaining authors. The results of this
process are depicted in Figure 2.

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Figure 2: Results of the Study Selection Process

8065 potentially relevant

studies identified

7005 studies excluded based

on title and abstract

1060 studies retrieved for

preliminary evaluation

811 studies excluded because:

Not in English (n=5); not primary analytic
research, systematic review or meta-
analysis (n=386); not relevant to any key
question (n=364); present in included
systematic reviews (n=50); other (n=6)

249 studies included for

data extraction

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Data Extraction and Synthesis

Data on the study author, year, design, objective, population, setting, sample size, power,
follow-up, and definitions and results of clinically relevant outcomes were extracted into
evidence tables (Appendix 2). Three evidence tables were developed, each of which
represented one of our key questions. Studies were extracted into the most relevant evidence
table. Then, studies were organized by the common themes that emerged within each evidence
table. Data were extracted by one author (R.K.A.) and cross-checked by another (C.V.G.).
Disagreements were resolved by the remaining authors. Data and analyses were extracted as
originally presented in the included studies. Meta-analyses were performed only where their use
was deemed critical to a recommendation, and only in circumstances where multiple studies
with sufficiently homogenous populations, interventions, and outcomes could be analyzed.
Systematic reviews were included in our review. To avoid duplication of data, we excluded
primary studies if they were also included in a systematic review captured by our search. The
only exception to this was if the primary study also addressed a relevant question that was
outside the scope of the included systematic review. Before exclusion, data from the primary
studies that we originally captured were abstracted into the evidence tables and reviewed. We
also excluded systematic reviews that analyzed primary studies that were fully captured in a
more recent systematic review. The only exception to this was if the older systematic review
also addressed a relevant question that was outside the scope of the newer systematic review.
To ensure that all relevant studies were captured in the search, the bibliography was vetted by a
panel of clinical experts.

Grading of Evidence

First, the quality of each study was assessed using scales adapted from existing methodology
checklists, and scores were recorded in the evidence tables. Appendix 3 includes the sets of
questions we used to assess the quality of each of the major study designs. Next, the quality of
32
the evidence base was assessed using methods adapted from the GRADE Working Group.
Briefly, GRADE tables were developed for each of the interventions or questions addressed
within the evidence tables. Included in the GRADE tables were the intervention of interest, any
outcomes listed in the evidence tables that were judged to be clinically important, the quantity
and type of evidence for each outcome, the relevant findings, and the GRADE of evidence for
each outcome, as well as an overall GRADE of the evidence base for the given intervention or
question. The initial GRADE of evidence for each outcome was deemed high if the evidence
base included a randomized controlled trial (RCT) or a systematic review of RCTs, low if the
evidence base included only observational studies, or very low if the evidence base consisted
34
only of uncontrolled studies. The initial GRADE could then be modified by eight criteria.
Criteria which could decrease the GRADE of an evidence base included quality, consistency,
directness, precision, and publication bias. Criteria that could increase the GRADE included a
large magnitude of effect, a dose-response gradient, or inclusion of unmeasured confounders
that would increase the magnitude of effect (Table 3). GRADE definitions are as follows:
1. High - further research is very unlikely to change confidence in the estimate of effect
2. Moderate - further research is likely to affect confidence in the estimate of effect and
may change the estimate
3. Low - further research is very likely to affect confidence in the estimate of effect and is
likely to change the estimate
4. Very low - any estimate of effect is very uncertain

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After determining the GRADE of the evidence base for each outcome of a given intervention or
question, we calculated the overall GRADE of the evidence base for that intervention or
question. The overall GRADE was based on the lowest GRADE for the outcomes deemed
critical to making a recommendation.

Table 3. Rating the Quality of Evidence Using the GRADE Approach

Type of Initial Criteria to Decrease Criteria to Increase Overall

Evidence Grade Grade Grade Quality Grade

RCT High Quality Strong association High

Serious (-1 grade) or Strong (+1 grade) or
very serious (-2 grades) very strong evidence Moderate
limitation to study quality of association (+2
Observational Low grades) Low
study Consistency
Important inconsistency Dose-response
Any other Very (-1 grade) Evidence of a dose- Very low
evidence low response gradient (+1
(e.g., expert Directness grade)
opinion) Some (-1 grade) or major
(-2 grades) uncertainty Unmeasured
about directness Confounders
Inclusion of
Precision unmeasured
Imprecise or sparse data confounders
(-1 grade) increases the
magnitude of effect
Publication bias (+1 grade)
High risk of bias (-1
grade)

Formulating Recommendations

Narrative evidence summaries were then drafted by the working group using the evidence and
GRADE tables. One summary was written for each theme that emerged under each key
question. The working group then used the narrative evidence summaries to develop guideline
recommendations. Factors determining the strength of a recommendation included 1) the
values and preferences used to determine which outcomes were "critical," 2) the harms and
benefits that result from weighing the "critical" outcomes, and 3) the overall GRADE of the
33
evidence base for the given intervention or question (Table 4). If weighing the "critical
outcomes" for a given intervention or question resulted in a "net benefit" or a "net harm," then a
"Category I Recommendation" was formulated to strongly recommend for or against the given
intervention respectively. If weighing the "critical outcomes" for a given intervention or question
resulted in a "trade off" between benefits and harms, then a "Category II Recommendation" was
formulated to recommend that providers or institutions consider the intervention when deemed
appropriate. If weighing the "critical outcomes" for a given intervention or question resulted in

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an "uncertain trade off" between benefits and harms, then a "No Recommendation" was
formulated to reflect this uncertainty.

Table 4. Formulating Recommendations

Weighing Benefits and
HICPAC Recommendation Harms for Critical Quality of Evidence
Outcomes
IA – High to Moderate
IB – Low or
Interventions with net benefits
Very Low (Accepted
STRONG (I) or net harms
Practice)
IC – High to Very Low
(Regulatory)
Inteventions with trade offs
WEAK (II) between benefits and harms High to Very Low

No recommendation/ Uncertain trade offs between

Low to Very Low
unresolved issue benefits and harms

For Category I recommendations, levels A and B represent the quality of the evidence
underlying the recommendation, with A representing high to moderate quality evidence and B
representing low quality evidence or, in the case of an established standard (e.g., aseptic
technique, education and training), very low quality to no evidence based on our literature
review. For IB recommendations, although there may be low to very low quality or even no
available evidence directly supporting the benefits of the intervention, the theoretical benefits
are clear, and the theoretical risks are marginal. Level C represents practices required by state
or federal regulation, regardless of the quality of evidence. It is important to note that the
strength of a Category IA recommendation is equivalent to that of a Category IB or IC
recommendation; it is only the quality of the evidence underlying the IA recommendation that
makes it different from a IB.

In some instances, multiple recommendations emerged from a single narrative evidence

summary. The new HICPAC categorization scheme for recommendations is provided in Table
1, which is reproduced below.

Table 1. Modified HICPAC Categorization Scheme for Recommendations

Category IA A strong recommendation supported by high to moderate quality evidence
suggesting net clinical benefits or harms
Category IB A strong recommendation supported by low quality evidence suggesting
net clinical benefits or harms or an accepted practice (e.g., aseptic
technique) supported by low to very low quality evidence
Category IC A strong recommendation required by state or federal regulation.
Category II A weak recommendation supported by any quality evidence suggesting a
trade off between clinical benefits and harms
No recommendation/ Unresolved issue for which there is low to very low quality evidence with
unresolved issue uncertain trade offs between benefits and harms

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Category I recommendations are defined as strong recommendations with the following

implications:
1. For patients: Most people in the patient’s situation would want the recommended course
of action and only a small proportion would not; request discussion if the intervention is
not offered.
2. For clinicians: Most patients should receive the recommended course of action.
3. For policymakers: The recommendation may be adopted as a policy.

Category II recommendations are defined as weak recommendations with the following

implications:
1. For patients: Most people in the patient’s situation would want the recommended course
of action, but many would not.
2. For clinicians: Different choices will be appropriate for different patients, and clinicians
must help each patient to arrive at a management decision consistent with her or his
values and preferences.
3. For policymakers: Policy making will require substantial debate and involvement of many
stakeholders.

It should be noted that Category II recommendations are discretionary for the individual
institution and are not intended to be enforced.

The wording of each recommendation was carefully selected to reflect the recommendation's
strength. In most cases, we used the active voice when writing Category I recommendations -
the strong recommendations. Phrases like "do" or "do not" and verbs without auxiliaries or
conditionals were used to convey certainty. We used a more passive voice when writing
Category II recommendations - the weak recommendations. Words like "consider” and phrases
like "is preferable,” “is suggested,” “is not suggested,” or “is not recommended” were chosen to
reflect the lesser certainty of the Category II recommendations. Rather than a simple statement
of fact, each recommendation is actionable, describing precisely a proposed action to take.

The category "No recommendation/unresolved issue" was most commonly applied to situations
where either 1) the overall quality of the evidence base for a given intervention was low to very
low and there was no consensus on the benefit of the intervention or 2) there was no published
evidence on outcomes deemed critical to weighing the risks and benefits of a given intervention.
If the latter was the case, those critical outcomes will be noted at the end of the relevant
evidence summary.

Our evidence-based recommendations were cross-checked with those from guidelines identified
in our original systematic search. Recommendations from previous guidelines for topics not
directly addressed by our systematic review of the evidence were included in our "Summary of
Recommendations" if they were deemed critical to the target users of this guideline. Unlike
recommendations informed by our literature search, these recommendations are not linked to a
key question. These recommendations were agreed upon by expert consensus and are
designated either IB if they represent a strong recommendation based on accepted practices
(e.g., aseptic technique) or II if they are a suggestion based on a probable net benefit despite
limited evidence.
All recommendations were approved by HICPAC. Recommendations focused only on efficacy,
effectiveness, and safety. The optimal use of these guidelines should include a consideration of
the costs relevant to the local setting of guideline users.

Reviewing and Finalizing the Guideline

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After a draft of the tables, narrative summaries, and recommendations was completed, the
working group shared the draft with the expert panel for in-depth review. While the expert panel
was reviewing this draft, the working group completed the remaining sections of the guideline,
including the executive summary, background, scope and purpose, methods, summary of
recommendations, and recommendations for guideline implementation, audit, and further
research. The working group then made revisions to the draft based on feedback from
members of the expert panel and presented the entire draft guideline to HICPAC for review.
The guideline was then posted on the Federal Register for public comment. After a period of
public comment, the guideline was revised accordingly, and the changes were reviewed and
voted on by HICPAC. The final guideline was cleared internally by CDC and published and
posted on the HICPAC website.

Updating the Guideline

Future revisions to this guideline will be dictated by new research and technological
advancements for preventing CAUTI and will occur at the request of HICPAC.

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VIII. Evidence Review

Q1. Who should receive urinary catheters?

To answer this question, we focused on three subquestions: A) When is urinary catheterization
necessary? B) What are the risk factors for CAUTI? and C) What populations are at highest risk
of mortality from urinary catheters?

Q1A. When is urinary catheterization necessary?

The available data examined five main populations. In all populations, we considered CAUTI
outcomes as well as other outcomes we deemed critical to weighing the risks and benefits of
catheterization. The evidence for this question consists of 1 systematic review,37 9 RCTs,38-46
and 12 observational studies.47-58 The findings of the evidence review and the grades for all
important outcomes are shown in Evidence Review Table 1A.

For operative patients, low-quality evidence suggested a benefit of avoiding urinary

catheterization.37-44,47-49 This was based on a decreased risk of bacteriuria/unspecified UTI, no
effect on bladder injury, and increased risk of urinary retention in patients without catheters.
Urinary retention in patients without catheters was specifically seen following urogenital
surgeries. The most common surgeries studied were urogenital, gynecological, laparoscopic,
and orthopedic surgeries. Our search did not reveal data on the impact of catheterization on
peri-operative hemodynamic management.

For incontinent patients, low-quality evidence suggested a benefit of avoiding urinary

catheterization.45,50-52 This was based on a decreased risk of both SUTI and
bacteriuria/unspecified UTI in male nursing home residents without urinary catheters compared
to those with continuous condom catheters. We found no difference in the risk of UTI between
having a condom catheter only at night and having no catheter. Our search did not reveal data
on the impact of catheterization on skin breakdown.

For patients with bladder outlet obstruction, very low-quality evidence suggested a benefit of a
urethral stent over an indwelling catheter.53 This was based on a reduced risk of bacteriuria in
those receiving a urethral stent. Our search did not reveal data on the impact of catheterization
versus stent placement on urinary complications.

For patients with spinal cord injury, very low-quality evidence suggested a benefit of avoiding
indwelling urinary catheters.54,56 This was based on a decreased risk of SUTI and bacteriuria in
those without indwelling catheters (including patients managed with spontaneous voiding, clean
intermittent catheterization [CIC], and external striated sphincterotomy with condom catheter
drainage), as well as a lower risk of urinary complications, including hematuria, stones, and
urethral injury (fistula, erosion, stricture).

For children with myelomeningocele and neurogenic bladder, very low-quality evidence
suggested a benefit of CIC compared to urinary diversion or self voiding.46,57,58 This was based
on a decreased risk of bacteriuria/unspecified UTI in patients receiving CIC compared to urinary
diversion, and a lower risk of urinary tract deterioration (defined by febrile urinary tract infection,
vesicoureteral reflux, hydronephrosis, or increases in BUN or serum creatinine) compared to
self-voiding and in those receiving CIC early (< 1 year of age) versus late (> 3 years of age).

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Evidence Review Table 1A. When is urinary catheterization necessary?

1A.1. Use urinary catheters in operative patients only as necessary, rather than routinely.
(Category IB)

1A.2. Avoid use of urinary catheters in patients and nursing home residents for management of
incontinence. (Category IB)

1A.2.a. Further research is needed on periodic (e.g., nighttime) use of external catheters in
incontinent patients or residents and the use of catheters to prevent skin breakdown. (No
recommendation/unresolved issue)

1A.3. Further research is needed on the benefit of using a urethral stent as an alternative to an
indwelling catheter in selected patients with bladder outlet obstruction. (No
recommendation/unresolved issue)

1A.4. Consider alternatives to chronic indwelling catheters, such as intermittent catheterization,

in spinal cord injury patients. (Category II)

1A.5. Consider intermittent catheterization in children with myelomeningocele and neurogenic

bladder to reduce the risk of urinary tract deterioration. (Category II)

Q1B. What are the risk factors for CAUTI?

To answer this question, we reviewed the quality of evidence for those risk factors examined in
more than one study. We considered the critical outcomes for decision-making to be SUTI and
bacteriuria. The evidence for this question consists of 11 RCTs59-69 and 37 observational
studies.9,50,54,70-103 The findings of the evidence review and the grades for all important outcomes
are shown in Evidence Review Table 1B.

For SUTI, 50,54,61,62,74,75,79,83,102,103 low-quality evidence suggested that female sex, older age,
prolonged catheterization, impaired immunity, and lack of antimicrobial exposure are risk
factors. Very low quality evidence suggested that catheter blockage and low albumin level are
also risk factors. For bacteriuria, 9,59-61,63-68,72,73,76-78,82,84-86,89-94,96-100 multiple risk factors were
identified; there was high quality evidence for prolonged catheterization and moderate quality
evidence for female sex, positive meatal cultures, and lack of antimicrobial exposure. Low-
quality evidence also implicated the following risk factors for bacteriuria: older age,
disconnection of the drainage system, diabetes, renal dysfunction, higher severity of illness,
impaired immunity, placement of the catheter outside of the operating room, lower professional
training of the person inserting the catheter, incontinence, and being on an orthopaedic or
neurology service. Our search did not reveal data on adverse events and antimicrobial
resistance associated with antimicrobial use, although one observational study found that the
protective effect of antimicrobials lasted only for the first four days of catheterization, and that
antimicrobial exposure led to changes in the epidemiology of bacterial flora in the urine.

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Evidence Review Table 1B. What are the risk factors for CAUTI?

1B.1. Following aseptic insertion of the urinary catheter, maintain a closed drainage system.
(Category IB)a

1B.2. Insert catheters only for appropriate indications, and leave in place only as long as
needed. (Category IB)b

1B.3. Minimize urinary catheter use and duration of use in all patients, particularly those at
higher risk for CAUTI such as women, the elderly, and patients with impaired immunity.
(Category IB)

1B.4. Ensure that only properly trained persons (e.g., hospital personnel, family members, or
patients themselves) who know the correct technique of aseptic catheter insertion and
maintenance are given this responsibility. (Category IB)

1B.5. Maintain unobstructed urine flow. (Category IB)c

a
More data are available under Question 2B.
b
More data are available under Question 2C.
c
More data are available under Question 2D.

Q1C. What populations are at highest risk of mortality from urinary catheters?

To answer this question, we reviewed the quality of evidence for those risk factors examined in
more than one study. The evidence for this question consists of 2 observational studies.7,74 The
findings of the evidence review and the grades for all important outcomes are shown in
Evidence Review Table 1C.

Low-quality evidence suggested that older age, higher severity of illness, and being on an
internal medicine service compared to a surgical service were independent risk factors for
mortality in patients with indwelling urinary catheters. Both studies evaluating these risk factors
found the highest risk of mortality in patients over 70 years of age. Low-quality evidence also
suggested that CAUTI was a risk factor for mortality in patients with catheters.

Evidence Review Table 1C. What populations are at highest risk of mortality from
catheters?

1C.1. Minimize urinary catheter use and duration in all patients, particularly those who may be
at higher risk for mortality due to catheterization, such as the elderly and patients with severe
illness. (Category IB)

Q2. For those who may require urinary catheters, what are the best
practices?

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To answer this question, we focused on four subquestions: A) What are the risks and benefits
associated with different approaches to catheterization?, B) What are the risks and benefits
associated with different types of catheters or collecting systems?, C) What are the risks and
benefits associated with different catheter management techniques, and D) What are the risks
and benefits associated with different systems interventions?

Q2A. What are the risks and benefits associated with different approaches to
catheterization?

The available data examined the following comparisons of different catheterization approaches:

1) External versus indwelling urethral

2) Intermittent versus indwelling urethral
3) Intermittent versus suprapubic
4) Suprapubic versus indwelling urethral
5) Clean intermittent versus sterile intermittent

For all comparisons, we considered SUTI, bacteriuria/unspecified UTI, or combinations of these

outcomes depending on availability, as well as other outcomes critical to weighing the risks and
benefits of different catheterization approaches. The evidence for this question consists of 6
systematic reviews,37,104-108 16 RCTs,62,63,109-122 and 18 observational studies.54,73,81,84,123-136 The
findings of the evidence review and the grades for all important outcomes are shown in
Evidence Review Table 2A

Q2A.1. External versus indwelling urethral

Low-quality evidence suggested a benefit of using external catheters over indwelling urethral
catheters in male patients who require a urinary collection device but do not have an indication
for an indwelling catheter such as urinary retention or bladder outlet obstruction.81,109,123 This
was based on a decreased risk of a composite outcome of SUTI, bacteriuria, or death as well as
increased patient satisfaction with condom catheters. Differences were most pronounced in men
without dementia. Statistically significant differences were not found or reported for the
individual CAUTI outcomes or death. Our search did not reveal data on differences in local
complications such as skin maceration or phimosis.

Q2A.2. Intermittent versus indwelling urethral

Low-quality evidence suggested a benefit of using intermittent catheterization over indwelling

urethral catheters in selected populations.84,104-106,110-114,124-126,135,136 This was based on a
decreased risk of SUTI and bacteriuria/unspecified UTI but an increased risk of urinary retention
in postoperative patients with intermittent catheterization. In one study, urinary retention and
bladder distension were avoided by performing catheterization at regular intervals (every 6-8
hrs) until return of voiding. Studies of patients with neurogenic bladder most consistently found a
decreased risk of CAUTI with intermittent catheterization. Studies in operative patients whose
catheters were removed within 24 hrs of surgery found no differences in bacteriuria with
intermittent vs. indwelling catheterization, while studies where catheters were left in for longer
durations had mixed results. Our search did not reveal data on differences in patient
satisfaction.

Q2A.3. Intermittent versus suprapubic

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Very low-quality evidence suggested a benefit of intermittent over suprapubic catheterization in

selected populations115,116,134-136 based on increased patient acceptability and decreased risk of
urinary complications (bladder calculi, vesicoureteral reflux, and upper tract abnormalities).
Although we found a decreased risk of bacteriuria/unspecified UTI with suprapubic
catheterization, there were no differences in SUTI. The populations studied included women
undergoing urogynecologic surgery and spinal cord injury patients.

Q2A.4. Suprapubic versus indwelling urethral

Low-quality evidence suggested a benefit of suprapubic catheters over indwelling urethral

catheters in selected populations.37,62,104,107,108,128-133,135,136 This was based on a decreased risk of
bacteriuria/unspecified UTI, recatheterization, and urethral stricture, and increased patient
comfort and satisfaction. However, there were no differences in SUTI and an increased risk of
longer duration of catheterization with suprapubic catheters. Studies involved primarily
postoperative and spinal cord injury patients. Our search did not reveal data on differences in
complications related to catheter insertion or the catheter site.

Q2A.5. Clean intermittent versus sterile intermittent

Moderate-quality evidence suggested no benefit of using sterile over clean technique for
intermittent catheterization.63,73,105,117-122 No differences were found in the risk of SUTI or
bacteriuria/unspecified UTI. Study populations included nursing home residents and adults and
children with neurogenic bladder/spinal cord injury.

Evidence Review Table 2A. What are the risks and benefits associated with different
approaches to catheterization?

2A.1. Consider using external catheters as an alternative to indwelling urethral catheters in

cooperative male patients without urinary retention or bladder outlet obstruction. (Category II)

2A.2. Intermittent catheterization is preferable to indwelling urethral or suprapubic catheters in

patients with bladder emptying dysfunction. (Category II)

2A.3. If intermittent catheterization is used, perform it at regular intervals to prevent bladder

overdistension. (Category IB)

2A.4. For operative patients who have an indication for an indwelling catheter, remove the
catheter as soon as possible postoperatively, preferably within 24 hours, unless there are
appropriate indications for continued use. (Category IB)*

2A.5. Further research is needed on the risks and benefits of suprapubic catheters as an
alternative to indwelling urethral catheters in selected patients requiring short- or long-term
catheterization, particularly with respect to complications related to catheter insertion or the
catheter site. (No recommendation/unresolved issue)

2A.6. In the non-acute care setting, clean (i.e., non-sterile) technique for intermittent
catheterization is an acceptable and more practical alternative to sterile technique for patients
requiring chronic intermittent catheterization. (Category IA)
* More data are available under Question 2C

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Q2B. What are the risks and benefits associated with different catheters or
collecting systems?

The available data examined the following comparisons between different types of catheters
and drainage systems:

1. Antimicrobial/antiseptic catheters vs. standard catheters

a. Silver-coated catheters vs. standard catheters
b. Nitrofurazone-impregnated catheters vs. standard catheters
2. Hydrophilic catheters vs. standard catheters
3. Closed vs. open drainage systems
4. Complex vs. simple drainage systems
5. Preconnected/sealed junction catheters vs. standard catheters
6. Catheter valves vs. catheter bags

For all comparisons, we considered CAUTI outcomes as well as other outcomes critical to
weighing the risks and benefits of different types of catheters or collecting systems. The
evidence for this question consists of 5 systematic reviews,37,137-140 17 RCTs,64,143-158 23
observational studies,82,86,89,97,159-163, 165-178 and 3 economic analyses.179180,181 The findings of the
evidence review and the grades for all important outcomes are shown in Evidence Review
Table 2B.

Q2B.1.a. Silver-coated catheters vs. standard catheters

Low-quality evidence suggested a benefit of silver-coated catheters over standard latex

catheters.37,82,86,137-139,143,159-163, 165,166 This was based on a decreased risk of
bacteriuria/unspecified UTI with silver-coated catheters and no evidence of increased urethral
irritation or antimicrobial resistance in studies that reported data on microbiological outcomes.
Differences were significant for silver alloy-coated catheters but not silver oxide-coated
catheters. In a meta-analysis of randomized controlled trials (see Appendix), silver alloy-coated
catheters reduced the risk of asymptomatic bacteriuria compared to standard latex catheters
(control latex catheters were either uncoated or coated with hydrogel, Teflon®, or silicone),
whereas there were no differences when compared to standard, all silicone catheters. The
effect of silver alloy catheters compared to latex catheters was more pronounced when used in
patients catheterized <1 week. The results were robust to inclusion or exclusion of non peer-
reviewed studies. Only one observational study found a decrease in SUTI with silver alloy-
coated catheters.166 The setting was a burn referral center, where the control catheters were
latex, and patients in the intervention group had new catheters placed on admission, whereas
the control group did not. Recent observational studies in hospitalized patients found mixed
results for bacteriuria/unspecified UTI.

Q2B.1.b. Nitrofurazone-impregnated catheters vs. standard catheters

Low-quality evidence suggested a benefit of nitrofurazone-impregnated catheters in patients

catheterized for short periods of time.137,138 This was based on a decreased risk of bacteriuria
and no evidence of increased antimicrobial resistance in studies that reported microbiological
outcomes. Differences were significant in a meta-analysis of three studies examining
nitrofurazone-impregnated catheters (only one individual study significant) when duration of
catheterization was <1 week. No differences were seen when duration of catheterization was >1
week, although the meta-analysis was borderline significant.

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Q2B.2. Hydrophilic catheters vs. standard catheters

Very low-quality evidence suggested a benefit of hydrophilic catheters over standard non-
hydrophilic catheters in specific populations undergoing clean intermittent catheterization.137,144-
148,169
This was based on a decreased risk of SUTI, bacteriuria, hematuria, and pain during
insertion, and increased patient satisfaction. Differences in CAUTI outcomes were limited to one
study of spinal cord injury patients and one study of patients receiving intravesical
immunochemoprophylaxis for bladder cancer, while multiple other studies found no significant
differences.

Q2B.3. Closed vs. open drainage systems

Very low-quality evidence suggested a benefit of using a closed rather than open urinary
drainage system.89,171 This was based on a decreased risk of bacteriuria with a closed drainage
system. One study also found a suggestion of a decreased risk of SUTI, bacteremia, and UTI-
related mortality associated with closed drainage systems, but differences were not statistically
significant. Sterile, continuously closed drainage systems became the standard of care based
on an uncontrolled study published in 1966 demonstrating a dramatic reduction in the risk of
infection in short-term catheterized patients with the use of a closed system.23 Recent data also
include the finding that disconnection of the drainage system is a risk factor for bacteriuria
(Q1B).

Q2B.4. Complex vs. simple drainage systems

Low-quality evidence suggested no benefit of complex closed urinary drainage systems over
simple closed urinary drainage systems.150-152,154,172,176,177 Although there was a decreased risk
of bacteriuria with the complex systems, differences were found only in studies published before
1990, and not in more recent studies. The complex drainage systems studied included various
mechanisms for reducing bacterial entry, such as antiseptic-releasing cartridges at the drain
port of the urine collection bag; see evidence table for systems evaluated.

Q2B.5. Preconnected/sealed junction catheters vs. standard catheters

Low-quality evidence suggested a benefit of using preconnected catheters with junction seals
over catheters with unsealed junctions to reduce the risk of disconnections.64,153,156,175 This was
based on a decreased risk of SUTI and bacteriuria with preconnected sealed catheters. Studies
that found differences had higher rates of CAUTI in the control group than studies that did not
find an effect.

Q2B.6. Catheter valves vs. drainage bags

Moderate-quality evidence suggested a benefit of catheter valves over drainage bags in

selected patients with indwelling urinary catheters.140 Catheter valves led to greater patient
satisfaction but no differences in bacteriuria/unspecified UTI or pain/bladder spasms. Details
regarding the setting for recruitment and follow-up of the patients in the studies were unclear,
and the majority of subjects were men. Our search did not reveal data on the effect of catheter
valves on bladder function, bladder/urethral trauma, or catheter blockage.

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Evidence Review Table 2B. What are the risks and benefits associated with different
catheters or collecting systems?

2B.1. If the CAUTI rate is not decreasing after implementing a comprehensive strategy to
reduce rates of CAUTI, consider using antimicrobial/antiseptic-impregnated catheters. The
comprehensive strategy should include, at a minimum, the high priority recommendations for
urinary catheter use, aseptic insertion, and maintenance (see Section III. Implementation and
Audit). (Category IB)

2B.1.a. Further research is needed on the effect of antimicrobial/antiseptic-impregnated

catheters in reducing the risk of symptomatic UTI, their inclusion among the primary
interventions, and the patient populations most likely to benefit from these catheters. (No
recommendation/unresolved issue)

2B.2. Hydrophilic catheters might be preferable to standard catheters for patients requiring
intermittent catheterization. (Category II)

2B.3. Following aseptic insertion of the urinary catheter, maintain a closed drainage system.
(Category IB)

2B.4. Complex urinary drainage systems (utilizing mechanisms for reducing bacterial entry such
as antiseptic-release cartridges in the drain port) are not necessary for routine use. (Category
II)

2B.5. Urinary catheter systems with preconnected, sealed catheter-tubing junctions are
suggested for use. (Category II)

2B.6. Further research is needed to clarify the benefit of catheter valves in reducing the risk of
CAUTI and other urinary complications. (No recommendation/unresolved issue)

Q2C. What are the risks and benefits associated with different catheter
management techniques?

The available data examined the following catheter management techniques:

1. Antimicrobial prophylaxis
2. Urinary antiseptics (i.e., methanamine)
3. Bladder irrigation
4. Antiseptic instillation in the drainage bag
5. Periurethral care
6. Routine catheter or bag change
7. Catheter lubricants
8. Securing devices
9. Bacterial interference
10. Catheter cleansing
11. Catheter removal strategies (clamping vs. free drainage prior to removal, postoperative
duration of catheterization)
12. Assessment of urine volumes

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For all comparisons, we considered CAUTI outcomes as well as other outcomes critical to
weighing the risks and benefits of different catheter management techniques. The evidence for
this question consists of 6 systematic reviews,37,105,106,182-184 56 RCTs,60,61,65-69,143,158,158,185-231 34
observational studies,83,85,88,90,96,102,133,167,178,232-258 and 1 economic analysis.180 The findings of the
evidence review and the grades for all important outcomes are shown in Evidence Review
Table 2C.

Q2C.1. Antimicrobial prophylaxis

Low-quality evidence suggested no benefit of antimicrobial prophylaxis in patients undergoing

short-term catheterization.37,60,61,83,85,133,158,178,182,185,186,189-191,232-234 This was based on
heterogeneous results for SUTI and bacteriuria/unspecified UTI and no adverse events related
to antimicrobials. Lack of consistency in specific factors, such as patient population,
antimicrobial agents, timing of administration, and duration of follow-up, did not allow for a
summary of evidence of the effect of antimicrobial prophylaxis on CAUTI in patients undergoing
short term catheterization. Only two studies evaluated adverse events related to antimicrobials.
Our search did not reveal data on antimicrobial resistance or Clostridium difficile infection.

Low-quality evidence suggested no benefit of antimicrobial prophylaxis in patients undergoing

long-term catheterization (indwelling and clean intermittent catheterization).106,183,192,194,235,238
This was based on a decreased risk of bacteriuria, heterogeneous results for SUTI, and no
differences reported for catheter encrustation or adverse events, although data were sparse.
One systematic review suggested an increase in antimicrobial resistance with antimicrobial use.

Q2C.2. Urinary antiseptics

Low-quality evidence suggested a benefit of methenamine for short-term catheterized

patients.196,197 This was based on a reduced risk of SUTI and bacteriuria and no differences in
adverse events. Evidence was limited to two studies of patients following gynecological surgery
in Norway and Sweden.

Very low-quality evidence suggested a benefit of methanamine for long-term catheterized

patients.106,236-239 This was based on a reduced risk of encrustation but no differences in risk of
SUTI or bacteriuria. Data on encrustation was limited to one study. Studies involved primarily
elderly and spinal cord injury patients with chronic indwelling catheters

Q2C.3. Bladder irrigation

Low-quality evidence suggested no benefit of bladder irrigation in patients with indwelling or

intermittent catheters.66,69,199-206,240-242 This was based on no differences in SUTI and
heterogeneous findings for bacteriuria.

Q2C.4. Antiseptic instillation in the drainage bag

Low-quality evidence suggested no benefit of antiseptic instillation in urinary drainage

bags.90,207-211,243-245 This was based on no differences in SUTI and heterogeneous results for
bacteriuria.

Q2C.5. Periurethral care

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Low-quality evidence suggested no benefit of antiseptic meatal cleaning regimens before or

during catheterization to prevent CAUTI.65,67,68,88,158,212-216,246,247 This was based on no difference
in the risk of bacteriuria in patients receiving periurethral care regimens compared to those not
receiving them. One study found a higher risk of bacteriuria with cleaning of the urethral
meatus-catheter junction (either twice daily application of povidine-iodine or once daily cleaning
with a non-antiseptic solution of green soap and water) in a subgroup of women with positive
meatal cultures and in patients not receiving antimicrobials. Periurethral cleaning with
chlorhexidine before catheter insertion did not have an effect in two studies.

Q2C.6. Routine catheter or bag change

Low-quality evidence suggested no benefit of routine catheter or drainage bag changes to

prevent CAUTI.102,217-219,248,249 This was based on no difference or an increased risk of SUTI and
no difference in bacteriuria with routine compared to as-needed changes or with more frequent
changing intervals. One study in nursing home residents found no differences in SUTI with
routine monthly catheter changes compared to changing only for obstruction or infection, but the
study was underpowered to detect a difference. Another study in home care patients found an
increased risk of SUTI when catheters were changed more frequently than monthly.

Q2C.7. Catheter lubricants

Very low-quality evidence suggested a benefit of using lubricants for catheter insertion.167,220-
223,250-254
This was based on a decreased risk of SUTI and bacteriuria with the use of a pre-
lubricated catheter compared to a catheter lubricated by the patient and a decreased risk of
bacteriuria with use of a lubricant versus no lubricant. Studies were heterogeneous both in the
interventions and outcomes studied. Several studies comparing antiseptic lubricants to non-
antiseptic lubricants found no significant differences.

Q2C.8. Securing devices

Low-quality evidence suggested no benefit of using catheter securing devices to prevent

CAUTI.224 This was based on no significant difference in the risk of SUTI or meatal erosion. The
only study in this category looked at one particular product.

Q2C.9. Bacterial interference

Moderate-quality evidence suggested a benefit of using bacterial interference in catheterized

patients.225 In the one study evaluating this intervention, urinary colonization with a non-
pathogenic Escherichia coli was associated with a decreased risk of SUTI in adults with spinal
cord injury and a history of frequent CAUTI.

Q2C.10. Catheter cleansing

Very low-quality evidence suggested a benefit of wet versus dry storage procedures for
catheters used in clean intermittent catheterization.255 This was based on a decreased risk of
SUTI with a wet storage procedure in one study of spinal cord injury patients undergoing clean
intermittent catheterization compared to a dry storage procedure where the catheter was left to
air dry after washing. In the wet procedure, the catheter was stored in a dilute povidone-iodine
solution after washing with soap and water.

Q2C.11. Catheter removal strategies

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a. Clamping vs. free drainage prior to removal

Low-quality evidence suggested no benefit of clamping versus free drainage before catheter
removal.37,184 This was based on no difference in risk of bacteriuria, urinary retention, or
recatheterization between the two strategies. One study comparing a clamp and release
strategy to free drainage over 72 hours found a greater risk of bacteriuria in the clamping group.

b. Postoperative duration of catheterization

Moderate-quality evidence suggested a benefit of shorter versus longer postoperative durations

of catheterization.37,184,227,228 This was based on a decreased risk of bacteriuria/unspecified UTI,
decreased time to ambulation and length of stay, no differences in urinary retention and SUTI,
and increased risk of recatheterization. Significant decreases in bacteriuria/unspecified UTI
were found specifically for comparisons of 1 day versus 3 or 5 days of postoperative
catheterization. Recatheterization risk was greater in only one study comparing immediate
removal to removal 6 or 12 hours after hysterectomy.

Q2C.12. Assessment of urine volumes

Low-quality evidence suggested a benefit of using portable ultrasound to assess urine volume in
patients undergoing intermittent catheterization.229,230 This was based on fewer catheterizations
but no reported differences in risk of unspecified UTI. Patients studied were adults with
neurogenic bladder in inpatient rehabilitation centers. Our search did not reveal data on the use
of ultrasound in catheterized patients in other settings.

Evidence Review Table 2C. What are the risks and benefits associated with different
catheter management techniques?

2C.1. Unless clinical indications exist (e.g., in patients with bacteriuria upon catheter removal
post urologic surgery), do not use systemic antimicrobials routinely as prophylaxis for UTI in
patients requiring either short or long-term catheterization. (Category IB)

2C.2.a. Further research is needed on the use of urinary antiseptics (e.g., methanamine) to
prevent UTI in patients requiring short-term catheterization. (No recommendation/unresolved
issue)
2C.2.b. Further research is needed on the use of methanamine to prevent encrustation in
patients requiring chronic indwelling catheters who are at high risk for obstruction. (No
recommendation/unresolved issue)

2C.3.a. Unless obstruction is anticipated (e.g., as might occur with bleeding after prostatic or
bladder surgery), bladder irrigation is not recommended. (Category II)
2C.3.b. Routine irrigation of the bladder with antimicrobials is not recommended. (Category II)

2C.4. Routine instillation of antiseptic or antimicrobial solutions into urinary drainage bags is not
recommended. (Category II)

2C.5.a. Do not clean the periurethral area with antiseptics to prevent CAUTI while the catheter
is in place. Routine hygiene (e.g., cleansing of the meatal surface during daily bathing) is

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appropriate. (Category IB)

2C.5.b. Further research is needed on the use of antiseptic solutions vs. sterile water or saline
for periurethral cleaning prior to catheter insertion. (No recommendation/unresolved issue)

2C.6. Changing indwelling catheters or drainage bags at routine, fixed intervals is not
recommended. Rather, catheters and drainage bags should be changed based on clinical
indications such as infection, obstruction, or when the closed system is compromised.
(Category II)

2C.7.a. Use a sterile, single-use packet of lubricant jelly for catheter insertion. (Category IB)
2C.7.b. Routine use of antiseptic lubricants is not necessary. (Category II)

2C.8. Further research is needed on the use of bacterial interference to prevent UTI in patients
requiring chronic urinary catheterization. (No recommendation/unresolved issue)

2C.9. Further research is needed on optimal cleaning and storage methods for catheters used
for clean intermittent catheterization. (No recommendation/unresolved issue)

2C.10.a. Clamping indwelling catheters prior to removal is not necessary. (Category II)
2C.10.b. Insert catheters only for appropriate indications, and leave in place only as long as
needed. (Category IB)
2C.10.c. For operative patients who have an indication for an indwelling catheter, remove the
catheter as soon as possible postoperatively, preferably within 24 hours, unless there are
appropriate indications for continued use. (Category IB)

2C.11.a. Consider using a portable ultrasound device to assess urine volume in patients
undergoing intermittent catheterization to assess urine volume and reduce unnecessary
catheter insertions. (Category II)
2C.11.b. Further research is needed on the use of a portable ultrasound device to evaluate for
obstruction in patients with indwelling catheters and low urine output. (No
recommendation/unresolved issue)

Q2D. What are the risks and benefits associated with different systems
interventions?

The available data examined the following systems interventions:

1. Infection control/quality improvement programs (multifaceted)
2. Catheter reminders
3. Bacteriologic monitoring
4. Hand hygiene
5. Patient placement
6. Catheter team versus self-catheterization
7. Feedback
8. Nurse-directed catheter removal

We considered CAUTI outcomes, duration of catheterization, recatheterization, and

transmission of pathogens when weighing the risks and benefits of different systems
interventions. The evidence for this question consists of 1 RCT259 and 19 observational

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studies.3,25,260-276 The findings of the evidence review and the grades for all important outcomes
are shown in Evidence Review Table 2D.

Q2D.1. Multifaceted infection control/quality improvement programs

Low-quality evidence suggested a benefit of multifaceted infection control/quality improvement

programs to reduce the risk of CAUTI.3,260-267 This was based on a decreased risk of SUTI,
bacteriuria/unspecified UTI, and duration of catheter use with implementation of such programs.
Studies evaluated various multifaceted interventions. The studies with significant findings
included: 1) education and performance feedback regarding compliance with catheter care,
emphasizing hand hygiene, and maintaining unobstructed urine flow; 2) computerized alerts to
physicians, nurse-driven protocols to remove catheters, and use of handheld bladder scanners
to assess for urinary retention; 3) guidelines and education focusing on perioperative catheter
management; and 4) a multifaceted infection control program including guidelines for catheter
insertion and maintenance. A program using a checklist and algorithm for appropriate catheter
use also suggested a decrease in unspecified UTI and catheter duration, but statistical
differences were not reported.

Q2D.2. Reminders

Very low-quality evidence suggested a benefit of using urinary catheter reminders to prevent
CAUTI.268-270 This was based on a decreased risk of bacteriuria and duration of catheterization
and no differences in recatheterization or SUTI when reminders were used. Reminders to
physicians included both computerized and non-computerized alerts about the presence of
urinary catheters and the need to remove unnecessary catheters.

Q2D.3. Bacteriologic monitoring

Very low-quality evidence suggested no benefit of bacteriologic monitoring to prevent

CAUTI.25,271 Although one study found a decreased risk of bacteriuria during a period of
bacteriologic monitoring and feedback, only 2% of SUTI episodes were considered potentially
preventable with the use of bacteriologic monitoring.

Q2D.4. Hand hygiene

Very low-quality evidence suggested a benefit of using alcohol hand sanitizer in reducing
CAUTI. This was based on one study in a rehabilitation facility that found a decrease in
unspecified UTI, although no statistical differences were reported.272 A separate multifaceted
study that included education and performance feedback on compliance with catheter care and
hand hygiene showed a decrease in risk of SUTI.265

Q2D.5. Patient placement

Very low-quality evidence suggested a benefit of spatially separating patients to prevent

transmission of urinary pathogens.273 This was based on a decreased risk of transmission of
urinary bacterial pathogens in nursing home residents in separate rooms compared to residents
in the same rooms.

Q2D.6. Catheter team versus self-catheterization

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Very low-quality evidence suggested no benefit of a catheter team to prevent CAUTI among
patients requiring intermittent catheterization.274 This was based on one study showing no
difference in unspecified UTI between use of a catheter care team and self-catheterization for
intermittent catheterization in paraplegic patients.

Q2D.7. Feedback

Very low-quality evidence suggested a benefit of using nursing feedback to prevent CAUTI.275
This was based on a decreased risk of unspecified UTI during an intervention where nursing
staff were provided with regular reports of unit-specific rates of CAUTI.

Q2D.8. Nurse-directed catheter removal

Very low-quality evidence suggested a benefit of a nurse-directed catheter removal program to

prevent CAUTI.276 This was based on a decreased risk of unspecified UTI during an intervention
where criteria were developed that allowed a registered nurse to remove a catheter without a
physician’s order when no longer medically necessary. Of the three intensive care units where
the intervention was implemented, differences were significant only in the coronary intensive
care unit.

Evidence Review Table 2D. What are the risks and benefits associated with different
systems interventions?

2D.1.a. Ensure that healthcare personnel and others who take care of catheters are given
periodic in-service training stressing the correct techniques and procedures for urinary catheter
insertion, maintenance, and removal. (Category IB)
2D.1.b. Implement quality improvement (QI) programs or strategies to enhance appropriate use
of indwelling catheters and to reduce the risk of CAUTI based on a facility risk assessment.
(Category IB)
Examples of programs that have been demonstrated to be effective include:
1. A system of alerts or reminders to identify all patients with urinary catheters and
assess the need for continued catheterization
2. Guidelines and protocols for nurse-directed removal of unnecessary urinary
catheters
3. Education and performance feedback regarding appropriate use, hand hygiene, and
catheter care
4. Guidelines and algorithms for appropriate peri-operative catheter management, such
as:
a. Procedure-specific guidelines for catheter placement and postoperative catheter
removal
b. Protocols for management of postoperative urinary retention, such as nurse-
directed use of intermittent catheterization and use of ultrasound bladder
scanners

2D.2. Routine screening of catheterized patients for asymptomatic bacteriuria is not

recommended. (Category II)

2D.3. Perform hand hygiene immediately before and after insertion or any manipulation of the
catheter site or device. (Category IB)

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2D.5. Maintain unobstructed urine flow. (Category IB)

2D.6. Further research is needed on the benefit of spatial separation of patients with urinary
catheters to prevent transmission of pathogens colonizing urinary drainage systems. (No
recommendation/unresolved issue)

2D.7. When performing surveillance for CAUTI, consider providing regular (e.g., quarterly)
feedback of unit-specific CAUTI rates to nursing staff and other appropriate clinical care staff.
(Category II)

Q3: What are the best practices for preventing UTI associated with
obstructed urinary catheters?
The available data examined the following practices:

1. Methods to prevent/reduce encrustations or blockage

2. Catheter materials preventing blockage

For this question, available relevant outcomes included blockage/encrustation. We did not find
data on the outcomes of CAUTI. The evidence for this question consists of 1 systematic
review,277 2 RCTs,278,279 and 2 observational studies.280,281 The findings of the evidence review
and the grades for all important outcomes are shown in Evidence Review Table 3.

Q3.1. Methods to prevent/reduce encrustations or blockage

Low-quality evidence suggested a benefit of acidifying solutions or oral acetohydroxamic acid in

preventing or reducing catheter encrustations and blockage in long-term catheterized
patients.277,278,280,281 No differences were seen with daily catheter irrigation with normal saline.

Q3.2. Catheter materials preventing blockage

Low-quality evidence suggested a benefit of silicone over latex or Teflon-coated catheters in

prevention or reducing catheter encrustations in long-term catheterized patients who were prone
to blockage. No differences were seen with different materials in patients considered “non-
blockers.”279

Evidence Review Table 3. What are the best practices for preventing UTI associated with
obstructed urinary catheters?

3.1.a. Further research is needed on the benefit of irrigating the catheter with acidifying
solutions or use of oral urease inhibitors in long-term catheterized patients who have frequent
catheter obstruction. (No recommendation/unresolved issue)

3.2.a. Silicone might be preferable to other materials to reduce the risk of encrustation in long-
term catheterized patients who have frequent obstruction. (Category II)

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265. Rosenthal VD, Guzman S, Safdar N. Effect of education and performance feedback on rates of catheter-associated urinary tract infection in intensive care
units in argentina. Infect Control Hosp Epidemiol. 2004;25(1):47-50.

266. Berg DE, Hershow RC, Ramirez CA, Weinstein RA. Control of nosocomial infections in an intensive care unit in guatemala city. Clin Infect Dis.
1995;21(3):588-593.

267. Cools HJ, van der Meer JW. Infection control in a skilled nursing facility: A 6-year survey. J Hosp Infect. 1988;12(2):117-124.

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268. Saint S, Kaufman SR, Thompson M, Rogers MA, Chenoweth CE. A reminder reduces urinary catheterization in hospitalized patients. Jt Comm J Qual Patient
Saf. 2005;31(8):455-462.

269. Huang WC, Wann SR, Lin SL, et al. Catheter-associated urinary tract infections in intensive care units can be reduced by prompting physicians to remove
unnecessary catheters. Infect Control Hosp Epidemiol. 2004;25(11):974-978.

270. Cornia PB, Amory JK, Fraser S, Saint S, Lipsky BA. Computer-based order entry decreases duration of indwelling urinary catheterization in hospitalized
patients. Am J Med. 2003;114(5):404-407.

271. Jacobson JA, Burke JP, Kasworm E. Effect of bacteriologic monitoring of urinary catheters on recognition and treatment of hospital-acquired urinary tract
infections. Infect Control. 1981;2(3):227-232.

272. Fendler EJ, Ali Y, Hammond BS, Lyons MK, Kelley MB, Vowell NA. The impact of alcohol and sanitizer use on infection rates in an extended care facility. Am
J Infect Control. 2002;30(4):226-233.

273. Fryklund B, Haeggman S, Burman LG. Transmission of urinary bacterial strains between patients with indwelling catheters - nursing in the same room and in
separate rooms compared. J Hosp Infect. 1997;36(2):147-153.

274. Wyndaele JJ, De Taeye N. Early intermittent self-catheterisation after spinal cord injury. Paraplegia. 1990;28(2):76-80.

275. Goetz AM, Kedzuf S, Wagener M, Muder RR. Feedback to nursing staff as an intervention to reduce catheter-associated urinary tract infections. Am J Infect
Control. 1999;27(5):402-404.

276. Dumigan DG, Kohan CA, Reed CR, Jekel JF, Fikrig MK. Utilizing national nosocomial infection surveillance system data to improve urinary tract infection
rates in three intensive-care units. Clin Perform Qual Health Care. 1998;6(4):172-178.

277. Mayes J, Bliss J, Griffiths P. Preventing blockage of long-term indwelling catheters in adults: Are citric acid solutions effective? Br J Community Nurs.
2003;8(4):172-175.

278. Muncie HL,Jr., Hoopes JM, Damron DJ, Tenney JH, Warren JW. Once-daily irrigation of long-term urethral catheters with normal saline. lack of benefit. Arch
Intern Med. 1989;149(2):441-443.

279. Kunin CM, Chin QF, Chambers S. Formation of encrustations on indwelling urinary catheters in the elderly: A comparison of different types of catheter
materials in "blockers" and "nonblockers". J Urol. 1987;138(4):899-902.

280. Burns JR, Gauthier JF. Prevention of urinary catheter incrustations by acetohydroxamic acid. J Urol. 1984;132(3):455-456.

281. Ruwaldt MM. Irrigation of indwelling urinary catheters. Urology. 1983;21(2):127-129.

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Received: 4 January 2018

DOI: 10.1002/nau.23519
| Accepted: 8 January 2018

SOUNDING BOARD

ICS Educational Module: Cough stress test in the evaluation of

female urinary incontinence: Introducing the ICS-Uniform
Cough Stress Test

Michael L. Guralnick1 | Xavier Fritel2 | Tufan Tarcan3 |

Montserrat Espuna-Pons4 | Peter F. W. M. Rosier5

1 Medical College of Wisconsin,

Milwaukee, Wisconsin Introduction: A cough stress test (CST) is recommended in the evaluation of the
2 Facultéde Médecine et Pharmacie, uncomplicated female patient with the complaint of stress urinary incontinence (SUI)
Université de Poitiers, Poitiers, France to identify the sign of SUI, and is often used as an outcome measure following SUI
3 Marmara University School of Medicine,
treatment. However, there has been no standardization of the performance or
Istanbul, Turkey
4 ICGON. Hospital Clínic., University of
reporting of CST. A working group of the International Continence Society (ICS) has
Barcelona, Barcelona, Spain developed an educational module, comprising a Powerpoint™ presentation and
5 UniversityMedical Center Utrecht, evidence base manuscript, to instruct on the performance, interpretation, and
Utrecht, The Netherlands reporting of the CST in a standardized manner: the ICS-Uniform Cough Stress Test
Correspondence
(ICS-UCST).
Michael L. Guralnick, MD, FRCSC, Methods: The working group performed a PUBMED literature search of articles
Medical College of Wisconsin, Milwaukee, (observational/experimental and reviews) published prior to 2017 that mentioned a
WI 53226.
Email: mguralni@mcw.edu CST. The evidence base examined various variables in performing a CST as well as
sensitivity/specificity and positive/negative predictive values of CST.
Results: The variables involved in performing/interpreting an ICS-UCST include:
patient positioning, degree of bladder filling, number, and forcefulness of coughs, and
method of SUI detection. For the ICS-UCST it is recommended that the patient be in a
supine/lithotomy position with 200-400 mL of fluid in the bladder. She coughs
forcefully 1-4 times and the examiner directly visualizes the urethral meatus for the
presence of leakage. Leakage of fluid from the urethral meatus coincident with/
simultaneous to the cough(s) is considered a positive test.
Conclusion: This module provides instructions to educate a uniform CST (the ICS-
UCST), with the aim of improving the clinical practice of cough stress testing in
female patients with urinary incontinence.

KEYWORDS
cough stress test, stress urinary incontinence

1 | INTRODUCTION

Roger Dmochowski led the peer-review process as the Associate Editor The cough stress test (CST) is a clinical test used in the
responsible for the paper. evaluation of urinary incontinence (UI). The patient coughs
Neurourology and Urodynamics. 2018;1–7. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | 1

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| GURALNICK ET AL.

and the visualization of urine loss synchronous with the cough literature to determine the predictive value of the clinical
confirms the presence of stress urinary incontinence (SUI).1 evaluation of SUI (history, physical exam with CST) using
CST is used to objectively make the diagnosis of SUI2 and multichannel UDS as the comparator, it was found that for
assess the outcome of treatment for SUI.3,4 Its use in the the diagnosis of genuine SUI, the CST alone had sensitivity
evaluation of UI (when symptoms of SUI are expressed; the (sens:) 57%, specificity (spec:) 71%, positive predictive
SUI syndrome: SUI-S5) has been endorsed by several value (PPV) of 55% and negative predictive value (NPV) of
societies including the French College of Gynecologists 73%.15 However, when other UDS diagnoses (eg, mixed
and Obstetricians; International Federation of Gynecology incontinence) were included, the PPV was 91%, indicating
and Obstetrics (FIGO); International Urogynecological that CST had been demonstrating UI but not “uncompli-
Association (IUGA), and American College of Obstetricians cated SUI” in all patients. When combined with the
and Gynecologists.2,6–8 Although the European Association symptoms of SUI-S, the CST had a PPV of 78-97%.15 A
of Urology guideline is brief about this test, the recent randomized trial of UDS prior to SUI surgery observed that
American Urological Association guideline considers it a an office evaluation including a CST correctly identified
sine- qua-non for the diagnosis of SUI.9,10 Based on their 97% of women found to have SUI on UDS and the
review, the FIGO working group recommended all patients demonstration of SUI during UDS subsequent to a positive
being evaluated for SUI-S should have a CST (Grade A)8 and CST did not improve the treatment success of SUI
in a research context, CST has been the most commonly used surgery.12 In a prospective study, when CST was compared
measure for evaluating the outcome of SUI surgery.3,4 to multichannel UDS and 24 h pad testing the agreement
Despite the support for the CST, standardization of how to between UDS and CST was 89% (k = 0.51), whereas
perform a CST does not exist. The ICS Urodynamics agreement between UDS and 24 h pad test was only 60%
Committee presents the teaching module “Cough stress test in (k = 0.08) and agreement between the CST and 24 h pad test
the evaluation of female urinary incontinence” to serve as a was only 67% (k = 0.26).16 Using UDS as the reference, the
standard for educating a CST for the evaluation of female UI sens, spec, PPV and NPV of the CST were 90%, 80%, 98%,
and/or SUI-S. and 44% respectively. CST during single channel cystom-
A new ICS term for the CST is introduced: ICS Uniform etry was compared to CST during multichannel UDS in
Cough Stress Test (ICS-UCST) because the secondary aim of another prospective study13 that alternated the gold standard
this module is to uniformize, by teaching, CST for clinical for diagnosing SUI (a cough UPP during multichannel UDS
routine and research. This manuscript provides the evidence versus CST and simple CMG). No significant difference
base for the ICS educational PowerPoint™ presentation that between the two methods was seen with both having sens,
accompanies this module as well as the arguments for the spec, PPV, and NPV between 80% and 87%. In a similar
uniformization. The aim of this module is to educate the study, when CST with simple bladder filling was compared
utilization and interpretation of the CST which will hopefully to CST during multichannel UDS (using CST during UDS
improve and facilitate the clinical diagnosis of SUI and the as the gold standard),14 for the diagnosis of SUI the CST
assessment/reporting of SUI treatment outcomes. with simple bladder filling had a sens 88%, spec 77%; PPV
82% and NPV 84%. It was concluded that CST with simple
bladder filling is a reliable method of diagnosing SUI and
2 | METHODS can replace complex UDS which is in keeping with an
assessment of AHCPR criteria for predicting SUI clinically
The working group for this module did an extensive literature (using UDS as the gold standard) that found that the most
review of more than 200 articles published prior to 2017 that helpful criterion was the CST which had sens 93%; spec
mention a cough stress test, via a PUBMED online search 56%; PPV 68% and NPV 89%.17
using the terms “cough and stress test and incontinence.” Despite the evidence supporting the use of CST there
These included observational/experimental studies as well as has not been any standardization of the performance or
review articles. References used specifically for this manu- reporting of CST. In fact, in reviewing 208 studies that
script are provided at the end and a full references list in an make mention of a CST (outcome assessment studies, test
accessory file on the publisher's website. evaluation studies) we found that only 62% specified the
patient positioning, 71% the bladder volume, 45%
the method of filling, 17% the number of coughs and
2.1 | The evidence base for standardization of
38% the method of SUI determination (Figures 1 and 2).
CST
The lack of standardization makes every statement about the
There is general consensus that the CST in combination predictive value of (history and) clinical examination (and
with the SUI-S is reliable in confirming that the CST) on the outcome of management for UI difficult to
pathophysiology of the UI is SUI.11–18 In a review of the evaluate and/or impossible to extrapolate.

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FIGURE 1 Studies assessing the outcome of a treatment

intervention that mentioned using a CST (references online).
*Positioning included: supine/lithotomy, semi-lithotomy, seated,
standing. **Bladder volumes included “empty,” “comfortably/
symptomatically full,” “full,” 100-700 mL. ***Natural fill or
retrograde fill via catheter (often done during UDS). ^Number of
coughs ranged from 1 to 10 or reported as “a series of coughs.” FIGURE 3 Educating the ICS-UCST
^^Direct visualization of incontinence or pad testing

2.2.1 | Preparation
2.2 | Educating the ICS-UCST A cough stress test is typically performed during the physical
From the available evidence we have selected the elements of examination of the patient in the outpatient clinic, but can be
CST: (1) preparation for the test; (2) performing the test: (a) done at the time of a procedure or during urodynamic testing.
patient positioning; (b) bladder volume; (c) number of The last being a urodynamic stress test and/or leak point
coughs; (d) leakage detection; and (3) interpretation and pressure (LPP) determination. Practice and validity of (UDS-)
reporting of the test. On the basis of our review of the LPP testing are not further discussed but are summarized, for
evidence, we propose, to educate the elements of the CST to example, in the ICI-consultation report.18
be performed in a standard manner, the ICS-UCST (Figure 3). We believe that before the ICS-UCST the patient should
be informed about the relevance and rationale for performing
the test and also the potential embarrassing nature of the test.
Apart from undressing the lower part of the body and some
issues mentioned below, the patient does not have to prepare
herself specifically for the test.

2.2.2 | Technique

Patient position
A CST can be performed in the supine, semi supine, standing,
sitting, or lithotomy positions. In the supine position (using
pads to measure the leakage), it was noted that only 49% of
women leaked during the cough stress test (when floor and
FIGURE 2 Studies looking at the evaluation of incontinence (e.g. trampoline jumping were used as the comparator).19 In
studies assessing clinical factors contributing to incontinence, studies
addition, CST was negative when done in a semi-supine
evaluating the performance of UDS, that mentioned using a CST
position in 14% of patients who complain of SUI in another
(references online). *Positioning included: supine/lithotomy, semi-
study on the effects of a UDS catheter on the diagnosis of
lithotomy, seated, standing. **Bladder volumes included “empty,”
“comfortably/symptomatically full,” “full,” 100-700 mL. ***Natural SUI.20 Furthermore, it has been noted that during LPP testing
fill or retrograde fill via catheter (often done during UDS). ^Number (done during CMG with a catheter in place), both Valsalva
of coughs ranged from 1 to 10 or reported as “a series of coughs.” LPP and CLPP are significantly lower when the patient is
^^Direct visualization of incontinence or pad testing standing versus supine.21

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However, probably the most convenient time to do a CST representative. Some patients may not routinely store more
is when the patient is undergoing a vaginal exam in the than 250-300 mL and it may be unrealistic for them to be
supine/lithotomy position (legs either in stirrups or abducted filled to a larger volume. The use of a “comfortably full
in a “frog-leg” position), when one assesses vaginal anatomy bladder might remedy this because one presumes that the
and pelvic floor function. This positioning allows for patient's bladder volume will be close to their functional
relatively easy visualization of the urethral meatus for the capacity but this reported sensation may be affected by
occurrence of urine leakage. anxiety level. Basing the CST volume on a percentage of the
Because of the observed potential for a false negative in patient's bladder (maximum) capacity seems logical and this
the supine position, reported in some cohort studies, it has concept was used in the context of pad weight testing using a
been recommended that patients undergo a CST in the upright bladder filled to a volume of 50% of cystometric capacity.27 It
position, especially if they had a negative test in the supine was concluded that this type of standardization reduced test
position.7,8 However, having the patient stand for the CST retest variation in the quantifying of UI volume. However,
requires more effort on the examiner's part to expose the determining cystometric capacity requires the patient undergo
urethral meatus for visualization of the leakage. As well, not UDS first. Another option is to base the CST volume on a
all patients are able to stand on their own, and testing in the percentage of the capacity/maximum voided volume on a
standing position may therefore be less relevant and/or frequency-volume chart, or use the “usual/average voided
representative in these patients. Furthermore, it is currently volume” avoiding the need for urethral instrumentation/UDS.
unknown if the pathophysiology of a patient who has a To our knowledge this has not been studied in the context of a
positive CST in the upright position but negative in the CST and therefore requires additional evaluation. For the
supine/lithotomy position is comparable to a patient who has a purposes of standardization for the ICS-UCST, we recom-
positive CST in the supine position. mend that the patient has a bladder volume in the range of
Conclusion for the purposes of uniformized practice of the 200-400 mL, and to ensure that this volume is not exceptional
ICS-UCST, we recommend that the CST be done in the (far too low or far too high) for this patient (LoE 2, GoR B).
supine/lithotomy position at the time of vaginal examination How one achieves/determines the bladder volume is also
(LoE 1b, GoR A). If the test is negative (ie, no leakage up for debate. Natural bladder filling or retrograde filling with
detected), then accessory stress testing such as repeating the a catheter can be used. Retrograde bladder filling allows for
test in the upright position should be considered. When filling to a preset amount independent of patient activity. This
reporting the results of an ICS-UCST, it can be assumed that requires catheterization which carries a small risk for
the test was done in the supine/lithotomy position. A patient infection and a potential to irritate/injure the urethral mucosa
with a negative test in the supine/lithotomy position and a which could affect the results.28 Natural bladder filling avoids
positive accessory stress test in the upright position should be urethral instrumentation albeit with lesser control over the
reported as: “ICS-UCST negative, accessory (upright CST) actual bladder volume. One may determine the patient's
positive.” bladder volume at the time of CST via an ultrasound bladder
scan prior to or immediately after a CST or one could do a
Bladder volume CST then have the patient void and add the voided volume to
A spectrum of CST bladder volumes has been used in the the postvoid residual volume (via bladder scanner or
literature from empty to 700 mL, including a “comfortably catheterization) to calculate the bladder volume retroactively.
full” or a “symptomatically full” bladder. No consensus exists For the ICS-UCST we recommend the patient be asked
regarding the bladder volume for CST and to our knowledge about their sense of bladder fullness and the time since the last
no one has evaluated CST at differing bladder volumes in the micturition to get an idea of the degree of fullness with natural
same patient. The effect of differing bladder volumes has filling. We propose the test be performed in a target range of
been evaluated in the context of LPP testing during UDS: bladder volumes between 200 and 400 mL with the frequency
Valsalva LPP was lower when bladder volumes were larger volume chart serving as a guide for usual normal desire to
and the detection of SUI on LPP testing increased with void. We recommend furthermore that a more precise
increased bladder volumes.22–25 During (cystometry-) LPP determination of the bladder volume during the test, using
testing in women with SUI-S, leakage was not detected in any one of the aforementioned methods, be reported (in mL) when
patient with a bladder volume <100 mL while leakage was reporting the results of the ICS-UCST. (eg, “ICS-UCST
detected in 19% of patients with a volume of 150 mL, 58% 380 mL positive”)
with a volume of 200 mL and 95% with a volume of
250 mL.26 It seems reasonable to extrapolate this to the CST Number/Forcefulness of coughs
done in the clinic: a larger bladder volume may be more likely The goal of a CST is to reproduce the patient's UI or at least to
to elicit a positive test. On the other hand, one wants to avoid determine the likelihood that SUI is a cause of the UI. The
overfilling the bladder and elicit results that are not CST, therefore, should ideally reproduce the kinds of

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provocative maneuvers that are experienced by the patient on cough as the definition of a positive CST.7,8,34 Incontinence
a day to day basis. In addition, the test must be easy to perform occurring subsequent to a cough (ie, after a brief delay) or
and interpret (ie, it should be of minimal burden to the patient incontinence that persists after the cough has subsided is
and provide clear, easy to interpret results). While it has been reported to be indicative of a concurrent detrusor contraction
demonstrated that with greater exertional effort (eg, jumping), and usually referred to as cough induced DO2 or cough
SUI will be more likely to be elicited,19,29 many women do associated DO.35
not routinely subject themselves to such exertion and While some have used pads to capture the incontinence,
furthermore, it may be unrealistic, or too risky, to expect avoiding the need for direct visualization of the inconti-
women to do such strenuous maneuvers in the clinic. Hence, nence,29,32 the lack of direct visualization of the moment of
on the basis of the available evidence as well as practicality, the incontinence could call into doubt whether one is dealing
we propose that coughing be the provocative maneuver within with actual SUI versus cough associated DO. For the ICS-
the ICS-UCST. UCST therefore, we recommend that a positive test requires
In many reports that used a CST there was no mention of direct visualization of the efflux of urine from the urethral
the number of times the patient was asked to cough meatus synchronous with the cough.
(Figures 1 and 2). There is some evidence that, during UDS,
multiple coughs are more likely to elicit leakage as was
2.2.3 | Accessory stress tests
demonstrated during a “1-3-5” cough test.30 The patient
initially coughs once and if no SUI is noted then coughs
three times and again if no SUI is noted then coughs five Upright CST
times. The “severity” of SUI was graded based on the As previously noted, a negative CST in the supine/lithotomy
occurrence of SUI after fewer coughs (more severe) versus position does not necessarily rule out the presence of SUI. It
many coughs (more mild). When compared with patient- has therefore been recommended that a patient with the
perception questionnaires (eg, ICIQ-FLUTS, King's Health complaint of SUI who has a negative CST in the supine/
Questionnaire, UDI-6, and UIQ-7), statistically significant lithotomy position undergo a repeat test in the upright
associations of higher grades of SUI (based on the 1-3-5 position.7 This can be done in the same fashion as the standard
CST) with higher scores of incontinence domains on the ICS-UCST (bladder volume of 200-400 mL), up to four
questionnaires were noted. Others have speculated that forceful coughs. If the upright CST is positive and the ICS-
(pelvic) muscular fatigue may have a role in SUI and its UCST (supine/lithotomy) is negative, the patient should be
diagnosis: by having patients cough repeatedly (up to seven reported as having ICS-UCST negative, accessory (upright
times), a greater than 20% decrease in MUCP was measured CST) positive.
in almost a quarter of patients with SUI-S.31
While standardization of cough effort/force has been Supine empty stress test (SEST)
attempted using an audiometer as a gauge (to measure audible A positive CST performed in the supine position with an
cough strength),32 it has been suggested that it is rather “empty” bladder (volume <100 mL) has been suggested to
difficult to achieve reliable standardization of coughing force/ indicate the presence of intrinsic sphincter deficiency (ISD).
effort33 and for the purposes of a routine office visit it is In a prospective series it was noted that a positive SEST was
impractical. Rather, the recommendation of three coughs “as associated with a lower MUCP (mean, 20 vs 36 cm H2O) and
hard as possible” seems reasonable.34 SEST had sens: 65-70% and spec: 67-76% for predicting ISD
Taking all of this together, we recommend that for the using low MUCP to diagnose ISD.36 A positive SEST was
ICS-UCST: The patient should cough as forceful as possible. also associated with a low LPP (40% of women with a positive
If no leakage is seen after the first cough, coughing should be SEST had a LPP of 60 cm H20 or less versus 10% with
repeated three more times (ie, total of four coughs) before negative SEST) with sens: 93.5%, spec: 90%, PPV 96.7% and
calling the test negative (LoE 2, GoR B). If no leakage is seen NPV 81.8% for detecting ISD using ALPP to define ISD.37
after four forceful coughs, accessory stress testing (eg, greater The IUGA suggests that SEST could be used as a simple test
number of coughs; upright testing; alternative provocations; to be reasonably assured that ISD is not present (without
ICS standard pad testing or UDS) can be performed, with no resorting to multichannel UDS)2 If a SEST is done as an
evidence based preference for any of these. We recommend accessory to (or preceding) an ICS-UCST, the results of each
this however to be reported specifically, especially for should be specified and reported.
scientific purposes. In a patient with UI or more specifically with SUI-S, a
negative ICS-UCST and a negative accessory CST, an ICS
Determination of SUI/Interpretation standard pad test38 and/or (full) urodynamic testing may be
Most reports that describe the method of CST use direct considered to evaluate the complete lower urinary tract
visualization of incontinence that occurs simultaneous with a function, as per current practice guidelines.

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3 | CONCLUSION 11. Swift SE, Ostergard DR. Evaluation of current urodynamic test
methods in the diagnosis of genuine stress incontinence. Obstet
This module has introduced and provided the evidence base Gynecol 1995;86:85–91.
12. Nager CW, Brubaker L, Litman HJ, et al. A randomized trial of
for the International Continence Society-Uniform Cough
urodynamic testing before stress-incontinence surgery. N Engl J
Stress Test (ICS-UCST) to standardize the performance and
Med. 2012;366:1987–1997.
reporting of the cough stress test used in the clinical and 13. Scotti RJ, Myers DL. A comparison of the cough stress test and
outcomes assessment of women with urinary incontinence. single-channel cystometry with multichannel urodynamic evalua-
tion in genuine stress incontinence. Obstet Gynecol. 1993;81:
430–433. PubMed PMID: 8437800.
ORCID 14. Wall LL, Wiskind AK, Taylor PA. Simple bladder filling with a cough
Michael L. Guralnick http://orcid.org/0000-0001-9869- stress test compared with subtracted cystometry for the diagnosis of
urinary incontinence. Am J Obstet Gynecol. 1994;171:1472–1477.
3076
discussion 1477-9. PubMed PMID: 7802056.
Peter F. W. M. Rosier http://orcid.org/0000-0003-0445- 15. Harvey MA, Versi E. Predictive value of clinical evaluation of
4563 stress urinary incontinence: a summary of the published literature.
Int Urogynecol J 2001;12:31–37.
16. Price DM, Noblett K. Comparison of the cough stress test and 24-h
pad test in the assessment of stress urinary incontinence. Int
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4. Zimmern P, Kobashi K, Lemack G. Outcome measure for stress cystometry catheter and type of stress test affect the measurement of
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urodynamics and female urology (SUFU) surveys. Neurourol incontinence (SUI). Neurourol Urodyn. 2010;29:536–539.
Urodyn. 2010;29:715–718. 21. Nguyen JK, Gunn GC, Bhatia NN. The effect of patient position on
5. Rosier PF, Giarenis I, Valentini FA, Wein A, Cardozo L. Do leak-point pressure measurements in women with genuine stress
patients with symptoms and signs of lower urinary tract dysfunction incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13:
need a urodynamic diagnosis? ICI-RS 2013. Neurourol Urodyn. 9–14.
2014;33:581–586. 22. Bump RC, Elser DM, Theofrastous JP, McClish DK. Valsalva leak
6. Fritel X, Fauconnier A, Bader G, et al. Diagnosis and management point pressures in women with genuine stress incontinence:
of adult female stress urinary incontinence: guidelines for clinical reproducibility, effect of catheter caliber, and correlations with
practice from the French College of Gynaecologists and Obstetri- other measures of urethral resistance. Continence Program for
cians. Eur J Obstet Gynecol Reprod Biol. 2010;151:14–19. Women Research Group. Am J Obstet Gynecol. 1995;173:551–557.
7. Evaluation of uncomplicated stress urinary incontinence in women 23. McLennan MT, Melick CF, Bent AE. Leak-point pressure: clinical
before surgical treatment. Committee Opinion No. 603 The application of values at two different volumes. Int Urogynecol J
American College of Obstetricians and Gynecologists. Obstet Pelvic Floor Dysfunct. 2000;11:136–141.
Gynecol 2014;123:1403–1407. 24. Miklos JR, Sze EH, Karram MM. A critical appraisal of the methods
8. Medina CA, Costantini E, Petri E, et al. Evaluation and surgery for of measuring leak-point pressures in women with stress inconti-
stress urinary incontinence: a FIGO working group report. nence. Obstet Gynecol. 1995;86:349–352.
Neurourol Urodyn. 2017;36:518–528. 25. Seo YH, Kim SO, Yu HS, Kwon D. Leak point pressure at different
9. Lucas MG, Bosch RJ, Burkhard FC, et al. EAU guidelines on bladder volumes in stress urinary incontinence in women:
assessment and nonsurgical management of urinary incontinence. comparison between Valsalva and cough-induced leak point
Eur Urol. 2012;62:1130–1142. Epub 2012 Aug 31. Erratum in: Eur pressure. Can Urol Assoc J. 2016;10:E23–E27.
Urol. 2013 Jul;64(1):e20. PubMed PMID: 22985745. 26. Faerber GJ, Vashi AR. Variations in valsalva leak point pressure
10. Kobashi KC, Albo ME, Dmochowski RR, et al. Surgical treatment with increasing vesical volume. J Urol. 1998;159:1909–1911.
of female stress urinary incontinence: AUA/SUFU Guideline. 27. Lose G, Rosenkilde P, Gammelgaard J, Schroeder T. Pad-weighing
J Urol. 2017;198:875–883. Epub 2017 Jun 15. PubMed PMID: test performed with standardized bladder volume. Urology.
28625508. 1988;32:78–80.

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28. Wu WY, Sheu BC, Lin HH. Comparison of 20-minute pad test 35. Rosier PFWM, Schaefer W, Lose G, et al. International continence
versus 1-hour pad test in women with stress urinary incontinence. society good urodynamic practices and terms 2016: urodynamics,
Urology. 2006;68:764–768. uroflowmetry, cystometry, and pressure-flow study. Neurourol
29. Papa Petros PE, Ulmsten U. An analysis of rapid pad testing and the Urodyn. 2017;36:1243–1260. Epub 2016 Dec 5. Review. PubMed
history for the diagnosis of stress incontinence. Acta Obstet PMID: 27917521.
Gynecol Scand. 1992;71:529–536. 36. Lobel RW, Sand PK. The empty stress test as a predictor of intrinsic
30. Grigoriadis T, Giannoulis G, Zacharakis D, Protopapas A, Cardozo urethral sphincter dysfunction. Obstet Gynecol. 1996;88:128–132.
L, Athanasiou S. The “1-3-5 cough test”: comparing the severity of 37. Mclennan MT, Bent AE. Supine empty stress test as a predictor of low
urodynamic stress incontinence with severity measures of subjec- Valsalva leak point pressure. Neurourol Urodyn. 1998;17:121–127.
tive perception of stress urinary incontinence. Int Urogynecol J. 38. Krhut J, Zachoval R, Smith PP, et al. Pad weight testing in the evaluation
2016;27:419–425. PMID: 26239956. of urinary incontinence. Neurourol Urodyn. 2014;33:507–510. Epub
31. Deffieux X, Hubeaux K, Dick J, Ismael SS, Raibaut P, Amarenco G. 2013 Jun 24. Review. PubMed PMID: 23797972.
Urine leakage related to physical fatigue in women with urinary
stress incontinence. J Obstet Gynaecol Res. 2009;35:738–745.
PMID: 19751336.
32. Norton PA, Baker JE. Postural changes can reduce leakage in How to cite this article: Guralnick ML, Fritel X,
women with stress urinary incontinence. Obstet Gynecol. Tarcan T, Espuna-Pons M, Rosier PFWM. ICS
1994;84:770–774. PubMed PMID: 7936510. Educational Module: Cough stress test in the
33. Luginbuehl H, Baeyens JP, Kuhn A, et al. Pelvic floor muscle reflex evaluation of female urinary incontinence:
activity during coughing − an exploratory and reliability study. Ann Phys Introducing the ICS-Uniform Cough Stress Test.
Rehabil Med. 2016;59:302–307. Epub 2016 Jun 2.PMID: 27265846.
Neurourology and Urodynamics. 2018;1–7.
34. Yalcin I, Versi E, Benson JT, Schäfer W, Bump RC. Validation of a
clinical algorithm to diagnose stress urinary incontinence for large
https://doi.org/10.1002/nau.23519
studies. J Urol. 2004;171:2321–2325. PubMed PMID: 15126813.

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Neurourology and Urodynamics

ICS Teaching Module: Detrusor Leak Point Pressures in

Patients With Relevant Neurological Abnormalities
Tufan Tarcan,1* Oktay Demirkesen,2 Mauricio Plata,3 and David Castro-Diaz4
1
Department of Urology, Marmara University School of Medicine, Istanbul, Turkey
2
Department of Urology, Istanbul University CerrahpaSs a Medical Faculty, Istanbul, Turkey
3
Department of Urology, Hospital Universitario de la Fundaci on Santa F
e de Bogot
a/Universidad de los Andes,
Bogota, Colombia
4
University Hospital of the Canary Islands, University of La Laguna, Santa Cruz de Tenerife, Spain

Aims: This manuscript serves as a scientific background review; the evidence base, for the presentation made available
on ICS website to summarize current knowledge and recommendations for the measurement and use of the DLPP.
Methods: This review has been prepared by a Working Group of The ICS Urodynamics Committee. The methodology
used included comprehensive literature review, consensus formation by the members of the Working Group, and review
by members of the ICS Urodynamics Committee core panel. Results: DLPP has been recommended and utilized in the
urodynamic evaluation of N-LUTD for many years, but it lacks standardization and there are numerous pitfalls in its
measurement. EFP and LPP associated with N-DO are frequently and mistakenly reported as DLPP. The information
that high DLPP predicts UUTD originates from retrospective cohort studies of a low level of evidence (LoE 3). Existing
data confirm that patients with lower DLPP do better than patients with higher DLPP in terms of their upper urinary
tract. However, there appears to be no reliable ‘safe/no safe’ cut-off for DLPP since there are other urodynamic factors that
influence UUTD such as bladder compliance and more. Conclusion: Although higher DLPP is associated with a greater
risk of UUTD, there is no reliable cut-off level to undoubtedly discriminate the risky group, including the traditional cut-
off level of 40 cm H2O. Therefore, DLPP should not be used as the sole urodynamic parameter. Future research should be
directed to standardization of the technique and better classification of DLPP cut-offs in N-LUTD. Neurourol. Urodynam.
# 2015 Wiley Periodicals, Inc.

Key words: detrusor leak point pressure; neurogenic bladder; urodynamics

INTRODUCTION unavailable, especially for the clinical practice aspects, and is

marked with: ‘‘EO’’ (expert’s opinion).
Detrusor leak-point pressure (DLPP) testing originates from
This module reviews the value of DLPP measurement in
observations of videourodynamic studies of children with
predicting UUTD in N-LUTD in light of the existing literature.
myelomeningocele (MMC) and urinary incontinence second-
Our purpose is to standardize and improve the method of DLPP
ary to impaired bladder compliance. McGuire retrospectively
measurement in patients with N-LUTD to minimize performer-
evaluated this group of children with the aim of finding
and patient-dependent variations.
predictors for upper urinary tract deterioration (UUTD).1–3
This concept has been further applied to different etiologies of
neurogenic lower urinary tract dysfunction (N-LUTD) in MATERIALS AND METHODS
adults.4 The International Continence Society (ICS) defines
All the requirements and instructions for the measurement
the DLPP as the lowest detrusor pressure at which urine
of DLPP described in this section follow the ICS reports on Good
leakage occurs in the absence of either a detrusor contraction
Urodynamic Practices (GUP)6 and urodynamic equipment
or increased abdominal pressure.5 The value of DLPP to
performance.7 The International Children’s Continence Society
predict UUTD is not known very precisely, and the measure-
(ICCS) report on the standardization of terminology of lower
ment of DLPP lacks standardization and carries pitfalls. For
urinary tract function in children and adolescents has been
example, although DLPP measurement has been recom-
taken into consideration for the measurement of DLPP in
mended in neurological patients with reduced bladder
children.8 DLPP is obtained during a standard cystometry and
compliance, some authors measure DLPP during involuntary
no specific other equipment or specific patient preparation is
detrusor contractions.5
needed to determine DLPP. DLPP uses detrusor pressure;
The ICS Urodynamics Committee presents the teaching
module ‘‘detrusor leak point pressures in patients with relevant
neurological abnormalities’’ to serve as a standard education of Prof. Christopher Chapple led the peer-review process as the Associate Editor
good urodynamic practice for everyone involved in indicating, responsible for the paper.
Potential conflicts of interest: Nothing to disclose.
performing, and analyzing urodynamic testing in general and 
Correspondence to: Tufan Tarcan, MD, PhD, Professor of Urology, Department of
more specifically, for those caring for patients with N-LUTD. The S
Urology, Marmara University School of Medicine, Fevzi Cakmak Mah., Muhsin
teaching module consists of a web-casted presentation, in Yazicioglu Cad. No:10 Ust Kaynarca, Pendik, Istanbul, Turkey. E-mail:
combination with this manuscript, which is available on the tufan@marmara.edu.tr
Received 25 November 2015; Accepted 25 November 2015
ICS website. The presentation explains testing requirements,
Published online in Wiley Online Library
clinical workup, and analysis. The presentation and this (wileyonlinelibrary.com).
manuscript contain experts’ opinion where evidence is DOI 10.1002/nau.22947

# 2015 Wiley Periodicals, Inc.

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2 Tarcan et al.
consequently, it cannot be obtained via a single channel observing for leakage and another observing the recording and
cystometry and, therefore, both vesical and intra-abdominal marking pressures using an event marker. However, the
pressure must be recorded. authors also stated that fluoroscopy visualization of contrast
around the catheter is more accurate than observing the
meatus or observing urine falling onto a sheet.9
Technique
It is suggested that the cystometry for patients with N-LUTD
The measurement of DLPP is a part of cystometric evaluation may be stopped when Pdet exceeds 40 cm H2O or the maximum
in patients with N-LUTD. Traditionally, the patient is positioned volume recovered at intermittent catheterization is reached or
supine and the bladder emptied. A small cystometry catheter if a detrusor contraction occurs.3 When cystometry ends
(10 F) is inserted into the urethra and standard urodynamic without leakage, the end filling pressure (EFP) should be noted.
equipment used to measure vesical pressure via a pressure If leakage occurs with an episode of neurogenic detrusor
transducer with a rectal probe to monitor intra-abdominal overactivity (N-DO) any time during filling cystometry, we
pressure changes.9 suggest that it should be noted as N-DO LPP. A similar definition
In suitable patients, the study can also be performed in the in non-neurogenic patients has recently been proposed as the
sitting position according to ICI recommendations, because this ‘‘detrusor overactivity leak point pressure’’ in women with
is reported to have a higher sensitivity for the diagnosis of filling urgency incontinence.16 The bladder volume at which leak
phase abnormalities (recommendation Grade B).10 No evidence occurs should also be noted, as it may be important for a
is available on the influence of positioning of patients with N- particular patient to organize their clean intermittent self-
LUTD on the DLPP. The size of the catheter has an influence on the catheterization (CIC) regimen.
DLPP and it has been shown that using progressively larger
catheters increases DLPP.11 According to the ICI 2013, there is
Basic Pathophysiology and Clinical Implications of DLPP in
evidence of level 3 that, in general, flow rate during voiding is
Patients With N-LUTD
reduced with a urodynamic catheter in the urethra and that this
reduction is partially caused by the size of the catheter. Use of, as DLPP is the pressure that overwhelms bladder outlet
thin as possible, ‘‘one-catheter systems’’ (dual lumen if fluid resistance, causing urinary leakage. DLPP is a reflection of the
filled) for filling and pressure recording during urodynamic resistance of the bladder outlet or external sphincter.1
testing is recommended with a level of evidence 4.10 This McGuire’s pioneering work has stated that patients with
recommendation may correspond to 5–8 F double lumen MMC and a LPP >40 cm were at risk of developing UUTD and
cystometry catheters during water cystometry. The consequence this cutoff has been traditionally accepted without a high level
of this recommendation is that DLPP is also done with a 5–8 F of evidence.2 It was shown in another study that reduction of
transurethral catheter. Another consequence is that when outlet resistance may improve bladder storage in the long-term
cystometry is performed via a suprapubic catheter, the DLPP and may preserve the upper tracts.12 Combs et al., however,
will theoretically be underestimated if compared with published reported that several of their patients with DLPPs of >40 cm
data, as this can also indirectly be deduced from a study where H2O (followed over a long period) showed no deterioration in
catheters were removed and reinserted during cystometry.13 their upper tracts, while by contrast some individuals
A cystometry filling rate is not standardized in the ICS GUP undergoing successful bladder augmentation required an
but is usually done with a rate dependent on age (from 20 ml/ artificial urinary sphincter, despite apparently good outlet
min in children to 30–60 ml/min in adults).6 There is some resistance before surgery.13 These authors suggested that
evidence that fluid temperature may not be relevant for the absolute values of DLPP reported previously were unreliable
outcome of cystometry; however, the influence on DLPP has not because the technique lacked standardization. Another retro-
been studied.14,15 spective study has challenged the single cutoff level of 40 cm
Detrusor adaptation to volume (compliance) may however, be H2O17 showing that UUT involvement rates are 18% in children
challenged if relatively high filling rates are used.9 The ICS with a DLPP below 20 cm H2O; 38% between 20 and 40 cm H2O;
classifies infusion rates as physiologic and non-physiologic and and 28% above 40 cm H2O, respectively. The authors concluded
no longer wishes to divide the filling rates as slow if <10 ml/min, that determining the cut-off value of the DLPP as 20 cm H2O
medium if 10–100 ml/min, or rapid if >100 ml/min, although instead of 40 cm H2O showed a higher sensitivity to predict the
almost all investigations are performed using medium filling risk group for UUT deterioration (Table I). They also suggested
rates within a wide range.5 It is advised to learn the day-to-day that children with MMC and a DLPP between 20 and 40 cm H2O
bladder capacity by using voiding (or catheterization) diary should be closely monitored, since 38.4% of children in their
volumes before the study, although particularly large or small study had UUT deterioration at the age of 3.17
capacities might affect the desired filling rates. For this reason, In spite of the ICS definition, DLPP is sometimes referred to as
we recommend a slow filling rate in adult neurogenic patients the elevation of the detrusor pressure during contractions
with a known hypocompliant bladder (EO). leading to leakage. In fact, this is not DLPP but is N-DO LPP.
According to the ICCS, filling rates (per minute) of 5–10% of However, the (clinical) significance of N-DO LPP versus DLPP in
known or predicted capacity may be used in children. Infusion
pump devices rather than gravity-type infusion systems are TABLE I. UUT Involvement According to Different DLPP Cut-Off Values17
recommended to avoid iatrogenic bladder pressure increases
during filling and inaccurate interpretation by pressure trans- Percentage of patients with upper tract Sensitivity (ROC
ducers.9–11 The ICCS also reports that the use of natural fill DLPP involvement analysis)
(ambulatory) cystometry provides a true physiological filling
rate and offers a more accurate representation of bladder >40 cm 18/64 (28.1%) 51.4%
activity than traditional cystometry in children and may be the H2O
technique of choice in pediatric urodynamics if time and >30 cm 24/88 (27.3%) 68.6%
H2O
equipment are available.8
>20 cm 33/102 (32.3%) 91.4%
According to an expert review, urinary leakage (in the H2O
absence of fluoroscopy) is best detected by having one person

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ICS Teaching Module: DLPP 3

TABLE II. Recommendations of the ICS Teaching Module for the Measurement, Clinical Utilization, and Future Research on DLPP

(1) Measuring and reporting of DLPP should be a part of cystometric evaluation of children and adults with N-LUTD to help predict (and prevent) UUTD
(Grade B/C)
a. The recommendations of the ICS and the ICCS should be followed for cystometric equipment and technique
(2) Discrimination of high-risk (UUTD) patients is, however, not very precisely possible on the basis of DLPP (Grade B/C)
(3) DLPP should not be used as the sole parameter to decide on invasive therapies such as bladder augmentation and sphincterotomy
a. UUTD in N-LUTD does not only depend on DLPP but will also depend on other factors such as bladder compliance; volume where leakage occurs; and
detrusor contraction duration and amplitude, with all of these related to CIC obtained volumes. On the other hand, the resistance of the bladder outlet to
the involuntary rise in detrusor pressure is another important parameter for deterioration
b. The traditional cut-off for DLPP of 40 cm H2O may have too low a sensitivity for the prediction of UUTD
(4) Future research should be directed to standardization of the technique and better classification of DLPP cut-offs in N-LUTD
a. The predictive value of LPP may differ according to underlying etiology of N-LUTD such as MMC, MS, or SCI
b. Cystometric readings should be sub-classified according to the presence of neurogenic DO (overactive detrusor contractions with or without leakage)
c. EFP should be taken into consideration if the leakage does not occur during cystometry, however, the clinical relevance of EFP is unclear

N-LUTD has not been investigated. Frequent DO episodes with CONCLUSION

high LPP are plausibly a similar risk for future upper tract
Although the causative relationship between the pressure
changes. The duration of the bladder contraction during an N-
within the urinary tract and UUTD has been acknowledged for
DO episode and DLPP >75 mmH2O is reported to have a
a long time, there are still many caveats regarding the
significant association with hydronephrosis.4,18 In a study with
standardization of urodynamic measurements and their
spinal cord lesion patients, the total duration of DO contrac-
predictive roles. According to the fifth International Consulta-
tions appeared as the only statistically significant urodynamic
tion on Incontinence, DLPP in patients with N-LUTD is
variable that correlated with upper tract dilatation or with
considered a relevant parameter with the recommendations
vesicoureteral reflux.18 Although DLPP is a measure of outlet
of grade B/C.10 It has been stated that DLPP is not consistently
resistance, treatment of patients with a high DLPP is directed
defined throughout the literature and that lack of standardiza-
toward reducing the vesical pressures and increasing the
tion is hindering comparison of studies.
bladder capacity. Reducing the number and amplitude of
Using a single ‘‘safe-unsafe’’ cut-off at 40 cm H2O may not
overactive detrusor contractions and improving bladder
reflect clinical reality and as McGuire suggested, a clinical
compliance, for example, with antimuscarincs, botulinum
management approach with an ‘‘as low as’’ reasonably
neurotoxin, or bladder augmentation is the mainstay of
achievable detrusor pressure over the entire daily volume
treatment. The clinical implication of DLPP is to help estimating
range is advisable.21
how much and how long the urinary tract system will be
The clinical recommendations on the basis of this review of
exposed to high pressure in-between bladder emptying periods
DLPP are summarized in Table II. Better standardization of
(with or without CIC) in the patient’s daily life.
DLPP measurements as well as better definition of urody-
namic capacity where leakage occurs and of EFP as well as of
End Filling Pressure (EFP) leak point pressure at overactive detrusor contraction will be
helpful. The bladder volume at which leakage occurs is very
Another problem with the utilization of DLPP is that a
important in order to adapt patients to CIC. Furthermore, EFP
significant number of patients with N-LUTD do not leak
and N-DO LPP should be separated from DLPP in urodynamic
during studies. It is generally accepted that the filling phase
investigations, and the definition should include the differ-
finishes when the detrusor pressure remains over 40 cm H2O
ence between these terms in order to prevent any confusion.
without leakage. In a recent study of 80 children with MMC
Prospective follow-up studies in patients with N-LUTD to
and a median age of 7 years (range 2–17), the majority of
evaluate the predictive value of these parameters for upper
children with MMC did not leak during urodynamics but
tract deterioration are recommended. This manuscript has
bladder wall thickness as well as urinary levels of TGF-b 1,
summarized the practice and interpretation of DLPP from a
NGF, and TIMP-2 were found to be significantly increased
clinical perspective.
when DLPP or EFP was greater than 40 cm H2O in this
cohort.19 Alternative methods, such as biomarkers, may
become available to predict UUTD. ACKNOWLEDGMENT
A recent study has challenged the predictive value of EFP in
We would like to thank the members of the ICS Urodynamics
predicting UUTD in a cohort of children who underwent
Committee core panel for establishing the teaching module and
bladder neck surgery (different types of slings) without
reviewing the manuscript.
augmentation for neurogenic incontinence.20 Seventeen
children with sustained EFP >40 cm for more than 1 year
despite anticholinergics were included in the study. During a REFERENCES
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Electromyography in the assessment and therapy of lower urinary tract dysfunction in adults
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Received: 28 December 2016

DOI: 10.1002/nau.23278
| Accepted: 10 March 2017

REVIEW ARTICLE

ICS Educational Module: Electromyography in the assessment

and therapy of lower urinary tract dysfunction in adults

Jan Krhut1 | Roman Zachoval2 | Peter F. W. M. Rosier3 | Beth Shelly4 |

Peter Zvara5

1 Department of Urology, Ostrava

University, University Hospital, Ostrava, Aim: To present the teaching module “Electromyography in the assessment and
Czech Republic therapy of lower urinary tract dysfunction in adults.” This teaching module embodies
2 Department of Urology, Thomayer
a presentation, in combination with this manuscript. This manuscript serves as a
Hospital and 1st and 3rd Faculty of
Medicine of Charles University, Prague,
scientific background review; the evidence base made available on ICS website to
Czech Republic summarize current knowledge and recommendations.
3 Departmentof Urology, University Methods: This review has been prepared by a Working Group of The ICS
Medical Center Utrecht, Utrecht, The
Urodynamics Committee. The methodology used included comprehensive literature
Netherlands
4 Beth Shelly Physical Therapy, Moline,
review, consensus formation by the members of the Working Group, and review by
Illinois members of the ICS Urodynamics Committee core panel.
5 Department of Urology and Biomedical Results: Electromyography (EMG) is a method to record spontaneous or artificially
Laboratory, University of Southern induced electrical activity of the nerve-muscle unit or to test nerve conductivity. EMG of
Denmark, Odense, Denmark
the anal sphincter using surface electrode is most widely used screening technique to
Correspondence detect detrusor-sphincter dyssynergia in urology. It is non-invasive and easy to perform.
Roman Zachoval, MD, PhD, Department of
EMG methods using needle electrodes are reserved for diagnostics in well selected
Urology, Thomayer Hospital, Vídeňská
800, 140 59 Praha 4. group of mainly neurogenic patients. These methods require expertise in the field of
Email: roman.zachoval@ftn.cz general EMG and are usually performed by neurologist and neuro-physiologist. The
evidence in many aspects of use of EMG in urology remains sparse.
Conclusions: Currently EMG methods rarely play a decision making role in selecting
proper treatment of lower urinary tract dysfunction. With the current efforts to
improve phenotyping of these patients in order to provide individualized treatment,
the role of EMG could increase.

KEYWORDS
bio-feedback, diagnostics, electrode, electromyography, ICS teaching module, urinary incontinence

1 | INTRODUCTION use of this method is limited. The aim of this communication is

to summarize the current evidence regarding the use of EMG in
The role of electromyography (EMG) is to record spontaneous adult urology and provide some suggestions for future research
or artificially induced electrical activity of the nerve-muscle which could lead to further development of this diagnostic and
unit or to test nerve conductivity. It is a component of the therapeutic method in urology. This paper was prepared by a
comprehensive urodynamic evaluation, however, the current Working Group of The ICS Urodynamics Committee. The
methodology used included comprehensive literature review,
Roman Zachoval led the review process. consensus formation by the members of the Working Group,
Neurourology and Urodynamics. 2018;37:27–32. wileyonlinelibrary.com/journal/nau © 2017 Wiley Periodicals, Inc. | 27

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and review by members of the ICS Urodynamics Committee potentials. Action potentials are waves of cell membrane
core panel. Literature review was performed according to the depolarization which travels toward the periphery. The
modified PRISMA (Preferred Reporting Items for Systematic transmission of neural action potential to a respective muscle,
Reviews and Meta-analysis) methodology in March 2016.1 which leads to its contraction, takes place at the neuromuscu-
Following Medical Subject Heading (MeSH) were used for lar junction. The action potentials are associated with changes
electronic search on MEDLINE database: (a) electromyogra- in extracellular and intracellular currents, which could be
phy; (b) neurofeedback; (c) lower urinary tract symptoms; recorded and processed for their quantitative (frequency and
(d) urodynamics; (e) pelvic floor disorders. Terms (a) and (b) amplitude of action potential) and qualitative (pattern of
were subsequently crossed with (c); (d); and (e). Total 1576 action potential) characteristics. Simultaneous activation of
publications were identified. After removing duplications multiple motor units leads to contraction of a single muscle.
(1576-355 = 1221), all articles published before 1986 Voluntary contraction force is modulated by the number of
(1221-302 = 919) and all articles in other than English recruited MU and changes in the activation frequency. The
language were excluded (919-132 = 787). We identified 81 number of recruited MU and their mean discharge frequency
relevant papers which served as a evidence base for of excitation determines the electrical activity, which could be
preparation of this manuscript and slide set. The ICS recorded using EMG. There is a direct relationship between
Urodynamics Committee presents this teaching module to the EMG and the muscle force.
serve as a standard education tool for professionals involved in
diagnostics and treatment of lower urinary tract dysfunctions.
The teaching module consists of a ICS Power 1.3 | Technical aspects of EMG
Point Presentation, available via http://www.icsoffice.org/
Most clinical EMG devices use a differential amplifier to
eLearning/ and this paper which serves as a scientific
enhance the display of information. This includes two or
background review. The presentation and this manuscript
more active electrodes placed in proximity to the target
contain experts’ opinion where evidence is, especially for the
muscle or muscle fibers and a common electrode placed
clinical practice aspects, unavailable and is marked with: “eo”
equidistant from the active electrodes or on a neutral
(expert opinion).
tissue. The differential amplifier compares the informa-
tion in all electrodes and discards any information that is
1.1 | History the same in all electrodes. This represents the background
electrical noise of the body. The remaining information
EMG is the oldest and most widely used electrophysiological
(the target muscle) is then amplified to reduce the
assessment method. The first records of EMG use involved
influence of artifact or environmental noise on the signal.
examination of skeletal muscles and it dates back to 19th
Technical parameters of the EMG unit play crucial role in
century. The first sphincter EMG was described by Beck in
validity of the obtained information. The quality of units used
1930.2 The EMG of the anal sphincter was first used in
in urology differs significantly. A minimal technical
clinical setting by Bailey in 1968.3 He used EMG as a part of
requirement for EMG unit for use in urology should include:
complex neuro-urological evaluation of 184 incontinent
Bandwidth: 30 hz-10 kHz; Time scale: 10-100 ms; Sensitiv-
children with neurogenic bladder. He also proposed that
ity: 0.1-2.0 mV; 5p DIN connector; 1.5 mm touch-proof
EMG could be used in adults with neurogenic bladder.
connector for common electrode; EMG processing average
Chantrain was the first to conduct comparative studies of
rectified curve, raw EMG curve, and audio EMG.
skeletal muscle and anal sphincter EMG.4 In 1979, Mayo
included EMG of the anal sphincter into the urodynamic
assessment.5 The future steps in the development of this
1.4 | Electrodes
diagnostic method were marked by neural conductivity
studies looking at sacral reflex pathways in 1970s and finally In general electrodes are used for recording changes in
introduction of sensory and motor evoked potentials testing the algebraic sum of motor unit action potentials, or for
which was first published in 1982.6,7 neural stimulation. The recording unit consists of two or
more active electrode and a ground electrode. The size of
the electrode determines the specificity of the recording.
1.2 | Electrophysiology Larger electrodes are used to record large muscle areas
An intact and functioning motor unit (MU) is the basic such as the activity of the entire pelvic floor muscle
component required for adequate function of any muscle. MU contraction. Smaller electrodes are used to evaluate
consists of a single α-motoneuron residing in the anterior horn single motor units. According to their design, technical
of the spinal cord, axon nerve fiber and corresponding characteristics and purpose (recording vs stimulation)
muscle fiber. Neurons conduct electrical impulses—action electrodes are divided in several groups:

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Needle electrodes are inserted into the recording muscle 2 | EMG METHODS USED IN
and are designed to record single fiber action potentials or UROLOGY
action potentials from a small number of units.
2.1 | Needle EMG of anal sphincter

1.4.1 | Coaxial needle electrode 2.1.1 | Principle

Is the most widely used type of needle electrode used in External anal sphincter is the component of the pelvic floor
myography performed by neurologists. It consists of the which is easiest to identify and target using a needle
platinum wire (active electrode) which is wrapped in a electrode. Due to close anatomical location and shared
steel sheet (reference/common electrode). The electrode innervation, it’s activity could implicate the activity of
records the differences in a single action potential other anatomical structures of the pelvic floor. It is
between the tip of the platinum wire and the conductive therefore used as a tool for indirect evaluation of the
sheet. urethral closing mechanism.

1.4.2 | Bipolar needle electrode 2.1.2 | Technique

Consists of two platinum wires embedded in the sheet and With the patient in the lateral decubitus or lithotomy
records the difference between action potentials recorded by position, under digital rectal control, needle electrodes are
the two active wires. inserted bilaterally, approximately 0.5 cm lateral to the
anus. The depth of insertion is 3-8 cm, depending on
patient’s constitution.
1.4.3 | Monopolar needle electrodes First, we assess the EMG during maximal relaxation,
Measure activity recorded by a conically shaped tip of the than during slight pelvic floor muscle contraction or during
needle which is embedded in the unconductive sheet. slow artificial bladder filling. Subsequently we assess the
Compared to coaxial needles, it has a larger recording sphincter activity during maximal voluntary contraction of
surface, and a wider pick-up field, resulting in higher the anal sphincter. To obtain reproducible results it is
amplitudes of recorded potentials. This does not allow for necessary to record at least 10-20 single action potentials
recording of action potential from a single muscle fiber in every phase of the assessment.8 This assessment is
and is therefore less specific. challenging for the patient, time consuming, requiring
skills, and expertise.

1.4.4 | Surface electrodes

2.1.3 | Evidence
Surface electrodes are placed on the skin overlaying the
muscle of interest. This includes both external patch and Anal sphincter EMG using needle electrodes allows the
internal vaginal or rectal probe electrodes. They consist physician to detect disturbances in neuroregulation of the
of silver chloride conductive discs or bars. They have a pelvic floor muscles, which could be due to spinal cord injury,
larger reception field, which means that they display a lower motor neuron lesion, demyelinating diseases, and
summary of the entire muscle not single action potential. Parkinson disease. It could indirectly detect detrusor-
They are however, easy to use and not associated with sphincter dyssynergia (eo).
needle insertion, therefore, despite their low sensitivity However, no systematic study or meta-analysis has been
they are the most widely used electrodes in urodynamic published during last two decades with the topic of the use of
evaluation. needle EMG of the anal sphincter in urology. Currently, only
limited evidence based on single center expert opinion is
available (eo).
1.4.5 | Stimulation electrodes
Their principal use is to provoke action potential remotely,
2.2 | Needle EMG of urethral sphincter
which is then picked up by the recording electrode for the
purpose of assessing the nerve conductivity and neuro-
muscular transmission. They could be designed as both
2.2.1 | Principle
needle or surface electrodes of different shapes according Direct detection of the activity of the striated external urethral
to the type of use (clip electrodes, band electrodes). sphincter.

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2.2.2 | Technique sphincter dyssynergia in patients with neurogenic bladder and

impaired pelvic floor muscle relaxation in patients with
In male patients the needles are inserted into the perineum
dysfunctional voiding. Recently it has been documented that
0.5 cm lateral to the midline at the point of projection of the
anal sphincter EMG using surface electrodes did not document
urethral bulb. The needle tip is directed toward the apex of the
pelvic floor muscle relaxation during voiding in the majority of
prostate and the depth of insertion is controlled by digital rectal
a large cohort of patients, suggesting the low sensitivity of this
examination (DRE) and by acoustic and visual evidence of
evaluation.12 However, in pediatric urology literature evidence
activity recorded by the EMG equipment. In female patients the
has been published in support of the beneficial role of
electrodes are inserted transvaginal, after the bladder neck is
simultaneous uroflowmetry and EMG to detect dysfunctional
identified with help of a urethral Foley catheter. The recording
voiding. The argument is that abnormal voiding pattern, that is,
technique is identical to that of the anal sphincter.
staccato and interrupted/fractionated voiding observed on
uroflowmetry alone, can lead to overdiagnosis of dysfunctional
2.2.3 | Evidence voiding or detrusor underactivity and that adding simultaneous
EMG could significantly improve the diagnostic accuracy.13 In
Allows direct recording of the urethral sphincter, however,
addition, evidence of usefulness of EMG lag time has been
due to its invasive nature and technical difficulty is used only
reported in children. EMG lag time is a uroflow/EMG
used in a limited number of carefully selected cases, most
measurement of the time interval between the moment that
often in research studies.9 Basic work describing the use of
relaxation of the pelvic floor EMG takes place and the moment
needle EMG of the urethral sphincter can be dated back to
urine flow begins. When the lag time is short it is supportive of
1984.10 More recently Mahajan confirmed the superiority of
the diagnosis of detrusor overactivity, while prolongation
needle urethral sphincter electrodes compared to surface
supports the diagnosis of primary bladder neck dysfunction,
electrodes.11 However, only limited evidence based on single
especially when they appear in combination with certain
center expert opinion is available.
LUTS and uroflow patterns.14 These data should stimulate
future studies exploring the role of simultaneous uroflow and
2.3 | EMG of anal sphincter using surface EMG in adults.
electrodes

2.3.1 | Principle 2.4 | Sacral reflex conductivity testing

Non-invasive detection of activity of the entire pelvic floor
muscles which is routinely used in urology in course of 2.4.1 | Principle
uroflowmetry or invasive urodynamics. Stimulation of the pudendal nerve to induce pelvic floor
muscle contraction. The presence or absence of response of
2.3.2 | Technique pelvic floor muscles is evaluated together with recording for
latency interval between the stimulus and the response. The
Surface patch electrodes are attached adjacent to the mucocuta- goal is to assess the peripheral limb of the micturition reflex.
neous line of anus bilaterally. The impedance of the skin is
reduced using careful degreasing. In some cases a careful
epidermis abrasion is required. Excessive hair and adipose tissue 2.4.2 | Technique
around the anal sphincter decrease accuracy of the EMG
reading. The electrode wires need to be positioned away from Neurostimulation is performed with surface electrodes
the urine stream. Practitioners are also cautioned not to place the attached at the dorsal aspect close to the base of the penis
electrodes too lateral in which case the gluteus muscles are being in men and to small labia in women. The response could be
recorded. The common electrode can be placed on the thigh or recorded by both surface or needle electrodes from the region
trochanter. The proper attachment of the electrodes is of anal sphincter or bulbocavernous muscle.
subsequently tested by recording increased activity during the
voluntary pelvic floor contractions.
2.4.3 | Evidence
This modality is potentially useful for evaluation of
2.3.3 | Evidence
bulbocavernosus and anorectal reflexes.
Evidence for using EMG diagnosis of anal sphincter Absence or delay in response, suggest lower motor neuron
dysfunction using surface electrodes in adults remains weak. impairment. No relevant recent study which could support the
This modality is used for screening purposes to detect detrusor- role of this examination in daily clinical work-up was found.

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KRHUT ET AL.
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2.5 | EMG biofeedback been written by Dr. Roberto Merletti.19 This document
summarizes technical information that has to be included for
2.5.1 | Principle each type of electrode, necessary data on detection mode,
amplification, rectification of signal and its computer processing.
Detect the pelvic floor muscle activity and transform it into a
In addition it provides guidelines on EMG amplitude and
visual and/or acoustic display in order to convey the information
frequency processing, normalization, EMG processing for
to the patient. This is subsequently used for biofeedback
estimation of muscle fiber conduction velocity and EMG
training.
crosstalk. Every medical professional using EMG, especially in
research, should follow these guidelines.
2.5.2 | Technique
Surface electrodes are placed close to the anal sphincter (as 2.8 | Suggestions for future research
described above) or inside the vaginal or rectal canal. The
There is a clear lack of evidence in many aspects of the use of
recording signal is transformed into sound or visual clue and
EMG in urology. High quality trials are required especially in
used to guide the patient to better understand the functional
following topics:
status of the pelvic floor muscles.
1. EMG pattern of the pelvic floor muscle under physiologi-
2.5.3 | Evidence cal and pathological conditions.
2. Role of the EMG in the comprehensive urodynamic
This technique is widely used in conservative treatment of
evaluation.
incontinence. Acoustic or visual clues help patients
3. Role of EMG in the phenotypisation of the patients
to improved awareness of their pelvic floor muscles and to
suffering from LUTS.
improve their ability to selectively contract the appropriate
4. Role of the pelvic floor muscle EMG as a biofeedback tool
group of muscles. EMG biofeedback seems to be effective in
in LUT dysfunctions.
the conservative treatment of stress urinary incontinence as
5. Role of audio monitoring during EMG in adults.
well as overactive bladder.15,16 However, there is only limited
6. Role of simultaneous uroflowmetry and EMG in detection
number of well designed randomized controlled studies to
of voiding dysfunctions, detrusor overactivity, and
support this observation.
detrusor underactivity in adults.
On the other hand, in dysfunctional voiders, EMG
biofeedback is used as a tool to help relax the pelvic floor
muscles during micturition. While being a well established
method in the treatment of voiding dysfunctions in the pediatric
3 | CONCLUSIONS
population, where combination of acoustic and visual biofeed-
The concept of the use of electrophysiological methods in
back plays an important role, evidence in adults is
urology is supported by good theoretical basis. However, the
lacking.17,18(eo).
evidence supporting the value of EMG techniques in diagnostics
is limited. With the current efforts to improve phenotyping of
2.6 | Patients perspective these patients in order to provide individualized treatment, the
role of EMG could increase. In contrary evidence in support of
Electromyography does not require any specific patient
EMG biofeedback exists and should be considered an integral
preparation. Patients must be properly instructedthat insertion
part of conservative treatment of incontinence, OAB, and
of EMG needles is associated with a certain degree of pain.
dysfunctional voiding.
Surface EMG is non-invasive and painless. However, the patient
must be informed that hair removal, skin defatting and, in some
cases, epidermis abrasion is required before placing electrodes.
REFERENCES
In all cases, but especially for EMG used for biofeedback,
patients should be physicaly and mentaly capable of following 1. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for
instructions given by the health care professional systematic reviews and meta-analyses: the PRISMA statement. Ann
(eg, contraction or relaxation of the pelvic floor muscles). Intern Med. 2009;151:264–269.
2. Beck A. Elektromyographische untersuchungen am sphincter ani.
(Ein beitrag zur tonusfrage). Pflugers Arch. 1930;224:278.
2.7 | Standards for reporting EMG data 3. Bailey J, Powers J, Walonis G. A clinical evaluation of electromyog-
raphy of the anal sphincter. Arch Phys Med. 1970;7:402–408.
The “Standards for Reporting EMG Data” endorsed by the 4. Chantraine A. Electromyographie des sphincters stries ureteral et
International Society of Electrophysiology and Kinesiology have anal humains. Rev Neurol. 1966;115:396–403.

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5. Mayo ME. The value of sphincter electromyography in 15. Dannecker C, Wolf V, Raab R, et al. EMG-biofeedback assisted
urodynamics. J Urol. 1979;122:357–360. pelvic floor muscle training is an effective therapy of stress urinary
6. Rushworth G. Diagnostic value of electromyographic study of or mixed incontinence: a 7-year experience with 390 patients. Arch
reflex activity in man. Electroenceph Clin Neurophysiol. 1967; Gynecol Obstet. 2005;273:93–97.
(Supl 25):65–73. 16. Wang AC, Wang YY, Chen MC. Single-blind, randomized trial
7. Badr GA, Fall M, Carlsson CA, et al. Cortical evoked potentials of pelvic floor muscle training, biofeedback-assisted pelvic
following the stimulation of the urinary bladder in man. floor muscle training, and electrical stimulation in the
Electroenceph Clin Neurophysiol. 1982;54:494–498. management of overactive bladder. Urology. 2004;63:61–66.
8. Chantraine A. EMG examination of the anal and urethral sphincters. 17. Koenig JF, McKenna PH. Biofeedback therapy for dysfunctional
In: Desmedt JE: New developments in electromyography and voiding in children. Curr Urol Rep. 2011;12:144–152.
clinical neurophysiology. Basel: Karger; 1973. 18. Combs AJ, Glassberg AD, Gerdes D, et al. Biofeedback therapy for
9. Vereecken RL, Derluyn J, Verduyn H. Electromyography of the children with dysfunctional voiding. Urology. 1998;52:312–315.
perineal striated muscles during cystometry. Urol Int. 1975;30:92–98. 19. Merletti R. Standards for reporting EMG data. JEK. 2015;25:1–2.
10. Fowler CJ, Kirby RS, Harrison MJG, et al. Individual motor unit
analysis in the diagnosis of disorders of urethral sphincter
innervations. J Neurol Neurosurg Psychiatry. 1984;47:637–641. SUPPORTING INFORMATION
11. Mahajan ST, Fitzgerald MP, Kenton K, et al. Concentric needle
Additional Supporting Information may be found online in
electrodes are superior to perineal surface-patch electrodes for
electromyographic documentation of urethral sphincter relaxation the supporting information tab for this article.
during voiding. BJU Int. 2006;97:117–120.
12. Kirby AC, Nager CW, Litman HJ, et al. Perineal surface
electromyography does not typically demonstrate expected relaxa-
tion during normal voiding. Neurol Urodyn. 2011;30:1591–1596. How to cite this article: Krhut J, Zachoval R,
13. Wenske S, Combs AJ, Van Batavia JP, et al. Can staccato and Rosier PFWM, Shelly B, Zvara P. ICS Educational
interrupted/fractionated uroflow patterns alone correctly identify the Module: Electromyography in the assessment and
underlying lower urinary tract condition? J Urol. 2012;187:2188–2193. therapy of lower urinary tract dysfunction in adults.
14. Combs AJ, Van Batavia JP, Horowitz M, et al. Short pelvic floor
Neurourology and Urodynamics. 2018;37:27–32.
electromyographic lag time: a novel noninvasive approach to
document detrusor overactivity in children with lower urinary tract
https://doi.org/10.1002/nau.23278
symptoms. J Urol. 2013;189:2282–2286.

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Received: 6 September 2016

| Accepted: 19 September 2016

DOI 10.1002/nau.23181

REVIEW ARTICLE

ICS teaching module: Cystometry (basic module)

Carlos Arturo Levi D’Ancona1 | Mario João Gomes2 | Peter F.W.M. Rosier3
1 Division of Urology, University of Campinas

School of Medicine, Campinas, Sao Paulo, Brazil Aims: To summarize the evidence background for education of good urodynamic
2 Inremembrance: Hospital Santo Antonio, Porto, practice, especially cystometry.
Portugal Methods: A search was done in PubMed for the last 5 years of publications selecting
3 Department of Urology, University Medical Center
only clinical studies, utilizing the following keywords: cystometry 133 articles and
Utrecht, The Netherlands
filling cystometry 53 articles.
Correspondence Results: The evidence with regard to clinical setting and cystometry technique, as
Carlos Arturo Levi D’Ancona, Division of Urology,
University of Campinas School of Medicine, well as for catheters and transducers type, infused solution and patient position is
Campinas, Sao Paulo, Brazil. presented with recommendations. Also the practice of determining bladder filling
Email: cdancona@uol.com.br sensation and capacity and the basis of detrusor storage function diagnosis is
educated.
Conclusions: This manuscript provides the evidence background for the practice
of cystometry.

KEYWORDS
cystometry, urodynamics

1 | INTRODUCTION performing, and analyzing urodynamic testing. The teaching

module consists of a presentation, in combination with this
Cystometry is the method by which the storage function of the manuscript. This manuscript serves as a scientific background
lower urinary tract (LUT) is measured during the filling of the review; the evidence base, for the ICS PowerPoint presenta-
bladder.1,3 The aim of urodynamics is to find an objective, tion; available via http://www.icsoffice.org/eLearning/......
pathophysiological, explanation for the patient's LUT The presentation explains normal physiology, testing require-
symptoms and to answer the clinical (or research) ques- ments, practice of testing, and analysis methods.
tion.3–5 Cystometry is an important part of invasive
urodynamics as it evaluates the storage function of the 1.1 | Clinical setting
bladder. Invasive urodynamics, that is, cystometry requires
Cystometry is part of invasive urodynamic investigation
insertion of catheters and technical instrumentation and also
and contemporary guidelines recommend that a LUT
depends on cooperation of the patient. Urodynamics is a
symptom questionnaire, a voiding diary, clinical examina-
replication of the LUT physiology in a laboratory situation
tion, and laboratory urine exam preceded invasive testing.
and the interpretation should be made with specific attention
Usually uroflowmetry and a post void residual urine (PVR)
to representativeness, technical details, as well as clinical
are also recommended before further testing. The voiding
relevance. Cystometry is the golden standard for LUT storage
diary informs about the range of the volume of micturition
function assessment.1–5
and the frequency of voiding. Uroflowmetry and PVR are
The ICS Urodynamics Committee presents this teaching
recommended for clinical reasons but also relevant to
module “Cystometry” as standard education of Good
evaluate the representativeness of pressure flow analysis
Urodynamic Practice2,3 for everyone involved with indicating,
(not further discussed here). For the practice of cystometry
however, PVR is also informative to be aware of the
Dr. Alan Wein led the peer-review process as the Associate Editor responsible for
“hidden” capacity of the bladder, not visible on the voiding
the paper. diary.

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Voided volumes (including PVR) provide a clue to the inserted together with a filling catheter (usually 8-10F) that is
urodynamic capacity that can be expected. Cystometry removed at the end of the filling to avoid excess obstruction
should result in a diagnosis of detrusor (muscle volumea- during voiding. Abdominal pressure, surrounding the bladder
daptation) function and bladder compliance as well as in the lower pelvis, is measured with a, preferably punctured,
diagnoses of bladder filling sensation and cystometric balloon filled with a small amount of fluid to prevent clogging
(bladder) capacity.1 Clinical stress-testing during examina- of the catheter by rectal content, but may also be an open fluid
tion can demonstrate urine loss however cystometry allows filled tube without balloon.2,3 Vaginal placing or via a stoma
stress (urinary incontinence) testing while intravesical are alternatives when the rectum is closed. Although this
volume and pressures are monitored, allowing to control is—especially stoma placement—less reliable.
for detrusor activity.6,7 All this information gives the The size of the abdominal pressure catheter is preferably
urodynamic diagnosis of storage phase function and is basis similar to that of the Pves so that the same sensitiveness to
for management of patients with symptoms and signs of transfer the pressure is present.
LUTD.5 The cystometry starts (after insertion of the
catheters) when the infusion begins and ends when the 1.4 | Pressure transducer
infusion stops under the command of the patient and/or
decision of the urodynamicist.1–3 Cystometry may also end Electronic external transducer, connected to the tubing via a
with loss (incontinence) of total bladder volume. pressure dome is the most frequently used in ICS standard
urodynamic evaluation and all pressure parameters are based
on this system. New microtip or air filled transducers have the
1.2 | Technique of cystometry advantage of no air bubbles in the fluid system or obstruction
of measuring holes, but the results obtained with these
Catheterization is performed trans-urethral however, can also systems are not entirely identical.11 New studies should
be done via the suprapubic route. ICS standard requires fluid elucidate the magnitude of the differences and uncover
filled catheters connected to an external pressure transducer. practical methods to calibrate the clinical results with the
Simultaneous recording of abdominal pressure (Pabd) is also alternative systems with the available reference values
standard and can be obtained with the use of a catheter in the
obtained with fluid filled systems.
rectum and connected to a pressure transducer.1–3
The external transducers are positioned at the level of the
upper border of symphysis pubic and zeroed at atmospheric
1.5 | Solution infused
pressure before connecting to the catheters, or via a tree-way Saline solution is the commonly used fluid for bladder filling.
stopcock while connected.3 Air bubbles in the connecting When videourodynamics is performed, a contrast solution is
tubes and catheters cause dampening of the pressure added. Body temperature fluid and room temperature fluid do
transmission and should be removed from the system before not differently affect bladder sensory thresholds and do not
insertion and measuring. unequally provoke DO or LUT irritation12,13 but forced
Before and during the exam, it is necessary to verify that diuresis (without external filling) does lead to a higher
both pressures are registering by asking the patient to cough.3 incidence of DO.14
The amplitude of pves and pabd should be similar. The vital The infusion rate is, by ICS good urodynamic
signs of respiration, talking of the patient, and movement practices, divided into Physiological filling rate—less
should be visible in pves and pabd throughout the entire than predicted maximum; calculated with body weight in
cystometry as a sign of pressure registering quality.2,8,9 kg divided by four expressed in mL/min; Non-physiologic
Rectal contractions may occur during cystometry and should filling rate; defined as filling rate greater than the predicted
not be misinterpreted as detrusor overactivity in the pdet maximum filling rate.1 A fill rate of 10% of anticipated
trace.9 On the other hand classification of intensity and capacity, based on voiding diary and PVR, per minute may
frequency of rectal contractions may be of relevance.10 be an acceptable rule of thumb to select the (non-
physiologic) fill rate.1–3
1.3 | Types of catheters
1.6 | Patient position
A double lumen catheter, as thin as possible (usually 7-8F), is
ICS good urodynamic practices standard. A double lumen The ICS standard position during cystometry is sitting upright
catheter requires an infusion pump on the filling lumen. Using or standing in all patients able to do. The initial resting
a double lumen catheter allows a smooth transition from pressures, if zeroed to the ICS reference, are 15-40 cmH2O
storage to voiding and permits the exam to be repeated (sitting) or 30-50 cmH2O (standing), both for the vesical as
without reinsertion of a filling catheter. well as intrarectal pressure. In the supine position, the vesical
A double lumen catheter may be considered too expensive pressure will be 5-20 cmH2O and the intrarectal pressure in an
in some health care systems and in that case a 6F catheter is individual, usually somewhat higher as a consequence of this

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position.15 By consequence the subtracted detrusor pressures without urinary leakage, is rarely reported in scientific
are around zero. Small differences (< + or − 10 cmH2O) can literature but may be of relevance in (ketamine) interstitial
be considered to be a result from differences in catheter tip cystitis.
position of both catheters inside the body and are therefore Cystometry is apart from urinary tract infection and
acceptable. urethral lesion not associated with excessive risks. In persons
with a spinal cord lesion, however, autonomic dysreflexia
1.6.1 | Bladder sensation may occur; immediate emptying of the bladder is the remedy
(further discussed in specific ICS module). After cystoplasty
During the exam verbal communication is maintained with
or myectomy of the detrusor there is an increased risk of
the patient so he/she can give information about the bladder
rupture of reservoir and especially in these patients (but not
sensation. This is a subjective parameter. ICS has defined
exclusively) the bladder should not be filled far beyond the
three points to be evaluated: First sensation of bladder
usual volumes.18,19
filling—is the feeling the patient has, during filling
cystometry, when he/she first becomes aware of the bladder
filling. First desire to void—defined as the feeling, during 1.6.3 | Detrusor function
filling cystometry, that would lead the patient to pass urine at Detrusor function can be normal or overactive.1 Normal
the next convenient moment, but voiding can be delayed if detrusor function—allows bladder filling with little or no
necessary. Strong desire to void—is defined, during filling change in pressure. Detrusor overactivity—is characterized
cystometry, as a persistent desire to void without the fear of by phasic detrusor pressure increments, which may be
leakage.1,3 These definitions should be put in practice as spontaneous or provoked. Examples of provocative maneu-
follows: First Sensation should be separated from the vers: non-physiological fast, for example, 100 mL/min
sensations that the catheterization has caused, that usually bladder filling, change of position, stress test, and washing
diminishes after the first minutes; The patient is asked “Tell hands.
me when you become aware that the bladder is not empty Detrusor overactivity should be classified as neurogenic
anymore.” Normal desire is (if no or little chronic post void or idiopathic. Detrusor overactivity is a urodynamic diagnosis
residual exists) usually roughly associated with “average” and clinical symptoms may be urgency, urgency and
FVC-BD volumes and can be asked as: “Tell me when you incontinence, or overactive bladder syndrome.1,7 When
have the sensation that normally tells you go to the toilet, detrusor overactivity is observed in a patient with a relevant
without any hurry. Strong desire is “the moment that you, neurologic abnormality (should be diagnosed based on
without any pain, will not likely postpone the voiding any history and clinical examination) the detrusor overactivity
more, and or will visit the nearest restroom, eg, while is neurogenic.
shopping.” Correlating the results of cystometry volume and
sensations with FVC-BD may provide background informa-
1.6.4 | Bladder compliance
tion regarding day to day sensory findings and bladder
volumes. Sensation volumes are “normally” occurring at Bladder compliance represents the relationship between
respectively ±30 and 60% of capacity, and are also associated change in bladder volume and change in detrusor pressure
with the dysfunction.16,17 Bladder sensation can be and shows the capacity of the detrusor to relax and to stretch
classified with the terms normal, absent, reduced, and to accommodate to volume increment. Also reduced
increased sensations. Sensation is considered increased compliance may result in frequent voiding.
when the sensations, as described above, occur early, at The module “cystometry advanced” discusses abnormal-
relatively small volumes.1 Bladder sensation can also be ities of sensation and or detrusor function abnormalities.
atypical, usually in patients with neurological abnormalities
(not further discussed in this module).

2 | CONCLUSION
1.6.2 | Bladder capacity during filling cystometry
Bladder capacity during filling cystometry is characterized The evidence with regard to clinical setting and cystom-
by cystometric capacity and maximum cystometric capac- etry technique, as well as for catheters and transducers
ity. Usually reported is capacity at strong desire which may type, infused solution, and patient position is presented
be interpreted as maximum cystometric capacity that with recommendations. Also the practice of determining
should be around 500 mL in women16,17 and somewhat bladder filling sensation and capacity and the basis of
less in elderly men.8 Filling of more than 800 mL is seldom detrusor storage function diagnosis is educated and
useful. provides the evidence background for the practice of
Maximum anesthetic capacity; the volume to which the cystometry shown in the ICS teaching module slides-set
bladder can be filled under deep general or spinal anesthetic, and presentation.

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| D’ANCONA ET AL.

3 | POTENTIAL CONFLICTS OF 10. Cho SY, Oh SJ. The clinical significance of rectal contractions that
INTEREST occur during urodynamic studies. Neurourol Urodyn. 2010;29:
418–423.

Dr. Rosier reports grants from T-doc, grants from MMS/ 11. Cooper MA, Fletter PC, Zaszczurynski PJ, Damaser MS.
Laborie, grants from Astellas, outside the submitted work; Comparison of air-charged and waterfilled urodynamic
pressure measurement catheters. Neurourol Urodyn. 2011;
Dr. D'Ancona reports grants from Astellas, outside the
30:329–334.
submitted work; Dr. Gomes has nothing to disclose.
12. Gelhrich AP, Hill MJ, McWilliams GD, Larsen W, McCartin T.
Comparison of urodynamic volume measurements using room
REFERENCES and body temperature saline: a double-blinded randomized
crossover study design. Female Pelvic Med Reconstr Surg.
1. Abrams P, Cardozo L, Fall M, et al. The standardisation of
2012;18:170–174.
terminology of lower urinary tract function: report from the
Standardisation Sub-committee of the International Continence 13. Klevmark B. Natural pressure-volume curves and conventional
Society. Neurourol Urodyn. 2002;21:167–178. cystometry. Scand J Urol Nephrol Suppl. 1999;201:1–4.

2. Schäfer W, Abrams P, Liao L, et al. Good urodynamic practices: 14. van Venrooij GE, Boon TA. Extensive urodynamic investigation:
uroflowmetry, filling cystometry, and pressure-flow studies. interaction among diuresis, detrusor instability, urethral relaxa-
Neurourol Urodyn. 2002;21:261–274. tion, incontinence and complaints in women with a history of
urge incontinence. J Urol. 1994;152:1535–1538.
3. Rosier PFWM, Schaefer W, Lose G, et al. International continence
15. Sullivan JG, Swithinbank L, Abrams P. Defining achievable
society good urodynamic practices and terms 2016
standards in urodynamics—a prospective study of initial resting
(ICS-GUP2016): urodynamics, uroflowmetry, cystometry and
pressures. Neurourol Urodyn. 2012;31:535–540.
pressure-Flow study. Neurourol Urodynam. 2016; In press.
16. Mahfouz W, Al Afraa T, Campeau L, Corcos J. Normal urodynamic
4. Abrams P, ed. Urodynamcis. 2nd ed. London: Sringer; 1997:1.
parameters in women. Part II—invasive urodynamics. Int
5. Rosier PF, Giarenis I, Valentini FA, Wein A, Cardozo L. Do Urogynecol J. 2012;23:269–277.
patients with symptoms and signs of lower urinary tract dysfunction
17. Wyndaele JJ. Normality in urodynamics studied in healthy adults.
need a urodynamic diagnosis? ICI-RS 2013. Neurourol Urodyn.
J Urol. 1999;161:899–902.
2014;33:581–586.
18. Blok BF, Al Zahrani A, Capolicchio JP, Bilodeau C, Corcos J.
6. Winters JC, Dmochowski RR, Goldman HB, et al. Urodynamic Post-augmentation bladder perforation during urodynamic inves-
studies in adults: AUA/SUFU guideline. J Urol. 2012;188: tigation. Neurourol Urodyn. 2007;26:540–542.
2464–2472.
19. Ehdaie B, Mason MD, Gray M, Peters CA, Corbett ST. Bladder
7. Haylen BT, de Ridder D, Freeman RM, et al. An International perforation in augmentation cystoplasty during urodynamic
Urogynecological Association (IUGA)/International Continence investigation: a case report and review of the literature. J Pediatr
Society (ICS) joint report on the terminology for female pelvic floor Urol. 2013;9:102–106.
dysfunction. Neurourol Urodyn. 2010;29:4–20.
8. Liao L, Schaefer W. Quantitative quality control during urody-
namic studies with TVRs for cystometry in men with lower urinary How to cite this article: D’Ancona CAL, Gomes
tract symptoms suggestive of benign prostatic hyperplasia. Int Urol MJ, Rosier PF. ICS teaching module: Cystometry
Nephrol. 2014;46:1301–1308. (basic module). Neurourology and Urodynamics.
9. Hogan S, Gammie A, Abrams P. Urodynamic features and 2017;36:1673–1676. https://doi.org/10.1002/nau.23181
artefacts. Neurourol Urodyn. 2012;31:1104–1117.

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Neurourology and Urodynamics 35:55–57 (2016)

Measurement of Post-Void Residual Urine

Anastasios D. Asimakopoulos,1 Cosimo De Nunzio,2
Ervin Kocjancic,3 Andrea Tubaro,2 Peter F. Rosier,4 and Enrico Finazzi-Agrò5*
1
UOC of Urology, Department of Surgery, University of Tor Vergata, Policlinico Casilino, Rome, Italy
2
Department of Urology, Sant’Andrea Hospital, Faculty of Health Sciences ‘‘La Sapienza’’ University of Rome, Rome, Italy
3
Director division of Pelvic Health and Reconstructive Urology, Department of Urology, University of Illinois at Chicago,
Chicago, Illinois
4
University Medical Centre Utrecht, Department of Urology, Utrecht, The Netherlands
5
Unit for Functional Urology, Policlinico Tor Vergata, Department of Experimental Medicine and Surgery,
Tor Vergata University of Rome, Rome, Italy

Aims: To present the teaching module ‘‘Measurement of Post-void residual urine.’’ Methods: This module has been
prepared by a Working Group of the ICS Urodynamics Committee. The methodology used included comprehensive
literature review, consensus formation by the members of the Working Group, and review by members of the ICS
Urodynamics Committee core panel. Results: In this ICS teaching module the evidence for and relevance of PVR
measurement in patients with lower urinary tract dysfunction (LUTD) is summarized; in short: The interval between
voiding and post-void residual (PVR) measurement should be of short duration and ultrasound bladder volume
measurement is preferred to urethral catheterization. There is no universally accepted definition of a significant residual
urine volume. Large PVR (>200–300 ml) may indicate marked bladder dysfunction and may predispose to unsatisfactory
treatment results if for example, invasive treatment for bladder outlet obstruction (BOO) is undertaken. PVR does not
seem to be a strong predictor of acute urinary retention and does not indicate presence of BOO specifically. Although the
evidence base is limited, guidelines on assessment of LUTS generally include PVR measurement. Conclusion:
Measurement of PVR is recommended in guidelines and recommendations on the management of LUTS and urinary
incontinence, but the level of evidence for this measurement is not high. This manuscript summarizes the evidence and
provides practice recommendations for teaching purposes in the framework of an ICS teaching module. Neurourol.
Urodynam. 35:55–57, 2016. # 2014 Wiley Periodicals, Inc.

Key words: bladder outlet obstruction; measurement; post-void residual urine; urinary incontinence; urinary tract
infections; urodynamics

INTRODUCTION examples. However, anatomical abnormalities for example,

bladder diverticulum or large volume vesicourethral reflux
The incomplete evacuation of the bladder leads to post-void
may also cause PVR (in the latter case due to very early refilling
residual urine (PVR). PVR is defined as the volume (ml) of urine
of the bladder by the refluxed urine).3 BOO may be a
left in the bladder at the end of micturition.1
consequence of prostate enlargement (BPE), urethral or meatal
The ICS Urodynamics Committee presents the teaching
stricture, or incomplete or interrupted sphincter relaxation.
module ‘‘Measurement of post-void residual urine’’ to serve
Rarely a bladder stone or tumor is the cause of PVR.3
as a standard education of Good Urodynamic Practice for
Underactive detrusor contraction can result from neurogenic,
everyone involved in indicating, performing, and analyzing
myogenic or psychogenic causes or be an effect or side effect
urodynamic testing in general and more specifically, perform-
of pharmacotherapy.3 In any individual, especially in the
ing analysis of voiding. The teaching module consists of a
elderly, or the neurologically affected, the pathophysiology of
PowerPoint presentation, in combination with this manuscript.
PVR may be multifactorial.3 Furthermore, threshold values
This manuscript serves as a scientific background review; the
delineating what constitutes an abnormal PVR are poorly
evidence base for the ICS PowerPoint presentation is available
defined.4–7
via http://www.icsoffice.org/eLearning/ or via the QR code on
this page. The presentation explains testing requirements,
clinical workup and analysis. The presentation and this PREPARATION
manuscript are based on the highest-level available published
evidence; evidence has been graded according to the modifica- PVR is measured after a flowmetry. However PVR can also be
tion of the Oxford Center for Evidence-Based Medicine levels measured after visiting a normal toilet. No evidence exists
of evidence used by the 5th International Consultation on about the reliability of PVR measurements in the last
Incontinence.2 Where evidence is unavailable, experts’ opinion
has been used and the sentence is marked as ‘‘eo’’ (experts’ Christopher Chapple led the peer-review process as the Associate Editor
opinion). responsible for the paper.
Potential conflicts of interest: Nothing to disclose.

Correspondence to: Enrico Finazzi Agr� o, Department of Experimental Medicine
PATHOPHYSIOLOGY and Surgery, University of Rome Tor Vergata, Rome, Italy. Email: efinazzi@tin.it
Received 11 February 2014; Accepted 1 August 2014
PVR is very frequently the consequence of lower urinary tract Published online 22 September 2014 in Wiley Online Library
dysfunction (LUTD), with bladder outlet obstruction (BOO) and (wileyonlinelibrary.com).
underactive or acontractile detrusor as its most prevalent DOI 10.1002/nau.22671

# 2014 Wiley Periodicals, Inc.

Measurement of Post-Void Residual Urine

720

56 Asimakopoulos et al.
mentioned situation. No specific patient preparation is needed. opinion prevails that very large PVR volumes (>200–300ml)
It may be reasonable to ask the patient if the voiding was may indicate detrusor underactivity and predict a less
similar to a typical micturition in his/her daily life. favorable response to treatment. PVR as such is not considered
a stringent contraindication for watchful waiting or medical
therapy. The use of PVR measurements is considered optional
TECHNIQUE
in men with uncomplicated LUTS undergoing noninvasive
Ideally, the interval between voiding and PVR measurement therapy. No level of residual urine, of itself, mandates invasive
is of short duration. Furthermore, unrepresentative results therapy 21 and no PVR ‘‘cut-point’’ is yet established for
may be obtained when voiding has to occur in unfamiliar decision-making.
surroundings or on command with a partially filled or overfilled
bladder. Although transurethral catheterization has been
PVR and Antimuscarinics in Men
accepted as the gold standard for PVR measurements, this
may cause discomfort for patients and carries a risk of urinary Some recent placebo controlled clinical trial data suggest that
tract infection and trauma.8 To overcome these limitations, anti-muscarinics (alone or in combination with tamsulosin) do
non-invasive ultrasound bladder volume measurement has not increase the risk of AUR and do not produce a clinically
been used as an alternative to urethral catheterization since it significant increase of PVR 22–23 in men, even in the presence of
represents a good compromise between accuracy and patients’ BPO. However, patients with significant PVR were excluded
safety/comfort.9–11,31 Traditionally, ultrasound bladder volume from these studies and the safety of anti-muscarinics in men
estimation can be performed in two ways; either by using real- with BPO remains to be confirmed in long-term trials.
time ultrasound to directly visualize the bladder 9–10 or by using
a portable bladder scanner to calculate the volume automati-
Bacteriuria
cally without directly visualizing the bladder.11 Portable
bladder scanners have many advantages over real-time Large and/or persistent PVRs may be associated with urinary
ultrasound. They are easy to use, require only basic training, tract infections (UTI), especially in persons at risk, such as
and can be used on the ward, freeing up precious radiology children or patients with spinal cord injury or diabetes.24
department resources. Furthermore, a bladder scanner may Although this association is confirmed in a pediatric popula-
reduce catheterizations; minimize the threat of urethral tion 24 and in patients with neurogenic dysfunction,25
injuries and causes less patient discomfort. Recently, in an other studies concluded that PVR does not correlate with
aim to improve accuracy, a portable ultrasound bladder scanner bacteriuria, incontinence, immobility, impaired cognition, or
equipped with an additional real-time pre-scan imaging (RPI) neurological disease.26–27
has been introduced. It seems to be able to enhance accuracy, as
it can provide examiners with pre-localization of the central
Chronic Kidney Disease (CKD)
target point as well as information on the shape of the
bladder prior to actual scanning, reducing the variability of Very large PVRs (>300 ml) may increase the risk of upper
the measured values.12 urinary tract dilation and renal insufficiency.24 A PVR > 100 ml
has been associated with CKD in elderly men with LUTS;28
however, other studies do not show a significant correlation
INTERPRETATION between PVR and CKD.29

PVR and Acute or Chronic Urinary Retention Female Incontinence

Chronic post-void residual has been widely accepted as It is currently recommended that PVR should be measured
corresponding to a consistent PVR of more than 300 ml;4 during the assessment of women with signs and symptoms of
however, some investigators have defined it as more than urinary incontinence and/or overactive bladder syndrome to
400 ml,13 as 100–500 ml 14 or have given it no definite number exclude voiding dysfunction.3 Although the available evidence
at all.15 On the other hand, (chronic) PVR does not seem to be a is still limited, antimuscarinic or anticholinergic medication
strong predictor of acute urinary retention (AUR).16 should generally be considered if PVR is low.30 Measurement of
PVR is recommended in the management of female urinary
incontinence.31
BOO
It is commonly thought that the increase in residual urine
Children
indicates the severity of BOO. However, abnormal measure-
ments of free uroflowmetry or PVR can detect only a voiding Assessment of PVR is mandatory in a variety of pediatric
dysfunction without indicating BOO specifically. Detrusor patients, such as those with voiding LUTS, UTIs, vesicoureteral
underactivity may be the only cause of a large PVR. Neverthe- reflux, posterior urethral valves or neural tube defects.24
less, PVR measurements are used as parameter of efficacy for
medical and surgical treatments for BPO.17–18
ACTUAL RECOMMENDATIONS
� The interval between voiding and PVR measurement should
PVR and Clinical Progression Of BPO
be as short as possible (eo). It is advisable to ask the patients if
High volume PVR is associated with an increased risk the voiding was similar to a typical micturition in his/her
of LUTS deterioration and considered a predictor of BPO daily life (eo).
progression.19–20 In the EAU Guidelines on the Management � Preferably use non-invasive ultrasound bladder volume
of Male Lower Urinary Tract Symptoms (LUTS), incl. Benign measurement instead of urethral catheterization (LE 3).
Prostatic Obstruction (BPO),21 it is paraphrased that very � Measurement of PVR is recommended in the management of
large PVRs may herald progression of disease. However, expert female urinary incontinence (LE 3).

Neurourology and Urodynamics DOI 10.1002/nau

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Measurement of Post-Void Residual Urine 57

� Assessment of PVR is considered mandatory in a variety of 7. Ghalayini IF, Al-Ghazo MA, Pickard RS. A prospective randomized trial
pediatric patients (LE 3). comparing transurethral prostatic resection and clean intermittent self-
catheterization in men with chronic urinary retention. BJU Int 2005;96:93.
8. Schaeffer AJ, Chmiel J. Urethral meatal colonization in the pathogenesis of
EVIDENCE SUMMARY catheter-associated bacteriuria. J Urol 1983;130:1096–9.
9. Griffiths CJ, Murray A, Ramsden PD. Accuracy and repeatability of bladder
� Unrepresentative results may be obtained when voiding has volume measurement using ultrasonic imaging. J Urol 1986;136:808–12.
10. Boomes GM, Millard RJ. The accuracy of portable ultrasound scanning in the
to occur in unfamiliar surroundings or on command with an
measurement of residual urine volume. J Urol 1994;152:2083–85.
only partially filled or an overfilled bladder (eo). 11. Hartnell GG, Kiely EA, Williams G, et al. Real-time ultrasound measurement of
� A portable bladder scanner may present some advantages bladder volume a comparative study of three methods. Br J Radiol 1987;
over real-time ultrasound (LE 3), especially if equipped with 60:1063–65.
12. Park YH, Ku JH, Oh SJ. Accuracy of post-void residual urine volume
additional real-time pre-scan imaging (LE 3).
measurement using a portable ultrasound bladder scanner with real-time
� There is no universally accepted definition of a significant pre-scan imaging. Neurourol Urodyn 2011;30:335–8.
residual urine volume. For clinical practice, PVR <30 ml can 13. Sakakibara R, Hattori T, Yasuda K, et al. Micturitional disturbance in acute
be considered insignificant, while residual volumes persis- disseminated encephalomyelitis (ADEM). J Auton Nerv Syst 1996;60:200.
14. Gallien P, Reymann JM, Amarenco G, et al. Placebo controlled, randomised,
tently >50 ml could be regarded as important (eo).
double blind study of the effects of botulinum A toxin on detrusor sphincter
� Large PVR (>200–300 ml) often indicates LUTD and may dyssynergia in multiple sclerosis patients. J Neurol Neurosurg Psychiatry
predispose to unsatisfactory treatment results if invasive 2005;76:1670.
BOO treatment is undertaken (LE 3). Nevertheless, no level of 15. Thomas AW, Cannon A, Bartlett E, et al. The natural history of lower urinary
tract dysfunction in men: The influence of detrusor underactivity on
residual urine, of itself, mandates invasive therapy and no
the outcome after transurethral resection of the prostate with a minimum
PVR threshold is yet established for decision-making (LE 3). 10-year urodynamic follow-up. BJU Int 2004;93:745.
� PVR cannot be used as a robust predictor of acute urinary 16. Roehrborn CG, Kaplan SA, Lee MW, et al: Baseline post void residual urine
retention (LE 3). volume as a predictor of urinary outcomes in men with BPH in the MTOPS
study. J Urol, suppl 2005;173:443 abstract 1638.
� PVR can detect only voiding dysfunction without indicating
17. Kaplan SA, Gonzalez RR, Te AE. Combination of alfuzosin and sildenafil is
BOO specifically (LE 2–3). superior to monotherapy in treating lower urinary tract symptoms and
� There is no evidence that PVR increases significantly in erectile dysfunction. Eur Urol 2007;51:1717–23.
patients treated with anti-muscarinic drugs (LE 2). However, 18. Zhao Z, Zeng G, Zhong W, et al. A prospective, randomised trial comparing
plasmakinetic enucleation to standard transurethral resection of the prostate
consider that patients with significant PVR were excluded
for symptomatic benign prostatic hyperplasia: Three-year follow-up results.
from studies published up to now. Eur Urol 2010;58:752–8.
� PVR may be associated with UTI, especially in persons at risk, 19. Roehrborn CG. BPH progression: Concept and key learning from MTOPS,
such as children or patients with neurogenic dysfunction ALTESS, COMBAT, and ALF-ONE. BJU Int 2008;101:17–21.
20. Crawford ED, Wilson SS, McConnell JD, et al. MTOPS RESEARCH Group.
(LE 3). This association among adults is far from clear (LE 3).
Baseline factors as predictors of clinical progression of benign prostatic
� Large PVR may be associated with chronic kidney diseases hyperplasia in men treated with placebo. J Urol 2006;175:1422–6 discussion
(LE 3). 6–7.
21. Oelke M, Bachmann A, Descazeaud A, et al. EAU Guidelines on the
Management of Male Lower Urinary Tract Symptoms (LUTS), incl. Benign
CONCLUSIONS Prostatic Obstruction (BPO), http://www.uroweb.org/gls/pdf/12_Male_
LUTS_LR%20May%209th%202012.pdf
Measurement of PVR is recommended in guidelines and 22. Roehrborn CG, Kaplan SA, Kraus SR, et al. Effects of serum PSA on efficacy of
recommendations on the management of LUTS and urinary tolterodine extended release with or without tamsulosin in men with LUTS,
including OAB. Urology 2008;72:1061–7 discussion 1067.
incontinence. However, there is still lack of evidence on the 23. Athanasopoulos A, Chapple C, Fowler C, et al. The role of antimuscarinics in
precise associations of PVR with most of the lower urinary tract the management of men with symptoms of overactive bladder associated
dysfunctions and, consequently, most of the ominous features with concomitant bladder outlet obstruction: An update. Eur Urol 2011;
associated with PVR are not evidence-based. We have reviewed 60:94–105.
24. Kelly CE. Evaluation of voiding dysfunction and measurement of bladder
the evidence and provided recommendations for ICS standard volume. Rev Urol 2004; 6 (Suppl 1):S32–7.
teaching purposes. 25. Dromerick AW, Edwards DF. Relation of postvoid residual to urinary
tract infection during stroke rehabilitation. Arch Phys Med Rehabil 2003;
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26. Omli R, Skotnes LH, Mykletun A, et al. Residual urine as a risk factor for lower
1. Abrams P, Cardozo L, Fall M, et al.; Standardisation Sub-committee of the urinary tract infection: A 1-year follow-up study in nursing homes. J Am
International Continence Society. The standardisation of terminology of Geriatr Soc 2008;56:871–4.
lower urinary tract function: Report from the Standardisation Sub-committee 27. Barabas G, M€ olstad S. No association between elevated post-void residual
of the International Continence Society. Neurourol Urodyn 2002;21:167–78. volume and bacteriuria in residents of nursing homes. Scand J Prim Health
2. Abrams P, Cardozo L, Khoury S, et al. Incontinence (5th International Care 2005;23:52–6.
Consultation on Incontinence, Paris February, 2012), ICUD-EAU 2013. 28. Rule AD, Jacobson DJ, Roberts RO, et al. The association between benign
3. Campbell-Walsh Urology, 9th edition. Section XIV, Chapter 57 ‘‘Pathophysi- prostatic hyperplasia and chronic kidney disease in community-dwelling
ology and classification of voiding dysfunction. Abnormalities of filling/ men. Kidney Int 2005;67:2376–82.
storage and emptying/voiding: Overview of pathophysiology.’’ 29. Hong SK, Lee ST, Jeong SJ, et al. Chronic kidney disease among men with
4. Abrams PH, Dunn M, George N. Urodynamic findings in chronic retention of lower urinary tract symptoms due to benign prostatic hyperplasia. BJU Int
urine and their relevance to results of surgery. Br Med J 1978;2:1258. 2010;105:1424–8.
5. Neal DE, Styles RA, Powell PH, et al. Relationship between detrusor function 30. Milleman M, Langenstroer P, Guralnick ML. Post-void residual urine volume
and residual urine in men undergoing prostatectomy. Br J Urol 1987;60:560. in women with overactive bladder symptoms. J Urol 2004;172:1911–4.
6. Neal DE, Styles RA, Powell PH, et al. Relationship between voiding pressures, 31. Lucas MG, Bedretdinova D, Bosch JLHR, et al. EAU Guidelines on
symptoms and urodynamic findings in 253 men undergoing prostatectomy. Urinary Incontinence. http://www.uroweb.org/gls/pdf/16052013Urinary_
Br J Urol 1987;60:554. Incontinence_LR.pdf

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Neurourology and Urodynamics 33:507–510 (2014)

Pad Weight Testing in the Evaluation

of Urinary Incontinence
Jan Krhut,1 Roman Zachoval,2* Phillip P. Smith,3 Peter F.W.M. Rosier,4 Ladislav Valansk�
y,5 Alois Martan,6
and Peter Zvara7
1
Department of Urology, Ostrava University, University Hospital, Ostrava, Czech Republic
2
Department of Urology, Thomayer Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic
3
Department of Surgery, University of Connecticut Health Center, Farmington, Connecticut
4
Department of Urology, University Medical Centre, Utrecht, The Netherlands
5
Department of Urology, PJS University, Kosice, Slovak Republic
6
Department of Gyneacology and Obstetrics, First Faculty of Medicine, Charles University, Prague, Czech Republic
7
Division of Urology, Department of Surgery, University of Vermont, Burlington, Vermont

Aim: To present the teaching module ‘‘Pad Weight Testing in the Evaluation of Urinary Incontinence.’’ This teaching
module embodies a presentation, in combination with this manuscript. This manuscript serves as a scientific background
review; the evidence base made available on ICS website to summarize current knowledge and recommendations.
Methods: This review has been prepared by a Working Group of The ICS Urodynamics Committee. The methodology
used included comprehensive literature review, consensus formation by the members of the Working Group, and review
by members of the ICS Urodynamics Committee core panel. Results: The pad test is a non-invasive diagnostic tool for
urinary incontinence. It is an easy to perform, inexpensive test with utilization in both the daily patient care and clinical
research. Despite it is clear value in initial diagnosis, selection of treatment, and follow-up evaluation, only less than 10%
of urologists perform the test routinely. A number of testing protocols with varying lengths of recording time exist,
however, only a 1-hr pad test has been standardized. One-hour pad tests are most suitable in establishing initial
diagnosis, the 24-hr test serves most often for evaluation of treatment outcomes, and longer pad tests are used in clinical
studies. Conclusions: The pad test is clearly underutilized. Well-designed studies providing level one evidence are
lacking. Numerous variations in how the test is performed by individual urologists make the evaluation of published
literature difficult. Future research goals should include randomized studies leading to establishment of optimal
protocols of testing for clinical research and daily care. Neurourol. Urodynam. 33:507–510, 2014.
# 2014 Wiley Periodicals, Inc.

Key words: diagnostics; ICS teaching module; urinary incontinence; urodynamics; pad weight test

INTRODUCTION Incontinence’’ to serve as a standard education of Good

Urodynamic Practice for everyone involved in indicating,
Pad testing is a non-invasive method of detecting and
performing and analyzing urodynamic testing in general and
quantifying severity of urine leakage. The 4th International
more specifically, performing analysis of voiding. The
Consultation on Incontinence defined pad testing as ‘‘an
teaching module consists of a presentation, in combination
optional test for evaluation of urinary incontinence.’’1 Diverse
with this manuscript. This manuscript serves as a scientific
testing durations have been reported in the literature and only
background review; the evidence base, for the ICS Power
for the 1-hr pad test a specific test protocol has been
Point presentation; available via http://www.icsoffice.org/
standardized.2,3 Although it is generally believed that longer
eLearning/ or via the QR code on this page. The presentation
tests are more reproducible, evidence on the accuracy of
explains, testing requirements, clinical workup and analysis.
different methods of pad testing is inconsistent. A 24-hr test is
The presentation and this manuscript contain experts’
more reproducible then a 1-hr test, but longer testing requires
opinion where evidence is, especially for the clinical practice
more preparation and a greater commitment on the part of the
aspects, unavailable and is marked’’ with: ‘‘eo’’ (experts
patient. Twenty-four-hour testing is reported to be adequate in
opinion).
routine clinical settings while 48- to 72-hr testing is deemed
necessary for clinical research.2,4

MATERIALS AND METHODS Heinz Koelbl led the peer-review process as the Associate Editor responsible for
the paper.
This review has been prepared by a Working Group of The ICS Conflict of interest: none.
Urodynamics Committee. The methodology used included 
Correspondence to: Ass. Prof. Roman Zachoval, M.D., Ph.D., Department of
comprehensive literature review, consensus formation by the Urology, Thomayer Hospital, Videnska 800, 140 59 Prague 4, Czech Republic.
members of the Working Group, and review by members of the E-mail: roman.zachoval@ftn.cz
Received 13 March 2013; Accepted 25 April 2013
ICS Urodynamics Committee core panel. Published online in Wiley Online Library
The ICS Urodynamics Committee presents the teaching (wileyonlinelibrary.com).
module ‘‘Pad Weight Testing in the Evaluation of Urinary DOI 10.1002/nau.22436

# 2014 Wiley Periodicals, Inc.

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508 Krhut et al.

RESULTS increase of 1–10 g is classified as representing mild inconti-
nence, 11–50 g moderate and >50 g severe incontinence. The
values for 24-hr pad test are classified as follows: Mild (4–20 g/
Preparation
24 hr), moderate (21–74 g/24 hr), and severe (>75 g/24 hr)
(1) Test selection: The type of pad test selected is based on goals. incontinence.9
A 1-hr test is usually administered during initial evaluation A weight gain of less than 1.4 g during 1-hr test or 4.4 g for 24-
to select treatment and estimate prognosis for cure (eo). hr test could be a result of sweating or vaginal discharge. If the
Twenty-four-hour or longer testing is necessary for findings are inconclusive, oral phenazopyridine which colors
quantifying the degree of urine leakage (eo). the urine orange could be used.10 Listed cut-off values are based
(2) Instruction: Detailed instruction is critical in order to elicit on studies performed in female patients. The values specific to
the full compliance of patients. males have not been yet determined.
(3) Filling the bladder to a set starting volume: The short The outcomes of studies which attempted to correlate the
duration pad test (1-hr or less) may be performed using an volume of leakage to the etiology (stress, urge, and mixed
instilled starting bladder volume. Usually, the bladder is incontinence) showed significant variability, suggesting that the
filled through a urethral catheter (or during cystoscopy). pad test is not appropriate for separating the types of inconti-
Most reported studies used 150–300 ml, some recommend a nence based on their etiology.11,12 Ryhammer et al. compared
volume equivalent to 50–75% of the functional bladder weight gain between two groups of randomly selected women, 79
capacity.5,6 Filling to the first desire to void or sensation of of whom reported continence and 38 reported incontinence. They
fullness has also been reported.7 Although studies have found no difference in the outcome of 24-hr pad test, suggesting
documented that this modification improves the quantita- that pad test should not be used as a screening tool.13 The
tive value of the test, the consensus on the ideal starting sensitivity and specificity of the 1-hr pad test reported in the
volume is lacking.3 literature varies significantly.14 The 1-hr pad test was shown to
have a high positive predictive value, however the false positive
results can occur in more then 50% of cases.15
Technique
The test is administered in a same manner to both male and
Recommendations
female patients (eo).
One-hour pad test. The testing protocol has been standardized -in the initial patient work-up, an objective measure of
by International Continence Society (ICS-pad test): incontinence loss volume such as the pad test may help in
treatment selection (e.g., male sling vs. artificial sphincter in
-the test is started by putting one pre-weighted pad without the treatment of the post-prostatectomy incontinence)
patient voiding, (Table I),16
-patient drinks 500 ml of sodium-free liquid in <15 min— -estimation of treatment prognosis (patients with high
then sits or rests, volume incontinence may experience lower cure rates) (eo),
-patient walks for 30 min, including climbing one flight of -objective measure of treatment outcome for anti-inconti-
stairs (up and down), nence procedures,
-patient performs the following activities: standing up from -the volume of leakage does not always correlate with the
sitting (10), coughing vigorously (10), running on the spot degree of bother (e.g., 2 g of urine leakage, which is roughly
for 1 min, bending to pick up an object from the floor (5), and equivalent to 40 drops, produces a large spot on the clothing),
washing hands in running water for 1 min (this activity therefore pad tests should be always interpreted in conjunc-
program may be modified according to the patient’s physical tion with history, clinical examination and self-assessment
fitness), questionnaires (eo),
-the total amount of urine leaked is determined by weighing -future research goals should include determination of the
the pad. optimal technique and duration of testing for both clinical
and research purposes with the ultimate goal of developing
an appropriate individualized testing protocol for patients
If a moderately full bladder cannot be maintained through and their varying circumstances (eo).
the hour (if the patient must void), the test has to be started One-hour pad test.
again. -the 1-hr pad test, using the ICS standardized protocol is
Twenty-four-hour pad test. appropriate in routine evaluation of patients during initial
-the test should be started with an empty bladder, work up,
-normal daily activities should be followed and recorded in a
voiding diary so that the same schedule will be observed
during follow-up re-testing (eo),
-to avoid urine loss trough leakage or evaporation the pads TABLE I. Basic Characteristics and Degree of Accuracy of Individual Types of
Pad Tests
should be worn inside waterproof underpants and exchanged
every 4–6 hr during daytime, Short-term tests Long-term tests
-pads should be weighed immediately. If weighing is (qualitative assessment) (quantitative assessment)
performed at the clinic, pads must be stored in airtight bag.
Bladder filling No artificial filling or No artificial filling
retrograde filling
Interpretation Physical activity Standardized activities Normal daily activities
The upper limit of weight increase for the 1-hr test in during test
continent women is 1.4 g (equivalent to 1.4 ml) and 1.3–4.4 g Evaluation Weight gain >1 g Weight gain >4 g/24 hr
Sensitivity 34–83%22 Insufficient data
for 24-hr test. These values may increase in situations of
Specificity 65–89%22 Insufficient data
increased perspiration.8 In the analysis of 1-hr pad test, an

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Pad Weight Testing 509

-if either the patient or physician have doubts about the incontinence severity (inactivity, fluid restriction) could affect
accuracy of the initial test, evaluation should be extended by the outcome significantly. The 1-hr pad test as standardized by
an additional hour or repeated, ICS is currently the only tool with a set protocol, and we
-the test should always be interpreted in conjunction with recommend using the original protocol. In the case that
standard self-assessment questionnaires including the both- artificial bladder filling is used, the bladder should be filled to
er index, 50–75% of its functional capacity prior to the initiation of the
-performing the test with a known start volume might test. The 24-hr test is sufficient in daily clinical practice.
increase the accuracy, but the data supporting this assump- Performing this test in conjunction with a voiding diary, or
tion is inconclusive and there is no consensus on what the simply recording fluid intake and frequency of incontinence
volume should be (eo). episodes, will significantly increase its utility. A standard
Twenty-four-hour pad test. protocol for 24- to 72-hr pad testing does not exist at the present
-it is more reproducible than 1-hr test, time, and we believe establishing one would be very helpful.
-highly dependent on patient compliance and therefore not Prescribing specific physical activity over 24–72 hr is problem-
suitable for all patients (eo), atic, therefore we recommend instructing the patient to follow
-detailed instruction and patient motivation are important, a normal daily routine. Despite the above limitations, the pad
-the test results depend on fluid intake, physical activity test provides objective assessment of involuntary urine loss. Its
levels, hormonal status, sexual activity, and environmental optimal utility depends upon understanding the impact of
factors (temperature, humidity), these limitations for diagnostic and prognostic use. The
-the protocol should be personalized based on patient’s correlations of specific testing protocols with subjective and
physical status (eo), objective measures must be performed so that the most
-the physical activity and detailed voiding diary should be appropriate testing protocol may be employed according to
recorded so that a similar protocol is followed during the circumstance. We believe that standardization of testing is an
initial and all follow-up (eo). important first step in improving the utilization of this simple
and inexpensive testing method.
DISCUSSION
Pad weighing as a diagnostic method for incontinence was REFERENCES
first described by James et al. in 1971.17 In 1981, Sutherst et al.
were the first to publicize the use of the pad test with a 1. Abrams P, Andersson KE, Birder L, et al. Fourth International Consultation on
Incontinence Recommendations of the International Scientific Committee:
prescribed set of activities and exercises.18 Since then, a number Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and
of published studies used various forms of the pad testing fecal incontinence. Neurourol Urodyn 2010;29:213–40.
protocols. Pad testing is easy and inexpensive, yet recent surveys 2. Persson J, Bergqvist CE, Wolner-Hanssen P. An ultra-short perineal pad-test
of the Society for Urodynamics and Female Urology members for evaluation of female stress urinary incontinence treatment. Neurourol
Urodyn 2001;20:277–85.
showed that only 4.5–8% of the members perform the pad test 3. Andersen JT, Blaivas JG, Cardozo L, et al. Seventh report on the standardisation
routinely in their practice.19 A number of studies have of terminology of lower urinary tract function: Lower urinary tract
documented that the longer the testing, the better the rehabilitation techniques. International Continence Society Committee on
correlation between the test results and the degree of inconti- Standardisation of Terminology. Scand J Urol Nephrol 1992;26:99–106.
4. Tennstedt S. Design of the Stress Incontinence Surgical Treatment Efficacy
nence. However, 24- to 72-hr pad tests are cumbersome and Trial (SISTEr). Urology 2005;66:1213–17.
require high levels of patient compliance.15,20 Test outcomes are 5. Wu WY, Sheu BC, Lin HH. Twenty-minute pad test: Comparison of infusion
affected by many factors and therefore have to be interpreted in of 250 ml of water with strong-desire amount in the bladder in women
combination with other methods of evaluation. Caution has to with stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2008;
136:121–5.
be exercised especially in giving too much weight to a negative 6. Jakobsen H, Vedel P, Andersen JT. Objective assessment of urinary
1-hr pad test (eo). Repeated short term testing is recommended incontinence: An evaluation of three different pad-weighing tests. Neurourol
especially in cases where the test result does not correlate with Urodyn 1987;6:325–30.
subjective assessment provided by the patient.21 Good correla- 7. Lose G, Rosenkilde P, Gammelgaard J, et al. Pad-weighing test performed with
standardized bladder volume. Urology 1988;32:78–80.
tion has been reported by Abdel-Fattah et al.22 between the self- 8. Figueiredo EM, Gontijo R, Vaz CT, et al. The results of a 24-h pad test in
assessment questionnaires and the 1-hr pad test. The King’s Brazilian women. Int Urogynecol J 2012;23:785–9.
Health Questionnaire showed a 96% sensitivity and 93% 9. O’Sullivan R, Karantanis E, Stevermuer TL, et al. Definition of mild, moderate
specificity of a 1-hr pad test in identifying incontinent and severe incontinence on the 24-hour pad test. BJOG 2004;111:859–62.
10. Wall LL, Wang K, Robson I, et al. The Pyridium pad test for diagnosing urinary
patients.22 The good correlation between self-assessment ques- incontinence. A comparative study of asymptomatic and incontinent
tionnaires and 1-hr pad test, but not the 24-hr pad test supports women. J Reprod Med 1990;35:682–4.
the value in standardization. Good correlation with the 24-hr 11. Matharu GS, Assassa RP, Williams KS, et al. Objective assessment of urinary
pad test and the International Consultation on Incontinence incontinence in women: Comparison of the one-hour and 24-hour pad tests.
Eur Urol 2004;45:208–12.
Questionnaire—Short Form (ICIQ-SF) has been documented.23 12. Fantl JA, Harkins SW, Wyman JF, et al. Fluid loss quantitation test in women
The biggest cost associated with the pad testing is the office visit, with urinary incontinence: A test-retest analysis. Obstet Gynecol
therefore home pad tests using the mail has been proposed.24 1987;70:739–43.
Longer testing protocols could potentially increase the sensitivi- 13. Ryhammer AM, Laurberg S, Djurhuus JC, et al. No relationship between
subjective assessment of urinary incontinence and pad test weight gain
ty and specificity, however, they require selection of highly in a random population sample of menopausal women. J Urol 1998;159:
motivated patients. The type of pad, leak, and evaporation could 800–3.
affect the outcome, therefore pad should be exchanged every 4– 14. Costantini E, Lazzeri M, Bini V, et al. Sensitivity and specificity of one-hour pad
6 hr during the 24-hr and longer pad testing.25 test as a predictive value for female urinary incontinence. Urol Int
2008;81:153–9.
15. Versi E, Orrego G, Hardy E, et al. Evaluation of the home pad test in the
investigation of female urinary incontinence. Br J Obstet Gynaecol
CONCLUSIONS 1996;103:162–7.
16. Kumar A, Litt ER, Ballert KN, et al. Artificial urinary sphincter versus male
The pad test is non-invasive and easy to perform, yet factors sling for post-prostatectomy incontinence-what do patients choose? J Urol
such as embarrassment and behavioral changes to reduce 2009;181:1231–5.

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510 Krhut et al.

17. James ED, Flack FC, Caldwell KP, et al. Continuous measurement of urine loss 21. Soroka D, Drutz HP, Glazener CM, et al. Perineal pad test in evaluating
and frequency in incontinent patients. Preliminary report. Br J Urol outcome of treatments for female incontinence: A systematic review. Int
1971;43:233–7. Urogynecol J Pelvic Floor Dysfunct 2002;13:165–75.
18. Zimmern P, Kobashi K, Lemack G. Outcome measure for stress urinary 22. Abdel-Fattah M, Barrington JW, Youssef M. The standard 1-hour pad test:
incontinence treatment (OMIT): Results of two society of urodynamics and Does it have any value in clinical practice? Eur Urol 2004;46:377–80.
female urology (SUFU) surveys. Neurourol Urodyn 2010;29:715–8. 23. Karantanis E, Fynes M, Moore KH, et al. Comparison of the ICIQ-SF and 24-
19. Victor A, Larsson G, Asbrink AS. A simple patient-administered test for hour pad test with other measures for evaluating the severity of urodynamic
objective quantitation of the symptom of urinary incontinence. Scand J Urol stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2004;15:111–6.
Nephrol 1987;21:277–9. 24. Flisser AJ, Figueroa J, Bleustein CB, et al. Pad test by mail for home evaluation
20. Sutherst J, Brown M, Shawer M. Assessing the severity of urinary of urinary incontinence. Neurourol Urodyn 2004;23:127–9.
incontinence in women by weighing perineal pads. Lancet 1981;1: 25. Karantanis E, O’Sullivan R, Moore KH. The 24-hour pad-test in continent women
1128–30. and man: Normal values and cyclical alterations. BJOG 2003;110:567–71.

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Artefacts in Urodynamic Pressure Traces (Basic Module)

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Neurourology and Urodynamics 36:35–36 (2017)

ICS Teaching Module: Artefacts in Urodynamic Pressure

Traces (Basic Module)
Andrew Gammie,1* Carlos D’Ancona,2 Hann-Chorng Kuo,3 and Peter F.W. Rosier4
1
Bristol Urological Institute, Southmead Hospital, Bristol, United Kingdom
2
University of Campinas–, UNICAMP, Sao Paulo, Brazil
3
Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University, Hualien, Taiwan
4
University Medical Centre–Urology, Utrecht, the Netherlands

Aims: To present the ICS Teaching Module on artefacts in urodynamics pressure traces. Methods: Slides from three
urodynamics centres were assembled. Descriptions and labels were agreed by the authors and the module presented at
the ICS Annual Scientific Meeting in Brazil 2014. Results: Ten artefacts that should be recognized while using water-
filled urodynamic systems are presented and remedial action described. Conclusions: This manuscript serves as
scientific background for the slide set made available on the ICS website. By following the guidelines in this teaching
module, good quality urodynamics can be more readily achieved. Neurourol. Urodynam. 36:35–36, 2017.
# 2015 Wiley Periodicals, Inc.

Key words: artefacts; pressure measurement; quality

INTRODUCTION  Empty bladder (poor response)
 Empty rectal catheter
The International Continence Society (ICS) Urodynamics
 Poor cough response
Committee presents the first teaching module of Artefacts in
 Poor response to live signal
Urodynamic Pressure Traces as a resource to enhance good
urodynamic practice.
An artefact is understood to be ‘Something . . .that is not
naturally present but occurs as a result of . . .the procedure.’1 The descriptions below are all with reference to water-filled
When artefacts arise during the test, they should be removed or pressure measurement systems, although some of these
can sometimes be compensated for, thus improving the quality artefacts do occur in other types of system. Each artefact has
of urodynamic results. If artefacts have not been corrected the observed effect, underlying cause and recommended
during the test they should be recognized during post-test remedy described.
evaluation. This module presents the artefacts that this
working group has considered to be the most prevalent ARTEFACT DESCRIPTIONS, CAUSES AND REMEDIES
when water-filled urodynamic systems are used. They are
described as patterns on the urodynamic traces, and all are
recognizable and correctable during the test. Some artefacts Movement/Tube Knock
may, however, necessitate repetition of the test.
Effect observed. High frequency, short duration pressure
We present ten artefact patterns with an explanation of their
causes and a description of the remedies. Further understand- spikes visible in pves, pabd, or both, with spikes always visible in
ing of the prevalence and nature of artefacts can be found in pdet.
Hogan et al.,2 and a full presentation of Good Urodynamic Cause of artefact. Knocking of one or both tubes. In the
Practices is found in in Schaefer et al..3 These underline that example, the knock is first on the pves line, then on the pabd line.
signal quality is only assured through using adequate Remedial action. Ensure tubes are away from the cause of the
equipment, with careful installation of the whole system and knock. Ignore these spikes when analysing the trace.
with skilled and alert staff performing the test. The teaching
module referred to here consists of this manuscript and a slide Patient Position Change
presentation available at www.ics.org/eLearning. An advanced
module will also be made available dealing with less common Effect observed. A lasting change in pves and pabd of equal
artefacts, along with those found in other types of pressure magnitude on both, usually between 8 and 35 cmH2O.2 It is
measurement systems. often accompanied by noisy signals as the lines are knocked.
Cause of artefact. A change in patient position. In the example,
CONTENTS the patient has begun supine, stood up, then sat down on the

The ten artefacts described in this module are:

Prof. Roger Dmochowski led the peer-review process as the Associate Editor
responsible for the paper.
 Movement/tube knock Potential conflicts of interest: Nothing to disclose
 Patient position change 
Correspondence to: Andrew Gammie, Bristol Urological Institute, Southmead
 Expelled vesical catheter Hospital, Bristol BS10 5NB, United Kingdom, E-mail: andrew.gammie@bui.ac.uk
Received 24 August 2015; Accepted 27 August 2015
 Expelled rectal catheter Published online 15 September 2015 in Wiley Online Library
 Flushed catheter (wileyonlinelibrary.com).
 Line open to syringe DOI 10.1002/nau.22881

# 2015 Wiley Periodicals, Inc.

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36 Gammie et al.

commode at a position below the level of the transducer. The Remedial action. Fill the bladder slightly (e.g. 50 ml) and test
level of the transducers was then adjusted to the level of the the pressure transmission again.
symphysis pubis.
Remedial action. Ensure the transducers are moved to the Empty Rectal Catheter
level of the symphysis pubis after any patient position change.
Transmission of pressure should also be checked after patient Effect observed. Deterioration in abdominal pressure trans-
movement. mission, with or without a change in pressure, during filling or
voiding.
Expelled Vesical Catheter Cause of artefact. Reduction of water in the rectal balloon. The
balloon fails to connect effectively with the rectal wall as a
Effect observed. A sudden drop in pves, usually to well below result.
zero, with no response to transmission checks. Remedial action. Refill balloon and test for good pressure
Cause of artefact. The vesical catheter is expelled from the transmission
patient, normally by the pressure of voiding.
Remedial action. Recatheterise and repeat the test, if the Poor Cough Response
urodynamic question has not been answered.
Effect observed. One cough spike is visibly smaller than the
other, despite a cough affecting pves and pabd equally.
Expelled Rectal Catheter
Cause of artefact. Usually an air bubble in the water-filled line,
Effect observed. A sudden drop in pabd, usually to well below reducing the transmission of pressure from patient to
zero. transducer.
Cause of artefact. The abdominal catheter is expelled from the Remedial action. Flush the line through with water, pushing
patient, normally by the pressure of valsalva or straining. the air bubble from the tube. The next cough should be
Remedial action. Recatheterise and repeat the test, if the registered equally on both traces. If not, flushing should be
urodynamic question has not been answered repeated.

Flushed Catheter Poor Response to Live Signal

Effect observed. An abrupt large increase in a single pressure Effect. Live signal is observed on one trace (in this case pves)
trace, maintained for some seconds, followed by a sudden and on pdet, despite a previous cough test being satisfactory.
normalisation of pressure.2 Cause. Usually an air bubble in the water-filled line, reducing
Cause of artefact. Water is pushed through the transducer the transmission of pressure from patient to transducer, in this
dome in order to remove air from the catheter and tubing. case in the abdominal line. It could also be the pump or patient
Remedial action. Check for good pressure transmission after causing noise on the affected line.
the flush. Ignore the high pressure generated when analysing Remedy. Check that there is no interference on the affected
trace. line by visual inspection and stopping the pump. If it is still
present, flush the line through with water (not visible on this
trace), pushing the air bubble from the tube.
Line Open to Syringe

Effect observed. Repeated flushes of the line do not restore a CONCLUSIONS

good response to a cough signal.
Poor quality urodynamic testing may easily result in
Cause of artefact. The syringe inadvertently remains con-
inadequate or wrong diagnosis. Maintaining good quality of
nected to the water line, and acts as a damper on the signal.
pressure transmission, recording, and display, and being able to
Since an air bubble is not the problem, flushing fails to resolve
interpret the traces correctly are therefore critical for patient
it.
benefit. Recognising artefacts in the pressure signals and
Remedial action. Set the taps correctly, so the syringe is not
dealing with them appropriately is an essential component of
connected to dome. Repeat the cough test for good pressure maintaining this quality. By following the guidelines in this
transmission. teaching module, good quality urodynamics can be more
readily achieved.
Empty Bladder (Poor Response)
REFERENCES
Effect observed. Response of the intravesical catheter to a 1. Oxford English Dictionary, www.oxforddictionaries.com accessed 26 02 2015.
pressure transmission test is poor when bladder volume is low. 2. Hogan S, Gammie A, Abrams P. Urodynamic features and artefacts. Neurourol
Urodyn 2012;31:1104–17.
Cause of artefact. When the bladder is empty, the catheter 3. Schaefer W, Abrams P, Liao L, et al. Good Urodynamic Practices: Uroflowme-
may touch the bladder wall, so pressure changes within the try, filling, cystometry and pressure flow studies. Neurourol Urodyn
lumen cannot be registered. 2002;21:261–74.

Neurourology and Urodynamics DOI 10.1002/nau

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Author Manuscript
J Clin Nurs. Author manuscript; available in PMC 2014 February 06.
Published in final edited form as:
NIH-PA Author Manuscript

J Clin Nurs. 2013 February ; 22(0): 356–367. doi:10.1111/jocn.12042.

Long-term Urinary Catheter Users Self-Care Practices and

Problems
Mary Wilde, RN, PhD1, Margaret V. McDonald, MSW2, Judith Brasch, RN, BS1, James M.
McMahon, PhD1, Eileen Fairbanks, RN, MS, PNP1, Shivani Shah, MPH2, Wan Tang, PhD1,
and Eileen Scheid, RN, MS1
1University of Rochester, School of Nursing

2Visiting Nurse Service of New York, Center for Home Care Policy and Research

Abstract
Aims—The aims were to characterize a sample of 202 adult community-living long-term
indwelling urinary catheter users, to describe self-care practices and catheter problems, and to
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explore relationships among demographics, catheter practices, and problems.

Background—Long-term urinary catheter users have not been well studied, and persons using
the device indefinitely for persistent urinary retention are likely to have different patterns of
catheter practices and problems.
Design—The study was a cross-sectional descriptive and exploratory analysis.
Methods—Home interviews were conducted with catheter users who provided information by
self-reported recall over the previous two months. Data were analyzed by descriptive statistics and
tests of association between demographics, catheter practices, and catheter problems.
Results—The sample was widely diverse in age (19–96 years), race, and medical diagnosis.
Urethral catheters were used slightly more often (56%) than suprapubic (44%), for a mean of 6
yrs. (SD 7 yrs.). Many persons were highly disabled, with 60% having difficulty in bathing,
dressing, toileting, and getting out of the bed; 19% also required assistance in eating. A high
percentage of catheter problems were reported with: 43% experiencing leakage (bypassing of
urine), 31% having had a urinary tract infection, 24% blockage of the catheter, 23% catheter-
associated pain, and 12% accidental dislodgment of the catheter. Treatments of catheter-related
problems contributed to additional health care utilization including extra nurse or clinic visits,
NIH-PA Author Manuscript

trips to the emergency department, or hospitalization. Symptoms of catheter associated urinary

tract infections were most often related to changes in the color or character of urine or generalized
symptoms.
Conclusions—Catheter related problems contribute to excess morbidity and health care
utilization and costs.
Relevance to clinical practice—More research is needed in how to minimize catheter
associated problems in long-term catheter users. Information from this study could help inform the
development of interventions in this population.

Corresponding Author: Mary Wilde, RN, PhD, Associate Professor Nursing and Center for Community Health, University of
Rochester, 601 Elmwood Ave., Box SON, Rochester, NY, 14642, Work: 585-275-9682, Fax: 585-273-1270,
mary_wilde@urmc.rochester.edu.
Study Design: MW, JM
Data Collection and Analysis: MW, MM, JM, JB, EF, SH, WT, ES
Manuscript Preparation: MW, MM, JM, JB, EF, SH, WT, ES

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Keywords
urinary catheterization; nursing; urinary tract infection; urinary retention; complications; self-care
NIH-PA Author Manuscript

Introduction and Background

Living with an indwelling urinary catheter presents numerous challenges that must be
addressed on a daily bases. Nevertheless, it can be indicated for persons unable to use any
other bladder management method, including people with persistent urinary retention who
lack sufficient cognition or hand dexterity for self-catheterizations and no one to do it for
them. Also a catheter can be an option to improve quality of life in selected cases of severe
incontinence or when a disability makes it difficult to use the bathroom (Cottenden et al.,
2009). The majority of long-term catheter users have a neurogenic bladder dysfunction
related to a disability, such as spinal cord injury (SCI) or multiple sclerosis (MS) (Wilde &
Dougherty 2006, Wilde et al. 2010).While catheter problems are well known—recurrent and
persistent blockage, catheter-related urinary tract infection (CAUTI), accidental
dislodgment, and leakage of urine (bypassing)--data on the frequency and severity of these
problems are limited. Information on catheter management, such as drainage bag
replacement and/or cleaning and caregiver assistance, is even less well known. Moreover,
community dwelling study samples are often small (<45) in persons with long-term use,
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(Wilde & Carrigan 2003, Wilde & Dougherty 2006, Wilde & Brasch 2008, Wilde et al.
2010), thus making it difficult to characterize the population and their needs.

This is a report of a cross-sectional analysis of data from 202 persons with long-term
indwelling urinary catheters (urethral or suprapubic [SP]). The purpose of this analysis is to
describe catheter care practices and catheter-related problems to inform clinicians and
researchers. Having information from a large sample will help fill a gap in the literature in
which small samples have been the norm.

Methods
Design
This analysis is based on baseline data collected for a single blinded randomized trial of an
educational program in urinary catheter self-management with long-term catheter users. This
analysis is based on data derived through a one-time home interview of 202 study
participants, prior to randomization, conducted by trained interviewers from June 2009
through June 2011. The aims of this analysis were to:
1. Characterize the sample of 202 community-dwelling long-term adult indwelling
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urinary catheter users who had catheter problems in the past 6–12 months or those
new to a catheter within the past year.
2. Depict how persons with catheters take care of the device on a day to day basis,
including others who help in this care.
3. Describe the prevalence and incidence of self-reported catheter-related problems
over a two month period.
4. Explore relationships among demographics, catheter practices, and catheter
problems

Setting and sample—The study was conducted at two sites—the University of

Rochester, NY (Utica to Buffalo region) and at the Visiting Nurse Service of New York
(VNSNY) in New York City and parts of Nassau and Westchester Counties —with separate

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teams conducting the study activities using the same procedures and tools. To be eligible for
the study, participants had to: (1) be 18 years of age or older; (2) expect to use an indwelling
urethral or SP catheter for at least one year; (3) report having a catheter-associated problem
NIH-PA Author Manuscript

(UTI in the last year, or blockage or dislodgement in the last six months) OR report using a
catheter for less than one year (4) complete study measurements alone or with the help of a
family member; and (5) communicate in English. Despite the need in the parent study to
include only persons who would benefit the most from the intervention, only 3.6% of those
screened were excluded for criteria #3 above. Individuals were excluded if they had a
terminal illness. Institutional approval was obtained and synchronized for human subject’s
ethics at both sites.

Data Collection
Measures—Two instruments were used for this cross sectional analysis: 1) Demographics
and Catheter Care Questionnaire (DMC) and 2) Catheter Problems Questionnaire (CPQ).
Both instruments were developed by the Principal Investigator (PI) for research in similar
populations (Wilde & Dougherty 2006, Wilde & Brasch 2008) and modified for this study.
For the DMC, 50 items measured demographics and catheter-related variables to describe
the sample, and included: 1) person/family--age, race/ethnicity, type/presence of caregivers
(e.g., relative or paid person), education, employment, insurance; 2) chronic conditions--
diagnosis, list of medications, and functional ability through the Katz score (Katz, Ford,
Moskowitz, Jackson, & Jaffee 1963) and 3) catheter related-- catheter type (e.g., silicone or
NIH-PA Author Manuscript

latex coated), interval for catheter changes, and bag care. The content validity scores were
found to be acceptable in previous studies using the same instrument (Wilde & Dougherty
2006, Wilde & Brasch 2008).

Catheter related problems (e.g., UTI, blockage [encrustation within the catheter]) were
measured using the CPQ. Content validity scores for a previous study (Wilde & Brasch
2008) indicated that the items were acceptable. CPQ was modified to include additional
information related to CAUTIs, i.e., severity and symptoms. Frequency of catheter related
problems was asked, and for CAUTI and blockage of the catheter, associated treatments
were solicited. Information was recorded for up to six CAUTI events and up to12 blockage
events (as blockages were sometimes frequent).

Procedures—Study participants at the Rochester site were recruited through provider

referral from clinics, home care agencies and private urological offices. In New York City, a
database was used to identify people with catheters. Potential participants at both sites were
screened for eligibility and interest by telephone call. At intake, participants provided
informed consent, and subsequent to enrollment—but prior to random assignment-- home
interviews were conducted. An electronic data collection system, Questionnaire
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Development System (QDS), was used to collect and manage data. Participants received an
honorarium of $20 for the interview.

Data Analysis
Prior to analysis, data were verified, cleaned and checked for consistency with a full range
of logic checks. Decisions about how to code missing data and outliers (Yang, Xie, & Ngee
Goh 2011) were made by the team, with input from the statistician. Data were analyzed
descriptively for central tendency (mean, median), dispersion (SD, range), and distribution
(skew, kurtosis). Specific emphasis was on describing prevalence and incidence of major
catheter problems of CAUTI, blockage, and dislodgment of the catheter. Associations were
explored (t-tests or Pearsons’ r for interval level data and Chi Sq. or odds ratios and
confidence intervals (CI) for categorical data) among variables believed to contribute to

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these catheter-related problems. Analyses were performed using IBM Statistical Program for
Social Sciences (SPSS) 19 and SAS 9.2.
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Results
Demographics
The sample was diverse by age, race, and medical diagnosis. The male to female ratio was
roughly equivalent at 51 and 49% respectively. Ages ranged from 19 to 96 with a mean and
median age of 61, SD of 17.4 years. The race identified most often by participants was white
(57%), followed by Black (30%), Asian (2%), American Indian or Alaskan Native (2%),
biracial (2%), and unknown (9%). Eleven percent of the sample was Hispanic. Diversity was
also demonstrated by the marital status selections, with approximately 34% of participants
reporting never having been married, over 19% separated or divorced, 18% widowed, 27%
married and 2 % common law married or living with a life partner. A single diagnosis
believed to affect bladder function was identified for each person and we labeled them as
“primary” in Table 1, categorizing by the order in the table. Many persons had other
diagnoses affecting the bladder, and these were labeled “secondary.” Spinal cord injury
(SCI) and multiple sclerosis (MS) were the most common medical diagnoses, with 40% and
23% respectively.

Medications included 26 different classes, and many persons took more than one medicine
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in a single category, for instance heart medicine was taken by 44%, but of these patients
over half took more than one cardiac medicine. Eleven percent were on antibiotics and 4%
on urinary antiseptics. Other bladder medicines included: anticholinergics (20%),
antispasmodic/ antimuscarinics (3%), alpha blocker (5%), and muscle relaxants (39%).
Frequent medicines were for MS (13%), anticonvulsants (30%), upper gastrointestinal ([GI]
33%), laxatives (34%), psychological/depression (44%), diuretics (24%), diabetes (17%),
hypertension (25%), respiratory (19%). Pain medicine was taken by many, including
NSAIDS/aspirin (38%), Tylenol (26%), and narcotics (34%). Smaller numbers took
medicine for cancer (8%), sleep (5%), or steroids (5%). Eighty-four percent reported taking
at least one vitamin or mineral, most typically a multivitamin, calcium or vitamin D.

The majority of participants lived with another person, generally family (55%); only 8%
lived with paid caregivers, and 37% lived alone. Employment rates were minimal with only
11 persons working, six of them full time. Most individuals had some type of public
insurance and 48% reported having private insurance. Education levels of the subjects varied
greatly with 16 % not completing high school, 27% with high school or GED, 19% with
some college, and 38 %with a college degree, including 12% with a graduate degree.
NIH-PA Author Manuscript

Activities of daily living (ADL)--in bathing, dressing, toileting, getting out of bed, and
eating---were evaluated by the Katz scale, with item responses calculated as 1 point for
independent and 2 points for needs assistance. The range was 5–10 for the total scale, with a
higher score indicating less functional ability; the mean was 7.75 (SD1.9) and mode was 9.
Twenty-four percent reported that they were independent in all activities, 24% needed
assistance with 1–3 ADLs, 35% needed assistance with 4 ADLs and 17% needed help with
all 5 ADLs.

Catheter Care Practices

Catheter characteristics—The length of time of catheter use varied considerably from 1
to 470 months (39 yrs.). The mean was 72.5 months or 6 yrs. (SD 85.4months, 7yrs.).
Median use was 3.25 yrs. Urethral catheters were used more often than SP, with 112 (56%)
and 89(44%), respectively; one person had both types (Table 2). Fifty-eight of those with SP

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had used urethral catheters in the past; whereas, only two currently using a urethral catheter
had tried a SP catheter. In the past, 35% had used an intermittent catheter, 16% an external
condom catheter, 29% had used Crede, and 83% had used absorbent products.
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Catheter sizes and the amount of water in the balloon varied. Catheter sizes ranged from 12–
30 Fr. with a mean of 18.5 (SD 3.2), and in general urethral catheters were significantly
smaller (mean 17.1 Fr., SD2.1) than SP catheters (mean 20Fr., SD 3.5; t test −7.29; df 182;
P< 0.01). Balloon size varied from 5–30 mL with 70% being 5–10mL; the water within the
balloon was reported as 2–50mL, with the majority (55%) using 5–10mL. Some people
(8%) did not know the size of the catheter and 23% did not know the balloon size or amount
of water instilled. (See Table 2 for details.)

Drainage bag use—Most persons (58%) used both leg and overnight (night) bags,
switching between them. Some individuals used just one type, with leg bags used alone by
17% and night bags used alone by 23%. Three persons used other collection methods: one a
belly bag, one connected tubing to empty the bladder directly from the catheter, and another
used a plastic cover over the end and emptied the catheter (without a clamp). Only four
persons (2%) used a leg bag continuously, connecting it to the night bag later in the day. The
majority switched between leg and night bag, and most also cleaned them (leg bags by 54%
and night bags by 59%). Solutions for cleaning bags and the frequency for replacing and
cleaning the bags are in Table 3.
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Catheter changes—Catheter changes were performed by professionals (nurses,

physicians) in homes, clinics and offices (Table 4). Unscheduled changes were reported in
the previous two months by 37% (n=74), with 3 who said this occurred weekly, 15 said
several times a month, 12 monthly, and 43 once in two months. Catheter users changed it
themselves 8% (n=16) of the time for routine changes and 10% (n=20) for unscheduled;
likewise spouses/family members did so 8% (n= 14) of the time for routine changes and
10% (n=19) for unscheduled. For regularly scheduled changes, out of 12 males who did this,
2 changed urethral and 10 SP; out of 4 females, all changed urethral catheters. For
unscheduled changes, out of 14 males who changed their own catheter, 2 had urethral and 12
had SP; out of 6 females, five had urethral catheters, and one had SP. Physicians or home
attendants also changed or assisted with catheter changes, for routine changes for 4 persons
and unscheduled for 9. Noteworthy is that in the previous two months, 3.5% had used the
emergency department (ED) for routine changes, and 31% among those who reported
unscheduled changes. Significant differences were found for routine changes in the ED by
study sites, with 6 in the NYC site and 1 in Rochester (Chi Sq. 7.0; df=1; P=.008.) However,
the unscheduled changes in the ED were not significantly different, with 52 in NYC and 11
in Rochester. (Chi Sq. 2.6; df=1; P=.106).
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Catheter irrigations—Irrigating the catheter, which is not a recommended practice

(Cottenden et al. 2009, Gould et al. 2009), was done by 42%. Of those who irrigated, 18%
did so daily or more often, 13% did it one or more times a week, 43% did it one or more
times a month, and 25% once in two months, and persons who irrigated daily were more
likely to have had blockage (Chi-Sq. 13.50, df =1, P = .019). Preventive irrigations were
done by 37%, for urine flow problems by 34%, and both preventively and for problems by
39%. Those who irrigated for prevention and problems were more likely to also have had
blockage, (Chi-Sq. 13.57, df =1, P = .001). Solutions for irrigation included: saline 76%,
sterile water 23%, tap water 9%, and Renacidin ™ (an acidic solution for instillation) 4%.
Irrigating the catheter was significantly related to blockage (Chi-Sq. 15.94, df =1, P = <.001)
but the pattern of irrigation and blockage vs. CAUTI varied by the individual. Out of 83 who
irrigated, 14 had both blockage and CAUTI, 17 had only blockage, 18 had only CAUTI, 32
had no blockage or CAUTI, and 2 did not know.

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Catheter Problems
Prevalence and incidence of self-reported catheter related problems for the previous two
months are described in Table 5, including means, SDs, and rates per 1000 catheter use days
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for CAUTI, blockage, and dislodgement. CAUTI was defined as a urinary infection treated
with an antibiotic. Self-reported prevalence of CAUTI was 31% (63/202). In 63 persons,
there were 75 episodes reported, with 54 persons having 1 event, seven having 2, one having
3 and one having 4. Blockage in the previous two months was reported by 48 persons (24%
prevalence) and frequency of the event was reported by 47of 48 persons: from 1–2 times in
31 persons, 3–4 times in 9, 7–9 times in 4, and 20 or more times in 3. Frequencies and other
details are reported in Table 5 of leakage (bypassing), sediment, kinks/twists, bladder
spasms, and autonomic dysreflexia (AD), a painful syndrome caused by injury to central
nerves.

Relationships among demographics, catheter practices, and complications—

No significant associations were found related to CAUTI in the past two months (Yes/No)
for catheter size, type of catheter (urethral or SP), leakage, kinks/twists or dislodgement of
the catheter. Younger persons were more likely to have reported CAUTI, with a mean age of
57.5 years (SD 16.3) as compared with 63 years (SD 17.6) for those who did not (t test=
2.11, df 199, P=. 0.036) and to have used the catheter for a longer period of time (Pearson’s
r= −.157, P= 0.026). Catheter size and length of time using a catheter were not significantly
correlated with the number of CAUTIs.
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All chi-square tests of associations were not significant for CAUTI or blockage (Yes/No) for
catheter management issues related to caregivers who assist with catheter care (e.g., spouse,
family, paid helpers); frequency of bag changes (night and/or leg bag); or cleaning the bag.

Blockage was significantly related to CAUTI, with the odds of having a CAUTI were 2.29
times as great (95% CI= 1.17, 4.48) among those with blockages compared with those
reporting no blockages. Out of 47 persons reporting frequency of blockage at least once in
two months, 22 had at least one UTI (46%); in contrast, out of 152 persons with no
blockage, 41 reported UTI (27%).

Treatments—Treatments associated with excess healthcare utilization for UTI or

blockage, such as extra nurse home visits or hospital visits, are listed in Table 6. All persons
reporting UTI had associated treatments, 96% of those with blockage had excess treatments,
and only one person out of 88 with either UTI or blockage had no excess treatments. Some
treatments required additional family or patient time or use of extra supplies. For example,
in those with blockage, the catheter position was adjusted by 19% in relation to blockages,
and irrigation was done for blockages by 49%. Doubtless some of the irrigations also were
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done by the catheter users or caregivers in the home, not nurses. In the previous two months,
17 study participants reported they were hospitalized for UTI for a total of 165 days. The
mean number of days hospitalized was 9.71 (SD 7.41), and if including all of those who had
UTI but were not hospitalized, the mean days per hospitalization was 2.62 (SD 5.75).

Symptoms of UTI—Questions of frequency and severity of UTI symptoms were asked.

Symptoms associated with 75 episodes of UTI were asked, with yes or no to each symptom
(Table 7). The most frequent symptoms were related to a change in the color (#1) or
character of the urine (odor #2; sediment #5). Generalized symptoms also were reported
often (malaise #3, bladder spasm #4). Severity of UTI symptoms were reported also for 74
events in two months. On a scale of 1–10 with 1 being very mild and 10 being the most
severe UTI you can imagine, a score of 1–4 was reported 22% of the time, a score of 5–7
was reported 43% of the time, and a score of 8–10 was reported 35% of the time.

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Leaking/sediment—Of the 86 persons (43%) who reported leaking (bypassing of urine),

8% indicated it was not a problem, 31% a small problem, 29% a moderate problem, and
32% a large problem. Sediment was noticed by 127 (63%), of these 41% saying it was a
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small amount (hardly noticeable); 34% a moderate amount (can be seen in tubing and bag if
looking for it); and 25% a large amount (very easy to see in tubing and bag. In the previous
two months, presence of sediment was associated with blockage (Chi-Sq. 13.93, df=1, P<.
001) but not CAUTI (Chi-Sq. .48, df=1, P=0.49).

Pain—Catheter related pain was reported by almost a quarter of the sample (n=46, 23%),
and of those with catheter pain it was attributed to positioning (e.g., sitting on it) by46%,
bladder spasms 46%, some catheter changes 30%, and every catheter change 26%. Fifteen
percent said that the pain bothered them very little, 46% said somewhat, and 39% said a
great deal. Three percent (n=6) said they have catheter pain all the time. In addition, AD can
be painful, and this was experienced by 41 persons (20%) at some time, most within the past
two months (Table 5). Primarily those with AD had SCI (38 of 41).

Difficult insertions/removals—Twenty-four individuals (12%) reported having

difficulty with the insertion of their catheter in the previous 2 month and 11 (5%) persons
had difficulty during removal. While 31 of 35 people said this difficulty had occurred just
once or twice in the past two months (mean 1.7, SD 1.1), four persons had experienced it
between 3 and 6 times. For those reporting any difficulty, the level of difficulty for the most
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difficult insertion or removal experienced (defined as difficult or challenging for the patient)
was assessed with a visual analogue scale from 1–10, with 1 being just a little more difficult
than usual and 10 being a very challenging situation. The difficulty mean score was 6.9 (SD
3.0), and more than half (54%) were rated from 8–10.

When asked if the catheter interfered with daily life, 29% said not at all, 26% said very little,
29% said somewhat and 16% said it interfered a great deal. However, in further analyses,
the catheter significantly interfered “a great deal” in persons with blockage (14 of 31; Chi
Sq. 9.53, df 3, P= 0.023) and those with difficult catheter changes (11of 32; Chi Sq. 8.65, df
3, P= 0.034).

Discussion
Although the majority of the persons enrolled in this study were recruited from a home care
agency in New York City (75%), the sample is believed to be a good representation of this
population because recruitment also took place through clinics and private offices in the
Rochester site. Only 3.6% of the persons recruited were not eligible because of not having
any major catheter problems, which is consistent with another study in this population in
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which not one of the 43 persons were problem free during the eight months’ study (Wilde et
al. 2010). The sample was older than in some previous studies, with a mean of 61 yrs. as
compared with a mean of 49yrs. in two recent studies (Wilde et al. 2010, Wilde & Brasch
2008) with similar populations that had more persons with SCI. The current sample, with a
total of 87% recruited through home care agencies, may reflect a more vulnerable
population than in earlier studies. Multiple secondary diagnoses and co-morbidities were
reported as well as a wide range of medications. Often large studies with catheter users
involve retrospective chart audits related to a single medical diagnosis, most often SCI,
aimed at finding out about urinary health or catheter management strategies over time
(Cameron et al. 2010, El-Masri, Chong, Kyriakider, & Wang 2011).

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Catheter Practices and Care

This is the first known large study (N=202) providing great detail on catheter management
practices and problems. Many people lacked knowledge about their catheters, such as the
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balloon size (47persons/23%) and a few gave us information that was questionable for
accuracy, such as catheter sizes of 15 and 17Fr, which are not known to exist. Also, 34%
said the catheter was all latex; it is possible that some did not know it might have a Teflon
™ coating, as this is a commonly used coating over latex and only one person indicated this
type. It was of concern that 29 persons said the balloon was size 30 mL since this is only
recommended for postoperative bleeding. The 8 persons who said their 30mL balloons were
inflated part way might also be mistaken, but if they were correct, inflating between 16–29
mL could contribute to asymmetry of the balloon and possible erosion into the bladder
mucosal lining (Cottenden et al. 2009). Patients and their caregivers need to know more
about the proper size of catheters and balloons so that the sizes can be decreased if increased
for a specific reason, such as bleeding.

It was not surprising that most people received help with managing their catheters (Table 2),
given the large number of people with neurological disorders and the high mean Katz score
of 7.8, which indicates a high level of disability. The level of disability is similar to the score
of 7.6 (Wilde & Dougherty 2006) cited in a study of 30 catheter users, and in another study
with 43 individuals, 44% required assistance from another to dress the upper body, and 91%
were in wheelchairs (Wilde et al. 2010).
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Drainage bag replacement and cleaning—There was much variation in how often the
drainage bag was replaced by a brand new one and/or cleaned, but the reason for the
frequency was not asked. Logically, the percentage of persons cleaning the leg bag increased
as the number of days between replacements extended. However, some people replaced the
bag infrequently (e.g., within 22–30 days or >30 days) and not all cleaned the bag between
replacements (Table 3). It was unanticipated that so few used a bleach solution to clean
since it is the only product recommended for cleaning drainage bags (Gould et al. 2009);
however, bleach is caustic and it can damage clothing and irritate the skin or eyes. Nor was
vinegar used much, and this had been the standard in home settings in the past (Wilde 1986,
Wilde 1991). A lack of research in this area, as well as whether supplies are reimbursed,
puts catheter users in a position to make their own decisions about cleaning and reuse of
bags. Somewhat surprising was that only 2% indicated they kept the leg bag attached all the
time, adding a night bag to it for continuous evening drainage. This practice is
recommended at the VNSNY and it is commonly recommended in the United Kingdom due
to a belief that this keeps the catheter less disturbed and more of a closed system.(Jones,
Brooks, Foxley, & Dunkin 2007, Royal College of Nurses (England 2008). In contrast to our
sample, in the U.K., leg and night bags are routinely changed every seven days or more
NIH-PA Author Manuscript

often if needed, i.e., appear dirty or have an odor. (Personal communication, M. Fader,
August 2011).

Catheter changes—This is the first time detailed information about who changes
catheters was reported and that catheter users and family members sometimes changed it
(Table 4). People in home settings with chronic illnesses often manage complex technology,
even as complicated as total parenteral nutrition. Yet catheter changes are not always simple,
particularly in men. However, significantly more males routinely changed their catheters
more often than females, and SP catheters were significantly more often changed than
urethral for unplanned changes. Providing careful teaching for those changing their own
catheters is essential to prevent traumatic insertions, especially when taking into
consideration the proportion of people who experienced difficult insertions (12%) and
removals (5%). Home care nurses changed the great majority of catheters, understandably

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since the majority of the sample came through home care agencies. Thus, it was particularly
surprising that unscheduled changes were often done in the emergency department (31% of
the time) and more often in NYC than in the Rochester site. Also ED visits for routine
NIH-PA Author Manuscript

changes (3.5%) contribute to substantial costs that could be reduced through planning and
use of home care agencies. The homebound restrictions in Medicare might have contributed
to this as people who are able to get out, hold a job, etc. are not eligible for home care
services under Medicare. Further research in reasons for catheter related ED use is
warranted.

Catheter Problems
Even though this is a selected group of patients who experienced catheter related problems
in the past year or were relatively new to catheter use, this analysis related to data from a
two month period confirms the widespread prevalence of catheter related problems. The
current report on nine catheter related problems, frequency of occurrence, and their
associated professional treatments is the first with this level of detail. In just two months
prior to study enrollment, 31% reported having had a CAUTI, blockage of the catheter was
reported by 24%, dislodgement by 12%., leakage by 43%, and pain by23 %. Though the
rates of CAUTI was 6.2/1000 catheter days (95% CI= 4.8, 7.6), lower than the 8.4/1000
days reported in a study of 43 long-term catheter users over a six month period (Wilde et al.
2010), it is much higher than the rate of 1.7/1000 days reported through a home care
benchmarking project which includes short and long-term catheter users (MAHC 2011). In
NIH-PA Author Manuscript

comparison with other research, (Maki & Tambyah 2001, Wilde et al. 2010) catheter size
and gender were not associated with CAUTI.

The rates for blockage and dislodgment are the first known to be published. This report
affirms the relationship of blockage and CAUTI reported in previous samples of 24 (Wilde
& Carrigan 2003) and 30 (Wilde & Dougherty 2006). Research is needed to explicate the
relationship between CAUTI and blockage, such as bladder mucosal bleeding from
distension related to poor urine flow (Pearman 1984) or bladder stones.

Symptoms of CAUTI—In a recent report of a study in 43 community dwelling adults, the

most frequently reported symptoms of CAUTI were urinary sediment, foul odor, general
malaise and changes in the color of the urine.(Wilde et al. 2010) In three other studies, foul
urine odor was a common symptom (Wilde 1986, Wilde & Dougherty 2006, Wilde &
Brasch 2008) though other symptoms varied. These symptoms were confirmed in the current
study with the top five being: changes in urine color and odor, malaise, weakness, and
sediment. While there are individual differences, this population did not report as often the
typical symptoms of UTI in the general public (i.e., burning, urgency, and fever). Of
concern, in a study of patients with intermittent urinary catheters, accuracy in predicting
NIH-PA Author Manuscript

UTIs based on their symptoms was not well validated (Massa, 2009). Although cloudy urine
was the most accurately reported symptom of UTI, the researchers concluded that most
patients were better at identifying when they did not have a UTI, rather than when it was
present. This study underlines the need for further symptom research in long-term
catheterized patients. Without better knowledge in this area, it is not known whether
symptom awareness alone can prevent episodes of symptomatic CAUTI. Thus for patients to
seek early treatment, they must know what symptoms to watch for and in particular which
ones are their own valid symptoms. This could benefit their health and reduce excess
healthcare utilization, especially if ED visits and/or hospitalization can be avoided.

Limitations
All data are self-reported, and thus we expect some errors. Also there were limitations in
sampling because the majority was recruited through one large home care agency and there

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were differences in recruitment processes (referral versus database). Persons more bothered
by catheter problems might have been more willing to join the study, contributing to
selection bias. Some information from study participants might have been inaccurate, for
NIH-PA Author Manuscript

instance catheter sizes of 15 and 17Fr. described above. However, we have confidence in the
accuracy of our self-reported data. In a comparison of self-report to chart accuracy in a small
sample of a similar population of catheter related problems, congruence was reported as
97% (Wilde et al. 2010).

Conclusion and Relevance to Clinical Practice

This report characterizes a diverse sample of the population of long-term indwelling urinary
catheter users in a way not reported before, providing detailed information about
demographics, catheter care practices, and numerous catheter related problems and
associated healthcare utilization. The widespread report of catheter problems is of concern
because the timeframe was just two months, this population is likely to need an indwelling
catheter indefinitely, and many of these problems negatively impact personal health and
associated healthcare expenditures. Gaps in research include optimal frequency for
replacement and methods of cleaning urinary drainage bags, increasing the predictive value
of CAUTI symptoms, decreasing excess ED use (especially for catheter changes), and best
practices for educating caregivers (family and paid carers). To better portray this vulnerable
population, prospective longitudinal research is needed with long-term catheter users having
NIH-PA Author Manuscript

a range of diagnoses. Also, for surveillance, CAUTI rates for short and long-term users
should be distinguished.

Implications for practice involve providing complete information about the catheter to those
who use the device, using the appropriate catheter balloon size and water inflation, and
consideration of criteria for teaching catheter changes to patients and caregivers. Moreover,
since disability levels can change over time, such as in those with MS, monitoring catheter
self-care capability over time could proactively identify people whose caregivers need to
learn more about catheter management.

Many of the catheter-related problems reported in this study could be prevented or

minimized with more attention to catheter management, early identification of problems,
and more evidence-based catheter practices. Therefore, information from this study is
critical to researchers who wish to plan interventions to address the persistent catheter
related problems that affect large proportions of long-term indwelling urinary catheter users.

Acknowledgments
NIH-PA Author Manuscript

We wish to thank persons who assisted in this study with: data collection, Yessica Terrero, Christopher Clinton,
Laura Edilitz, JoAnn Moda, Manny Schwimmer, Paula Wilson, and Maria Viterbo-Verna; information technology,
Brian Harrington, Michael Fisher, Annette Curtis, Sridevi Sridharan, Timothy Peng, Richard Dumpson; nursing
consultation, Paula Wilson, Seon Lewis-Holman, Yanick Martelly; medical consultation, Bob Mayer; data and
safety monitoring, Susan Fisher, Christopher Murtaugh; and administrative guidance Penny H. Feldman, Pamela
Sawdey.

Funding for this study was through the United States National Institute of Nursing Research, National Institutes of
Health #R01 NR0155.

References
Cameron AP, Wallner LP, Tate DG, Sarma AV, Rodriguez GM, Clemens JQ. Bladder management
after spinal cord injury in the united states 1972 to 2005. The Journal of Urology. 2010; 184(1):
213–217. [PubMed: 20478597]

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Cottenden, A.; Bliss, D.; Fader, M.; Getliffe, K.; Buckley, B.; Wilde, MH., et al. Management using
continence products. incontinence, 4th international consultation in incontinence. 4th ed.. Paris:
Health Publication Ltd; 2009.
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El-Masri YWS, Chong T, Kyriakider AE, Wang D. Long-term follow-up study of outcomes of bladder
management in spinal cord injury patients under the care of the midlands centre for spinal injuries in
oswestry. Spinal Cord. 2011
Gould, CV.; Umscheid, CA.; Agarwal, RK.; Kuntz, G.; Pegues, DA.; and the Healthcare Infection
Control Practices Advisory Committee (HICPAC). Guideline for prevention of catheter-associated
urinary tract infections 2009. Atlanta, GA: Centers for Disease Control and Prevention; 2009.
Jones S, Brooks A, Foxley S, Dunkin J. Care of urinary catheters and drainage systems. Nursing
Times. 2007; 103(42):48–50. [PubMed: 17985750]
Katz S, Ford A, Moskowitz R, Jackson B, Jaffee M. Studies of illlness in the aged. the index of ADL:
A standardized measure of biological and psychosocial function. JAMA. 1963; 185:914–915.
[PubMed: 14044222]
MAHC. Bladder catheter infection rate comparison Q32011 Infection Surveillance Project. 2011
Missouri Alliance for Home Care.
Maki DG, Tambyah PA. Engineering out the risk for infection with urinary catheters. Emerg Infect
Dis. 2001; 7(2):342–347. [PubMed: 11294737]
Massa LM, Hoffman JM, Cardenas DD. Validity, accuracy, and predictive value of urinary tract
infection signs and symptoms in individuals with spinal cord injury on intermittent catheterization.
The Journal of Spinal Cord Medicine. 2009; 32(5):568–573. [PubMed: 20025153]
Pearman, J. Prevention and management of infection: The urinary tract. In: Bedford, SG., editor.
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Lifetime care of the paraplegic patient. New York: Churchill Livingstone; 1985. p. 106-118.
Royal College of Nurses (England). Catheter care: RCN guidance for nurses. 2008. Pub. Code. 003–
237 ed. www.rcn.org.uk.
Wilde MH. Living with a foley. Am J Nurs. 1986; 86(10):1121–1123. [PubMed: 3639703]
Wilde MH. Foley catheter management at home. Home Healthc Nurse. 1991; 9(3):39–45. [PubMed:
2061084]
Wilde MH, Brasch J, Getliffe K, Brown KA, McMahon JM, Smith JA, et al. Study on the use of long-
term urinary catheters in community-dwelling individuals. Journal of Wound, Ostomy, and
Continence Nursing : Official Publication of the Wound, Ostomy and Continence Nurses Society /
WOCN. 2010; 37(3):301–310.
Wilde MH, Carrigan MJ. A chart audit of factors related to urine flow and urinary tract infection. J
Adv Nurs. 2003; 43(3):254–262. [PubMed: 12859784]
Wilde MH, Dougherty MC. Awareness of urine flow in people with long-term urinary catheters.
commentary by B. Roe. Journal of Wound, Ostomy, and Continence Nursing. 2006; 33:164–175.
Wilde MH, Brasch J. Self-monitoring of urine flow in people with long-term urinary catheters. Res
Nurs Health. 2008; 31(5):490–500. [PubMed: 18418847]
Yang J, Xie M, Ngee Goh T. Outlier identification and robust parameter estimation in a zero-inflated
poisson model. Journal of Applied Statistics. 2011; 38(2):421–424.
NIH-PA Author Manuscript

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Table 1
Primary and secondary diagnoses

5. ICS Education Modules

Primary Secondary
n
Wilde et al.

# % MS Diabetes Stroke Prostate Spina Neuroge

bifida nic
bladder
SCI 81 40 1 20 9 8 1 39

MS 46 23 7 4 3 23

Diabetes 25 12 7 7 5 10

Stroke 4 2 4 7 3 2

Prostate 20 10 3 5 3 13

Spina bifida 2 1 1

Neurogenic 16 8 23 15 2 13 1
Bladder

Parkinsons 3 2

Other 5 3

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Table 2
Catheter characteristics and catheter care practices

Time using catheter % Catheter material # (%)

Wilde et al.

Up to 1 yr. 22 All latex 69/34

> 1 to 3 yrs. 26 Teflon™ coated latex 1/1

> 3 to 5 yrs. 13 Silicone coated 71/35

> 5 to 10 yrs. 22 All silicone 12/6

>10 to 15 yrs. 8 Hydrogel coated 3/2

>15 to 20 yrs. 6 Silver coated 5/3

> 20 to 40 yrs. 5

Catheter size (Fr) Urethral SP Balloon size Urethral SP

all # (%) # # all #/% # #

12 1(1) 1 0 5–10 124(61 62 62

mL.
14 8(4) 7 1 30 mL. 29(14 19 10
15–16 62(31) 45 17 Don’t 47(23
know
17–18 57(28) 34 23 Other 2(1
Text 15
20 16(8) 7 9 Amount of water Urethral SP
in balloon # #
all # (%)

22 18(9) 2 16 <5cc 2(1) 1 1

24 17(8) 3 14 5–10 110(55) 54 56

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26 3(2) 0 3 11–15 10(5) 8 2
28 1(1) 0 1 16–29 12(5) 8 4

30 2(1) 0 2 30 9(5) 7 2

Not 17(8) 14 3 40–50 2(1) 2 0

known

Helps with catheter

#(%) (some selected more than one)
No one 47(23) Friend 7(4)
Spouse/partner 38(19) Paid aide 126(62)
Page 13

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# (%)
1(1)
NIH-PA Author Manuscript

Catheter material
Other
34(17)
%
Other family member
Time using catheter
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Table 3
Drainage bag cleaning and replacements
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Type of bag used (%) Cleaning Percentage in Percentage in

solutions leg bag users night bag users
Leg bag only 17 Soap & water 29 27
Night bag only 23 Water alone 35 31

Both leg and night bag 58 Vinegar & 33 36

Water

Leg bag always attached, 2 Bleach and 16 22

& adds night bag water

Other (e.g., homemade 2 Commercial 1 1

clamp) product, e.g.,
Urolux™
Household 12 12
cleaners, e.g.,
Lysol™

Other 1 2

Replacement with brand Leg bag users (%) Night bag users (%)
new bag, within:
Replacement Also cleans Replacement Also cleans
leg bag (%) night bag (%)
NIH-PA Author Manuscript

1–7 days 49 62 31 64
8–14 days 20 77 26 69
15–21 days 11 88 14 83

22–30 days 16 75 20 76

>30 days 5 86 9 93
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Table 4
Routine & unscheduled catheter changes

5. ICS Education Modules

Person Routine changes Unscheduled changes
changing # (%) # (%)
Wilde et al.

catheter
(some selected #(%) # # # (%) # #
more than one) all UR-SP M-F all UR-SP M-F

Self 16(8) 6–10 *12–4 20(10) *7–13 14–6

Spouse-partner 7(4) 3–4 4–3 9(5) 4–5 6–3

Family member 7(4) 5–2 2–5 10(5) 7-3 4–6

Home care 112 **73/3 ***42– 96(46) **63– 38–58

Nurse (55) 9 70 33

Nurse or 45(22) *19–26 31-14 45(22) 20–25 25-20

physician at
clinic
Nurse or 29(14) 12–17 19-10 22(11) 9–13 16-6
physician at
private medical
office
Emergency 7(4) 6-1 3–4 63(31) 32-31 40-23
department

UR= urethral; SP= suprapubic catheter. Significant differences in Chi Square tests
*
P= ≤ .05
**
≤ .01
***
<.001

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Table 5
Catheter problems

Key catheter Number Percentage Mean (SD) entire Rate/1000 catheter

problems in past persons * sample days
Wilde et al.

two months
UTI 63 31 0.37 (0.63) 6.22

Blockage 48 24** 0.67 (1.71) 6.22

Dislodgement 25 12 0.21 (0.68) 11.08

Other catheter Number Percentage Frequency of those with problem (%)

problems in past persons *
two months Daily Once - Once - Once
several several in past
Times Times 2
week month months

Leaking (bypassing 86 43 9 10 51 29
urine)

Sediment 127 63 24 29 39 7
Kinks/twists 40 20 13 8 40 40

Bladder spasms 72 36 37 24 30 10

Autonomic 26 13 4 31 38 27
dysreflexia

*
Indicates the percentage of study participants who had this happen at any time during the previous two months, rounded to nearest percent.
**
The outlier test based on zero-inflated Poisson models (Yang et al. 2011) identified three observations in blockage variable. Outliers were replaced with the observations closest to them, 9, for the
calculation of means.

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Table 6
Treatments associated with catheter problems in two months

5. ICS Education Modules

Treatments/ UTI (n=63) Blockage (n=47)*
Wilde et al.

Total # % affected **Mean Total # % **Mean

events (SD) events affected (SD)
Extra nurse home visit 14 19 0.22 (0.49) 26 30 0.55(.99)

Extra office visit 18 25 0.29 (0.52) 13 23 0.28

(0.54)

ED visit 25 35 0.40 (0.61) 16 19 0.34

(0.84)

Hospitalized** 20 27 0.32 (0.56) N/A

Rehab or nursing home

stay

Catheter changed 48 65 0.76 (0.64) 58 70 1.23

(1.22)

Urine cultured 54 76 0.86 (0.59) N/A

Antibiotic prescribed 75 100 1.19 (0.53)

*
One additional person had blockage but did not know the frequency.
**
Means (SDs) calculated only for those affected with the problem, i.e., 63 with UTI and 47 with blockage. Treatments were not asked for blockages over 12 events/person, which was reported by three
persons.

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Table 7
Symptoms of UTI (n=63)
NIH-PA Author Manuscript

Symptom Mean (SD) Times Percent with Rank order of

reported symptom* frequency

Urine color change 0.94 (0.74) 59 76 1

Odor in urine 0.84 (0.77) 53 68 2

Malaise 0.71 (0.77) 45 59 3

Weakness 0.60 (0.73) 38 51 4
Sediment 0.59 (0.75) 37 48 5

Pain Bladder 0.57 (0.76) 36 46 6

Burning 0.57 (0.78) 36 44 7

Bladder Spasm 0.51 (0.64) 32 43 8

Chills 0.49 (0.72) 31 41 9

Blood 0.49 (0.69) 31 40 10

Fever 0.44 (0.62) 28 40 11

Pain Back/Side 0.44 (0.67) 28 37 12

NIH-PA Author Manuscript

Muscle Spasm 0.40 (0.71) 25 32 13

Other 0.29 (0.52) 18 25 14

Mental Changes 0.27 (0.51) 17 24 15

Leakage 0.25 (0.47) 16 24 16

Autonomic dysreflexia 0.21 (0.63) 13 14 17

*
Percentage with symptom rounded to a whole number.
NIH-PA Author Manuscript

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NIH Public Access

Author Manuscript
Nurs Res. Author manuscript; available in PMC 2016 January 01.
Published in final edited form as:
NIH-PA Author Manuscript

Nurs Res. 2015 ; 64(1): 24–34. doi:10.1097/NNR.0000000000000071.

Self-Management Intervention for Long-Term Indwelling Urinary

Catheter Users: Randomized Clinical Trial
Mary H. Wilde, RN, PhD [Associate Professor],
University of Rochester, School of Nursing, Rochester, New York

James M. McMahon, PhD [Associate Professor],

University of Rochester, School of Nursing, Rochester, New York

Margaret V. McDonald, MSW [Associate Director of Research Studies],

Visiting Nurse Service of New York, Center for Home Care Policy and Research

Wan Tang, PhD [Research Associate Professor],

University of Rochester, Department of Biostatistics and Computational Biology, Rochester, New
NIH-PA Author Manuscript

York

Wenjuan Wang, PhD [Post-Doctoral Fellow],

University of Rochester, Department of Biostatistics and Computational Biology, Rochester, New
York

Judith Brasch, RN, MS [Project Nurse],

University of Rochester, School of Nursing, Rochester, New York

Eileen Fairbanks, RN, MS, PNP [Health Project Coordinator],

University of Rochester, School of Nursing, Rochester, New York

Shivani Shah, MPH [Research Analyst],

Visiting Nurse Service of New York, Center for Home Care Policy and Research

Feng Zhang, RN, BS [MS/PhD Student], and

University of Rochester, School of Nursing, Rochester, New York
NIH-PA Author Manuscript

Corresponding author: Mary H. Wilde, RN, PhD, Associate Professor Nursing and Center for Community Health, University of
Rochester, 601 Elmwood Ave., Box SON, Rochester, NY, 14642. mary_wilde@urmc.rochester.edu.
Mary H. Wilde, RN, PhD, is Associate Professor, University of Rochester, School of Nursing, Rochester, New York.
James M. McMahon, PhD, is Associate Professor, University of Rochester, School of Nursing, Rochester, New York.
Margaret V. McDonald, MSW, is Associate Director of Research Studies, Visiting Nurse Service of New York, Center for Home
Care Policy and Research.
Wan Tang, PhD, is Research Associate Professor, University of Rochester, Department of Biostatistics and Computational Biology,
Rochester, New York.
Wenjuan Wang, PhD, is Post-Doctoral Fellow, University of Rochester, Department of Biostatistics and Computational Biology,
Rochester, New York.
Judith Brasch, RN, MS, is Project Nurse, University of Rochester, School of Nursing, Rochester, New York.
Eileen Fairbanks, RN, MS, PNP, is Health Project Coordinator, University of Rochester, School of Nursing, Rochester, New York.
Shivani Shah, MPH, is Research Analyst, Visiting Nurse Service of New York, Center for Home Care Policy and Research.
Feng Zhang, RN, BS, is MS/PhD Student, University of Rochester, School of Nursing, Rochester, New York.
Ding-Geng (Din) Chen, PhD, is Professor, University of Rochester, School of Nursing and Department of Biostatistics and
Computational Biology, Rochester, New York.
Clinical Trial Registration number from clinicaltrials.gov is NCT00883220.
Conflicts of Interest Statements: Mary H. Wilde has been a consultant with NovaBay Pharmaceutics Inc. since June 2013. The
remaining authors have no conflicts of interest to report.

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Ding-Geng (Din) Chen, PhD [Professor]

University of Rochester, School of Nursing and Department of Biostatistics and Computational
Biology, Rochester, New York
NIH-PA Author Manuscript

Abstract
Background—People using long-term indwelling urinary catheters experience multiple
recurrent catheter problems. Self-management approaches are needed to avoid catheter-related
problems.

Objectives—The aim was to determine effectiveness of a self-management intervention in

prevention of adverse outcomes (catheter-related urinary tract infection, blockage, and accidental
dislodgement). Healthcare treatment associated with the adverse outcomes and catheter-related
quality of life was also studied.

Method—A randomized clinical trial was conducted. The intervention involved learning
catheter-related self-monitoring and self-management skills during home visits by a study nurse
(twice during the first month and at four months—with a phone call at two months). The control
group received usual care. Data were collected during an initial face-to-face home interview
followed by bimonthly phone interviews. A total of 202 adult long-term urinary catheter users
NIH-PA Author Manuscript

participated. Participants were randomized to treatment or control groups following collection of

baseline data. Generalized estimating equations (GEE) were used for the analysis of treatment
effect.

Results—In the intervention group, there was a significant decrease in reported blockage in the
first six months (p = .02), but the effect did not persist. There were no significant effects for
catheter-related urinary tract infection or dislodgment. Comparison of baseline rates of adverse
outcomes with subsequent periods suggested that both groups improved over 12 months.

Discussion—A simple–to–use catheter problems calendar and the bimonthly interviews might
have functioned as a modest self-monitoring intervention for persons in the control group. A
simplified intervention using a self-monitoring calendar is suggested—with optimal and consistent
fluid intake likely to add value.

Keywords
longitudinal research; quality of life; randomized clinical trial; self-management; urinary
NIH-PA Author Manuscript

catheterization

Indwelling urethral or suprapubic catheters are used by individuals with chronic urinary
retention who are unable to perform intermittent-catheterization because of poor hand
dexterity, no caregiver assistance, difficulty in using the bathroom, or in select cases of
incontinence. While many catheter users have spinal cord injury (SCI) or multiple sclerosis
(MS), the population also includes those with other neurological disorders, diabetes, or
disease/injury to the bladder region. Unfortunately, indwelling urinary catheters are seldom
trouble free (Cottenden et al., 2013; Wilde, McDonald et al., 2013). Data collected in a
longitudinal study of 43 long-term catheter users indicated that recurrent problems affect the
great majority. Prevalence rates during eight months of catheter use were 70% for catheter-
associated urinary tract infection (CAUTI) with a rate of 8.4/1000 catheter days; 74% for

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blockage; and 33% for catheter expulsion or dislodgement (Wilde, et al., 2010). For a two-
month period prior to the beginning of this randomized clinical trial (RCT), catheter
problems were reported as: 31% for CAUTI, 24% blockage, and 12% dislodgment (Wilde,
NIH-PA Author Manuscript

McDonald et al., 2013).

These complications are distressing to patients/families (Wilde & Cameron, 2003; Wilde,
2003) and contribute to increased healthcare expenses, such as additional clinic, home care,
or emergency department visits or hospitalization (Wilde, McDonald et al., 2013).
Interventions to address prevention of CAUTI in long-term catheter users such as the use of
silver coated or antimicrobial coatings on the catheter (Parker et al., 2009) installations to
the drainage bag (Thompson et al., 1984), or special cleaning of the urinary meatus (Burke,
Jacobson, Garibaldi, Conti, & Alling, 1983) have not been successful. Although research in
self-management of chronic conditions in diabetes (Coyle, Francis, & Chapman, 2013),
stroke (Lennon, McKenna, & Jones, 2013), and asthma (van Gaalen et al., 2013) has grown,
no self-management clinical trials have been found in catheter users (Cottenden et al., 2013;
Niël-Weise, van den Broek, Peterhans, da Silva, & Silva, 2012).

The research clinical trial (RCT) for the current report was developed inductively through
six previous studies conducted primarily by the first author (MHW). These studies included
NIH-PA Author Manuscript

research with 30 individuals who kept a urinary diary and were interviewed twice to
determine what their self-care practices were (Wilde & Dougherty, 2006). A concept
analysis was next conducted of self-monitoring, delineating key attributes and how it fit
within self-management literature (Wilde& Garvin, 2007). Then a pilot study teaching self-
monitoring of urine flow in long-term catheter users was conducted. The results of the pilot
study indicated that optimal fluid intake and preventing dislodgment were the most useful
self-management components reported by study participants. Importantly, CAUTI decreased
in the six months during the single group pilot (Wilde & Brasch, 2008a). Taken together, the
theoretical model for the current study proposed that the intervention would affect catheter
self-management indirectly through self-efficacy, and directly; and that higher levels of
awareness, monitoring, and behaviors related to catheter care would improve outcomes
(Figure 1; Wilde, Zhang et al., 2013).

The aim of the study was to determine the effect of the self-management intervention on
health outcomes compared to the usual care control. It was hypothesized that the self-
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management group would: (a) have fewer episodes of UTI (and severity), blockage, and
dislodgement of the catheter; (b) have decreased unplanned catheter-related healthcare
utilization, including hospitalizations, emergency department visits, and fewer nurse
home/or clinic visits; and (c) report higher catheter-related quality of life.

Methods
Design
The study was a randomized, single-blinded experimental design with repeated measures
every two months over a 12-month period. The design called for 101 individuals to receive
the self-management intervention and 101 to receive usual care (catheter-related care
provided by home care nurses, clinics, or private providers).

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Inclusion/Exclusion Criteria
Eligible participants were adults age 18 and over. Inclusion criteria were: (a) expect to use
an indwelling urethral or suprapubic catheter for at least one year, and will be in the study
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region for at least four months; (b) can complete study measurements alone or with the help
of a caregiver; (c) speak English; and (d) have access to a telephone for data collection.
Because we wanted to target only individuals who might benefit from this study and, thus,
better determine effectiveness, our participants also must have had a catheter problem of
CAUTI within the last year, or blockage or dislodgement within the last six months, or be
new to a catheter within the last year. Individuals were excluded for terminal illness or
cognitive impairments. Children under 18 were not included because they might not have
the capacity for self-care, which includes directing others.

Setting and Recruitment

Participants consisted of community-dwelling individuals recruited in two distinct regions
by two study sites: (a) a university in a large northeastern U.S. state, and (b) a home care
agency which conducts research in a large metropolitan area in the same state. For the
university site, participants were recruited through nurses or physicians in home care
agencies, medical center clinics, hospitals, and private medical offices (e.g., urology).
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Screening for eligibility and interest in participation was conducted by phone by the first
author (MHW) or the project coordinator after contact information was received from
providers who had permission to do so from potential participants. Some catheter users
contacted the researchers themselves. In the home care agency, their database was used to
identify potential participants with a catheter for telephone call screenings and recruitment
by trained study interviewers. Using data from the agency’s U.S. Outcome and Assessment
Information Set (OASIS) for home care, catheter users were screened and excluded if they
had a poor prognosis/life expectancy, cognitive impairment, confused, severe speech
impairment, behavior problems, diagnosis indicating dementia, or had been previously
interviewed (in another study or declined). Data were collected from June 2009-June 2012
in the homes of community-dwelling individuals and through telephone contacts over 12
months of participation.

Sample Size and Power Calculations

Power calculations were performed to determine a sample size for an adequately powered
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study to detect clinically meaningful effects across multiple outcomes. For each of the
primary outcomes, a priori range of clinically meaningful effect sizes was determined based
on previous research. All calculations employed a significance level of .05 and 80% power.
Power analyses were performed with SAS 9.1 using Monte Carlo simulation resampling
techniques for general estimating equation (GEE) analysis (Gastañaga, McLaren, & Delfino,
2006; Yuan & Hayashi, 2003). The analysis indicated that a sample of 220 (160 completers)
would provide sufficient power to detect medium effect sizes (15% to 30% differences
between groups) for the primary health status outcomes. However, health care utilization
measures, such as hospitalizations and ED visits, require larger samples due to their
relatively rare frequency of occurrence.

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Ethics/Human Subjects
The study was approved at each site by their respective bodies for protection of human
subjects. A coordinated approach assured that the same processes were used, including the
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same consent form with stamps and contact information from both sites. A Data Safety
Monitoring Board was formed and convened annually to assess interim results and potential
adverse events.

Randomization and Blinding

Randomization was conducted by the main study statistician who directed the processes
with the study coordinators at each site—each of whom subsequently enrolled participants at
their own site and allocated them to treatment or usual care after completion of the baseline
home visit (HV) interview. Participants were stratified by site to balance the large number of
study subjects in the large metropolitan area (75% of participants), as compared with the
university site (25% of participants) which was a combination of urban, suburban, and rural
areas. Block randomization with random block sizes of 4, 6, or 8 was carried out
independently at the two sites to balance the two treatment groups. For each site, a sequence
of random assignments was generated by the study statistician and sealed in sequentially
numbered envelopes by the study coordinator. The participants were sequentially assigned
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the treatment after completing the consent and initial HV interview; then, the study nurse
called those allocated to the intervention and made arrangements for the first nurse contact
in the home. Study investigators, data gathering teams, and statisticians were blinded to
allocation status until the final analyses were completed.

The Urinary Catheter Self-Management Intervention

The intervention designed to improve self-management in people with long-term, indwelling
urinary catheters was based on self-efficacy theory (Bandura, 1997). Sources of urinary
catheter self-efficacy were targeted in the nurse home visit interventions—specifically
mastery experiences—vicarious observation, verbal persuasion, and knowledge about
physiological status.

Each of the two study sites followed identical intervention protocols, which consisted of
three home visits and one telephone call by a trained registered nurse to deliver the
intervention. Two home visits took place in the first month and a third (booster) visit
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occurred at four months. During the first home visit, participants were taught to conduct
self-monitoring using a three-day urinary diary to record observations and measurements of
fluid intake and output (I & O), urine characteristics, and sensations of flow. This was to
teach awareness of urine flow, basic self-monitoring skills, and to increase their level of
mastery, thus, contributing to increased catheter related self-efficacy. During the second
home visit, about a week later, self-management skills were taught first by reviewing the
information from the urinary diary, calculating the intake and output averages and
comparing these to an optimal volume (30ml/kg body weight), and identifying the
individual’s catheter-related problems. Anything notable about I & O, the color/character of
urine, or of urinary sensations, was discussed and implications for self-management pointed
out.

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An educational booklet which had been piloted and viewed as very helpful (Wilde, Zhang,
et al., 2013) was then provided and discussed, which focused on basic catheter self-
management skills related to: (a) maintaining optimal and consistent fluid intake; and (b)
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preventing catheter dislodgement—which were the key components of the intervention. In

the presence of certain bacteria which cause urea in the urine to split, sodium, magnesium,
and calcium will precipitate from the urine—often at about a pH of 6.8, causing sediment
and encrustation. However, researchers found that urine pH could increase to as high as 9 or
10, and the catheter might not block if fluid intake is increased to dilute the concentration of
minerals (Khan, Housami, Melotti, Timoney, & Stickler, 2010). This is our foundation for
the fluid intake requirements, which we set at 30ml/kg body weight (Gray & Krissovich,
2003).

Other modules of the booklet were reviewed briefly or in-depth, depending on interest or
need. These were: recognizing early symptoms of CAUTI; living with the catheter;
promoting optimal catheter change intervals; decreasing caffeine; decreasing leakage;
emptying and cleaning the drainage bag; making adjustments for sex; and recognizing early
symptoms of autonomic dysreflexia (for people with spinal cord injury/disease). Goals, if
any, were written in the educational booklet. A motivational bookmark with quotes and
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pictures was reviewed to help encourage participants to be attentive to urine flow.

Two weeks later, the study nurses called to answer questions and, if needed, helped the
participants revise goals or plans. At four months, a third home visit served as a booster of
the intervention to further refine or modify goals/plans as the catheter user desired. Family
or caregivers were encouraged to be present, but the intervention was delivered to the
catheter user.

Intervention compliance and fidelity—Two study nurses (one at each site), who were
trained together at the beginning of the project, delivered all the intervention components.
Multiple strategies were used to establish and sustain the fidelity and integrity of the
intervention. These involved: (a) standardization of the intervention and training, including
use of a detailed training manual that incorporated Bandura’s self-efficacy concepts
(Bandura, 1997); (b) randomly selected fidelity assessments of 10% of the interventions—
half by audiotape and half in-person home observations; (c) at least monthly conference
calls; (d) training study nurses together; (e) tracking study nurse activities and
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responsiveness of the participants; (f) assessment of participant skills at the end of the study;
and (g) inclusion of fidelity assessment in the analysis plan. The results of the audiotape and
in person fidelity assessment indicated that competence and adherence to the intervention
parameters were highly scored with most means between 4–5 (5 was the highest possible
score). Also, because there was little variability in the proportion of the intervention
participants who received the intervention contacts (i.e., 98% for HV1, 95% for HV2, 93%
TC at two weeks, and 91% HV3 at four months), we decided it was not necessary to adjust
for fidelity in the main outcomes analysis. All participants, regardless of group allocation,
continued to receive usual nursing and medical care.

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Usual Care
Participants randomized to the control group received usual care.
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Measures
Measures were developed for this study based on previous research of the first-author’s team
(Wilde & Brasch, 2008a; Wilde & Dougherty, 2006). Instrumentation was modeled on the
Stanford Chronic Disease Self-Management programs (http://
patienteducation.stanford.edu/). Participants in both groups were administered identical data
collection instruments. At baseline, self-report was used for data collection related to the
two-month timeframe prior to the study (for evaluating equivalence of the groups), and
every two months for 12 months thereafter through telephone call interviews. To improve
accuracy of recall, all participants were asked to maintain an ongoing catheter calendar over
the 12 months of the study, using letter symbols for problems: CAUTI (U), blockage (B),
and dislodgement (D). Treatments were identified as antibiotic (A), extra nurse home visit
(HV), extra office visit (O), hospitalization (H), and emergency department visit (ED). For
missed interviews, data were collected for the primary outcomes at the next scheduled
interview—if the study participant had kept track of problems in their catheter calendar.
This occurred only nine times.
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Outcomes
Primary outcomes consisted of catheter-related complications of CAUTI, blockage, and
dislodgement. CAUTI was defined as a urinary tract infection that was treated with an
antibiotic prescribed by the person’s healthcare provider. Blockage was defined as an
occurrence in which the urine would not flow through the catheter due to an obstruction of
the catheter tube. Blockage was distinguished from kinks or twists that are external to the
catheter tube. Dislodgement occurred when the catheter fell out or became displaced
accidentally due to traction (i.e., pulling on it). Catheter-related quality of life was also a
primary outcome using our previously developed measure with a five-point Likert scale
from 1 = strongly agree to 5 = strongly disagree; higher scores reflect better quality of life
(Wilde, Brasch, Getliffe, McMahon et al., 2010).

Excess healthcare expenditures (treatments) related to catheter problems were also primary
outcomes; these included extra nurse or clinic visits, hospitalizations, rehabilitation, and
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emergency department visits. Additional information was asked about each episode of
CAUTI regarding the perceived severity of the infection (on a scale of 1–10, with 1 = very
mild and 10 = most severe imaginable), and the number of days hospitalized or in
rehabilitation specifically related to the CAUTI.

Data Analysis
Standard data cleaning procedures were applied to screen for errors and potential univariate
and multivariate outliers. These procedures led to the removal of blockage data
(percentages/month, counts, treatments) for one participant due to inconsistent and
contradictory responses. All other data were used; several outliers for blockage were

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adjusted by windsorizing to 9 as the maximum number of events in a two-month period for

testing group differences.
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Intention-to-treat analysis was used. Data were analyzed with SAS 9.3 (SAS Institute Inc.,
Cary, NC, USA). Generalized linear models were utilized with an identity link function for
continuous outcomes (CAUTI severity and QOL) and a logit link function for binary
outcomes. Randomization achieved comparability on demographic characteristics of
participants and aspects of catheter use (Tables 1 and 2) in treatment and usual care groups.
The groups were similar on key outcome variables during the two months prior to the study,
except for catheter blockage (p < .05) and days hospitalized (p < .01) (Table 2). Thus, we
fitted each of the models with and without controlling for baseline information on the
outcome variable. First, data for the first six months were modeled; then, data from the
entire 12 month period of the study were modeled.

First six months—We let “group” be the indicator of treatment assignment (0 = usual
care; 1 = treatment), and yit be the outcome for the ith subject at month t. Three models were
developed for each outcome over the first six months of the study: a group differences
model, a model for interaction of group and time; and a model controlling for baseline and
time. The group differences model is
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(1)

where f is the appropriate link function, the intercept β0 is the y-intercept in the usual care
group when f is an identity function and mean log odds for the usual care group when f is the
logit link, β1 is the treatment effect, and the “*” symbol denotes multiplication. The
interaction model, controlling for baseline and time is

(2)

When the interactions in Equation 2 were not significant, we further modeled the data
controlling for baseline and time, with

(3)
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In the models given in Equations 1 and 3, inference about β1 provides information about the
treatment effect, either as difference in outcome (CAUTI severity, quality of life) or
difference in log odds of the outcome (binary outcomes) as a function of group (Equation 1)
or group, baseline, and time in months (Equation 3).

Complete 12 month outcomes—We applied the same group difference model in

Equation 1 to the 12-month data (i.e., t = 2, 4, 6, 8, 10 and 12). For the models controlling
for baseline and time (Equations 2 and 3), an indicator variable “second” was added to allow
modeling differences between the first and second six months of the study (scored 0 when t
= 2, 4, or 6 months and 1 when t = 8, 10, and 12 months). An interaction term between

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“second” and “group” was added to the models described in Equations 2 and 3 to detect
possible treatment effects between the first and last six months of the study, shown as
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(4)

and

(5)

To deal with the dependency among the repeated measures, generalized estimating
equations (GEE) with a first order autoregressive structure for the working correlation were
utilized. We chose to use GEE because of the complexity and difficulty in modeling the
correlations among the repeated measures—especially for discrete outcomes. As a
semiparametric approach, GEE has the advantage that the inference is robust to the
misspecification of the working correlation matrix—in the sense that estimates are
consistent even when the working correlation departures from the true correlations among
repeated measures (Diggle, Heagerty, Liang, & Zeger, 2002). Nominal p-values of .05 for
two-tailed tests were used.
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Results
Sample Description
Baseline characteristics of participants are displayed in Table 1. Ages ranged from 19–96
years (Mdn = 61). The range in duration of catheter use was 1 to 470 months (39 years).
Self-reported diagnoses involved SCI (40%), MS (23%), diabetes (12%), stroke (2%),
prostate (10%), spina bifida (1%), neurogenic bladder not otherwise reported (8%),
Parkinson’s disease (2%), and other (3%). Indications for indwelling catheter use were:
immobility or difficulty moving around (58%), incontinence (57%), neurogenic bladder
(54%), obstructed urine (32%), healing wounds (11%), and other reasons (11%). More than
one indication could be listed. Additional detailed information about the participants at
baseline is available in Wilde, McDonald et al. (2013).

Table 2 lists catheter-related health status, healthcare related to CAUTI, healthcare related to
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blockage, and quality of life at baseline by treatment group. Following randomization,

groups appeared equivalent except that, during the two months prior to the study, the
percentage of participants who had catheter dislodgement and the number of days
hospitalized for a catheter-related CAUTI were higher in the control group.

Attrition was similar in both groups (Figure 2). There were more deaths in the experimental
group than the control group (10 vs. 7). More participants whose catheters were removed
were in the control group, mostly late in the study (3 vs. 10). Three persons withdrew from
each arm of the study.

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Treatment Effects
Table 3 lists treatment effects for primary outcomes for models depicted in Equation 3 (short
term effects during the first six months of the study, controlling for baseline value and time)
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and Equation 5 (longer-term effects, controlling for baseline value, time, and first vs. second
half of study). Complete statistical results are available from the authors (MHW).

First six months—Without controlling for any covariates, the overall short-term effect of
the intervention relative to the control condition was assessed over the first six months
(Equation 1). During the first six months, patients in the experimental group were less likely
to report catheter blockage (p < .05) and fewer blockage-related nurse visits (p < .05), but
they reported experiencing more severe CAUTI (p < .001) and significantly more CAUTI-
related emergency room visits (p < .05), in terms of the percentage reporting such events. As
shown in Table 3, we obtained similar conclusions controlling for the outcome variables at
baseline (such as CAUTI) as well as time (Equation 3).

Complete 12 month outcomes—Without controlling for any covariates, the overall

long-term effect of the intervention compared to the control condition was assessed over the
whole 12-month period (Equation 1, with t = 2, 4, 6, 8, 10, 12). However, the overall
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difference in blockage between the two groups was not significant over this longer period.
The experimental group continued to report significantly higher CAUTI severity scores (p
< .01) and CAUTI-related emergency room visits (percentage reporting these events [p < .
001] and frequencies of events [p < .01], as well as more hospitalizations for CAUTI
(percentage [p < .01], frequencies [p < .01], and days hospitalized [p < .05]; Table 3; Table 4
[days hospitalized]).

Additional statistical tests of treatment effect controlling for baseline outcomes, time, and
study period (“second”) were conducted (Equation 4, not shown in a table.). The
experimental group tended to report more CAUTI compared to the control group in the
second half ( ; 95% CI [0.03, 1.30], p = .04), and no difference between the two
groups during the first half year. The experimental group reported higher CAUTI severity
than the control group in the first half year ( ; 95% CI [−4.62, −0.97], p < .0001),
but no difference between the two groups during the second half. This indicates that the
experimental group’s CAUTI severity scores decreased relative to the control group from
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the first to the second half of the year. Blockages were fewer in the experimental group (by
percentage) compared with the control group in the first half of the year ( , 95% CI
[0.38, 1.97], p < .05), but not in the second half of the year.

For other outcomes, the interaction was not significant, and was therefore removed.
Treatment effect was estimated controlling for baseline outcomes and time. The
experimental group had higher hospitalization for CAUTI (p < .01) and emergency room
visits (p < .001; Table 3). Catheter-related quality of life did not differ significantly by group
(Table 3).

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Rates Comparisons
Table 4 provides detailed information about rates of blockage, CAUTI, dislodgement, and
hospitalizations within groups over the course of the study and between groups. See Table 4
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for a figure displaying the percentage of persons who reported experiencing catheter adverse
outcomes of blockage, CAUTI, or dislodgement by group over time.

Catheter-related health status—Comparison of between- and within-groups rates per

1000 catheter days from baseline provided further details about changes in the primary
outcomes over the first six months, second six months, and full study of 12 months.
Blockage rates were significantly lower in the experimental group during the first six
months (p < .01) and for the full study (p = .03), but there were no differences during the
second half of the study (p = .31). Blockage improved significantly within each group at
each assessment time from baseline.

For CAUTI, there were significant rate differences favoring the control group during the
second half of the study (p = .01), but no differences for the first half (p = .55) or the full
study (p = .16). Compared with baseline rate estimates, the experimental group had
significant decreases in CAUTI rates during the first half of the study (p = .02), and for the
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overall full study time period of 12 months (p = .05). The control group had a significant
decrease in CAUTI during the second half of the study (p = .02).

For dislodgement, rates decreased steadily in both groups by six months and 12 months, and
there were no significant group differences. Dislodgement rates were lower in the
experimental group at baseline, and larger decreases in dislodgement took place over time in
the control group. During the second half of the study, the experimental group rate was
slightly better than the control, but not significantly so (p = .06).

Hospitalization rates—Hospitalizations were significantly higher in the experimental

group for most time points (Table 4). While the hospitalization rates favored the control
group, rates decreased in both groups compared with their respective rates at baseline. Slight
increases in rates were found during the second six months in the experimental group,
compared with the first six months, but control group rates continued to decrease during the
second six months. With further analysis at the individual level, we found that one person
(in the experimental group) was hospitalized six times during the study, and five of these
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occurred in the second six months of the study. All others hospitalized in either group were
hospitalized either once or twice during the study.

Discussion
Key Findings
Four Cochrane reviews concluded that there was an astounding lack of evidence to guide
practice in long-term catheter use (Cottenden et al., 2013). Almost all intervention research
in the past has focused on applications such as silver or antibiotic coatings (Johnson,
Kuskowski, & Wilt, 2006) to the catheter, special cleaning of the urinary meatus (Burke,
Jacobson, Garibaldi, Conti, & Alling, 1983), or drainage bag additives (Washington, 2001).
None have proven effective in long-term catheter users. We believe this study is a unique

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contribution because it is the first known study of its kind using a randomized clinical trial
with an inductively derived, theory-based behavioral intervention (Wilde, 2002; Wilde &
Brasch, 2008b; Wilde and Dougherty, 2006; Wilde & Garvin, 2007) to assess whether
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teaching catheter users self-management skills could decrease short-term, catheter-related

problems, and whether improvements could be sustained over 12 months.

The GEE analyses indicated that there was a significant group difference in the first six
months only for the blockage outcome—favoring the experimental group. Several
interactions suggested that effects of the intervention were stronger for the first six months
than the long-term effects over 12 months. Comparisons of rates for the first six months,
second six months, and full study of 12 months—as well as the changes in rates from
baseline—provided additional information suggesting that both groups improved over time.
The line graphs (see Supplemental Digital Content) also indicate a general downward trend
for both groups over the 12-month study.

The decreases in rates for CAUTI and blockage are believed to be clinically meaningful in
both groups. In a recent report from the Agency on Healthcare Research and Quality (2013,
p. 26), decreases in CAUTI in hospitalized persons went down in two months from 2.56 to
2.39/1000 catheter days—a relative reduction of 6.3%. The rate decreased even further at 14
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months to 2.14/1000 catheter days—a 16.1% relative reduction in 14 months. These changes
reflected that “progress has been made” toward national goals. CAUTI rates in community-
dwelling persons can be as high as 8.4/1000 catheter days (Wilde, Brasch, Getliffe, Brown
et al., 2010). In our study in the experimental group, the baseline CAUTI rate of 6.93/1000
catheter days decreased to 4.89 (a 29% relative reduction) and in the control group from
5.5/1000 catheter days to 4.12 (a 25% relative reduction; see Table 4).

Blockage prevalence is often cited as about 50% (Getliffe, 2003), but our previous research
reflects a wide range of 74% over eight months in 43 persons (Wilde, Brasch, Getliffe,
Brown et al., 2010) to 24% in our cross-sectional analysis—before random assignment at
baseline in the current study (Wilde, McDonald et al., 2013). Importantly, there is no
agreement of whether blockage is a one-time occurrence or a persistent pattern, and this
might explain the wide range in blockage prevalence. Because our study tested group
differences in this randomized trial, the blockage rates reported should be viewed with
caution because blockage outliers were adjusted statistically to a maximum of 9 in a two-
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month time period. Prior to our study, there were no known reports of dislodgement rates.
Therefore, we recommend that in future research, rates per 1000 catheter days should be
calculated for blockage and dislodgement, as well as CAUTI.

Although blockage decreased significantly in the first six months in the experimental group
—as compared with the control group—it is not known whether this was truly of benefit
since the control group also improved and started with more blockages. In addition, since
this effect did not last over the full 12 months, and the three nurse home visits took place in
months one and four, there might be a benefit in expanding the intervention dose over time.

One major issue remains: whether the self-management intervention contributed to more
hospitalizations, whether the experimental group was sicker and more prone to severe

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CAUTIs requiring hospitalization, or whether this group simply noticed signs of CAUTI and
acted on them more quickly. A priori, we had identified hospitalization as an indicator of
CAUTI severity. Nevertheless, we had hypothesized that the intervention participants would
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contact care providers earlier and, thus, avoid some of the hospitalizations. However, if the
experimental group were to have been more prone to serious CAUTIs—as severity scores
suggested—then seeking early care—even if it included hospitalization—might have kept
them from more serious consequences, such as long hospitalizations, sepsis, or death. There
is no way to know this.

In a recent analysis addressing reasons for rehospitalization, chronic disease and

vulnerability in patients’ conditions seem to play a big role. Also, morbidity and mortality
appeared to be inversely related, meaning sicker patients were treated more often at a
hospital and extending their lives. Thus, hospitalization is not necessarily an indicator of
poor quality in care (American Hospital Association, 2011). As with the other primary
outcomes, we found a pattern of both groups improving over time in relation to
hospitalization. That is, rates in hospitalization (times hospitalized and days hospitalized)
decreased in both groups, and there were larger decreases in the first six months of the study
(see Supplemental Digital Content).
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The experimental and control groups both appeared to have improved during the study.
Simple self-monitoring through use of the catheter calendar for bimonthly data collection by
study participants in both groups could have contributed to fewer catheter problems overall.
Essentially, it is possible that study participants in both groups became more aware of
catheter problems due to the calendar, and were reminded of their catheter through the
phone call interviews every two months. This could have contributed to changes in self-
management behaviors, such as increasing fluids for early CAUTI symptoms. Teaching
people with indwelling urinary catheters to keep track of key catheter problems (self-
monitoring) in a simple notation calendar could be easy and practical to implement in
practice. Because blockage decreased significantly in the first six months of the study, in the
intervention group, there could be added value in teaching about optimal and consistent fluid
intake.

Research implications include replication with additional nurse contacts over time,
simplifying the intervention to focus on optimal fluid intake and preventing dislodgement,
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and using a simple catheter calendar as a self-monitoring intervention. Testing in a multisite

RCT using data collection forms embedded in the home care patient records could eliminate
self-reported data for outcomes. Evidence-based policies will lag until more randomized
trials—or other forms of scientifically sound research—are conducted in this understudied
and vulnerable population that use indwelling catheters for long-term bladder management.

Limitations
Self-reported data were used because standardized health records were not available. The
catheter calendar was used to minimize self-report error. In addition, recall during the pilot
study was excellent using bimonthly telephone interviews (Wilde & Brasch, 2008a).
Agreement between self-reported catheter problems (CAUTI, blockage, dislodgement) and
chart data was high in another study (97%; Wilde, Brasch, Getliffe, Brown et al., 2010).

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Use of a medical diagnosis with antibiotic treatment for defining CAUTI could include some
inaccurate diagnoses because some providers could have treated asymptomatic bacteriuria.
Because bacteriuria is universal in this population after 30 days, colony counts would be
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useless. It was not possible to review multiple sources of data in multiple agencies to
determine symptoms which might have been used for treatment decision making. Moreover,
symptoms vary among individuals and over time. Thus, the decision for treating
symptomatic CAUTI is complex, and it requires clinical judgment of the provider.

Attrition was similar in both groups. It was addressed regularly by the team during monthly
meetings. Each of the 17 deaths that occurred during the study was evaluated. At the large
home care agency site, charts were audited to determine whether there was any person
whose death might have been related to the study. In one or two instances, details about
comorbidities were discussed with the urologist on the team. The data safety monitoring
board (DSMB) met annually with the lead investigators, statistician, urologist, and an
outside researcher to review information about each death. The DSMB conclusion was that
no deaths were related to the study, and that comorbidities contributed to each event.

Conclusions
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Adults with a variety of health conditions are challenged with managing urinary catheter
self-care to avoid complications and enhance quality of life. In a one-year RCT setting,
participants receiving a self-monitoring, self-management intervention had less catheter
blockage during the first six months. No other differences between treatment and control
groups were noted. Participants in experimental and control groups improved over 12
months, compared with baseline. The simple-to-use catheter problems calendar and
bimonthly interviews used for data collection may have served as a modest intervention in
both groups.

Supplementary Material
Refer to Web version on PubMed Central for supplementary material.

Acknowledgments
The authors acknowledge funding by National Institute of Nursing Research, National Institutes of Health (U.S.)
#R01 NR01553.
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The authors also acknowledge Penny Feldman, PhD, Sr. Vice President at the Center for Home Care Policy and
Research, Visiting Nurse Service of New York; Harriet Kitzman, RN, PhD, Senior Associate Dean for Research,
University of Rochester School of Nursing; and Robert Mayer, MD, Professor, University of Rochester/Strong
Memorial Hospital.

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FIGURE 1.
Theoretical model for self-management of urine flow intervention (Wilde, Zhang et al.,
2013). Used with permission.
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FIGURE 2.
CONSORT flow diagram
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TABLE 1

Baseline Characteristics by Group

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Intervention Control

Characteristic M (SD) M (SD)

Age (years) 60.6 (16.6) 62.2 (18.2)
Catheter (months) 73.1 (87.4) 71.9 (83.8)
Catheter size (Fr) 18.4 (3.3) 18.7 (3.2)

n (%) n (%)

Gender (male) 53 (52.4) 50 (50.0)

Catheter type
Urethral 57 (56.4) 55 (54.5)
Suprapubic 43 (42.6) 46 (45.5)
Both 1 (0.0) 0 (0.0)
Catheter balloon size
5–10 ml 64 (63.4) 60 (59.4)
30 ml 11 (10.9) 18 (17.8)
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Other 1 (1.0) 1 (1.0)

Unknown/no answer 25 (24.8) 22 (21.8)

Note. There were 101 participants in each group. None of the characteristics was significantly associated with treatment group assignment. Median
duration of catheter use in the intervention group was 42 months; control group median was 37 months. Additional detailed information about the
sample is available in Wilde, McDonald et al. (2013).
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TABLE 2

Baseline Comparison of Key Outcomes by Group (For the Two Months Prior to the Study)

Intervention Control
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Outcome M (SD) %a Rateb 95% CI M (SD) %a Rateb 95% CI p

Catheter-related health status
Urinary tract infection (yes) .42 (0.71) 33 6.9 [5.0, 9.4] .33 (0.53) 30 5.50 [3.8, 7.7] ns
Catheter blockage (yes) .56 (1.55) 21 9.3 [7.0, 12.1] .69 (1.67) 26 11.50 [9.0, 14.6] .05
Dislodgement (yes) .17 (0.68) 8 2.8 [1.6, 4.5] .26 (0.68) 17 4.33 [2.8, 6.4] ns
Healthcare related to CAUTI
Hospitalization (number) 0.11 (0.37) 9 1.8 [0.9, 3.3] 0.1 (0.32) 8 1.50 [0.69, 2.85] ns
Hospitalization (days) 0.61 (2.33) 9 10.2 [7.8, 13.1] 1.0 (4.26) 8 17.17 [14.01, 20.82] .01

Note. CAUTI = catheter-associated urinary tract infection; CI = confidence interval; ns = not significant at p < .05; SD = standard deviation.
a
Percent experiencing the event during the two months prior to the study.
b
Rate per 1000 catheter days.

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Treatment Effects for Primary Outcomes

First six monthsa Full 12 monthsb

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Outcome (SE) p 95% CI (SE) p 95% CI

Catheter-related health status
CAUTI (yes) −0.17 (0.266) ns [−0.69, 0.35] 0.16 (0.222) ns [−0.27, 0.60]

CAUTI severityc 2.76 (0.590) < .001 [1.60, 3.92] 1.60 (0.467) < .01 [0.68, 2.51]

Blockage (yes) −0.74 (0.343) < .05 [−1.42, −0.07] −0.23 (0.291) ns [−0.81, 0.34]
Dislodgment (yes) 0.29 (0.328) ns [−0.36, 0.93] 0.01 (0.287) ns [−0.55, 0.57]
Healthcare for CAUTI
Hospitalized (yes) 0.81 (0.527) ns [−0.23, 1.84] 1.33 (0.428) < .01 [0.49, 2.17]
Emergency visit (yes) 0.88 (0.373) < .05 [0.15, 1.61] 1.06 (0.337) < .001 [0.40, 1.72]
Nurse home visit (yes) −0.06 (0.402) ns [−0.85, 0.73] 0.00 (0.317) ns [−0.62, 0.62]
Clinic visit (yes) −0.37 (0.408) ns [−1.17, 0.43] −0.06 (0.333) ns [−0.71, 0.59]
Healthcare for blockage
Emergency visit (yes) −0.62 (0.978) ns [−2.53, 1.30] 1.10 (0.575) ns [−0.02, 2.23]
Nurse home visit (yes) −1.35 (0.642) < .05 [−2.61, −0.09] −1.02 (0.470) < .05 [−1.95, −0.10]
Clinic visit (yes) −0.62 (0.629) ns [−1.86, 0.61] −0.42 (0.560) ns [−1.52, 0.68]

Quality of lifed −1.66 (1.581) ns [−4.76, 1.44] −2.03 (1.389) ns [−4.75, 0.69]

Note. CAUTI = catheter-associated urinary tract infection; CI = confidence interval; ns = not significant at p < .05; SE = standard error. A positive sign for B1 favors the control (usual care group); a

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negative sign favors the intervention group. Complete statistical results are available from the authors (MHW).
a
Treatment effects were obtained controlling for baseline outcomes and time (Equation 3).
b
Treatment effects were obtained controlling for baseline outcomes, time from 2 to 12 months, and first vs. second half of the study (Equation 5).
c
Scored from 1 = very mild to 10 = most severe imaginable.
d
Scored from 1 = strongly agree to 5 = strongly disagree; higher scores reflect better self-rated quality of life.
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TABLE 4

Rates of Blockage, CAUTI, Dislodgement and Hospitalization in Treatment and Control Groups Over Time

Experimental Control Within groupsa (p)

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Outcome Rateb 95% CI Rateb 95% CI p E C

Blockage
Baseline 9.26 [6.98, 12.05] 11.50 [8.95, 14.55] ns
First 6 months 4.28 [3.32, 5.43] 7.41 [6.14, 8.86] < .01 < .0001 .004
Second 6 months 5.31 [4.15, 6.67] 4.45 [3.41, 5.71] ns < .0001 < .0001
Full 12 months 4.76 [4.00, 5.62] 6.04 [5.20, 6.99] .03 < .0001 < .0001
CAUTI
Baseline 6.93 [5.00, 9.37] 5.50 [3.79, 7.72] ns
First 6 months 4.37 [3.40, 5.53] 4.83 [3.82, 6.03] ns .02 ns
Second 6 months 5.48 [4.31, 6.87] 3.29 [2.41, 4.39] .01 ns .02
Full 12 months 4.89 [4.12, 5.75] 4.12 [3.42, 4.91] ns .05 ns
Dislodgement
Baseline 2.80 [1.63, 4.49] 4.33 [2.83, 6.35] ns
First 6 months 2.60 [1.86, 3.52] 2.74 [1.99, 3.67] ns ns ns
Second 6 months 1.45 [0.89, 2.24] 2.44 [1.69, 3.41] ns .05 .03
Full 12 months 2.06 [1.58, 2.65] 2.60 [2.06, 3.24] ns ns .02
Hospitalizations (number)
Baseline 1.82 [0.91, 3.25] 1.50 [0.69, 2.85 ns
First 6 months 1.01 [0.58, 1.65] 0.43 [0.17, 0.89] ns ns .01

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Second 6 months 1.68 [1.07, 2.52] 0.22 [0.04, 0.63] <.001 ns .004
Full 12 months 1.32 [0.94, 1.81] 0.33 [0.16, 0.61] <.001 ns .001
Hospitalization (days)
Baseline 10.23 [7.84, 13.12] 17.17 [14.01, 20.82] .01
First 6 months 7.73 [6.4, 9.23] 4.03 [3.11, 5.13] .01 ns < .0001
Second 6 months 8.26 [6.81, 9.93] 1.01 [0.55, 1.69] .001 ns < .0001
Full 12 months 7.98 [6.99, 9.06] 2.63 [2.08, 3.28] .001 ns < .0001

Note. C = control; E = experimental.

a
Change from baseline.
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Rate is per 1000 catheter days. Wilde et al. Page 23

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b
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Author Manuscript
Home Healthc Nurse. Author manuscript; available in PMC 2014 October 01.
Published in final edited form as:
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Home Healthc Nurse. 2013 October ; 31(9): 465–473. doi:10.1097/NHH.0b013e3182a89791.

Perceived Value of a Urinary Catheter Self-Management Program

in the Home
Mary Wilde, RN, PhD [School of Nursing],
University of Rochester, Rochester, New York.
Feng Zhang, RN, BS [School of Nursing],
University of Rochester, Rochester, New York.
Eileen Fairbanks, RN, MS, PNP [School of Nursing],
University of Rochester, Rochester, New York.
Shivani Shah, MPH [Visiting Nurse Service of New York],
Center for Home Care Policy and Research, New York City, New York.
Margaret V. McDonald, MSW [Visiting Nurse Service of New York,], and
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Center for Home Care Policy and Research, New York City, New York.
Judith Brasch, RN, MS [School of Nursing]
University of Rochester, Rochester, New York.

Abstract
A long-term indwelling urinary catheter intervention was tested in a randomized trial that is
described in this article. The perceived value of the intervention to the catheter users, one of the
study’s specific aims, was assessed at the end of their 12-month participation and is reported here.
Study participants’ responses, our findings, and implications for home healthcare are discussed.

Introduction and Purpose of the Study

There is limited evidence to guide long-term urinary catheter users for self-management.
They ordinarily are not in support groups of any sort and might not know others using such a
device, yet many use an indwelling urinary catheter (suprapubic or urethral) for years
(Wilde et al., 2013) or indefinitely. Those with intractable urinary retention who are unable
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to perform intermittent catheterization or have no one to do it are sometimes without other

options. This type of urinary retention is most often caused by a neurologically based injury
or disease, such as a spinal cord injury, multiple sclerosis, diabetes, or by obstructive
prostate disease (Cottenden et al., 2013). In our experience, individuals with long-term
catheters often learn about self-managing through piecemeal instruction from healthcare
providers and by trial and error.

This report describes a new intervention to teach self-management to community-living

long-term indwelling urinary catheter users and their perceived value of the intervention.

Address for correspondence: Mary Wilde, RN, PhD, Associate Professor Nursing and Center for Community Health, University of
Rochester, 601 Elmwood Ave., Box SON, Rochester, NY 14642, (mary_wilde@urmc.rochester.edu).
Study Nurses: Paula Wilson, RN, BSN, MPH (VNSNY) and Margaret Lash, RN, MS (Rochester); also at Visiting Nurse Service of
New York: Penny Feldman, PhD, Seon Lewis-Holman RN, MS-C; Yanick Martelly-Kebreau, RN, MS, CWOCN.
The authors declare no conflicts of interest.

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Understanding how the study participants responded provides information that could be
useful in dissemination and/or changes in the research.
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Background and Literature Review

Although policies and procedures are well developed for patients with indwelling urinary
catheters in home care and in clinics, an emphasis on self-management is not the norm. Self-
management is a form of collaborative care with a healthcare provider (nurse or physician)
in which the patient learns to pay attention to bodily symptoms, makes observations and
recordings (e.g., diaries), and determines how behavioral changes they are making affect the
condition. Self-management research is often conducted with people having chronic
conditions, such as arthritis (Ackerman et al., 2013), diabetes (Rothman et al., 2008), or
asthma (Kaptein et al., 2010), but self-management research has not been done in indwelling
urinary catheter users.

The National Home and Hospice Care Study conducted in 2000 by U.S. National Center for
Health Statistics estimated that there are 148,400 urinary catheter users in the United States,
for a prevalence of 0.05% in the adult population in community settings (CDC, 2013a). A
more recent National Home and Hospice Care Survey in 2007 reported catheter prevalence
in home care (excluding hospice) at 9% (n = 4683) (CDC, 2013b) or 135,000 people with
catheters of the 1.5 million home care patients in 2007 (http://www.cdc.gov/nchs/fastats/
homehealthcare.htm). However, it is not known how many of them have long-term catheters
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nor whether they use indwelling or nonindwelling catheters (Lisa Dwyer, National Center
for Health Statistics, personal communication, June 20, 2013).

Persistent catheter-related problems are common in long-term catheter users. In one recent
study of 43 people over an 8-month period, 74% experienced blockage of the catheter from
encrustations, 70% had catheter-associated urinary tract infection (CAUTI), 79% had
leakage of urine (bypassing), and 33% had accidental dislodgement (Wilde et al., 2010). In a
larger study with 202 long-term indwelling urinary catheter users, catheter problems were
recorded by recall for the previous 2-month period, and in this short period of time, 31% had
experienced CAUTI, 24% had blockage, 12% had accidental dislodgment, 43% had leakage
of urine, and 23% had catheter-associated pain (Wilde et al., 2013).

Most research in the past has focused on improving the catheter itself through: coatings,
such as silver or antibiotic (Johnson et al., 2006), catheter materials like silicone (Schumm
& Lam, 2008), instillations into the drainage bag (Washington, 2001), and special care to the
urinary meatus (Burke et al., 1983), but none have proven effective in preventing blockage
or CAUTI (Parker et al., 2009). Other interventions, commonly believed to be of value, such
as smaller catheter size, cranberry juice consumption (Jepson & Craig, 2008), and acidic
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instillations or irrigations, have not been tested in randomized controlled trials in people
with catheters (Moore et al., 2009). Closed drainage, which has been shown to significantly
reduce the rate of CAUTI, is the only critical innovation in the last 40 years to prove
beneficial (Stickler & Feneley, 2010). However, many persons with catheters open them
daily to switch from leg to night bags or to clean the bags between uses. In the
aforementioned larger study of 202 long-term catheter users, 58% used both leg and
overnight bags, and a majority cleaned their bags, using water, soap and water, or a solution
of water with bleach or vinegar (Wilde et al., 2013). Cleaning with a diluted bleach solution
was shown in a seminal study to increase bag life to 1 month; however, rates of CAUTI
remained unchanged (Dille et al., 1993). Consumption of a citrated drink (water with lemon
juice) or additional fluids was tested in one study, and results are promising that either can
decrease catheter blockage (Khan et al., 2010), but trials have not been done. Thus,
evidence-based self-management strategies for persons using indwelling urinary catheters
remain in a preliminary stage.

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A first step for catheter users to prevent or minimize catheter-related problems (e.g.,
CAUTI, blockage, or accidental dislodgement) is to become aware of what to notice and
how to self-monitor urine flow. Strategies can then be selected for self-managing the
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catheter based on this knowledge to address problems early to prevent more serious
complications, such as an insidious CAUTI requiring intravenous antibiotics and
hospitalization.

Study Description
A research study was conducted, building on the prior investigations. A new catheter self-
management educational intervention was piloted (Wilde & Brasch, 2008a, 2008b) and
tested for effectiveness in a randomized clinical trial in long-term indwelling urinary
catheter users. The 4-year study was conducted in one northeastern U.S. state, including a
large city and a mix of urban/suburban and rural areas. Two hundred and two adult persons
with long-term indwelling catheters (56% urethral and 44% suprapubic) who were expecting
to use catheters indefinitely, or at least for a year, were enrolled in the study for 12 months.
Equal numbers of 101 were assigned to the intervention group or the control group. One
hundred seventy-five study participants (87%) were recruited through home care agencies
(one large city agency enrolled 152 persons); the rest were referred through a combination
of clinics or private urological offices. Approximately equal numbers of men and women
were enrolled, aged 19 to 96 years (mean 61, SD 17.4), with racial and ethnic diversity
(White 57%, Black 30%, other races 13%).
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The self-management intervention was theoretically based on Bandura’s self-efficacy theory

(Bandura, 1997). Self-efficacy is the confidence to perform a specific behavior and, in this
study, optimal and consistent levels of fluid intake and preventing accidental dislodgment
were the key behaviors targeted. Study participants were taught to pay attention to urine
flow, self-monitor bodily changes, and choose appropriate self-management behaviors. The
theoretical concepts of awareness, self-monitoring, and self-management (Wilde & Garvin,
2007) were central to the intervention, and Stanford’s Chronic Disease Self-management
program (Lorig et al., 2001) provided the overall model (Figure 1). The intervention was
designed to enhance self-management of urine flow in the intervention group. The control
group received only their usual care.

Study outcomes were: (a) catheter-related complications (CAUTI, catheter blockage, and
accidental dislodgement), (b) complications’ associated costs, and (c) quality of life. To
measure study outcomes, data were collected from both groups about catheter-related
problems for a year, once face to face in their homes when enrolled and then in six follow-
up bimonthly telephone interviews with trained interviewers.
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The intervention group was visited by a study nurse in their home three times, for a total of
three home visits. Two of them occurred in the first month. The first home visit was to teach
about self-monitoring using a urinary diary, and the second home visit was to use this
information to plan for improved self-management and to introduce an educational booklet.
This was followed by one phone call 2 weeks later to identify any additional issues and to
reinforce the teaching. The third home visit was a “booster” of the intervention at 4 months
to further refine teaching.

Specifically, study participants were taught to increase their awareness of sensations of urine
flow and to learn how these change with daily activities or catheter-related problems.
Problem areas were identified in conjunction with information from the 3-day urinary diary
(intake and output and open-ended journal). After learning about basic catheter self-
management (Table 1 from the Paying Attention Educational Booklet), all were taught to
pay attention to fluid intake and catheter position to prevent dislodgement. Then the study

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nurse reviewed all sections of the educational booklet, focusing on areas of individual
interest (Table 2 and Figure 2). The study nurse filled out forms after each encounter, which
were similar to a care plan, to remind her of the participant’s catheter problems and interests
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or goals. Whenever possible, measurable goals were set and written into the educational
booklet.

Below is a report of one of the specific aims of this study, to describe the perceived value of
the self-management intervention received by the intervention group. A full report of the
main outcomes for this research will be published elsewhere.

Perceived Value of the Catheter Self-Management Program

Methods
Study participants who received the catheter self-management intervention were contacted
by phone by one of the two study coordinators within a month of their year-long study
participation to assess their perceived value of the intervention. Not everyone was able to be
reached or was not able to be interviewed; therefore, out of the 74 persons who completed
the intervention arm of the study, 60 brief telephone interviews were conducted. Study
participants were asked several quantitative questions about helpfulness of each component
of the intervention, using a modification of items previously piloted (Wilde & Brasch,
2008a, 2008b), on a scale of 1 to 10, with 1 being not helpful at all and 10 being very
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helpful. Study participants were also asked five open-ended questions, allowing for
comments to be shared, related: (a) goals, (b) changes to behavior, (c) impact on self-
management, (d) helpfulness of the program, and (e) suggestions for improving the program.
The interviewers took brief notes to obtain the comments data, which were entered into a
spreadsheet and SPSS.

Data Analysis
Quantitative items were analyzed descriptively for means and standard deviations. For the
comments data, a descriptive analysis was conducted using simple coding by two
researchers, the principal investigator and a doctoral student. Coded comments were then
organized into tables before writing a descriptive summary of responses for each item. Both
coders agreed on the final codes, the organization of data, and the summary.

Results
Based on the scores, the study nurse visits and the intake and output part of the urinary diary
were the most favored elements of the intervention (Table 3). A large majority of the
persons rated each component of the intervention (i.e., intake and output, journal,
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educational booklet, study nurse encounters, and learning self-management) between 8 and
10 on the 10-point scale. The means (SD) for each component ranged from 7.25 (2.40) to
8.33 (3.15). The open-ended journal, which was identified in the study nurses’ process
recordings (not reported in this article) as being used by only 2% of the intervention sample,
was valued less with the lowest mean score 7.25 (3.15).

Out of the 60 persons interviewed, goals were recalled by 21 persons (35%), not set by 36
(60%), and 3 (5%) did not remember. Responses to whether they were doing anything
differently with the catheter because of the study were: 25 (42%) said no, 18 (30%) said yes
somewhat, and 17 (28%) said yes greatly. 43 (71%) had suggestions for improving the
program and 17 (29%) did not.

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Goals Set During the Study

Fifteen persons had goals related to hygiene or preventing urinary tract infections (UTI),
specifically cleaning near the catheter, drinking adequate fluids, and preventing UTI. Self-
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monitoring goals by 14 persons involved noticing changes in the urine, such as watching for
sediment or urine color, or in paying attention to the catheter to maintain an appropriate
position, or prevent dislodgment, kinks/twists, or leaks. Two persons also stated they wanted
to stay healthy urologically.

Changes to Behavior
Study participants who had said they were doing things differently because of the study
were asked to describe in what ways. Some reported changes that were similar to the goals
they cited. Self-monitoring of the catheter was identified by nine persons related to
repositioning the catheter to prevent leakage and twists, or checking the catheter position in
relation to the bag or body; or watching for changes in the urine, sediment, or color. Eight
said they paid attention more often to urine output or to avoid letting the bag get too full.
Nine said they have increased their fluid intake and two said they keep better track of fluids.
Eleven were focused more on the catheter itself, such as knowing the exact amount of water
in the balloon, about irrigation or cleaning the bag, changing the catheter more often, and in
managing the catheter when traveling by using a larger bag at home and smaller one for
travelling, or knowing the locations of available bathrooms. Two stated they knew better
when to call the provider for catheter problems. One worked on bowel management more
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and one stays away from caffeine. One reported fewer UTIs.

Impact on Self-Management
Participants also were asked how the study affected their catheter self-management. Six said
they were more aware in relation to: cleaning the catheter, noticing urine color, emptying the
bag to prevent urine buildup, and knowing where bathrooms were. Six reported having
fewer UTIs, and two had less sediment, blockage, or mucus. One individual had more
catheter comfort and was pain-free. Five people spoke of being more knowledgeable about
and supported with the catheter, or knew when to call the provider. A few recognized
patterns of problems, such as burning sensations and kinks. One noted being hospitalized
four times recently (but we are not sure what that meant).

Helpfulness of the Program

The comments related to whether learning self-management was helpful or not were aimed
at understanding more about the value of the catheter self-management intervention.
Comments from 17 individuals were primarily about catheter-related knowledge gained,
skills acquisition (including enhanced awareness of their bodily symptoms related to the
NIH-PA Author Manuscript

catheter), and feeling cared for by the study nurse making home visits. There were just four
negative comments: three who did not learn anything new and one who did not think
program helped. Also three persons said they do not self-mange, but one said it was helpful
to know.

Suggestions for Improving the Self-Management Program

Many suggestions and comments were received also, including more use of Web sites,
combining the urinary diary forms (i.e., intake and output forms with the journal), managing
pain, and sketches of instructions. Several asked for better designed catheters and
equipment.

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Discussion
For the quantitative assessment of intervention components, there was a possible small
ceiling effect with higher percentages reporting 10 (very helpful) for the study nurse
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encounters and intake and output, by 41% and 32% of the sample respectively. The open-
ended journal was not used by most study participants (2%) and this was the case also
during the pilot study (Wilde & Brasch, 2008a, 2008b), and thus it should probably be
eliminated from future tests of this intervention.

The information solicited about goals at the end of this 12-month intervention with 60
individuals is in stark contrast to the information collected by the study nurses in their
process forms in which 82 persons set initial goals (81% of 101 in the self-management
intervention group), and over 70% said they met their goals during the phone call in month 2
or the home visit in month 4. Perhaps goal setting was not a high priority or there was
insufficient recall at 12 months, when so much time had passed after the intervention visits.
However, those persons who did set goals used language to reflect the key components
taught in the intervention, such as goals about fluid intake, preventing UTI, and noticing
changes in urine or in the position of the catheter.

Intervention participants showed that they understood key study concepts because they
described activities that demonstrated awareness, self-monitoring, and self-management
related to fluid intake, preventing CAUTI, and proper positioning of the catheter. Some
NIH-PA Author Manuscript

seemed to have an emotional connection with the study nurse, saying they felt “cared for”
by her. A few said that no one else has talked with them like this about the catheter and in
such depth, and this made them feel valued as persons. Responses also illustrated individual
variation in how much the self-management intervention was liked and for what reasons.

Implications for Practice

Long-term indwelling catheter users can be taught to pay attention to urine flow.
Specifically they should know how much fluid intake is right for them and what types of
fluids should be monitored (e.g., caffeine). By noticing catheter-related changes—such as
the color or character of the urine, catheter position, or kinks/twists in the tubing—and by
responding quickly, catheter-related problems might be avoided or minimized. In this study,
catheter users’ comments indicated how they valued and learned from the self-management
intervention. Home care nurses are in an important and unique position to partner with their
patients with catheters and their families to improve care and quality of life.

Conclusion
This may be the first self-management intervention in long-term indwelling urinary catheter
NIH-PA Author Manuscript

users. Knowing how the study participants responded to the intervention is critical in
determining its dissemination and overall research value. In summary, research participants
seemed to like the intervention, were able to identify what they should pay attention to, and
told us what they were doing differently related to their catheter. These new behaviors
should be beneficial in their catheter-related health. Although this intervention is not ready
yet for full dissemination—due to ongoing analysis and writing reports of the main study
results—many of the components, such as the urinary diary (I and O), the basic self-
management tips in Table 1, and the sample educational page on identifying UTI, could be
useful for home care nurses teaching catheter self-management to long-term indwelling
urinary catheter users.

Acknowledgments
Funding by National Institute of Nursing Research, National Institutes of Health (U.S.) #R01 NR01553.

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Figure 1.
Theoretical Model of the Study. UTI = urinary tract infection.
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Figure 2.
Sample of educational module (Note: the quotes are from previous study participants (Wilde
& Brasch, 2008a, 2008b).1 UTI = urinary tract infection.

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Table 1
Basic Catheter Self-Management
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• Stay aware. Having a catheter requires that you stay aware of your body and how you feel.

• Drink more water than any other beverage! Limit coffee, and consider substituting tea and decaffeinated beverages.
• Drink consistently. Fluid intake needs to be at a good level for your weight and you need to drink in a consistent way to help
prevent catheter blockage.
• Your body needs fluids. Most people need 2,000 to 3,000 cc of fluid a day. For instance, a 150-lb person would need 2,550 cc that
is equivalent to about 10.5 glasses per day. More fluids are needed for hot weather or when exercising. My fluid goal is ______.
• Pay attention to the color of your urine. It should be light yellow all day long. The color of urine can be used a quick way to know
whether you are drinking enough during the day.
• Notice changes. If the urine color changes, notice if you are doing something different, such as drinking less water or more
caffeinated beverages or are using a diuretic medicine or water pill, such as furosemide or chlorothiazide.
• Notice catheter position. Notice where the catheter is after each change in your position and reposition it if needed. If you have
others who help you, teach them to do this.
• Check for kinks and twists in the catheter by feeling with your hand from where the catheter leaves your body all the way to the
drainage bag.
• Ask for help. If you need assistance with the catheter, learn to ask for help.
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Table 2
Quick Guide to Catheter Problems (from the Paying Attention Educational Booklet)
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Problem Action Strategies

Decreased/inconsistent fluid intake Increase fluid intake
Urinary tract infection Increase fluid intake
Recognize early symptoms of urinary tract infection and act on it
Catheter blocks Increase fluid intake
Promote catheter changes at best intervals
Adjustment to living with a catheter Approaches for living with a catheter
Not sure of the best schedule for catheter changes Promote catheter changes at best intervals
Kinks, twists, or tugs on catheter Prevent kinks, twists, or tugs on catheter
Too much caffeine Decrease caffeine
Catheter leaks Decrease catheter leakage
Empty urine bag
Urine bag odor Clean urine drainage bag
Changes with sex Make adjustments for sexual activity
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Table 3
Helpfulness of the Self-Management Program Components

On a scale of 1–10, With 1 Being Almost No n M SDs 1–4 5–7 8–10

Help, and 10 Meaning It Was a Very Big
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Help
1. Intake and output 56 8.04 2.40 11% 12% 77%
2. Catheter journal 56 7.25 3.15 20% 14% 66%
3. Educational booklet 57 7.72 2.79 12% 19% 68%
4. Study nurse’s home visits and TC 58 8.33 2.53 10% 12% 78%
5. How helpful was learning self-management 60 8.18 2.65 10% 18% 63%

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A Web-Based Self-Management Intervention for Intermittent Catheter Users

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A Web-Based Self-Management Intervention for Intermittent Catheter Users

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A Web-Based Self-Management Intervention for Intermittent Catheter Users

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A Web-Based Self-Management Intervention for Intermittent Catheter Users

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A Web-Based Self-Management Intervention for Intermittent Catheter Users

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A Web-Based Self-Management Intervention for Intermittent Catheter Users

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A Web-Based Self-Management Intervention for Intermittent Catheter Users

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Cystometry in children
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Cystometry in children
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Cystometry in children
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Cystometry in children
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Cystometry in children
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Cystometry in children
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Received: 26 February 2018

DOI: 10.1002/nau.23729
| Accepted: 16 May 2018

REVIEW ARTICLE

ICS educational module: Cystometry in children

Jian G. Wen1,2 | Jens Christian Djurhuus MD3 | Peter F.W.M. Rosier4 |

5
Stuart B. Bauer

1 Pediatric Urodynamic Centre, the First

Affiliated Hospital of Zhengzhou Aims: To introduce the standard procedure of cystometry and interpretation of the
University, Zhengzhou, China results in children.
2 Department of Pediatric Surgery, the First
Methods: The literature on cystometry in children in PubMed for the last 20 years
Affiliated Hospital of Xinxiang Medical
University, Weihui, China
was reviewed. The updated knowledge regarding indication, preparation, technique,
3 Department of Clinical Medicine, Aarhus and interpretation of cystometry in children were summarized.
University, Aarhus N, Denmark Results: Filling cystometry is the core content of a paediatric urodynamic study. In
4 Departmentof Urology, University this section, the technique for performing cystometry is introduced in details.
Medical Centre Utrecht, Utrecht, The
Emphasis is placed on correctly setting up the equipment according to ICS and ICCS
Netherlands
5 Department of Urology, Boston Children's
guidelines, using appropriate terminology, providing indications for its performance
Hospital, Boston, Massachusetts with specific considerations for children, and proper interpretation of results.
Conclusions: Cystometry can be used in children including newborn to evaluate
Correspondence
Jian G. Wen, Pediatric Urodynamic Centre, lower urinary tract dysfunction.
the First Affiliated Hospital of Zhengzhou
University, Jianshe East Road No.1, KEYWORDS
Zhengzhou, 450052, China. children, cystometry, procedure, urodynamics
Email: wenjg@hotmail.com

1 | INTRODUCTION Filling cystometry is the core content of a paediatric

urodynamic study. In this section, the technique for perform-
The International Continence Society (ICS) and International ing cystometry will be discussed in detail. Emphasis will be
Children Continence Society (ICCS) define filling cystom- placed on correctly setting up the equipment according to ICS
etry as the urodynamic procedure by which the pressure- and ICCS guidelines,2–4 using appropriate terminology,
volume relationship of the bladder is measured. Filling providing indications for its performance with specific
cystometry is done to provide information on storage function considerations for children, and proper interpretation of
(detrusor activity, sensation, compliance, and cystometric results.5 Other elements of a urodynamic investigation, for
capacity). Filling cystometry in children is usually performed example, pressure flow study or video-urodynamic study will
in combination with perineal EMG skin electrodes to add be covered in specific educational modules.
information regarding pelvic floor striated muscle activity.1–4
On rare occasions needle electrodes are inserted into the
pelvic floor musculature to precisely define denervation in 2 | INDICATIONS AND
patients with neurogenic bladder dysfunction. PREPARATION
The ICS educational module consists of an oral
presentation in combination with this manuscript, the latter Filling cystometry is indicated when history and clinical
serving as a scientific background review; the evidence examination raises a suspicion of either anatomic and/or
gathered for the ICS PowerPoint presentation is available via neurologic lower urinary tract dysfunction involving primar-
http://www.icsoffice.org. The presentation explains when ily the storage phase, or there is a question that cannot be
and how to do a filling cystometry and how to analyze the answered by less invasive testing. Additionally, filling
results in children. cystometry is relevant when anatomical or functional bladder
2306 | © 2018 Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/nau Neurourology and Urodynamics. 2018;37:2306–2310.

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outflow obstruction (voiding phase) (eg, valve bladder Inserting the catheter and placement of surface EMG
syndrome, detrusor-sphincter dyssynergia associated with electrodes
neuropathic bladder), or congenital anomalies of the bladder
(exstrophy, ureteroceles, multiple bladder diverticula) may be (1) A transurethral catheter is used to measure the pressure
causing symptoms and signs of dysfunction that may need within the bladder. A 6 Fr double-lumen catheter that
further delineation.6 When a urodynamic investigation is allows both filling and recording of pressure is
ordered the patient and/or his/her parents should fully recommended. The catheter is inserted after applying
understand the reason(s) for the test. It is assumed results lubricating gel. No evidence exists regarding how well
of the investigation will define pathophysiology and influence this gel acts as an anesthetic in children. In some
treatment strategies. When constipation exists, it should be facilities, a suprapubic double lumen catheter is inserted
managed according to set guidelines before cystometry is following administration of a short anesthetic the day
undertaken. Having an empty rectum before the urodynamic before the test.
study is advantageous as this allows for accurate monitoring (2) The transurethral urodynamic catheter can be used to
of abdominal pressure and hence detrusor pressure. empty the bladder before starting the cystometry; if a
Apart from a comprehensive history and complete relatively large volume is measured ultrasonographi-
physical examination, a voiding (or catheterization) diary, cally or expected, it may be helpful to empty the residual
uroflowmetry, and post-void residual volume, as measured by by aspirating the bladder via the urodynamic catheter.
ultrasonography, are to be conducted before ordering this (3) A completely fluid filled open 8-Fr. feeding tube or a
invasive urodynamic study. In children, more than one small air-free fluid filled balloon catheter is inserted into
uroflowmetry is strongly suggested to establish with certainty the rectum to record abdominal pressure.
the necessity of an invasive study.1,2 The child is advised to (4) Both transurethral and rectal catheters should be secured
arrive at the urodynamics suite with a full bladder if possible with tape adjacent to their respective skin openings.
and the examination starts with a free uroflowmetry. This is After insertion, the catheters are attached, via connecting
best accomplished by adequate but not excessive hydration tubes, to the external pressure transducers and leveled to
beforehand and/or appropriate timing of a previous void so the height of the pubic symphysis.
the bladder is relatively full at the time the child arrives at the (5) After cleaning the skin two surface EMG electrodes are
urodynamics facility. positioned symmetrically, left, and right from the
The (parents and) child should be instructed that all external anal sphincter, to record reactivity of pelvic
lower urinary tract modulating medications be taken either floor muscles. No specific evidence regarding skin
at a set time before the study or stopped at a sufficient preparation to reduce impedance or electrode placement
interval to minimize their effect. Depending on the reason is available.2 A third reference electrode should be
for the study, it should be however decided individually placed at an electrically neutral position; preferably over
whether to continue or to stop medication (eg, in follow up a bony prominence and not an abdominal or leg muscle.
evaluation). For children who are anxious or fearful beyond Position and zeroing the pressure
consolation, administration of a sedative (not anesthetics) (6) Filling cystometry is preferably best performed in a
may be considered but its timing and dose should be seated position; however, lying supine or an infant held
documented. in mother's arm is also acceptable.
(7) Before filling the bladder, the bladder pressure channel
must be zeroed to atmospheric pressure with the
3 | TECHNIQUE transducer situated at the level of the symphysis pubis,
irrespective of the position of the child.
Current guidelines recommend multichannel fluid filled (8) Testing the catheter and sensor: Initial resting pressure
pressure recordings for filling cystometry as the standard in should roughly represent the weight of the abdominal
children. This educational module combines ICCS and ICS contents (below the diaphragm, in centimeter “water”-
standards, into practical protocol elements to perform column) above the pelvic floor, for example, 15-25 cm
cystometry. H2O. The fluid filled transurethral catheter requires
As the documents related to the tip-transducer or air- some fluid in the bladder to allow for a degree of
charged catheter used in pediatric urodynamic studies are “unfolding” in order to obtain an accurate initial resting
limited and the pressures measured using air-charged pressure. Furthermore, when using gel to insert the
catheters, microtip catheters are not readily comparable catheter, it should be flushed away from the pressure
with fluid-filled systems, also in pediatric urodynamic measuring side holes. When the child is upright the
studies fluid—filled systems are considered the ICS initial substracted detrusor pressure should be close to
standard. zero. To further test catheter and sensor function in

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infants the lower abdomen is gently pressed (Credéd) is relaxed enough so that a more accurate tracing of the
whereas older children are encouraged to cough. The filling phase is obtained.
abdominal pressure rise should have a response peak End of test
similar to bladder pressure so detrusor pressure remains (16) When the filling cystometry (and pressure flow study) is
about zero. conclusive, all catheters and the EMG electrodes are
(9) Even though children usually move and/or talk during removed.
the investigation, causing pressure variations that may (17) Children are instructed to carry out their normal
serve as a quality control measure during the test, activities but advised to drink an additional water after
regular cough “tests,” or Credé maneuvers in infants, the test to “void away” any urethral irritation as well as
should be promoted throughout filling to continuously to reduce chances of developing a urinary tract infection.
check the catheters’ ability to accurately record (18) A clinical evaluation report is completed immediately
pressures. after the test to be optimally able to integrate
(10) In children old enough (and neurologically able) to urodynamic observations and features with clinical
respond: the sensation of filling should be ascertained observations during the measurement, while still fresh in
according to the ICS standard sequence, as defined by: the mind of the observer.
“first sensation of filling” and subsequently and
respectively, “normal desire” and “strong desire to Notes:
void.” These landmarks should be indicated on the
urodynamic tracing. 1. For EMG kinesiologic recording, surface electrodes are
Filling cystometry widely used in children to study pelvic floor activity.
(11) Based on bladder diary notations or estimating Electrophysiologic standards require that the skin should
capacity based on age (age [yrs] + 1 × 30 = capacity be degreased and desquamated tissue removed before
[mL]) bladder filling should occur at a rate approxi- applying a conductive gel and the electrodes. Hooked
mating 5-10% of estimated capacity per minute, using needle electrodes can be used for kinesiologic EMG
saline, as recommended by the ICCS. Apart from the recording when it is important to determine denervation in
bladder diary, age related and expected capacities neurologically compromised individuals; however, the
should be kept in mind.7,8 invasiveness of obtaining this measurement should be
(12) During filling, intravesical and abdominal pressures weighed against the expected gain from the information.
are recorded and subtracted simultaneously to Concentric needle electrodes are useful for motor unit
obtain true detrusor pressure. During the recording, potential analysis during urodynamic testing when it is
the flowmeter is kept in position so leakage or necessary to know if new onset or progressive sacral spinal
incontinence will be shown in the uroflow tracing cord denervation is present.
curve. 2. For retrograde filling, 0.9% saline is recommended. In
(13) When voiding or leakage occurs, or a strong desire to young children, temperature of the filling solution as well
void is expressed (movement in newborns or infants or as the medium itself may influence bladder capacity and
curling of toes in older children) these observations detrusor activity. It has been established that filling rate
may be interpreted as a sign of a full bladder. The and fluid medium have an impact on bladder function.9 It is
filling is stopped and this event marked as the end of important to use an appropriate rate of filling (5-10% of
filling. It also represents the end of the filling estimated bladder capacity per minute) in infants.1,5
cystometry. Storage function is evaluated until this 3. A double lumen catheter has the advantage that it can stay
point. in place (especially during voiding if adequately secured)
(14) Subsequently, as an older child is encouraged to urinate, for a second filling cystometry, if deemed necessary.
voiding pressures, and uroflow measurements are 4. It is unnecessary to routinely use a warmed infusion
recorded simultaneously, thus obtaining a pressure solution for urodynamic studies in children; however, for
flow study. The pressure flow study will not be discussed those younger than 2 years, a warmed solution (37°C) is
further here. recommended.10
(15) Directly after voiding an evaluation of the technical 5. The best position for the child during standard cystometry
quality as well as the clinical representativeness of the is in a sitting position, watching a video or DVD
study should be undertaken to determine whether a surrounded by one or both parents, so as to minimize
second filling cystometry (and pressure flow study) is anxiety. Young children (infants) may be held in their
necessary. Depending on the specific question being mother's (or caregiver's) arms to achieve a meaningful
asked or the local protocol, performing a second filling evaluation. It has not been proven in children that patient
cystometry may be initiated. Often at this time the child position during the procedure has a significant and

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clinically relevant effect on cystometry. However, this has 4. Incontinence is defined when any loss of fluid during the
been proven in adults, patient position during the filling phase is detected. In children unable to void
procedure plays a significant and clinically relevant role.11 willingly, fluid loss occurring before the expected bladder
6. The study should not be performed under general capacity is also called incontinence (as opposed to
anesthesia; intranasal midazolam may be administered in physiologic—normal but uninhibited- voiding when it
certain situations, as it does not appear to have a significant occurs at “normal for age” capacity).
effect on outcome.12 5. Leak point pressure (LPP) indicates the pressure at which
leakage occurs. Detrusor leak point pressure (DLPP)
indicates the lowest value of detrusor pressure at which
4 | INTERPRETATION leakage is observed in the absence of increased abdominal
pressure or a detrusor contraction. Abdominal leak point
Parameters during the Filling Phase pressure (ALPP) refers to measures of the lowest value of
intentionally increased intravesical pressure that provokes
1. The filling detrusor pressure (Pdet.fill) means the detrusor urinary leakage in the absence of a detrusor contraction.
pressure during filling. The maximum detrusor filling High DLPP (eg, >40 cm H2O) is usually induced by a
pressure (Pdet.fill.max) may be reported in the analysis. decrease in bladder compliance and/or detrusor underac-
Detrusor compliance is calculated on the basis of the tivity, is associated with upper urinary tract deteriora-
difference between the initial resting pressure and the tion.1,5 Low DLPP indicated urethral incompetence.1,5
detrusor pressure at cystometric capacity. Any phasic Techniques and evaluation are not further standardized in
pressure increments, interpreted to be caused by detrusor this document describing filling cystometry.
overactivity, should be omitted in the evaluation of the 6. Bladder filling sensation should be reported, on the basis of
detrusor compliance calculation. It may be advantageous observations during the test or, when applicable, on the
to stop the infusion when reduced compliance is observed basis of the child's report. ICCS standard terms in this
to allow the pressure to “equilibrate” for a minute or two in regard apply also for children.1,2,6
order to uncover artificially reduced compliance, which is
sometimes observed as a consequence of too rapid filling
rate.
5 | RECOMMENDATIONS
2. Phasic detrusor pressure increments of any amplitude,
during the filling cystometry (until end of filling and
Based on standards and clinical practice guidelines, the
permission to void is given) are defined as detrusor
results of complete patient history, comprehensive clinical
overactivity. Detrusor overactivity may arise spontaneous
examination, bladder diary, uroflowmetry, and PVR should
or be provoked by a cough or Credé. When history and/or
be available before considering a filling cystometry (and/or
clinical examination have confirmed a relevant neurologic
other invasive urodynamic tests).
abnormality the term neurogenic detrusor overactivity is
Filling cystometry is preferably done with a 5-6 Fr double
used.1–4,13 Otherwise, idiopathic detrusor overactivity is
lumen catheter and at a filling rate of ±10% per minute of a diary
the preferred term.
determined maximum or age—expected bladder capacity.
3. Detrusor compliance (compliance = ΔV/ΔP) is an impor-
Filling cystometry should be performed in the sitting
tant parameter to note during cystometry. It represents
position. When relevant medication or sedation is used it
detrusor elasticity or volume adaption. A value of
should be accounted for while evaluating the filling
<10 mL/cm H2O indicates low bladder compliance.
cystometry and be included in the report. In addition, it is
Assessing the entire pressure curve during filling in this
important to note the time of last administration of medication
regard may determine when it is best to measure. The ΔP
in relation to the start of the cystometrogram, in order to
represents the detrusor pressure difference until just before
determine the influence of any bladder modulating medica-
voiding (or pressure at the end of filling); consequently,
tion. Immediate evaluation of the test (before removing the
compliance will represent the overall bladder compliance,
catheters) should be done to determine technical quality and
from start to a completely full bladder. It has been
clinical relevance, as well as the ability to answer the clinical
suggested that quartiles of compliance measurements
question that prompted the investigation, initially.
during filling be considered. The filled volume does not
take into account the amount of actual diuresis occurring
during the test. To integrate this volume the cystometric 6 | CONCLUSION
capacity and filling phase compliance should be calculated
using voiding volume plus PVR measured immediately To understand the characteristics as well as following good
after voiding or emptying. urodynamic practice (GUP), recommendations from the ICS

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and ICCS are the basis of successful testing. This educational the International Children's Continence Society. Neurourol Urodyn.
module provides recommendations for good clinical practice 2016;35:471–481.
to completing filling cystometry in children using these 6. Austin PF, Bauer SB, Bower W, et al. The standardization of
terminology of lower urinary tract function in children and
standards. This narrative manuscript is based on expert
adolescents: update report from the Standardization Committee
consensus about the information contained in the existing
of the International Children's Continence Society. J Urol. 2014;
literature. We hope that this teaching module will also serves 191:1863–1865.
as a challenge to improving (evidence-based) practice. 7. Wen JG, Yeung CK, Chu WC, et al. Video cystometry in young
infants with renal dilation or a history of urinary tract infection.
Urol Res. 2001;29:249–255.
ORCID 8. Holmdahl G, Hanson E, Hanson M, et al. Four-hour voiding
Jian G. Wen http://orcid.org/0000-0003-0952-118X observation in healthy infants. J Urol. 1996;156:1809–1812.
9. Sorensen SS, Nielsen JB, Norgaard JP, et al. Changes in bladder
Peter F.W.M. Rosier http://orcid.org/0000-0003-0445-
volumes with repetition of water cystometry. Urol Res. 1984;12:
4563 205–208.
10. Chin-Peuckert L, Rennick JE, Jednak R, et al. Should warm
infusion solution be used for urodynamic studies in children? A
prospective randomized study. J Urol. 2004;172:1657–1661.
REFERENCES
11. Al-Hayek S, Belal M, Abrams P. Does the patient's position
1. Wen JG, Lu YT, Cui LG, et al. Bladder function development and influence the detection of detrusor overactivity? Neurourol Urodyn.
its urodynamic evaluation in neonates and infants less than 2 years 2008;27:279–286. Review. PubMed PMID: 17724734.
old. Neurourol Urodyn. 2015;34:554–560. 12. Bozkurt P, Kilic N, Kaya G, et al. The effects of intranasal
2. Abrams P, Cardozo L, Fall M, et al. The standardisation of midazolam on urodynamic studies in children. Br J Urol. 1996;78:
terminology in lower urinary tract function: report from the 282–286.
standardisation sub-committee of the International Continence 13. Abrams P. Describing bladder storage function: overactive
Society. Urology. 2003;61:37–49. bladder syndrome and detrusor overactivity. Urol. 2003;62:
3. Gammie A, Clarkson B, Constantinou C, et al. International 28–37.
Continence Society guidelines on urodynamic equipment perfor-
mance. Neurourol Urodyn. 2014;33:370–379.
4. Rosier P, Schaefer W, Lose G, et al. International continence How to cite this article: Wen JG, Djurhuus JC,
society good urodynamic practices and terms 2016: urodynamics, Rosier PF, Bauer SB. ICS educational module:
uroflowmetry, cystometry, and pressure-flow study. Neurourol
Cystometry in children. Neurourology and
Urodyn. 2017;36:1243–1260.
5. Austin PF, Bauer SB, Bower W, et al. The standardization of
Urodynamics. 2018;37:2306–2310.
terminology of lower urinary tract function in children and https://doi.org/10.1002/nau.23729
adolescents: update report from the standardization committee of

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Received: 26 February 2018

DOI: 10.1002/nau.23730
| Accepted: 14 May 2018

REVIEW ARTICLE

ICS educational module: Pressure flow study in children

Jian G. Wen1,2 | Jens C. Djurhuus MD3 | Peter F.W.M. Rosier4 |

5
Stuart B. Bauer

1 Pediatric Urodynamic Centre, The First

Affiliated Hospital of Zhengzhou Aims: To introduce the standard procedure and results interpretation of pressure/flow
University, Zhengzhou, China study (PFS) in children.
2 Department of Pediatric Surgery, The First
Methods: The literature on PFS in children in PubMed for the last 20 years was
Affiliated Hospital of Xinxiang Medical
University, Weihui, China
reviewed. The updated knowledge on PFS in children in children regarding
3 Department of Clinical Medicine, Aarhus indication, preparation, technique, and interpretation were summarized.
University, Aarhus N, Denmark Results: This educational module explains when and how to do a PFS and how to
4 Departmentof Urology, University analyze the results. All requirements and instructions for the PFS in children
Medical Centre Utrecht, Utrecht, The
described in this document follow ICS reports on Good Urodynamic Practice and
Netherlands
5 Department of Urology, Boston Children's
urodynamic equipment performance as well as guidelines from the ICCS. PFS can be
Hospital, Boston, Massachusetts obtained subsequent to filling cystometry with no specific additional equipment
(apart from a flowmeter) or patient preparation needed. It requires both vesical and
Correspondence
Jian G. Wen, Pediatric Urodynamic Centre, intra-abdominal pressures being recorded. Information from clinical history, physical
the First Affiliated Hospital of Zhengzhou examination, voiding diaries, and free uroflowmetry with or without perineal patch
University, Jianshe East Road No. 1,
EMG and pertinent imaging results should be available before undertaking
Zhengzhou, 450052, China.
Email: wenjg@hotmail.com urodynamic testing.
Conclusions: Following ICS and ICCS guidelines, PFS is an easy procedure and a
useful tool to provide information on voiding function in children.

KEYWORDS
children, pressure/flow study, procedure, urodynamics

1 | INTRODUCTION baseline, so that changes resulting from treatment and/or

growth can be assessed, indicating that the investigation may
Pressure/flow study (PFS) provides information on voiding need to be repeated, and to provide some guidelines for the
function (outflow obstruction, flow pattern, detrusor contrac- choice of treatment (although results of urodynamic testing
tility, and its sustainability as well as intravesical pressure). may not necessarily be the deciding factor).
Combined with filling cystometry, it is the gold standard for The ICS Urodynamics Committee presents this educa-
evaluating voiding function in children with lower urinary tional module “Pressure/flow analysis in children” to serve as
tract dysfunction (LUTD)/lower urinary tract symptoms a standard education module of Good Urodynamic Practice
(LUTS), especially when less invasive studies fail to provide for everyone concerned when prescribing, performing, and
an adequate explanation for the symptoms and/or the signs of analyzing pressure/flow testing in general and especially in
dysfunction.1–7 children with symptoms and signs of LUTD. The educational
The aim of pressure/flow studies is to reproduce module consists of a presentation, in combination with this
symptoms, to identify the underlying causes for voiding manuscript. This manuscript serves as a scientific background
symptoms, and to quantify related pathophysiological review; the evidence base, for the ICS PowerPoint presenta-
processes. It is used to establish as clearly as possible a tion; available via http://www.icsoffice.org/. The presentation
Neurourology and Urodynamics. 2018;37:2311–2314. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | 2311

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explains when and how to do a PFS and how to analyze the voiding. The pressures are recorded through the same catheter
results. The presentation and this manuscript use expert's that is used for cystometry. During the recording, a flowmeter
opinion where evidence is, especially for the clinical practice connected to the urodynamic equipment, allows flowrate
aspects, unavailable and is marked with: “eo” (expert's parameters to be juxtaposed against pressure data and
opinion). correlated with one another. At the completion of voiding
Voiding dysfunction is prevalent in pediatric urology the detrusor relaxes and the urethra/bladder outlet “closes.”
practice. The subjective bias by both the child and the During voiding the detrusor may be classified as normal,
clinician and the considerable overlap between symptoms underactive, or acontractile. Normal voiding is achieved by a
from varying disorders make it difficult to evaluate voiding voluntarily initiated detrusor contraction; it is sustained and
function without employing some objective parameters. cannot be suppressed easily once it has begun. In the absence
All requirements and instructions for the PFS in children of bladder outlet obstruction, a normal contraction will
described in this section follow ICS reports on Good lead to complete emptying.6 When the child feels voiding
Urodynamic Practice2,3 and urodynamic equipment perfor- is complete, this phase ends and storage phase begins
mance4 as well as guidelines from the ICCS.5 Pressure/flow again. During the voiding phase, a flowmeter connected to
measurements can be obtained subsequent to filling cystom- the urodynamic equipment, allows flowrate parameters to be
etry with no specific additional equipment (apart from a juxtaposed against pressure data and correlated with one
flowmeter) or patient preparation needed. It requires both another.
vesical and intra-abdominal pressures being recorded. During PFS Qmax and voided volume are recorded.
Information from clinical history, physical examination, Pressure parameters that can be obtained during the voiding
voiding diaries, and free uroflowmetry with or without phase are: pre-micturition pressure, opening pressure,
perineal patch EMG and pertinent imaging results should be opening time, maximum detrusor pressure, detrusor pressure
available before undertaking urodynamic testing. at maximum flow, closing pressure, minimum voiding
pressure. The maximum detrusor pressure (Pdet.max) is
clinically relevant in determining the presence of bladder
2 | INDICATIONS AND
outlet obstruction (BOO) or contractile detrusor.
PREPARATION
After the PFS, the PVR is measured again through the
catheter and confirmed by ultrasound.
The indications and preparation for PFS are similar to that for
cystometry. Whether the child is able to void voluntarily or
not, evaluation of the voiding, measured in a continuous 3.1 | Cooperation
fashion after the filling cystometry is complete, can be
Cooperation is important for successful cystometry and PFS.
regarded as standard practice. The child and caregiver should
The following steps might be valuable for achieving this.
be informed in advance along with an explanation as to why
both phases, storage (filling), and voiding are going to be
� Bowel or rectum preparation; defecation (at home) before
measured. The child's cooperation is explicitly sought
the test whenever possible.
whenever possible.
� Dedicated and knowledgeable staff able to provide an
explanation about the procedure and the aim of urodynamic
3 | TECHNIQUE studies to the patient is paramount: if applicable, engage the
child to increase cooperation.
PFS is defined as measuring the detrusor pressure and uroflow � Administration of sedatives (not anesthetics), and doc-
during the micturition or voiding phase. The detrusor pressure umenting if the child was very fearful is mandatory.
is equal to the bladder pressure minus the abdominal pressure, � Prior application of 1% lidocaine jelly or a liquid solution
thus representing the pressure produced by the detrusor. The instilled into the urethra as a topical anesthetic may aid in
voiding phase begins when the child and the urodynamicist catheter insertion.
decide that “permission to void” has been given, or when � The approach to urodynamic evaluation should be, start
involuntary voiding begins.6 This occurs when the maximum with as minimally invasive tests as possible and proceed
cystometric capacity (MCC) has been reached in children with invasive investigations, as necessary, to answer the
with no voiding dysfunction.7 During this phase the detrusor question.
contracts, producing voiding detrusor pressure as the bladder � If the child is still agitated after inserting the catheter in the
outlet relaxes. It is not always possible to have very young bladder, having parents present to help calm their child, is
children follow instructions to void, but in older children it is. advisable.
At this phase, the detrusor pressure increases as the pelvic � Toys, video games, or movies during the examination are
floor relaxes and the urethral pressure decreases resulting in very helpful to distract the child and minimize artifact.

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� Two cycles of cystometry and PFS to determine the encouraging the child to void, dripping water on the pubic
consistency or representativeness of findings is preferable. area, or lower extremity and/or having the mother or
caregiver encourage the child to void, helps in the process
to induce the child to urinate.
4 | INTERPRETATION 7. A high voiding detrusor pressure (usually >74 cmH2O in
boys, 63 cmH2O in girls7) with a low urine flow indicates
The aim is to analyze accurately, and to critically report BOO; low pressure with a low flow indicates underactive
results after carefully performing the PFS in children. detrusor. A pressure flow plot is useful to evaluate the
pressure flow relationship in this regard, although clinical
1. Normal voiding detrusor function- Normal detrusor calibration is not yet available for children.
function is characterized by an initial (voluntary) 8. High voiding detrusor pressures may be induced by
relaxation of the external urethral sphincter/pelvic floor significant resistance as is seen in BOO where the
followed immediately by a continuous detrusor contrac- detrusor compensates for BOO. Conversely if urethral
tion that leads to complete bladder emptying within a resistance is low this may be reflected by a low pressure
normal time span, in the absence of obstruction. (high velocity) detrusor contraction.
2. Maximum voiding detrusor pressure (Pdetr.void.max) 9. A post voiding contraction indicates a detrusor contrac-
should be reported and related to the flowrate to tion that occurs immediately after micturition is
determine diagnosis. The flowrate should be compared complete. Its clinical relevance is uncertain, but it may
to the free flowrate as one means of evaluating the be related to detrusor overactivity and/or a sign of CNS
representativeness of the (pressure/flow) voiding. dysfunction as well as collapsing mucosa on catheter
3. Detrusor-Sphincter Dyssynergia (DSD): describes a pressure channel openings.
detrusor contraction concurrent with an involuntary 10. Bladder voiding efficiency(BVE) = (voided volume/total
contraction of the urethral and/or periurethral striated bladder capacity) × 100%.9
muscle. Occasionally the flow may be prevented 11. Cystometry volume parameters can be corrected for any
altogether diuresis during the test after pressure flow study by
.. DSD is usually evaluated by a pressure/flow/EMG immediately recording the PVR and adding it to the
study or with simultaneous bladder/urethral pressure voided volume.
recordings. High Pdetr.void.max in infants or a staccato
detrusor pressure curve during voiding when flowrate The parameters of free flow measurement such as the
reductions are synchronous with detrusor pressure PVR and maximum flowrate are useful for determining
increments indicate the existence of DSD. the accuracy of the flowrate and PVR obtained from PFS. If
4. PVR>20 mL or >15% of bladder capacity (BC) in the flowrate and PVR show substantial differences from
children age 7-12 years and >30 mL or >21% BC for those obtained during PFS, it indicates an artifact may exist.
children 4-6 years on two consecutive uroflows indicates For example, if the flowrate is lower and the PVR,
an abnormality.8 The uroflow is considered normal if the significantly higher compared to that obtained from free
bladder empties at least once during two uroflow flowmetry (before catheterization), the PFS results may be
measurements. If a low PVR is demonstrated during not representative.
free flow uroflowmetry then any raised PVR during the
urodynamic assessment can be considered as an artifact
due to the artificial circumstances of the test and the 5 | CONCLUSION
presence of an in-situ urethral catheter.
5. Detrusor underactivity is defined as a voiding contraction PFS is a useful tool for evaluating lower urinary tract function
of reduced strength and/or duration, resulting in in children. It should be considered as one procedure, along
prolonged bladder emptying and/or a failure to achieve with a “free” voiding uroflowmetry and filling cystometry,
complete bladder emptying within a normal time span.8 but not the only one, to clarify the diagnosis and to make
Pressure flow nomograms or calculations are needed to therapeutic decisions as well as to follow up treatment
quantify detrusor contractility. Detrusor underactivity responses to the voiding dysfunction, when less invasive
may occur with or without an elevated PVR. studies are inconclusive. To understand the characteristics in
6. An acontractile detrusor does not demonstrate any PFS, normal voiding parameters as well as following GUP
contractile activity during urodynamic assessment. recommendations from the ICS and ICCS are the basis of
Some children, however, cannot or will not generate a successful testing. We present the evidence background for
detrusor contraction in a “laboratory” setting. This could the PowerPoint presentation, to be used for educational the
be mistaken for a diagnosis. Spending extra time practice of the test, as is available on the ICS website.

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ORCID of the lower urinary tract in children. Neurourol Urodyn. 2015;34:

640–647.
Jian G. Wen http://orcid.org/0000-0003-0952-118X 6. Christopher RC, Scott AM, Anand P. Urodynamics Made Easy. 3rd
Peter F.W.M. Rosier http://orcid.org/0000-0003-0445- ed. London: Elsevier Churchill Livngstone; 2009;83–102.
4563 7. Wen JG, Tong EC. Cystometry in infants and children with no
apparent voiding symptoms. Br J Urol. 1998;81:468–473.
8. Austin PF, Bauer SB, Bower W, et al. The standardization of
terminology of lower urinary tract function in children and
REFERENCES adolescents: update report from the standardization committee of
the International Children's Continence Society. Neurourol Urodyn.
1. Wen JG, Lu YT, Cui LG, et al. Bladder function development and its
2016;35:471–481.
urodynamic evaluation in neonates and infants less than 2 years old.
9. Abrams P. Bladder outlet obstruction index, bladder contractil-
Neurourol Urodyn. 2015;34:554–560.
ity index and bladder voiding efficiency: three simple
2. Schafer W, Abrams P, Liao L, et al. Good urodynamic practices:
indices to define bladder voiding function. BJU Int. 1999;84:
uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol
14–15.
Urodyn. 2002;21:261–274.
3. Rosier P, Schaefer W, Lose G, et al. International Continence Society
good urodynamic practices and terms 2016: urodynamics, uro-
flowmetry, cystometry, and pressure-flow study. Neurourol Urodyn. How to cite this article: Wen JG, Djurhuus JC,
2017;36:1243–1260. Rosier PF, Bauer SB. ICS educational module:
4. Gammie A, Clarkson B, Constantinou C, et al. International Pressure flow study in children. Neurourology and
Continence Society guidelines on urodynamic equipment perfor-
Urodynamics. 2018;37:2311–2314.
mance. Neurourol Urodyn. 2014;33:370–379.
5. Bauer SB, Nijman RJ, Drzewiecki BA, et al. International Children's
https://doi.org/10.1002/nau.23730
Continence Society standardization report on urodynamic studies

Pressure flow study in children

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6. ICS GLOSSARY
Welcome to the ICS Glossary of Terminology. Find the latest terms standardised by ICS.

Please also visit www.ics.org/glossary to browse by glossary section, by letter or search to find the terms
and appropriate reference you need to cite in your work.

Bernard Haylen
ICS Glossary Editor & Standardisation Steering Committee Chair

A
Abdominal leak point pressure (ALPP - cm H2O) Abdominal signs
Investigation Sign
This is a dynamic test. It is the intentionally increased abdominal pressure Amongst numerous possible abdominal signs are: (I) Bladder fullness / re-
that provokes urine leakage in the absence of a detrusor contraction. tention: The bladder may be felt by abdominal palpation or suprapubic per-
cussion; (ii) Other abdominal masses: or distension (e.g. ascites); (iii) Scars:
Abdominal Leak Point Pressure (female) - ALPP - cm H20 indicating previous relevant surgery or traumas or evidence of previous ra-
Investigation diotherapy; (iv) Renal Area: Examination for tenderness, masses.
Abdominal leak point pressure (abdominal LPP): This is a dynamic test. It
is the lowest value of the intentionally increased intravesical pressure that Abnormal (bladder filling) sensations
provokes urinary leakage in the absence of a detrusor contraction.32 The Symptom
increase in pressure can be induced by a cough (cough LPP) or Valsalva (Val- Complaint of an awareness of sensation in the bladder, urethra or pelvis,
salva LPP). Multiple estimates at a fixed bladder volume (200–300 ml) are described with words like “tingling”, “burning” or “electric shock”, in the set-
desirable. Catheter size will influence LPP values and should be standard- ting of a clinically relevant neurologic disorder (e.g. incomplete spinal cord
ized. LPP values might also be affected by many other factors such as the lesion).
technique to confirm urine loss, location of catheter, type of pressure sensor,
bladder volume, rate of bladder filling, and patient position. A low abdomi- Abnormal sensations - Filling cystometry
nal LPP is suggestive of poor urethral function. Investigation
Awareness of sensation in the bladder, urethra or pelvis described with the
Abdominal Pressure Catheter for Urodynamics words like “tingling”, “burning” or “electric shock” in the setting of a clinically
Investigation relevant neurologic disorder (e.g. incomplete spinal cord lesion).
‘Flaccid filled’ punctured balloon in the rectal ampulla are used to measure
abdominal (‘perivesical’) pressure. vaginal or stoma placement of the ab- Abnormal urethral function during voiding - pressure flow studies
dominal pressure catheter is used alternatively only if rectal catheter place- Investigation
ment is impossible. The urethral sphincter(s) do not relax completely or they are (temporarily)
contracted during voiding, resulting in increased detrusor pressure. Bladder
Abdominal pressure (p abd - female) emptying may be complete or incomplete (PVR present).
Investigation
The pressure surrounding the bladder. It is usually estimated from meas- Absent bladder filling sensation
uring the rectal pressure, though vaginal and infrequently the pressure Symptom
though a bowel stoma can be measured as an alternative. The simultaneous Complaint of both the absence of the sensation of bladder filling and a defi-
measurement of abdominal pressure is essential for interpretation of the nite desire to void.
intravesical pressure trace. Artefacts on the detrusor pressure trace may be
produced by an intrinsic rectal contraction. Absent bladder sensation - filling cystometry
Investigation
Abdominal pressure (Pabd - cm H20) - male No bladder sensation during filling cystometry, at least to expected capacity
Investigation of 500 mL.
The pressure in the abdominal cavity surrounding the bladder. Usually esti-
mated by measuring the rectal pressure, though pressure through a bowel Absorbent Products
stoma can be an alternative. The simultaneous measurement of abdominal Conservative Management – Female
pressure is essential for interpretation of the intravesical pressure trace. Ar- Absorbent products are those that have been specifically developed to help
tifacts on the detrusor pressure trace may be produced by a rectal contrac- manage leakage or soiling, such as absorbent pads and pants, absorbent
tion. bed sheets and chair covers.

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Abstinence (sexual) due to pelvic organ prolapse men) in mature individuals in the context of clinically confirmed relevant
Symptom neurologic disorder.
Non-engagement in sexual activity due to prolapse or associated symp-
toms. Adult neurogenic lower urinary tract dysfunction (ANLUTD) - symptoms
Symptom
Accuracy of Uroflowmeters LUTS are classified neurogenic in the presence of a relevant neurological
Investigation disease ONLY.
The desired clinical accuracy may differ from the technical accuracy of a
flow meter. The ICS Technical report recommended the following standards: Aims of Clinical Urodynamics
a range of 0-50 ml/s for Qmax and 0-1,000 ml for voided volume, maximum Investigation
time constant of 0.75 s ; an accuracy of 5% relative to full scale, although a The aim of clinical urodynamics is to reproduce symptoms whilst making
calibration curve representing the percentage error over the entire range of precise measurements in order to identify the underlying causes for the
measurement should be made available. symptoms, and to quantify the related pathophysiological processes. By
However, technical specifications from the manufacturers are rare and of- doing so, it should be possible to establish objectively the presence of a
ten not in accordance with ICS recommendations: this situation should be dysfunction and understand its clinical implications. Thus, we may either
rectifed . confirm a diagnosis or give a new, specifically urodynamic diagnosis. The
quantitative measurement may be supplemented by imaging (video-uro-
Acontractile detrusor - pressure flow studies dynamics).
Investigation
The detrusor cannot be observed to contract (i.e. no increase in Pdet) during Aims of filling cystometry
urodynamic studies resulting in failure to void (CHANGED). Limited voiding Investigation
may occur by straining. The possibility of “inhibition” of a detrusor voiding These are to assess bladder sensation, bladder capacity, detrusor activity
contraction must be considered if the man subsequently voids normally and bladder compliance as well as to document (the situation of and detru-
post-cystometry. An acontractile detrusor can be of neurogenic or non-neu- sor pressures during) urine leakage.
rogenic origin.
Altered libido
Acute on chronic retention Symptom
Diagnosis Complaint of change in interest in sexual activity
An individual with chronic retention goes into acute retention and is unable
to void. Ambulatory urodynamics
Investigation
Acute Pain A functional test of the lower urinary tract for which a transurethral catheter
Symptom is placed in the bladder -performed outside the clinical setting, involving
Pain related to acute trauma, infection or other well-defined disease pro- natural bladder filling by drinking and continuous recording of bladder
cess. pressure (Pves) for a longer period of time (e.g. 12 hours). It can reproduce
bladder function and urine loss during an individual’s everyday activities.
Acute urinary retention
Symptom Anal Canal - Endoanal ultrasonography (EAUS)
Complaint of a rapid onset, usually painful suprapubic sensation (from a Imaging
full bladder) due to the inability to void (non-episodic), despite persistent Anal Canal - The anal canal in adults is between 2.5 and 5cm in length and
intensive effort. begins as the rectum narrows, passing posteriorly between the levator ani.
Three levels of assessment in the axial plane.
Acute urinary retention (1) Upper level: the hyperechoic sling of the puborectalis muscle (PR) and
Diagnosis the complete ring of the internal anal sphincter (IAS).
A patient is unable pass any urine despite having full bladder, which on ex- (2) Middle level: corresponds to the superficial part of the EAS (concentric
amination is painfully distended and readily palpable or percussible. band of mixed echogenicity), the conjoined longitudinal layer, the IAS (con-
centric hypoechoic ring), and the transverse superficial perinei muscles.
Acute urinary tract infection symptoms (3) Lower level: corresponds to the subcutaneous part of the EAS where the
Symptom IAS is absent.
Symptoms such as increased bladder sensation, urgency, frequency, dy-
suria/stranguria, pain in the lower urinary tract with or without urgency uri- Anal endosonography (AES) - ultrasound imaging (male)
nary incontinence might suggest lower urinary tract infection. Confirmation Imaging
of a UTI requires evidence of significant microorganisms and pyuria. Anal ultrasound imaging looking for sphincter defects.

Adult Anal fissures

Sign Sign
Fully grown and physically mature. Longitudinal split in the skin of the anal canal, exposing the internal anal
sphincter muscle. The majority of fissures are found in the mid-line posteri-
Adult neurogenic lower urinary tract dysfunction (ANLUTD) orly and there may be a skin tag associated with them.
Diagnosis
Abnormal or difficult function of the bladder, urethra (and/or prostate in Anal incontinence
Symptom

Terms A
864

Complaint of involuntary loss of flatus or feces. contribution to resting tone is variable along the length of the anal canal
with the proximal two thirds being more reliant on IAS tone to maintain ad-
Anal laxity equate resting pressures. The range of maximal resting pressure is typically
Symptom between 60 and 120cm H2O.The EAS has constant tonic activity contribut-
Complaint of the feeling of a reduction in anal tone. ing to the resting anal canal pressure.

Anal Manometry Anal Manometry - Maximum Squeeze Pressure

Investigation Investigation
Anal manometry is a test to assess the mechanical strength of the anal The maximum squeeze pressure is the maximum pressure generated in the
sphincters. A range of methods is available, including water perfused, solid anal canal during a voluntary contraction. Although the EAS contributes to
state, and micro-balloon systems. The length of the canal is measured either the resting pressure the specific function of the EAS can be assessed during
by station pull-through or continuous pull-through. Station pull-through in- the squeeze and cough maneuvers.The pressure increment above resting
volves inserting the catheter to 6cm from the anal verge, withdrawing the pressures during these maneuvers is a direct representation of EAS func-
catheter at 5–10mm intervals and measuring for 1–5min at each ‘‘station’’. tion.The normal range, as stated above, varies according to measurement
Continuous pull-through involves withdrawing the catheter at a set speed modality in each laboratory, but is approximately above 60 cm H2O. Typ-
by hand or by a mechanical puller. As normal values can differ substantially ically, higher values are obtained by automated pull-through rather than
between laboratories according to the style of catheter used, each unit is station withdrawal methodologies.
encouraged to generate its own normal data. In patients with fecal inconti-
nence the value of manometry is: (a) To define functional weakness of one Anal Manometry - Rectoanal Inhibitory Reflex (RAIR)
or both sphincter muscles (as a compliment to anal endosonography). (b) Investigation
To support findings of other tests and to monitor outcome and predict re- The recto-anal inhibitory reflex (RAIR) a relaxation response in the IAS fol-
sponse to biofeedback training. (c) In cases where anal endosonography is lowing rectal distension. A drop of at least 25% of resting pressurehas to
not available, vector manometry may help identify anatomic defects of the occur with subsequent restoration to at least two thirds of resting pressure
anal sphincter complex. In constipated patients the value of manometry is: for it to be deemed present. It is elicited by rapid insufflation and disinflation
(a) To exclude Hirschsprung’s disease. (b) To identify and predict responses of 50mls of air into a balloon positioned in the distal rectum during anal
to biofeedback training (pelvic floor dyssynergia = failure to expel a wa- manometry at the level of the proximal high pressure zone. This reflex is ab-
ter-filled balloon). sent in Hirschsprung’s disease: of greater physiological meaning, this reflex
is thought to underlie the sampling response that allows rectal content to
Anal Manometry - Balloon expulsion pressure be sensed by the anal mucosa, thus ensuring continence of flatus and stool.
Investigation
The balloon expulsion pressure is the anal canal pressure during straining Anal Manometry (Advanced) - High Resolution Manometry
with a filled balloon in the rectum. Balloon expulsion can be performed on Investigation
patients with evacuatory difficulty. An inappropriate increase in sphincter In this technique, a catheter with a large number of pressure sensors spaced
pressure on attempted voiding evacuation is usually reported as a present less than 0.5mm apart along the length of the catheter. This allows com-
or absent response, rather than numerically. Such increased pressure is re- plete definition of the intra-anal pressure environment. The resulting data is
ferred to as ‘‘anismus’’ or ‘‘paradoxical sphincter contraction.’’ displayed on a topographical three dimensional plot to allow easier pattern
recognition. It is a measurement with the variables of pressure (displayed
Anal Manometry - Endurance Squeeze Pressure as the color), distance into the anal canal (y-axis) and time (x-axis). Normal
Investigation ranges are slightly higher than measured with standard manometry, but the
The endurance squeeze pressure is the length of time the individual is readings agree well with each other.
able to maintain the pressure during a voluntary contraction. To assess the
endurance squeeze pressure, measurements are taken during a 5–10sec Anal Manometry (Advanced) - Vector Manometry
squeeze (normal 5sec). Incontinent patients typically have fatigue rate Investigation
of greater than two-thirds of initial pressure at the end of the sustained Vector manometry is a quantitative measure of radial symmetry and vol-
squeeze. By calculating fatigability, the fatigue rate (using linear regression ume of the anal sphincter. It involves withdrawing (commonly using a me-
on the mean pressure over one second periods throughout the endurance chanical puller) a radially arranged multi-channel anorectal manometry
squeeze) can be derived. catheter through the length of the anal canal. The following parameters
are identified: Radial asymmetry index (RAI) is a quantitative measure of
Anal Manometry - Involuntary Maximum Squeeze Pressure the radial symmetry and can be calculated at any level in the anal canal but
Investigation most commonly refers to the level at which the highest resting pressure is
A common maneuver is a maximal cough to measure this involuntary in- generated. The principle is that an asymmetrical sphincter is more likely to
crement, usually reported as a present or absent response, rather than nu- have a sphincter defect. The vector volume is the volume of the 3D shape
merically. generated and provides a value which reflects the overall length and sym-
metry of the sphincter.
Anal Manometry - Maximum resting pressure
Investigation Anal Plugs
The maximum resting pressure is the maximum resting pressure generat- Conservative Management – Female
ed in the anal canal at rest. Strictly speaking, it is defined as the difference Anal plugs are containment devices aimed at blocking the loss of stool to
between the intrarectal pressure and the highest recorded rectal pressure control fecal incontinence. Plugs come in different designs, sizes, and com-
at rest. However, rectal contents may affect the accuracy of rectal pressure positions, such as polyurethane and polyvinyl-alcohol.
measurements. The internal anal sphincter (IAS) exhibits continuous tonic
activity and is responsible for 55–85% of the resting anal canal pressure. Its

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Anal sexual practices with body parts body actions and decreased activity in sleep. Needle EMG however is re-
Symptom garded as superior. Some centers use surface EMG as an indicator of anal
Stimulation of the anus and/or rectum with bodily parts other than the pe- sphincter activity to provide feedback for patients undergoing behavioral
nis (e.g., finger, fist) for sexual purposes by the recipient and/or a partner. biofeedback training for fecal incontinence or constipation.

Anal Sexual practices with non-living objects Anorectal Neurophysiology (female) - Concentric fibre EMG
Symptom Investigation
Stimulation of the anus and/or rectum with non-living objects (e.g., dildo) Concentric needle EMG can be used to record activity in the external sphinc-
for sexual purposes by the recipient and/or a partner. ter and puborectalis. The responses of these muscles to voluntary contrac-
tion, coughing and straining can be displayed.The data are qualitative and
Anejaculation compared to appearances in these muscles at rest. The muscles can also be
Symptom studied at several sites to define areas of functioning muscle and identify
Complaint of the absence of seminal fluid emission. May be associated with sites of muscle injury (sphincter mapping) although this is has now been
the absence of the sensation of orgasm or anorgasmia. superseded by anal endosonography.

Anodyspareunia Anorectal neurophysiology (female) - single fibre EMG

Symptom Investigation
Complaint of pain or discomfort associated with attempted or complete A single fiber needle EMG technique is used to measure the muscle fiber
anal penetration. density in the external sphincter and puborectalis. A raised fiber density
indicates re-innervation in the muscles, which may occur following partial
Anorectal examination - female position denervation. Calculating EAS fiber density is another method of assessing
Sign denervation and re-innervation of the EAS. It is used almost exclusively as
The patient lies in the left lateral position with hips flexed and ankles away a research tool. Conventional EMG can be used to quantify the re-innerva-
from the examiner. Dorsal lithotomy position could also be used. tion of the EAS by detecting prolongation in the duration of the motor unit
potential.
Anorectal examination (female) - perianal sensation/ reflex
Sign Anorectal pain symptoms
In patients with possible neurogenic pelvic floor dysfunction there should Symptom
be particular note of those neurological signs related to S2-4 but these Complaint of pain, pressure or discomfort particularly during defecation or
should be complimented by a more general neurological examination as straining to defecate, but can occur at any time.
indicated. Specific to ano-rectal dysfunction, assessment of anal reflex, and Pain during defecation or straining to defecate.
perianal sensation should be performed. Inflammatory: characterized by burning or stinging
Non-inflammatory: blunted anorectal or muscular-spasm type pain
Anorectal incontinence
Symptom Anorectal Pain Syndromes (Female)
Complaint of involuntary loss of flatus or feces. Diagnosis
1: Levator ani syndrome: Episodic rectal pain caused by spasm of the levator
Anorectal Manometry - Ambulatory ani muscle. Proctalgia fugax (fleeting pain in the rectum) and coccydynia
Investigation (pain in the coccygeal region) are variants of levator ani syndrome. 2: Proc-
Using solid-state catheters, prolonged ano-rectal motor events have been talgia fugax definition: Proctalgia fugax (or Levator syndrome) is a severe,
recorded, including in ambulant subjects. The clinical applicability of these episodic, rectal and sacrococcygeal pain. It can be caused by cramp of the
techniques has not been established. pubococcygeus or levator ani muscles 3: Pudendal neuralgia Pudendal Neu-
ralgia (PN) is a painful condition that is caused by inflammation of the pu-
Anorectal Neurophysiology - Pudendal Nerve Terminal Motor Latencies dendal nerve involving it’s dermatome. It can affect both men and women.
(PNTML)
Investigation Anorectal prolapse
The PNTML is a measurement of the delay between the electrical stimula- Symptom
tion of the pudendal nerve and the EMG activity of the EAS. The pudendal Complaint of external protrusion (bulge) of the anus or rectum (differen-
nerve is stimulated as it passes over the ischial spine using a specially de- tiation on subsequent examination between rectal mucosal prolapse and
signed electrode attached to the index finger of the assessor in the rectum. full thickness rectal wall prolapse which includes muscle and serosal layers).
The surface EMG recording electrode which sits on the base of the asses-
sor’s index finger and measures external sphincter activity. The test does not Anorectal prolapse (female)
reliably reflect the pudendal nerve damage. This may be because PNTMLs Symptom
measure the speed of nerve conduction, which involves the fastest nerve Complaint of a ‘‘bulge’’ or ‘‘something coming down’’ towards or through the
fibers that are least susceptible to damage. The latencies are reported as anus/rectum.The woman may state she can either feel the bulge by direct
normal if below 2.2msec, but are also very operator dependent, with poor palpation or see it aided with a mirror
reproducibility and hence not recommended for general clinical use.
Anorectal prolapse (female)
Anorectal neurophysiology - Surface EMG Sign
Investigation Full thickness eversion of the lower part of the rectum and anal canal. The
Electrodes placed on the skin of the perineum or inside the vagina or rec- exposed mucosa is red with circumferential folds around the central pit,
tum. Surface recordings from the sphincter show increased activity with

Terms A
866

which is the lumen of the rectum. Look for associated utero-vaginal pro- Anorgasmia or difficulty in achieving orgasm (female)
lapse, fistulas, sepsis, and ulcers. Symptom
Complaint of lack of orgasm; the persistent or recurrent difficulty, delay in
Anorectal sensory measurements (female) - Assessment of rectal sensation or absence of attaining orgasm following sufficient sexual stimulation and
to distension arousal, which causes personal distress.
Investigation
Rectal sensation to distension is most commonly assessed by manually in- Anorgasmic intercourse
flating an intrarectal domestic balloon at a rate of approximately 5ml/sec- Symptom
ond.The following are elicited: Volume which elicits the first sensation of Complaint of lack of orgasm; the persistent or recurrent difficulty, delay in
balloon expansion (threshold) [typical normal range 12–25ml], Volume to or absence of attaining orgasm following sufficient sexual stimulation and
get an urge to defecate (typical normal range 35–65ml), Maximal tolerated arousal, which causes personal distress.
volume (typical normal range 120–300ml) - [normal ranges for the latter two
sensations are highly variable due to lack of consensus on measurement Anoscopy of proctoscopy
technique especially of the nature and speed of inflation of the balloon]. Investigation
The pressure required to elicit these sensations can also be measured using This is the inspection of the anal canal to identify anal fissure, fistula, or hem-
an electro-mechanical barostat and may be more reproducible. The barostat orrhoids as a cause of anal symptoms.
measures the volume and the pressure required to elicit these volumes
sensations.Typically distension thresholds with a barostat are higher, with Anterior enterocele
larger volumes being required to elicit the same sensation. However, again, Sign
the published ranges vary widely between units: typically distension vol- Hernia of peritoneum and possibly abdominal contents into the anterior
umes 1.5 to 3 times are published for thresholds with a barostat compared vaginal vault, most commonly after prior reconstructive surgery.
to manual balloon inflation. Distension sensitivity testing is of proven value
in: (a) Patients with fecal incontinence to help with biofeedback training Anterior vaginal repair - colporrhaphy - native tissue
by normalization of the initial sensation sensory thresholds. (b) Identifying Surgery – Female
visceral hypersensitivity, poor rectal compliance, or rectal irritability if max- Repair the vaginal by excision and suturing of the edges of any defect, most
imal tolerated volumes are low. There is no evidence to support use of the commonly by midline fascial plication.
sensory thresholds for diagnosis and biofeedback training of patients with
constipation. Compliance testing has also not proven valuable in identifying Anterior vaginal repair (colporrhaphy) - mesh or graft re-inforcement
candidates for specific therapies. Surgery – Female
A structural addition or inclusion used to give additional strength in func-
Anorectal sensory measurements (female) - Mucosal Electrosensitivity tion. It should be noted whether the graft is biologic, absorbable synthetic
Investigation or permanent synthetic.
This is test to measure anal and rectal sensory thresholds. Mucosal electrical
stimulation is performed using a probe with two ring electrodes between Anterior vaginal wall (compartment) prolapse
which a small electrical potential is applied generating an alternating square Sign
wave with a variable frequency. Normal ranges have been established as Observation of descent of the anterior vaginal wall (compartment). Most
anal electrosensation <10mA, and rectal as <30mA. In general, prolonged commonly this might represent bladder prolapse (cystocele). Higher stage
anal electrosensation is suggestive of damage to the sensory fibers of pu- anterior vaginal wall prolapse will generally involve descent of uterus or
dendal nerve, and prolonged rectal electrosensation is suggestive of auto- vaginal vault (if uterus is absent). Occasionally there might be an anterior
nomic neuropathy. enterocele (hernia of peritoneum and possibly abdominal contents), most
commonly after prior reconstructive surgery.
Anorectal Sepsis
Diagnosis Anterior vaginal wall (compartment) prolapse
1: Abscess Infection in a (non Crohn’s) anal gland, located at the base of the Imaging
dentate line, that initially forms an abscess, which can be located in one Diagnosis by symptoms and clinical examination, assisted at times by any
of the potential spaces surrounding the anus and rectum. 2: Ano-rectal/ relevant imaging (i.e. clinically evident) descent of the anterior vaginal wall
vaginal/perineal fistula: Rectovaginal fistula is a communication from the (compartment).
rectum to the vagina and rarely the perineal area. An anovaginal/perineal
fistula is an abnormal communication from the anal canal to the vagina or Anterior vaginal wall (compartment) prolapse
perineal area. Diagnosis
Clinically evident (symptoms, signs or any relevant imaging) descent of the
Anorectal/vaginal/perineal fistula anterior vaginal wall (compartment).
Sign
Is an abnormal communication from the anal canal to the vagina or perineal Anteverted uterus
area. Sign
The axis of the uterus is directed forwards overlying the bladder. Cervix is
Ano-rectal/vaginal/perineal fistula noted in/ towards the posterior fornix with fundus perhaps palpable anteri-
Sign orly on bimanual palpation.
Is an abnormal communication from the anal canal to the vagina or perineal
area. Aseptic intermittent catheterization
Conservative Management – General

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This implies genital antiseptic preparation and the use of sterile (single-use) This is a syndrome resulting from upper thoracic or cervical spinal cord in-
catheters and instruments/gloves in a designated clean area. jury above T6, elicited by a stimulus in the field of distribution of the au-
tonomous sympathetic nucleus, characterized by unregulated sympathetic
Associated POP-related Radiology (female) function below the lesion and compensatory autonomic responses. Can be
Imaging asymptomatic if there in an increase in blood pressure without any other
Defecography demonstrates normal anatomy of the anorectum as well as symptoms.
disorders of rectal evacuation. With barium paste inserted rectally prior to
defecation, measurement of the anorectal angle is allowed with evidence Average (urine) flow rate (AUFR - mL/s) - Qave
of the presence, size or emptying of any rectocele. Enteroceles, rectal intuss- Investigation
susception and mucosal prolapse might be diagnosed as well as a spastic Voided volume divided by the flow time.
pelvic floor (anismus).
Average voided volume
Atrophic Sign
Sign Summation of volumes voided divided by the number of voided during an
Decrease from previous normal size of the body or a part, cell, organ, or assessment period of frequency-volume chart (FVC).
tissue. An organ or body part’s cells may be reduced in number, size or both.
Atrophy of some cells and organs is normal at certain points in the life cy-
cle. Other causes include malnutrition, disease, disuse, injury, and hormone
over- or underproduction

Autonomic dysreflexia
Diagnosis

B
properties of the detrusor: e.g. post-radiation changes of the detrusor wall;
Balanitis xerotica obliterans (BXO - syn lichen sclerosis et atrophicus) (iii) Starting point for compliance calculations: Usually the detrusor pressure
Symptom at the start of bladder filling and the corresponding bladder volume (usually
Depigmentation of the penile skin, scrotum or glans. zero); (iv) End point for compliance calculations: The detrusor pressure (and
corresponding bladder volume) at cystometric capacity or immediately
Balanoposthitis before the start of any detrusor contraction that causes significant leakage
Sign (and therefore causes the bladder volume to decrease, affecting compliance
Inflammation of the foreskin and glans penis. calculations). Both points are measured excluding any detrusor contraction.

Behavioral and Cognitive Therapies Bladder (detrusor) compliance - filling cystometry (mL/cmH2O)
Conservative Management – Female Investigation
The way someone behaves, especially toward other people, and behavioral Relationship between the change in bladder volume and change in detru-
science is the study of human behavior. sor pressure as a measure for the distensibility of the bladder. Compliance
1. Behavior therapy: a type of psychotherapy that attempts to modify ob- = Change Vol/ change Pdet. Compliance reflects the amount of fluid in the
servable maladjusted patterns of behavior by substituting a new response bladder to increase the bladder pressure by 1cm H2O (mL per cm H2O)
or set of responses to a given stimulus. The treatment techniques involve
the methods, concepts, and procedures derived from experimental psy- Bladder diary
chology; they include assertiveness training, aversion therapy, contingency Sign
management, flooding, modeling, operant conditioning, and systematic Adds to the Frequency Volume Chart (FVC) , the fluid intake, pad usage, in-
desensitization. It is also called behavior modification. 2. Cognitive thera- continence episodes, the degree of incontinence and the circumstances at
py: any of the various methods of treating mental and emotional disorders the time of the leakage.
that help a person to change their attitudes, perceptions, and patterns of Episodes of urgency and sensation might also be recorded, as might be the
thinking, from rational to realistic thoughts about the self and situations. activities performed during or immediately preceding the involuntary loss
The technique is often used in association with behavior therapy principles. of urine. Additional information obtained from the bladder diary involves:
3. Cognitive behavior therapy (CBT): Cognitive techniques are often used in severity of incontinence in terms of leakage episodes and pad usage.
association with behavior therapy principles; this is called cognitive behav-
ior therapy (CBT). Bladder expression
Conservative Management – General
Bladder abnormalities - ultrasound imaging (male) This refers to various compression manoeuvres aimed at increasing intra-
Imaging vesical pressure to facilitate bladder emptying with or without obvious sen-
Tumor, foreign body, overdistension, stones, diverticulum. sation from the bladder.

Bladder compliance - factors affecting (female) Bladder filling (sensory) symptoms

Investigation Symptom
(i) Bladder filling: Faster filling is more provocative. An artifact may be pro- Abnormal sensations experienced during bladder filling.
duced which settles when filling is interrupted; (ii) Contractile / relaxant

Terms A - B
868

Bladder outlet obstruction (BOO - male) Bladder Pain Syndrome (BPS - Chronic)
Diagnosis Symptom
A diagnosis based on urodynamic investigations (pressure-flow studies +/- Persistent or recurrent chronic pelvic pain, pressure or discomfort perceived
imaging +/- EMG), generally (but not always) with relevant symptoms and to be related to the urinary bladder accompanied by at least one other uri-
signs, manifest by an abnormally slow urine flow rate, with evidence of ab- nary symptom such as an urgent need to void or urinary frequency.
normally high detrusor voiding pressures and abnormally slow urine flow
during pressure-flow studies, with or without a high PVR. Bladder wall thickness (BWT) - ultrasound imaging (male)
BOO can be functional (bladder neck obstruction, detrusor sphincter dys- Investigation
functions or pelvic floor overactivity) or mechanical (prostatic enlargement, Distance from the outer border of the mucosa to the outer border of the
sphincter sclerosis, urethral stricture, meatal stenosis). adventitia on the anterior bladder wall with a linear 7,5MHz linear array in a
bladder filled to over 250ml.
Bladder outlet obstruction (BOO) - pressure flow studies (male +/- VCU, EMG)
Investigation Bowel diary
This is the generic term for obstruction during voiding. It is a reduced urine Sign
flow rate with a simultaneously increased detrusor pressure. PVR may be It is a recording of bowel actions. Bowel diaries have been widely used in
present. diagnostic and intervention studies. Patient recall is less accurate than a di-
ary. Patients tend to underestimate symptom frequency, in one study by
Bladder outlet obstruction (female) over 50 %. However, there are few published examples and no consensus
Investigation on what should be included. Elements that might be included: (i) urgen-
This is the generic term for obstruction during voiding. It is a reduced urine cy; (ii) fecal incontinence (amount, consistency); (iii) flatus incontinence; (iv)
flow rate and/or presence of a raised PVR and an increased detrusor pressure passive staining/soiling (tends not be discrete episodes); (v) pads (changes,
. It is usually diagnosed by studying the synchronous values of urine flow degree of soiling); (vi) straining/difficulty/time in the toilet; (vii) unsuccessful
rate and detrusor pressure and any PVR measurements. A urethral stricture attempts to defecate; (viii) assistive measures (e.g. digital stimulation, man-
or obstruction due to higher degrees of uterovaginal prolapse or obstructed ual evacuation, irrigation); (ix) laxative or rectal evacuant use; (x) diet and
voiding after stress incontinence procedures are amongst possible causes. fluids (type and/or timing). Patients often need careful and detailed instruc-
tions on how to complete a diary, and still many are poorly completed. An
Bladder oversensitivity - filling cystometry incomplete diary is difficult to interpret and is liable to misinterpretation as
Investigation a low bowel/event frequency.
Increased sensation during bladder filling with: early first desire to void; ear-
ly strong desire to void, which occurs at low bladder volume; lower cysto- Bulbospongiosus reflex (BSR)
metric bladder capacity; no abnormal increases in detrusor pressure. Sign
A reflex contraction of the striated muscle of the pelvic floor (anal sphincter)
Bladder Oversensitivity (BO) and the bulbo-spongiosus muscle that occurs in response to various stimuli
Diagnosis in the perineum or genitalia.
Increased perceived bladder sensation during bladder filling with specific
cystometric findings of early first desire to void; early strong desire to void, Burch colposuspension - open, laparoscopic, robotic
which occurs at low bladder volume; low maximum cystometric bladder ca- Surgery – Female
pacity; no abnormal increases in detrusor pressure. Elevation or attachment of the upper paraurethral tissue adjacent to the
bladder neck region to the iliopectineal ligament bilaterally. Although a rec-
Bladder pain ognized treatment for stress incontinence, this procedure will often correct
Symptom associated anterior wall prolapse.
Complaint of suprapubic or retropubic pain, pressure or discomfort related
to the bladder, and usually associated with bladder filling. It may persist or
be relieved after voiding.

C
This is the use of a clean technique. This implies ordinary hand and genitals
Catheterization washing techniques and use of disposable or cleansed reusable catheters.
Conservative Management – General
This is a technique for bladder emptying employing a catheter to drain the Catheterization - indwelling
bladder or a urinary reservoir. Conservative Management – General
An indwelling catheter remains in the bladder, urinary reservoir or urinary
Catheterization - aseptic intermittent conduit for a period longer than one emptying.
Conservative Management – General
This implies genital antiseptic preparation and the use of sterile (single-use) Catheterization - intermittent (IC)
catheters and instruments/gloves in a designated clean area. Conservative Management – General
Drainage of the bladder or a urinary reservoir with subsequent removal of
Catheterization - clean intermittent (CIC) the catheter mostly at regular intervals
Conservative Management – General

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Catheterization - no-touch technique intermittent of muscle tone, for example, surface electromyography, dynamometry,
Conservative Management – General real-time ultrasound, elastometry, myo-tonometry. i. Pressure manometry
This was introduced as an easier way for the patient to perform self-intermit- is the measurement of resting pressure or pressure rise generated during
tent catheterization with a ready-to-use catheter (pre-lubricated catheter, contraction of the pelvic floor muscles using a pressure device (a manome-
usually a hydrophilic catheter). A pull-in aid or special packages are used ter) inserted into the urethra, vagina or anus. ii. Surface electromyography
to handle the catheter without directly touching the sliding surface of the (sEMG) refers to the bioelectrical activity generated by muscle fibres. iii. Dy-
hydrophilic catheter. namometry is the measurement of pelvic floor muscle resting and contrac-
tile forces using strain gauges mounted on a speculum (a dynamometer),
Catheterization - sterile intermittent which is inserted into the vagina. iv. Real-time ultrasound measures pelvic
Conservative Management – General floor muscle morphology and function via a non-invasive (trans-abdominal
Complete sterile setting, including genital skin antisepsis, sterile gloves, for- or trans-perineal) probe. v. Elastometry measures the elasticity of a tissue.
ceps, gown and mask. 4. Trigger point injection or needling has been used as a diagnostic test to
identify pain generators. 5. Imaging
Central sensitization i. X-Ray. ii. Ultrasound. iii. MRI.
Symptom
Nociceptor sensitization results in synaptic strengthening by incoming Chronic Neuropathic Pain Syndromes - Evaluation
afferent volleys (sensitization) and is expressed as hyperalgesia (a form of Investigation
non-associative learning characterized by an increase in responsiveness A. Neuropathic Pain Questionnaires 1. VAS Pain Score. 2. Pain DETECT (Vali-
upon repeated exposure to a stimulus) dated for CPPS evaluation). 3. Leeds Assessment for neuropathic symptoms
and signs (not validated for chronic pelvic pain).4. Douleur Neuropathique 4
Centrally generated pain/ Deafferentiation pain Questionnaire. B. Quantitative Sensory Testing
Symptom 1. 1Q-tip touch sensitivity. 2. Sensory pain mapping. 3. Reflex evaluation. 4.
Pain which may result from injury to either the peripheral or central nerv- Electromyography.
ous system, leading to burning pain below the level of the lesion. It can be C. Nerve Blocks 1. May/may not be done under Computed Tomography, Ul-
sympathetic-nervous system maintained pain, which may result in chronic trasound or EMG guidance.
regional pain syndrome (CRPS). There is increased responsiveness of noci- D. Imaging
ceptive neurons in the central nervous system to normal or sub-threshold 1. Ultrasound 2. Magnetic resonance Imaging (MRI)
afferent input.
Chronic Pain
Chronic Bladder Pain Syndrome - Cystoscopic evaluation Symptom
Investigation Persistent or continuous/recurrent pain for at least 6 months. If non-acute
Cystoscopic findings by hydrodistension are important in subclassification and central sensitization pain mechanisms are well documented, then the
of Bladder Pain Syndrome (BPS) / Interstitial Cystitis (IC). pain may be regarded as chronic, irrespective of the time period.
i. Glomerulation during cystoscopy with hydrodistension, glomerulations,
with or without waterfall lesions (blood trickling downwards), may often be Chronic Pain and Fatigue Syndromes
observed ii. Hunner Lesion. Diagnosis
A Hunner lesion is not an ulcer, but an inflammatory infiltrate. Morphologic Chronic pain and fatigue syndromes are characterized by pain, often wide-
findings in Hunner Lesion spread; fatigue; sleep disturbances; and disability.The symptoms are usually
1. Inflammatory infiltrate on examination of biopsy taken with electro-re- medically unexplained, have no known pathophysiology or organic basis
section or by cold cup biopsy. 2. Lymphocyte-like cells dominate in the infil- and show no abnormal laboratory. or imaging investigations.The literature
trate, but neutrophilic and eosinophilic granulocytes as well as plasma cells suggests that many of these conditions share demographic characteristics,
and mast cells are also found. 3. Perineural and perivascular arrangement of clinical course and psychosocial profiles.Examples are:
lymphocyte-like cell infiltrates. Granulation tissue. 1. Fibromyalgia: symptoms are widespread musculoskeletal pain, fatigue,
non-restorative sleep, psychological distress, and regions of localized ten-
Chronic Intra-abdominal Female Genital Pain Syndrome - Evaluation derness. 2. Temporomandibular Joint Disorders: symptoms consist of com-
Investigation plaints of facial, jaw, neck, or shoulder pain. The pain is experienced in or
1. Questionnaires around the ear with chewing, speaking, or opening the mouth, with or
i. Visual Analog Scale for pain. without migraine. 3. Chronic Fatigue Syndrome: is defined as clinically eval-
2. Laboratory Testing uated, unexplained, persistent or relapsing fatigue plus four or more specifi-
i. Culture. ii. Complete blood count. cally defined associated symptoms (self-reported impairment in short term
3. Laparoscopy (with or without biopsy) 4. Ultrasound (US) 5. MRI 6. Venog- memory or concentration; sore throat; tender cervical or axillary nodes;
raphy (to rule out Pelvic Congestive Syndrome) muscle pain; pain in multiple joints without redness or swelling; headaches
of a new pattern or severity; unrefreshing sleep).
Chronic Musculoskeletal Pain Syndromes - Evaluation
Investigation Chronic Pelvic Floor Muscle Pain Syndrome
1. Questionnaires i. McGill Pain Questionnaire. ii. Pelvic Floor Distress In- Investigation
ventory (PFDI). iii. Female Sexual Function Index (FSFI). iv. Female Sexual 1. Questionnaires. i. Visual Analog Scale for pain. ii. Pelvic Floor Distress
Distress Scale (FSDS). 2. Pain Location Drawing (Pain Mapping) i. Pain Chart Inventory (PFDI). iii. Prolapse and Incontinence Sexual Questionnaire
body map. 3. Evaluation of Muscle Tension There is no single tool which is (PISQ).111
able to measure all components of muscle tone. Some tools may beable 2. Laboratory Testing
to measure aspects of tone such as contractility, stiffness or elasticity. In- i. Wet Mount, Culture. ii. Biopsy.
strumented methods may have a role in the valid and reliable evaluation 3. Imaging References

Terms B - C
870

i. Ultrasound (4D if available for visualization of mesh, where applicable). ii. Chronic (persistent or recurrent) penile pain syndrome
MRI (with or without defecography). iii. Defecography. Diagnosis
Pain within the penis that is not primarily in the urethra and may be:
Chronic Pelvic Joint, Ligament or Bone Pain Syndrome i. Persistent or recurrent. ii. Spontaneous, or reproduced by digital pressure
Diagnosis and physical activities. iii. Lower urinary tract symptoms or sexual dysfunc-
1. Joint pain: tion.
i. Sacroiliac or pubic symphysis joint.
2. Ligament pain: Chronic (persistent or recurrent) Prostate Pain Syndrome
i. Sacro-spinous or Sacro-tuberous ligament. Diagnosis
3. Bony pain: Persistent or recurrent prostate pain, associated with symptoms suggestive
i. Pain described in or along the margins of the pubic ramus, ilium, ischial of urinary tract and/or sexual dysfunction. No proven infection or other ob-
spine or ischial tuberosity. vious pathology is present to account for the symptoms. Bladder, perineal,
testicular, penile and/or groin pain.
Chronic Pelvic Pain i. Perception of pain: variable. ii. Persistent or recurrent. iii. Dyspareunia or
Diagnosis erectile dysfunction. iv. Voiding and post micturition symptoms (for exam-
Chronic pelvic pain is characterized by persistent pain lasting longer than 6 ple: hesitancy, intermittency, feeling of incomplete emptying).
months or recurrent episodes of abdominal/pelvic pain, hypersensitivity or
discomfort often associated with elimination changes, and sexual dysfunc- Chronic (persistent or recurrent) Scrotal Pain Syndrome
tion often in the absence of organic etiology. Diagnosis
Chronic scrotal pain (generic term used when site of pain is not clearly in the
Chronic Pelvic Pain - Characteristics testis or epididymis).
Symptom i. Persistent or recurrent episodic pain, unilateral or bilateral. ii. Spontane-
a: Duration of pain: Six months or more of persistent pain. b. Location of ous, or reproduced by digital pressure and physical activities. iii. Pain is not
pain: Pelvis, lower abdomen, low back, medial aspect of thigh, inguinal area, in the skin of the scrotum but perceived within its contents. iv. Lower urinary
perineum. c. Perception of pain: Patients may describe the pain as sharp, tract symptoms or sexual dysfunction.
burning, aching, shooting, stabbing, pressure or discomfort, sexual pain
(dyspareunia). d. Modality of pain: Persistent and/or continuous, recurrent Chronic (persistent or recurrent) testicular pain syndrome
and/or episodic and/or cyclic (related to menstrual cycle). Diagnosis
i. Persistent or recurrent episodic pain. ii. Spontaneous, or reproduced by
Chronic (persistent or recurrent) Anorectal Pain Syndrome digital pressure and physical activities. iii. Lower urinary tract symptoms or
Diagnosis sexual dysfunction.
1. Chronic Proctalgia—rectal pain, more than 20min of duration per epi-
sode, for at least 3 months with symptom onset at least 6 months prior to Chronic Prostatic Pain Syndrome - Evaluation
diagnosis. Investigation
i. Persistent or recurrent rectal pain. ii. Rectal pressure or aching episodes. iii. 1. Quantitative assessments. i. Bladder diary. ii. CPSI (Chronic Prostatitis
In the absence of other causes of rectal pain. Symptom Index). iii. Visual Analog Scale for Pain (VAS).
2. Levator Ani Syndrome(the term may refer to the same syndrome as ‘‘pelvic 2. Laboratory Testing
floor muscle pain syndrome’’/ ‘‘tension myalgia of the PFM’’). i. Urinalysis (including post prostate massage). ii. Urine Culture post prostate
i. Pain with sitting. ii. Pain with defecation. massage. iii. Semen Culture.
3. Proctalgia Fugax 3. Uroflowmetry, Post voiding residual volume, pressure flow study 4. Cys-
i. Severe recurrent episodic pain localized in the anus or lower rectum. ii. toscopy 5. Ultrasonography, with or without biopsy
Duration seconds to minutes. iii. No pain between episodes.
Chronic retention of urine (female)
Chronic (persistent or recurrent) Epididymal Pain Syndrome Diagnosis
Diagnosis This is defined as a nonpainful bladder, where there is a chronic high PVR.
Pain is specific/localized to the epididymis.
i. Persistent or recurrent episodic pain. ii. Spontaneous, or reproduced by Chronic Scrotal, Epididymal, Testicular and Penile Pain Syndrome - Evalua-
digital pressure and physical activities. iii. Lower urinary tract symptoms or tion
sexual dysfunction. Investigation
1. Quantitative assessments i. VAS for Pain. 2. Ultrasonography
Chronic (persistent or recurrent) Pelvic Muscle Pain Syndrome
Diagnosis Chronic Sexual Pain Disorder
1. Pelvic Floor Muscle Pain (Pelvic Floor Myalgia): Diagnosis
i. Pain in the muscles of the pelvic floor (perineal or levator ani). Dyspareunia
2. Intra-pelvic Muscle Pain: i. Female sexual pain: Burning, ripping, tearing, or aching sensation asso-
i. Pain in the pelvic side wall muscles (obturator internus, piriformis, coccy- ciated with penetration. The pain can be at the vaginal opening, deep in
geus). the pelvis, or anywhere between. It may also be felt throughout the entire
3. Anterior Pelvic/Lower Abdominal Muscle Pain: pelvic area and the sexual organs and may occur only with deep thrusting. ii.
i. Pain in the rectus abdominus, oblique or transverse abdominus muscles, Male sexual pain: Sexual activity may induce a central sensitization process
described below the umbilicus. characterized by hypersensitivity or hyperalgesia. History should include
4. Posterior Pelvic/Buttock Muscle Pain: duration of symptoms, identification of disorder, impact on quality of life,
i. Pain in the gluteal muscles. and partner relationship. Partner interviews may be very helpful as erectile

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dysfunction, delayed or premature ejaculation in males with hypoactive Climacturia

sexual desire disorder result in a 4–30 times increased risk of female partner Symptom
desire, arousal or orgasmic disorder. Complaint of involuntary loss of urine at the time of orgasm.

Chronic Sexual Pain Syndrome Closing pressure

Diagnosis Investigation
i. Penile Pressure recorded at the end of measured flow.
1. Prior to penetration (example: pain with erection). 2. With penetration. 3.
Post coital. Closure of the Enterocele Sac - Open, Laparoscopic, Robotic
ii. Perineal Surgery – Female
1. During intercourse. 2. After intercourse. (a) Moschowitz procedure - Concentric purse-string suture(s) are placed
iii. Orgasmic Pain (during ejaculation) around the cul-de-sac to include the posterior vaginal wall, pelvic side-walls
1. Penile. 2. Anorectal. 3. Pelvic. and serosa of the sigmoid. (b) Halban procedure- Obliteration of the cul-de-
sac by using successive sutures placed sagittally between the uterosacral
Chronic Urethral Pain Syndrome - Evaluation ligaments. (c) Uterosacral ligament plication – transverse plication of the
Investigation uterosacral ligaments to obliterate the cul-de-sac. Successive sutures are
1. Quantitative assessments placed into the medial portion of one ligament, into the back wall of the
i. Bladder diary. ii. VAS for Pain. vagina and into the medial border of the opposing ligament.Variations in
2. Laboratory Testing technique for all abdominal mesh/graft procedures
i. Urinalysis (including post prostate massage, Ureaplasma/Chlamydia as
appropriate). Coccygeal pain (coccydynia)
3. Urethroscopy/Urethrography 4. Ultrasonography Symptom
Complaint of pain, pressure or discomfort felt in the coccygeal region
Chronic urinary retention
Symptom Coccyx Pain Syndrome
Complaint of chronic or repeated inability to empty the bladder, despite the Diagnosis
ability to pass some urine. This may result in the frequent passage of small Complaint of chronic or recurrent pain in the coccyx or sacro-coccygeal
amounts of urine or urinary incontinence and a distended bladder. joint.

Chronic (urinary) retention Coital fecal (flatal) incontinence (female)

Diagnosis Symptom
This defined as a generally (but not always) painless and palpable or per- Fecal (flatal) incontinence occurring with vaginal intercourse.
cussible bladder, where there is a chronic high PVR where the patient expe-
riences slow flow and incomplete bladder emptying. Overflow incontinence Coital fecal incontinence
can occur. Some individuals with retention present with impaired renal Symptom
function and/or hydronephrosis. Complaint of involuntary loss of stool occurring with intercourse.

Chronic Vulvar, Vestibular and Clitoral Pain Syndromes - Evaluation Coital fecal urgency (female)
Investigation Symptom
1. Questionnaires i. Visual Analog Scale for pain. ii. Female Sexual Function Feeling of impending bowel action during vaginal intercourse.
Index (FSFI). iii. Female Sexual Distress Scale (FSDS).
2. Laboratory Testing Coital urinary incontinence
i. Culture. ii. Biopsy. Symptom
3. Diagnostic Testing Urinary incontinence occurring during or after vaginal intercourse.
i. Vulvoscopy, with or without biopsy. ii. Quantitative Sensory Testing (Q-tip
touch sensitivity test). Coital urinary incontinence (female)
Symptom
Chyluria (albiduria) Complaint of involuntary urine loss during or after coitus. This symptom
Symptom might be further divided into that occurring with penetration and that oc-
Complaint of the passage of chyle (pain or white, milky cloudy) urine. curring at orgasm.

Classification Coital urinary urgency (female)

Surgery – Complication related Symptom
A systematic arrangement into classes or groups based on perceived com- Feeling of urgency to void during vaginal intercourse.
mon characteristics.
Colonoscopy
Clean intermittent catheterization (CIC) Investigation
Conservative Management – General Colonoscopy examines the entire colon following a full oral preparation to
This is the use of a clean technique. This implies ordinary hand and genitals clear the bowel to allow this.
washing techniques and use of disposable or cleansed reusable catheters.
Colonoscopy
Investigation

Terms C
872

The entire colon is examined following a full oral preparation to clear the contrast, used to clarify diagnoses such as (i) tumors; (ii) renal disease; (iii)
bowel to allow this. abnormal fluid collections/abscesses (iv) bladder pathology.
(2) CT Kidneys, ureter, bladder (CT- KUB): Non-contrast study aimed primarily
Colpocleisis at identifying stones but may identify other pathology. Aka “stone protocol”.
Surgery – Female
Operation for obliterating the lumen of the vagina. Computerized tomography (CT) of the pelvic floor
Imaging
Colporecto-cystourethrography (colpo-cystodefecography) Computed tomography (CT) is not routinely recommended for imaging the
Imaging pelvic floor mainly due to irradiation and poor soft tissue contrast. However
This involves the instillation of radio-opaque media into bladder, vagina, multiplanar spiral CT may offer an accurate visualization of the pelvic floor
and rectum simultaneously for pelvic floor evaluation with images obtained soft and bony structures by reconstruction of axial images using 1 mm thick
during rest and straining slices without gaps thus increasing the diagnostic accuracy of pelvic floor
anatomical disorders (ie. LAM trauma).
Colporecto-cystourethrography: (Colpo-cystodefecography)
Imaging Conditions for cystometry - female
This involves the instillation of radio-opaque media into bladder, vagina Investigation
and rectum simultaneously for pelvic floor evaluation with images obtained (i) Pressures: All systems are zeroed at atmospheric pressure; (ii) External
during rest and straining. pressure transducers: Reference point is the superior edge of the pubic sym-
physis; (iii) Catheter mounted transducers: Reference point is the transducer
Combination therapy (also known as polytherapy, multimodal therapy or itself; (iv) Initial bladder volume: Bladder should be empty;(v) Fluid medium:
combined modality therapy) Usually water or saline (or contrast if radiology involved); (vi) Temperature
Conservative Management – Female of fluid: Should ideally be warmed to body temperature; (vii) Position of
Combination therapy is the use of more than one intervention concurrently patient: Sitting position is more provocative for abnormal detrusor activity
to treat a single condition with one or multiple symptoms, for example, a than the supine position. At some point in the test, filling might desirably
combination of medication with PFM training (PFMT). take place with the patient standing; (viii) Filling rate: The filling rate, includ-
1. Adjunctive therapies: any treatment or modality used to augment or as- ing any changes during testing, should be noted on the urodynamic report.
sist the main treatment. In conservative treatments, adjunctive therapies
often refer to equipment or a secondary therapy used to supplement the Constipation (General)
effect of the primary therapy, e.g., biofeedback-assisted PFMT or neuromus- Symptom
cular electrical stimulation to augment PFMT. Complaint that bowels motions are infrequent and/or incomplete and/
or there is a need for frequent straining or manual assistance to defecate
Complaint (Rome IV criteria)
Symptom
The description of the symptom. Constipation (obstructed defecation)
Symptom
Complex Regional Pain Syndrome (CRPS) Complaint of difficulty in evacuation due to a mechanical obstruction.
Diagnosis
Sympathetic, centrally generated pain. 1. CRPS 1- Triggered by tissue injury Constipation (slow transit)
with no underlying nerve injury. 2. CRPS 2- Associated with nerve injury. Symptom
i. Burning pain. ii. Increased skin sensitivity. iii. Changes in skin temperature, Infrequent bowel motions due to a delay in transit of bowel contents to
color, and/or texture. reach rectum.

Compliance - bladder (female) Continuous urinary incontinence

Investigation Symptom
This describes the relationship between a change in bladder volume and Complaint of continuous involuntary loss of urine
change in detrusor pressure. Compliance is calculated by dividing the vol-
ume change (Change V) by the change in detrusor pressure (Change Pdet) Contraction
during that change in bladder volume (Compliance = Change V/Change Surgery – Complication related
Pdet). Compliance is expressed as ml per cm H2O. Shrinkage or reduction in size.

Complication Contraction pressure at maximum flow

Surgery – Complication related Investigation
A morbid process or event that occurs during the course of a surgery that is This is the difference between pressure at maximum flow and the premic-
not an essential part of that surgery. turition pressure.

Compromise Cough-Associated Detrusor Overactivity

Surgery – Complication related Investigation
Bring into danger. Cough associated DO is reported when the onset of the DO (with or without
leakage) occurs immediately following the cough pressure peak. No precise
Computerized tomography (CT) - male definition of cough associated detrusor activity is available. ‘Cough induced
Imaging DO’ is sometimes reported, although the precise (patho-)physiology re-
(1) CT Urogram (CT-U): CT study of the urinary tract system using injected mains speculative and only the association in time can be observed. The ICS

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6. ICS Glossary
 873

WG presents a descriptive definition and does not discuss the consequenc- Cystometrogram
es for management. Investigation
Graphical recording of the bladder pressure(s) and volume(s) over time.
Counseling in Pelvic Floor Dysfunction
Conservative Management – Female Cystometry
Counseling is the provision of professional assistance and guidance in re- Investigation
solving personal or psychological problems and may be part of any clini- Measurement of the pressure-volume relationship of the bladder during
cian’s management. filling.
1. Patient education: providing patients with knowledge and understand-
ing of their condition, thereby empowering them to play an active role in Cystometry - Aftercontraction
its management. 2. Motivational interviewing: a directive, client-centered Investigation
counseling style for eliciting behavior change by helping clients to explore An after-contraction, is a continued or new detrusor pressure rise immedi-
and resolve ambivalence. Compared with nondirective counseling, it is more ately after flow ended. It is important to note if this occurs with the com-
focused and goal-directed. The examination and resolution of ambivalence plete emptying of the bladder.
is its central purpose, and the counselor/clinician is intentionally directive
in pursuing this goal. 3. Coping strategies: intervention aimed at helping Cystometry - Catheter flush
patients to live with the condition in the best way possible under the cir- Investigation
cumstances, to regain a feeling of being in control, to adjust their lifestyle When one of the catheters is flushed during the test a steep pressure rise is
where necessary, and to take a positive rather than a negative approach. 4. observed in that pressure line for one or two seconds followed by an imme-
Self-care: the set of activities that comprise daily living, such as bed mobili- diate fall to resting pressure.
ty, transfers, ambulation, dressing, grooming, bathing, eating, and toileting.
5. Self-help: various methods by which individuals attempt to remedy their Cystometry - conditions (female)
difficulties without making use of formal care providers. 6. Self-efficacy: an Investigation
individual’s belief that he or she is capable of successfully performing a cer- (i) Pressures: All systems are zeroed at atmospheric pressure; (ii) External
tain set of behaviors. pressure transducers: Reference point is the superior edge of the pubic sym-
physis; (iii) Catheter mounted transducers: Reference point is the transducer
Cremasteric reflex itself; (iv) Initial bladder volume: Bladder should be empty; (v) Fluid medi-
Sign um: Usually water or saline (or contrast if radiology involved); (vi) Tempera-
Contraction of the ipsilateral cremaster muscle, drawing the testis upwards, ture of fluid: Should ideally be warmed to body temperature; (vii) Position of
when the upper inner aspect of the thigh is stroked longitudinally. patient: Sitting position is more provocative for abnormal detrusor activity
than the supine position. At some point in the test, filling might desirably
CTS Complication code take place with the patient standing; (viii) Filling rate: The filling rate, includ-
Surgery – Complication related ing any changes during testing, should be noted on the urodynamic report.
The category (C), time (T) and site (S) classes and divisions have a sensitivi-
ty that should encompass all conceivable scenarios for describing insertion Cystometry - Cough Pressure Peak
complications and healing abnormalities. The CTS code for each complica- Investigation
tion, involving three (or four) letters and three numerals is likely to be very A cough pressure peak is recognizable during post-test evaluation as a pha-
suitable for any surgical audit or registry, particularly one that is proce- sic positive pressure change observed in pves and in pabd.
dure-specific.
Cystometry - Dead Signal
Cyclical (menstrual) pelvic pain Investigation
Symptom A signal that is not showing small pressure fluctuations and is not adequate-
Cyclical pelvic pain related to menses that raises the possibility of a gyne- ly responding on straining, patient movements or coughing is reported as
cological cause. a dead signal.

Cystic dilatations of epididymal tubules Cystometry - Expelled Catheter

Sign Investigation
Cystic dilatations of epididymal tubules (epididymal cysts or spermatocele) When a catheter is expelled, this is observed as a sudden drop in either pves
and hydroceles (fluid collections between the visceral tunica albuginea and or pabd, usually below zero.
parietal layer of the testicular peritoneum)- usually benign. The examination
of these structures would be generally non-tender and without pain. Cystometry - Poor Pressure Transmission
Investigation
Cystometric capacity - filling cystometry Poor pressure transmission has occurred when the cough/effort pressure
Investigation peak signals on pves and pabd are not nearly equal.
Bladder volume at the end of filling cystometry, when a “permission to void”
is usually given by the urodynamicist. Cystometry - Position Change
Investigation
Cystometric capacity - filling cystometry (mL) A change in patient position, either active or passive (e.g. tilting), is visible
Investigation on the cystometry trace by a lasting change of equal magnitude in both
Bladder volume at the end of filling cystometry, when a “permission to void” pves and pabd. Note: A position change should be (is readily) noted dur-
is usually given by the urodynamicist. ing the test and followed by readjustment of the external pressure sensors
height to the standard so that the physiological pves and pabd are observed

Terms C
874

again. A position change should not affect pdet. The position change pat- Cystometry - Tube Knock
tern should be recognized during post-test evaluation of the cystometry. Investigation
Tube Knock is observable as high frequency, short duration spikes visible in
Cystometry - Pressure Drift pves, pabd, or both, and with spikes also usually visible in pdet .
Investigation
Continuous slow fall or rise in (one of either) pressure, that is physiologically Cystometry - Urodynamic Stress Test
inexplicable. Investigation
The urodynamic stress test is used for any physical effort of the person test-
Cystometry - Pump Vibrations ed, to elevate abdominal pressure, during cystometry with the aim of test-
Investigation ing for (urodynamic) stress urinary incontinence.
Pump vibrations are visible as stable frequency oscillations of small but ICS has defined urodynamic stress incontinence. Evidence is lacking (or con-
constant amplitude if the filling tube touches the pressure connecting tube flicting) with regard to the preferred technique of stress testing. Note: The
(when a two catheter system is used) and the pump is switched on (switch- provocation method, the pressure measuring catheter(size) and method,
ing of the pump can ascertain the situation). the leak detection method as well as the absolute or relative (percentage of
Note: ICS standard is double lumen catheter, and despite the channels be- cystometric capacity) intravesical volume(s) while testing may be reported.
ing side by side, with the usual filling rate and measuring scale, oscillations
are not typically observable. Cystometry Position
Investigation
Cystometry - Rectal Contractions ICS standard cystometry is done in the vertical position (standing or nor-
Investigation mally seated) whenever physically possible. A pressure-flow study is done
Rectal Contractions are temporary phasic increases in pabd without syn- comfortably seated (women, some men) or standing if that is preferred po-
chronous change in pves resulting in negative deflections of pdet. sition (men).

Cystometry - Straining
Investigation
Straining is observable as a temporary increase in both pves and pabd pres-
sure. Straining may be associated with (patient -active) position change
(such as repositioning from leaning backwards to upright).

D
Complaint of a decreased interest in sexual activity in comparison with pre-
Daytime vious experience
Sign
The period between waking up with the intention of rising until going to Decreased libido or sexual desire (female)
bed with the intention of sleeping (awake hours - ideally recorded on chart Symptom
or diary) Absent or diminished feelings of sexual interest or desire, absent sexual
thoughts or fantasies, and a lack of responsive desire. Motivations (here de-
Daytime (urinary) frequency fined as reasons/incentives) for attempting to become sexually aroused are
Sign scarce or absent. The lack of interest is considered to be beyond the norma-
Number of micturitions during daytime (awake hours, including first void tive lessening with lifecycle and relationship duration.
after waking up from sleep and last void before sleep).
Decreased libido or sexual desire (female)
De novo (postoperative) dyspareunia Symptom
Symptom Absent or diminished feelings of sexual interest or desire, absent sexual
Dyspareunia first reported after surgery or other interventions thoughts or fantasies, and a lack of responsive desire. Motivations (here de-
fined as reasons/incentives) for attempting to become sexually aroused are
De novo postoperative) sexual dysfunction symptoms scarce or absent. The lack of interest is considered to be beyond the norma-
Symptom tive lessening with lifecycle and relationship duration.
New onset sexual dysfunction symptoms (not previously reported before
surgery) Decreased (low) semen volume
Symptom
Decreased arousal (female) Complaint of smaller amount of seminal fluid than normal or previously ex-
Symptom perienced.
Persistent or recurrent inability to achieve or maintain sexual excitement.
This may be expressed as lack of excitement, lack of lubrication, lack of Deep dyspareunia
vaginal and clitoral engorgement, or lack of expression of other somatic Symptom
responses. Complaint of pain or discomfort on deeper penetration (mid or upper va-
gina)
Decreased libido (male)
Symptom

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 875

Defecatory dysfunction (female) which leakage is observed in the absence of increased abdominal pressure
Diagnosis or a detrusor contraction. High detrusor LPP (e.g., over 40 cm H2O) may put
A diagnosis by clinical history and examination, assisted, at times, by the patients at risk for upper urinary tract deterioration, or secondary damage
results of diagnostic tests involving the confirmation of abnormal or difficult to the bladder in the cases of known underlying neurological disorders such
function in the initiation, passage or completion of defecation. as paraplegia or MS. There are no data on any correlation between detrusor
LPP and upper tract damage in nonneurogenic patients.
Defecatory/Post-defecatory symptoms
Symptom Detrusor leak point volume (DLPV)
Symptoms experienced during or following the act of defecation. Investigation
The bladder volume at which urine leakage first occurs, either with detrusor
Defecography (female) overactivity or low compliance.
Imaging
This demonstrates normal anatomy of the anorectum as well as disorders of Detrusor opening pressure (cm H2O) - pressure flow studies
rectal evacuation. Barium paste is inserted rectally prior to defecation over a Investigation
translucent commode. Measurement of the anorectal angle is allowed with Detrusor pressure recorded immediately before the initial isovolumetric
evidence of the presence, size or emptying of any rectocele. Enteroceles, contraction.
rectal intusssusception and mucosal prolapse might be diagnosed as well
as a spastic pelvic floor (anismus). Detrusor overactivity - filling cystometry
Investigation
Defecography (male) The occurrence of detrusor contraction(s) during filing cystometry. These
Imaging contractions, which may be spontaneous or provoked, produce a waveform
This demonstrates the anatomy of the anorectum as well as disorders of on the cystogram, of variable duration and amplitude. Symptoms, e.g. ur-
rectal evacuation. Barium paste is inserted rectally prior to defecation over gency and/or urgency incontinence or perception of contraction may or
a translucent commode. may not occur.

Deficient perineum / cloacal-like defect Detrusor overactivity - Subtypes

Sign Diagnosis
A spectrum of tissue loss from the perineal body and rectovaginal septum (i) Idiopathic (primary) detrusor overactivity: No identifiable cause for the
with variable appearance. There can be a common cavity made up of the involuntary detrusor contraction(s).
anterior vagina and posterior rectal walls or just an extremely thin septum (ii) Neurogenic (secondary) detrusor overactivity: There is detrusor over-
between the anorectum and vagina. activity and evidence (history; visible or measurable deficit) of a relevant
neurological disorder.
Dehiscence (iii) Non-neurogenic (secondary) detrusor overactivity: An identifiable pos-
Surgery – Complication related sible non-neurological cause exists for involuntary detrusor contraction(s)
A bursting open, splitting or gaping along natural or sutured lines. during bladder filling. e.g. functional (obstruction); stone, tumor (e.g. carci-
noma in situ), UTI.
Delayed ejaculation
Symptom Detrusor Overactivity (DO)
Complaint of an increase in the time taken for ejaculation to occur. Diagnosis
In men and women with LUT/PF symptoms when detrusor muscle contrac-
Detrusor acontractility (male) tions occur during filling cystometry.
Diagnosis
A diagnosis by urodynamic investigation, generally (but not always) with Detrusor overactivity (DO) - filling cystometry
relevant signs and symptoms, manifest by the absence of an observed det- Investigation
rusor contraction during pressure-flow studies resulting in prolonged blad- The occurrence of detrusor contraction(s) during filling cystometry. These
der emptying and/or a failure to achieve complete bladder emptying within contractions, which may be spontaneous or provoked, produce a wave form
a normal time span. Voiding is usually achieved by straining or manual pres- on the cystometrogram, of variable duration and amplitude. The contrac-
sure on the bladder resulting generally in an abnormally slow urine flow rate tions may be phasic or terminal. They may be suppressed by the patient,
and/or an abnormally high postvoid residual. or uncontrollable. Symptoms, e.g. urgency and/or urgency incontinence or
Subtypes: perception of the contraction may (note if present) or may not occur.
(I) Neurogenic
(II) Non-neurogenic Detrusor Overactivity (female)
Diagnosis
Detrusor leak point pressure (DLPP - cm H2O) This diagnosis by symptoms and urodynamic investigations is made in
Investigation women with lower urinary tract symptoms (more commonly OAB-type
This is a static test. The pressure is the lowest value of the detrusor pressure symptoms—when involuntary detrusor muscle contractions occur during
at which leakage is observed in the absence of either a detrusor contraction filling cystometry
or increased abdominal pressure.
Detrusor overactivity leak point pressure (DOLPP)
Detrusor Leak Point Pressure (female) - DLPP - cm H20 Investigation
Investigation Lowest detrusor pressure rise with detrusor overactivity at which urine
This a static test. The pressure is the lowest value of the detrusor pressure at

Terms C - D
876

leakage first occurs in the absence of a voluntary detrusor contraction or of the symptoms and signs of a disease; laboratory: investigative options/
increased abdominal pressure. procedures to be mentioned.

Detrusor pressure at end of flow (Pdet-ef – unit: cm H2O) - pressure flow Digital rectal examination (DRE - female)
studies Sign
Investigation The gloved finger should be placed in the center of the anus with the finger
Detrusor pressure recorded at the end of urine flow. parallel to the skin of the perineum in the midline.The finger should then
be pressed gently into the anal canal but at the same time pressed back-
Detrusor pressure at maximum flow (Pdet-Qmax – unit: cm H2O) wards against the skin of the posterior wall of the anal canal and underlying
Investigation sling of the puborectalis muscle. This overcomes most of the tone of anal
Detrusor pressure recorded at maximum urinary flow rate. sphincter and allows the finger to straighten and slip into the rectum. This
will allow assessment of: (a) Resting anal tone, voluntary squeeze of the anal
Detrusor pressure (Pdet - cm H20) sphincter as well as the levator muscles, sustained squeeze over 5 sec and
Investigation involuntary contraction elicited during a cough; (b) Obvious hemorrhoids
The component of intravesical pressure that is created by forces in the blad- can be palpated but grade II and grade III. Hemorrhoids are better assessed
der wall (passive and active). It is calculated by subtracting abdominal pres- by proctoscopy. Painful examination may be associated with fistula in ano,
sure from intravesical pressure fissure in ano, infection or pilonidal abscess; (c) Palpable anal sphincter gap.
(Pdet = Pves - Pabd). An assessment can be made of a palpable anal sphincter gap to assess if
there has beenprevious obstetric or surgical damage.The perineal body can
Detrusor sphincter dyssynergia (DSD) - female be assessed for deficiency; (d) Rectal contents. The contents of the rectum
Investigation can be assessed. The feces may be hard or soft, the rectum may be empty
This is incoordination between detrusor and sphincter during voiding due or collapsed and sometimes ballooned out. This allows assessment of fecal
to a neurological abnormality (i.e. detrusor contraction synchronous with impaction; (e) Confirmation of presence of rectocele, enterocele, or perine-
contraction of the urethral and/or periurethral striated muscle). This is a ocele. Use of POP-Q for staging of prolapse; (f ) Bidigital examination may be
feature of neurological voiding disorders. Neurological features should be carried out with the patient supine in a gynecological examining position.
sought. Videocystourethrography (VCU) is generally valuable to conclude By inserting the index finger in the vagina and the middle finger in the rec-
this diagnosis. tum, the rectovaginal septum and any intervening small bowel loops can
be palpated to differentiate a rectocele from an enterocele, during a Valsal-
Detrusor sphincter dyssynergia (DSD) - pressure flow studies (male +/- VCU, va maneuver; (g) Rectal lesions such as carcinoma, intussusception or rec-
EMG) to-vaginal fistula. If a mass is felt on a fingertip, the patient should be asked
Investigation to strain, and this will often move the mass down to bring it within reach; (h)
Dyscoordination between detrusor and smooth or striated sphincter func- An assessment can be made of the rectovesico/rectouterine pouch to look
tion during voiding due to a neurological abnormality (i.e. detrusor contrac- for extra rectal masses.
tion synchronous with contraction of the urethral and/or periurethral striat-
ed muscle). This is a feature of neurological voiding disorders. Digital Recto-vaginal examination
Sign
Detrusor underactivity (DU) While the patient is straining and the prolapse is maximally developed.The
Diagnosis aim is to try to differentiate between a high rectocele and an enterocele.
A diagnosis based on urodynamic investigations, generally (but not always)
with relevant symptoms and signs, manifest by low detrusor pressure or Digitation (female)
short detrusor contraction in combination with a low urine flow rate result- Symptom
ing in prolonged bladder emptying and/or a failure to achieve complete Use of fingers in rectum or vagina to manually assist in evacuation of stool
bladder emptying within a normal time span (a high postvoid residual may contents.
be present).
Diminished rectal sensation (rectal hyposensitivity)
Detrusor underactivity (DU) - pressure flow studies. Symptom
Investigation Complaint of diminished or absent sensation of filling in the rectum.
Low detrusor pressure or short detrusor contraction time, usually in combi-
nation with a low urine flow rate resulting in prolonged bladder emptying Direct electrical neurostimulation
and/or a failure to achieve complete bladder emptying within a normal time Conservative Management – General
span. This is a direct stimulation of the nerves or neural tissue to effect function of
the end organ. It is done through electrodes implanted directly or near the
Detrusor wall thickness (DWT) or Bladder wall thickness (BWT) nerve or neural tissue.
Imaging
Transabdominal visualization of the anterior bladder wall with a (linear) high Directly
frequency ultrasound scanner for the detection of BOO if DWT is ≥2 mm in Surgery – Complication related
bladders filled with ≥250 ml (or BWT is ≥5 mm in bladders filled with 150 ml. Without an intermediary or intervening factor.

Diagnosis Disability associated urinary incontinence

Diagnosis Symptom
The determination of the nature of a disease; clinical: made from a study Complaint of urinary incontinence in the presence of a functional inability

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 877

to reach a toilet/urinal in time because of a physical impairment, (e.g. ortho- involuntary intermittent contractions of the peri-urethral striated or levator
pedic, neurological) and/or mental impairment. muscles during voiding in neurologically normal women. This type of void-
ing may also be the result of an acontractile detrusor (abdominal voiding)
Discharge (female) with electromyography (EMG) or video-urodynamics required to distinguish
Sign between the two entities.
Perianal or vaginal bloody or mucus discharge.
Dyspareunia
Diurnal polyuria Symptom
Symptom Complaint of persistent or recurrent pain or discomfort associated with at-
Complaint that daytime urine excretion volume is noticeably larger than the tempted or complete vaginal penetration.
previous experience.
Dyspareunia - deep
Division Symptom
Surgery – Complication related Complaint of pain or discomfort on deeper penetration (mid or upper va-
A separation into two or more parts. gina).

Double incontinence Dyspareunia - superficial (introital)

Symptom Symptom
Complaint of both anal incontinence and urinary incontinence. Complaint of pain or discomfort on vaginal entry or at the vaginal introitus.

Dysfunction Dyspareunia with penile vaginal movement

Diagnosis Symptom
Difficult or abnormal function Pain that is caused by and is dependent on penile movement.

Dysfunctional voiding - pressure flow studies (male +/- VCU, EMG) Dysuria
Investigation Symptom
This is characterized by an intermittent and/or fluctuating flow due to in- Complaint of pain, burning or other discomfort during voiding. Discomfort
adequate or variable relaxation generally of the external sphincter during may be intrinsic to the lower urinary tract (e.g. bladder or urethra), external
voiding in neurologically normal men (i.e. no historical, visible or measura- or referred from other adjacent similarly innervated structures e.g. lower
ble evidence of neurological disease). ureter.

Dysfunctional voiding (female)

Investigation
This is characterized by an intermittent and/or fluctuating flow rate due to

E
of these medium, alternating sine wave currents ranges between 2,000 and
Ejaculatory dysfunction 5,000 cycles per second.
Symptom
Complaint of alteration of the emission of seminal fluids during ejaculation. Electrical neuromodulation
Conservative Management – General
Ejaculatory pain This is the stimulation of the nerves or neural tissue to modulate function
Symptom and induce therapeutic response of the LUT.
Complaint of pain, pressure or discomfort felt in the perineum, suprapubic
region and/or penis during ejaculation but may continue for a time after- Electrical Therapies - Mode of Application
wards. Conservative Management – Female
1. Surface electrodes: non-invasive placement of electrodes, including intra-
Electrical Currents Used in Pelvic Floor Therapies vaginal and intra-anal electrodes, in contrast to electrodes that pierce the
Conservative Management – Female skin, i.e., needle stimulation. a) Non-invasive electrical nerve stimulation or
a) Faradic current: an alternating and interrupted low frequency current transcutaneous electrical nerve stimulation (TENS): the application of elec-
capable of stimulating (depolarizing) nerve fibers through the skin using trical energy to stimulate cutaneous nerve and peripheral motor nerves, via
surface-stimulating electrodes. It is used to stimulate innervated muscles, suprapubic, perineal or sacral placement of electrodes, or other external
causing them to contract. b) TENS: an alternating and interrupted low-fre- sites, or intravaginal or intra-anal plug electrodes. Tibial nerve stimulation
quency current capable of stimulating (depolarizing) nerve fibers through (TNS) is a form of peripheral neuromodulation targeting symptom relief of
the skin using surface-stimulating electrodes for pain modulation or pain overactive bladder (OAB) and urinary urge incontinence. Indirect access to
relief. c) Interferential current: a medium frequency, amplitude modulated the sacral plexus is achieved by intermittent, electrical stimulation of the
electrical current that results from the interference (hence the word inter- tibial nerve, which lies behind the medial malleolus, using skin surface elec-
ferential) caused by crossing two or more medium-frequency alternating trodes applied to the medial malleolar area (transcutaneous TNS). There are
sine wave currents with different carrier frequencies. The carrier frequency two main types of electrical stimulation with surface electrodes: i) Long-
term or chronic electrical stimulation: is delivered below the sensory thresh-

Terms D - E
878

old. It is aimed at inhibiting detrusor activity by afferent pudendal nerve Electrostimulation - transcutaneous electrical nerve stimulation (TENS)
stimulation.The device is used 6–12h per day for several months. ii) Maximal Conservative Management – General
neuromuscular electrical stimulation: applies a high-intensity stimulus, set This is electrical stimulation of the nerves through intact skin to modulate
just below the pain threshold. It is aimed at improving urethral closure, via function and induce therapeutic response of the LUT.
striated muscle recruitment. Detrusor inhibition by afferent pudendal nerve
stimulation has also been suggested as a mechanism of effect. Maximal Endoanal Ultrasonography (EAUS) or Anal Endosonography (AES)
electrical stimulation (35–70Hz) is applied over short period (15 to30min), is Imaging
used several times perweek (and up to 1–2 times daily), and may be provid- Ultrasound of the anal canal performed with a pole-like ultrasound probe
ed via in-clinic application or via portable devices at home). placed in the anal canal giving a 360 degree image of the anal canal. It is
usually performed with the patient placed in the lithotomy, prone position
Electrical Therapy or sometime left lateral. Two dimensional AES; three dimensional AES –
Conservative Management – Female three-dimensional reconstruction of the anal canal is performed using ei-
Electrical therapy is the use of electric potential or currents to elicit thera- ther axial or sagittal images.
peutic responses. Current may be directed at motor or sensory functions. It
is not within the scope of this document to define all electrical stimulation Enterocele
terms. Electrical muscle stimulation (also known as neuromuscular electrical Sign
stimulation or electromyo stimulation). Electrical muscle stimulation (EMS) Bulge of upper wall of the vagina associated with herniation of the perito-
is the application of electric impulses directly to striated PFM (end-plate) to neal sac and loops of small bowel.
facilitate contraction. EMS is often referred to as “pelvic floor muscle elec-
trical stimulation” (PFES) or “functional electrical stimulation.” PFES is the Enterocele
application of electrical current to the PFM. All of these stimulations may Sign
(indirectly) cause inhibition of the detrusor contraction. Hernia of peritoneum and possibly abdominal contents into the vault.

Electromyography Enuresis
Investigation Symptom
Electromyography (EMG) is the recording of electrical potentials generated Complaint of intermittent incontinence that occurs during periods of sleep.
by the depolarization of muscle fibers. Electromyographic diagnosis is made If it occurs during the main sleep period, then it could be qualified by the
by evaluating the state of the muscle (muscle pathology) by recording and adjective “nocturnal”. The patient has to be asleep when enuresis happens
analyzing the electrical activity generated by the muscle. 1. Intramuscular and is usually unaware of it.
EMG: insertion of a wire or needle electrode into the muscle to record motor
unit action potentials. 2. Surface electromyography: electrodes placed on Enuresis
the skin of the perineum or inside the urethra, vaginal or rectum. Sign
“Wetting” while asleep
Electrophysiological Parameters
Conservative Management – Female Enuresis - acquired
1. Electrical current: the flow (current) of electrons (electricity) from an Symptom
electron source (stimulator) the wires and electrodes used to deliver such Complaint of intermittent incontinence that occurs during periods of sleep
an electrical current to soft tissues. There are three types of current: direct, that has developed in adulthood.
alternating, and pulsed. – a) Direct: the continuous, unidirectional flow of
charged particles for 1s or longer, the direction of which is determined by Enuresis - primary
the polarity selected. Polarity refers to two oppositely charged poles, one Symptom
positive and one negative. Polarity determines the direction in which cur- Complaint of intermittent incontinence that occurs during periods of sleep
rent flows. b) Alternating: the continuous, bidirectional flow of charged that has been present lifelong.
particles, for 1s or longer, relative to the isoelectric baseline. c) Pulsed: the
noncontinuous, interrupted, and periodic flow of direct (DC) or alternating Episodic inability to void
(AC) currents. Symptom
Complaint of inability to initiate voiding despite relaxation and/or intensive
Electrostimulation - direct electrical neurostimulation effort (by abdominal straining, Valsalva or suprapubic pressure).
Conservative Management – General
This is a direct stimulation of the nerves or neural tissue to effect function of Epispadias
the end organ. It is done through electrodes implanted directly or near the Sign
nerve or neural tissue. Urethral meatus sited on dorsal surface of the penis, either congenital or
acquired, proximal to its normal position on the tip of the glans.
Electrostimulation - electrical neuromodulation
Conservative Management – General Erectile dysfunction (male)
This is the stimulation of the nerves or neural tissue to modulate function Symptom
and induce therapeutic response of the LUT. Complaint of inability to achieve and sustain an erection firm enough for
satisfactory sexual performance.
Electrostimulation - pelvic electrical stimulation
Conservative Management – General Excoriation
This is the application of electrical current to stimulate the pelvic viscera or Sign
their nerve supply. Perianal excoriation, skin rashes.

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 879

Exercise and Exercise Training A surgically excised prosthesis or graft.

Conservative Management – Female
Exercise is a form of leisure time activity that is usually performed on a Exposure
repeated basis over an extended period of time (exercise training) with Surgery – Complication related
specific external objectives, such as improvement of fitness, physical per- A condition of displaying, revealing, exhibiting or making accessible e.g.
formance, or health. Exercise training includes: endurance training, strength vaginal mesh exposure. (NB: “erosion” is not an ICS definition).
training, flexibility training, and motor control (including balance), all of
which may apply to the PFM. Extra-pelvic Muscle Activity
Therapeutic exercise/exercise therapy: consists of interventions directed Conservative Management – General
toward maximizing functional capabilities. It includes a broad range of ac- Is the contraction of muscles other than those that comprise the pelvic floor,
tivities intended to improve strength, range of motion (including muscle for example the abdominal, gluteal and adductor muscles. Extra-pelvic
length), cardiovascular fitness, flexibility,or to otherwise increase a person’s muscle activity is needed for maximal pelvic floor muscle effort.
functional capacity.
1. Rehabilitation/re-education: help individuals to regain skills and abilities Extra-urethral incontinence
that have been lost as a result of illness, injury or disease, or incarceration, Sign
restoring a disabled individual to maximum independence commensurate Observation of urine leakage through channels other than the urethral me-
with his or her limitations. Mode of exercise training: is not only the type of atus, e.g. fistula.
activity to be performed (for instance, fast walking, jogging, or swimming,
strength training) , but also the temporal pattern of activity that is recom- Extrusion
mended (that is, continuous or intermittent activity), with a detailed specifi- Surgery – Complication related
cation of the duration of exercise and rest periods in the case of intermittent Passage gradually out of a body structure or tissue, e.g. a loop of tape pro-
activity bouts. Authors are encouraged to specifically describe all compo- truding into the vaginal cavity. (NB “Erosion” is not an ICS definition)
nents of the mode of exercise and the dose provided.

Explant
Surgery – Female

F
Fecaluria
Fecal (flatal) urgency incontinence. Symptom
Symptom Complaint of passage of feces (per urethram) in the urine.
Complaint of an involuntary loss of feces (flatus) associated with fecal ur-
gency. Feeling of incomplete (bladder) emptying
Symptom
Fecal incontinence Complaint that the bladder does not feel empty after voiding has ceased.
Symptom
Complaint of involuntary loss of feces. Feeling of incomplete bowel evacuation
- when feces is solid and/or Symptom
- when feces is liquid Complaint that the rectum does not feel empty after defecation. May be
accompanied by the desire to defecate again.
Fecal Incontinence (Female)
Diagnosis Female Anorectal Dysfunction - Assessment of Pelvic Floor Muscle Function
Fecal incontinence: involuntary loss of solid or liquid stool and could be Sign
due to: 1: Anal sphincter disruption is due to discontinuity of the external Pelvic floor muscle function can be qualitatively defined by the tone at rest
anal sphincter, internal anal sphincter or both; 2: Hypocontractile/acontrac- and the strength of a voluntary or reflex contraction as strong, normal, weak,
tile sphincter is due to neuropathy or atrophy; 3: Combined anal sphincter or absent or by a validated grading symptom. Voluntary pelvic floor muscle
disruption and hypocontractile/acontractile sphincter. 4: Rectal overactivity contraction and relaxation may be assessed by visual inspection, by digital
due to exaggerated smooth muscle contraction of the rectum could also be palpation (vaginal or anorectal) (circumferentially), electromyography, dy-
associated with hypersensitivity; 5: Overflow incontinence seepage of stool namometry, manometry, or ultrasound. Factors to be assessed include mus-
due to fecal impaction. cle strength (static and dynamic) (graded as strong, normal, weak or absent),
voluntary muscle relaxation (graded as absent, partial, complete, delayed),
Fecal (rectal) urgency muscular endurance (ability to sustain maximal or near maximal force), re-
Symptom peatability (the number of times a contraction to maximal or near maximal
Complaint of a sudden compelling desire to defecate that is difficult to de- force can be performed), duration, co-ordination, and displacement. Assess-
fer. ment can be made of each side of the pelvic floor separately to allow for any
unilateral defects and asymmetry. Assessment of displacement (perineal el-
Fecal urgency warning time evation or descent) of the pelvic floor can be made during cough or Valsalva.
Symptom Normally, there is some downward movement of the pelvic floor muscles or
Time from first sensation of urgency to voluntary defecation or fecal incon- there is a ventral movement (perineal elevation, inward (cephalad) and up-
tinence. ward movement of vulva, perineum, and anus). Rectal examination obser-

Terms E - F
880

vations can include: (a) Anal sphincter tone and strength: given the absence ocele: defined as a herniation of the peritoneal sac, which contains omental
of a formal quantitative assessment via the rectal route, assessment of anal fat (peritoneocele), small bowel (enterocele) or sigmoid (sigmoidocele), into
tone and strength on digital examination, can be graded using the same the rectovaginal or rectovesical space below the PCL. The largest distance
convention used when grading transvaginally—as strong, normal, weak, or between the PCL and the most inferior point of the enterocele is measured
absent or by a validated grading symptom. (b) Anal sphincter tear: may be with a perpendicular line. Depending on this distance, small (<3cm), moder-
recognized as a clear ‘‘gap’’ in the anal sphincter on digital examination. ate (3–6cm), and large (>6cm) enteroceles are distinguished, • Dyssynergic
defecation: different structural imaging findings can be seen on dynamic
Female Anorectal Dysfunction - Clinical Applications of Defecating Proctog- pelvic MRI, including prominent impression of the puborectal sling, narrow
raphy anal canal, prolonged evacuation, a lack of descent of the pelvic floor and
Imaging thus a failure to increase the ARA. In comparison with clinical examination
Assuming that posterior wall prolapse and rectocele can be considered the (POP-Q), dynamic MRI has no additional value in the prediction of symp-
same anatomic entity, clinical examination is not accurate in diagnosing toms with increasing degree of POP. 4: Perianal abscesses and fistulas.
anatomical defects of posterior vaginal wall and enteroceles compared to
defecography as reference standard. Clinical examination overestimates the Female Anorectal Dysfunction - Defecating Proctography
presence of the posterior wall defects (large false positive rates) but misses Imaging
enterocele in patients with primary POP (large false negative rates). The ma- Evaluates in real time the morphology of rectum and anal canal in correla-
jor function of proctography is not merely to document evacuatory abnor- tion with pelvic bony components both statically and dynamically by injec-
malities, but also to classify those abnormalities into those potentially sur- tion of a thick barium paste into the rectum and its subsequent evacuation.
gically relevant, those likely to benefit from behavioral biofeedback therapy Contrast administration into the bladder and vagina provides a more com-
alone, or indeed those which are incidental. 1: Pelvic floor descent: Pelvic prehensive assessment of the pelvic organs and has been labelled ‘‘dynamic
floor descent, defined as the distance moved by the ARJ or ARA at rest to the cystoproctography.’’ At rest, the anal canal is closed and rectum assumes its
point of anal canal opening, is considered abnormal if it exceeds 3cm.2: In- normal upright configuration. The position of the pelvic floor is inferred by
tussusception and prolapse Intussusception refers to infolding of the rectal reference to the PCL (inferior margin of pubic symphysis to the sacro-coccy-
wall into the rectal lumen. It may be described as intra-rectal, intra-anal or geal junction). Perineal descent is measured from this line to the ARJ, and
external to form a complete rectal prolapse. 3: Rectocele: Rectocele diagno- may be up to 1.8cm at rest. Some pelvic floor descent during evacuation
sis on evacuation proctography is defined as any anterior rectal bulge. The is considered normal and a descent of up to 3cm from the rest position to
depth of a rectocele is measured from the anterior border of the anal canal anal canal opening is acceptable. The ARA is defined as the angle between
to the anterior border of the rectocele. A distance of <2cm is classified as the anal canal axis and the posterior rectal wall, and on average is around
small, 2–4cm as moderate and >4cm as large. Of more relevance however is 90 degrees. The puborectalis length (PRL) can be estimated by measuring
barium trapping at the end of evacuation (defined as retention of >10% of the distance between the ARA and symphysis pubis. A normal emptying
the area, and this itself is related the size of the rectocele. 4: Enterocele: An phase at the proctogram is described by five elements: • Increase in the ARA
enterocele is diagnosed when small bowel loops enter the peritoneal space by around 20–30 degrees; • Obliteration of the puborectalis impression and
between the rectum and vagina. Diagnosis of an enterocele on proctogra- the PRL should increase by around 3–4cm; • Wide opening of the anal ca-
phy is only really possible if oral contrast has been administered before the nal within a couple of seconds; • Evacuation of rectal contents proceeding
examination. Herniation of the sigmoid into the rectogenital space (sigmoi- promptly and to completion; • Lack of significant pelvic floor descent. After
docele) is significantly less common than an enterocele. 5: Dyssynergic def- evacuation is complete, the anal canal should close, the ARA recover and
ecation Various proctographic abnormalities have been described including the pelvic floor return to its normal baseline position. Post toilet imaging
prominent puborectal impression, a narrow anal canal and acute anorectal may be required, particularly in those suspected of retained barium within
angulation. However these observations may be found in normal controls rectoceles.
and are in themselves unreliable distinguishing features.
Female Anorectal Dysfunction - Endoanal ultrasonography (EAUS)
Female Anorectal Dysfunction - Clinical Applications of MRI in the Posterior Imaging
Compartment The majority of current systems provide 2D & 3D Imaging which give a 360
Imaging degree axial view of the anal canal and of the rectal wall. Endoanal ultra-
1: Fecal incontinence Endoanal ultrasound and endoanal magnetic res- sound can be performed with the patient placed in the dorsal lithotomy, left
onance imaging (MRI) have been demonstrated to be comparable in the lateral or prone position. Irrespectiveof the position, the probe should be
detection of external sphincter defects. External phased array coil MRI can rotated so that the anterior aspect of the anal canal is superior (12 o’clock)
replace endoluminal MRI with comparable results. 2: Levator ani injuries and left lateral is right (3 o’clock) on the screen. The anal canal is divided
Abnormalities of the LA are identified on MRI as present or absent. Defect into three levels of assessment in the axial plane referring to the following
severity is further scored in each muscle from 0 (no defect) to 3 (complete anatomical structures: • Upper level: the hyperechoic sling of the puborec-
loss). A summed score for the two sides (0–6) is assigned and grouped as mi- tals muscle (PR) and the complete ring of the internal anal sphincter (IAS)
nor (0–3) or major (4–6). 3: Obstructed defecation During maximal Valsalva are visualized • Middle level: corresponds to the superficial part of the EAS
maneuver, dynamic MRI may be used to demonstrate: • Rectocele: meas- (concentric band of mixed echogenicity), the conjoined longitudinal layer,
ured as the depth of wall protrusion beyond the expected margin of the the IAS (concentric hypoechoic ring), and the transverse superficial perinei
normal anorectal wall. Based on sagittal MR-sections through mid of pelvis, muscles ; • Lower level: corresponds to the subcutaneous part of the EAS
rectoceles are graded as small (<2cm), moderate (from 2 to 4cm), and large where the IAS is absent. The acquisition of a three-dimensional data vol-
(>4cm), • Rectal intussusception: the infolding of the rectal mucosa occur- ume (3D ultrasound) and the underlying techniques vary. Acquisition may
ring during defecation. Depending on the location, an intrarectal intussus- be ‘‘free-hand’’ (low resolution 3D) or‘‘automatic computer-controlled’’ (high
ception, limited to the rectum, is distinguished from an intra-anal intussus- resolution 3D).
ception extending into the anal canal. The location of the intussusception
may be anteriorly, posteriorly, or circumferentially. The intussusception ei- Female Anorectal Dysfunction - Squeeze pressure
ther involves only the mucosa or the full thickness of the rectal wall, •Enter- Sign

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Measurement of squeeze pressure involves the exertion of pressure, com- supports). • Level I: at the highest level the bladder base is visualized on the
pressing the assessor’s finger during digital palpation or using a mechanical screen at 12 o’clock position and the inferior third of the rectum at 6 o’clock
device. The patient is asked to squeeze the PFM as hard as possible (max- position. • Level II: corresponds to the bladder neck, the intramural region
imum strength), to sustain the squeeze contraction (endurance), or to re- of the urethra and to the anorectal junction. At this level the subdivisions
peat squeeze contractions (repetitions). The measurement can be done in of the LA (pubovaginalis, puboperinealis, puboanalis, puborectalis, and il-
the anorectum using manual muscle testing with digital rectal palpation or iococcygeus) may be identified. • Level III: corresponds to the midurethra
pressure manometry in the vagina using manual muscle testing with digital and to the upper third of the anal canal. At this level, the LA is visualized as
vaginal palpation or pressure manometry, or dynamometry. So far, not all a multilayer hyperechoic sling coursing lateral to the vagina and posteriorly
quantitative assessments and scales of pelvic floor squeeze pressure have to the anal canal and attaching to the inferior pubic ramus. In the axial plane
the same methodological qualities, like validity, reproducibility, and respon- of minimal hiatal dimensions, identified as the minimal distance between
siveness. Pelvic floor muscle spasm was defined as persistent contraction of the inferior edge of the SP and the anterior border of the LA at the ARA,
striated pelvic floor muscle that cannot be released voluntarily. If the con- the biometric indices (anteroposterior and transverse diameters, area) of
traction is painful, this is usually described as a cramp. Spasm over days or the LH can be determined. • Level IV: at the outer level, the perineal mus-
weeks may lead to a contracture. Pelvic floor muscle tenderness: sensation cles (bulbospongiosus, ischiocavernosus, and superficial transverse perineii
of discomfort with or without pain; discomfort of pelvic floor muscle elicit- muscles), the perineal body, the distal urethra and the middle and inferior
ed through palpation. Tenderness can be scored during a digital rectal (or third of the anal canal are visualized. The anteriorposterior diameter of the
vaginal) examination of levator ani, piriformis and internal obturator mus- urogenital hiatus (UGH), corresponding to the SP-perineal body distance,
cles bilaterally, according to each subject’s reactions: 0, no pain; 1, painful can be determined. Transvaginal ultrasound may be also performed with
discomfort; 2, intense pain; with a maximum total score of 12. Although not electronic probes with linear array, which provide mid-sagittal image of the
universally accepted, pelvic floor muscle traction is the use of a pulling force posterior compartment. The main advantage of this technique is the dy-
to examine or treat pelvic floor muscles, postulated to end pelvic muscle namic assessment of the anorectal region, during Valsalva and pelvic floor
spasm or relieve pain. muscle contraction (PFMC).

Female Anorectal Dysfunction - Transperineal ultrasonography (TPUS) Female Anorectal Dysfunction - Ultrasonography to Assess Fecal Inconti-
Imaging nence
Conventional convex transducers (frequencies between 3 and 6MHz and Imaging
field of view at least 70 degrees) provide 2D imaging of the pelvic floor. Anal inspection and digital rectal examination can give information about
Transperineal ultrasound is performed with the patient placed in the dorsal internal and external anal sphincter function but are inaccurate for deter-
lithotomy position, with the hips flexed and abducted. If necessary, the pa- mining external anal sphincter defects < 90 degrees and internal sphincter
tient can be examined standing, to maximise descent of pelvic organs, espe- defects. Therefore, a sufficient diagnostic work-up should comprise at least
cially if the patient finds it difficult to produce an effective Valsalva maneu- rectal examination, anal inspection and endoanal ultrasonography. EAUS
ver. No rectal or vaginal contrast is used. Perineal ultrasound provides has become the gold standard for morphological assessment of the anal ca-
sagittal, coronal and oblique sectional imaging, with the mid-sagittal plane nal. The International Consultation on Incontinence (ICI) has recommended
being the most commonly used as this gives an overall assessment of all an- EAUS as the first line imaging investigation for fecal incontinence to differ-
atomical structures (bladder, urethra, vaginal walls, anal canal, and rectum) entiate between those with intact anal sphincters and those with sphincter
between the posterior surface of the symphysis pubis (SP) and the posterior lesions (defects, scarring, thinning, thickening, and atrophy). Routine use of
part of the levator ani (LA). The imaging is usually performed at rest, on transperineal, transvaginal and translabial ultrasonography to image the
maximal Valsalva maneuver and on pelvic floor muscle contraction (PFMC). anal sphincter complex are not recommended, although research is ongo-
The access to the mid-sagittal plane allows the following evaluations: •In- ing.The operator should identify if there is a combined or isolated lesion of
tegrity of the perineal body: appearing as a triangular shaped, slightly hy- the IAS and EAS and report the number of defects, as well as the extent of
perechoic structure anterior to the anal sphincter, • Measurement of the the defect circumferentially (radial angle in degrees or in hours of the clock)
anorectal angle (ARA): formed by the longitudinal axis of the anal canal and and longitudinally (proximal, distal or full length). Using 3D EAUS, two scor-
the posterior rectal wall, • Dynamic assessment of the posterior compart- ing systems have been proposed to define the severity of anal sphincter
ment. During Valsalva it is possible to visualize descent of an enterocele, to damage. EAUS has an important role in detecting undiagnosed anal sphinc-
assess the movement of the anterior rectal wall to detect a rectocele, and to ter injuries following vaginal delivery and can be useful in the management
evaluate movement of the PR and ARA to diagnose pelvic floor dyssynergy. of subsequent pregnancies following OASIS. It is also useful to evaluate the
3D TPUS may be performed with volumetric probes (electronic curved array results of treatment (anterior sphincter repair, bulking agent injections).
of 4–8MHz). An advantage of this technique is the opportunity to obtain to-
mographic or multi-slice imaging, for example, in the axial plane, in order to Female Anorectal Dysfunction - Ultrasound Imaging (General)
assess the entire PR and its attachment to the pubic rami. It is also possible Imaging
to measure the diameter and area of the levator hiatus (LH) and determine Ultrasound is increasingly being incorporated as an investigation of pos-
the degree of hiatal distension on Valsalva. Four dimensional (4D) imaging terior compartment disorders. An integrated multi-compartmental pelvic
indicates real-time acquisition of volume ultrasound data. floor ultrasonography with a combination of different modalities has been
described to assess pelvic floor dysfunction for a global and multi-compart-
Female Anorectal Dysfunction - Transvaginal Ultrasound (TVUS) mental perspective. Modalities in current routine clinical use: (a) Endoanal:
Imaging intra-anal 360 degree sector scanning using rotational mechanical probe or
Transvaginal ultrasound is performed with the patient placed in the dorsal radial electronic probe. (b) Transperineal: curved array probe applied in the
lithotomy position. Currently, the transducers used for pelvic floor 3D TVUS perineum between the mons pubis and the anal margin. This term incorpo-
are high multi-frequency (9–16MHz), 360 degree rotational mechanical rates trans-labial ultrasound. Introital ultrasound is usually assumed to im-
probe or radial electronic probe. The pelvic floor is divided into four levels ply the placement of transducer with smaller footprints (such as end-firing
of assessment in the axial plane referring to the following anatomical struc- endo-vaginal probe) within the introitus. (c) Transvaginal: intra-vaginal cur-
tures (not to be confused with Delancey’s description of vaginal Levels of vilinear, linear array, or 360 degree sector scanning.

Terms F
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Female Anorectal Dysfunction - Ultrasound in the Assessment of Levator Ani the inferior border of the symphysis pubis to the last or second last coccy-
Injuries geal joint. The anorectal junction (ARJ) is defined as the cross point between
Imaging a line along the posterior wall of the distal part of the rectum and a line
Levator avulsion is the disconnection of the muscle from its insertion on the along the central axis of the anal canal. To determine pathologic pelvic floor
inferior pubic ramus and the pelvic sidewall, whereas tears may occur in any descent, the measurements are made on the images, which show maximal
part of the muscle. Avulsion is a common consequence of overstretching of organ descent, usually during maximal straining or during evacuation. The
the levator ani during the second stage of labor and it is detectable by 3D anorectal angle (ARA) is defined as the angle between the posterior wall of
TVUS and 3D TPUS imaging as the lateral attachments of the pubic bone the distal part of the rectum and the central axis of the anal canal and can
are clearly visualized. Defects are usually visualized most clearly on maximal be measured at rest, squeezing and straining. The extent of rectoceles and
PFMC. Tomographic ultrasound imaging isparticularly useful. Levator ani in- enteroceles are measured. The degree of pelvic floor relaxation is measured
juries affect the size of the levator hiatus, with a hiatal enlargement to over with two reference lines: the H line which represents hiatal widening and
25sq cm on Valsalva maneuver defined as ‘‘ballooning,’’ and are related to extends from the inferior aspect of the symphysis pubis to the posterior wall
symptoms and signs of prolapse. of the rectum at the level of the ARJ and the M line which represents hiatal
descent and extends perpendicularly from the PCL to the posterior end of
Female Anorectal Dysfunction - Ultrasound in the Assessment of Obstructed the H line. Lesions of the pelvic musculofascial support result in widening
Defecation Sydndrome (ODS) of the hiatus and descent of the levator plate. Thus, the H and M lines tend
Imaging to elongate with pelvic floor relaxation, widening the levator plate descent.
The term obstructed defecation syndrome (synonym: ‘‘outlet obstruction’’) Abnormal pelvic floor relaxation is present, when the H line exceeds 6cm,
encompasses all pelvic floor dysfunctions, which are responsible for an in- and when the M line exceeds 2cm in length.
complete evacuation of fecal contents from the rectum, straining at stool
and vaginal digitations. During maximal Valsalva maneuver, dynamic TPUS Female Anorectal Dysfunction - Use of Nuclear Colonic Transit Study
and TVUS may be used to demonstrate. • Rectocele: herniation of a depth of Imaging
over 10mm of the anterior rectal wall; • Rectal intussusception: invagination Colon scintigraphy is performed at 6, 24, and 48 hr in ventral and dorsal pro-
of the rectal wall into the rectal lumen, into the anal canal or exteriorized jection after oral administration of methacrylatecoated capsule of non-re-
beyond the anal canal (rectal prolapse); • Enterocele: herniation of bowel sorbable 111 Indium-labeled polystyrene (111ln-DTPA) micropellets.The ge-
loops into the vagina. It can be graded as small, when the most distal part ometric center, as the sum of products of colon segment activity and colon
descends into the upper third of the vagina, moderate, when it descends segment number (1 - ascending colon, 2 - transverse colon, 3 - descending
into the middle third of the vagina, or large, when it descends into the lower colon, 4 - rectosigmoid, and 5 -evacuated feces) dividing by the total counts
third of the vagina; • Dyssynergic defecation: the ARA becomes narrower, is used to determine the velocity of colonic transit. Meals normally reach the
the LH is shortened in the anteroposterior dimension, and the PR muscle cecum at 6 hr and are evacuated in 30 to 58 hr. Retention of radioactivity in
thickens as a result of contraction. the proximal colon at 48hr, indicates slow colonic transit while retention in
the rectum indicates anorectal dysfunction.
Female Anorectal Dysfunction - Use of a Contrast Enema
Imaging Female Anorectal Dysfunction - Use of Radiological Colonic Transit Studies
Contrast enema is used to identify colon pathology (benign and malignant Imaging
lesions, diverticular disease, inflammatory conditions, congenital anoma- Segmental and total colonic transit time is assessed with the use of ra-
lies, intrinsic and extrinsic abnormalities). 1: Single-contrast barium enema: dio-opaque markers and sequential abdominal X-rays. There are different
Using an appropriate catheter, a barium-water mixture or a water-soluble protocols. Most frequently used, utilizes a capsule containing 24 markers
solution of diatrizoate sodium (Gastrografin) is inserted into the colon with of 1 x 4.5mm. Patient takes one capsule on day 0 by mouth and X-ray is
the patient in the prone position until the column of barium reaches the performed on day 5. Patients who expel at least 80% markers on day5 have
splenic flexure. 2: Double-contrast or air-contrast barium enema: This pro- normal colonic transit. Patients who retain 6 or more markers may have
cedure has become the routine study for evaluation of the bowel.With the follow-up abdominal X-rays within several days. If remaining markers are
double-contrast examination, the colon is coated with a thin layer of con- scattered about the colon, the condition is slow transit or colonic inertia. If
trast material and the bowel is distended with air so that the entire mucosal the remaining markers are accumulated in the rectum or rectosigmoid, this
circumference is visualized. suggests functional outlet obstruction.

Female Anorectal Dysfunction - Use of Dynamic Magnetic Resonance Imag- Female Anorectal Dysfunction - Use of Static Magnetic Resonance Imaging
ing (MRI) (MRI)
Imaging Imaging
With the development of fast multi-slice sequences MR imaging has gained Static MRI provides detailed information of the pelvic floor anatomy. Cur-
increasing acceptance for dynamic imaging of the pelvic floor. Because the rent state-of-the art MR imaging of the pelvic floor includes imaging at a
posterior compartment is traditionally in the focus of interest, dynamic MR magnetic field strength of 1.5 Tesla (T), using pelvic or phased-array coils
imaging of the pelvic floor is often called ‘‘MR defecography.’’ Dynamic pel- and T2-weighted fast-spin echo (FSE) sequences. The spatial resolution
vic imaging may be performed in an open-configuration MR system in the can be enhanced by using endoluminal (endorectal, endovaginal) coils. In
sitting position, or in a closed configuration MR-system in the supine posi- combination with T2-weighted FSE sequences, endoluminal coils provide
tion. Both techniques are equally effective in identifying most of the clinical- improved signal-to-noise ratio (SNR) and high resolution images. Based on
ly relevant abnormalities of the pelvic floor. For evaluation of the posterior T2-weighted turbo spin-echo sequences, muscles are relative hypointense,
compartment of the pelvic floor, the rectum should be filled with a contrast ligaments and fascia hypointense while fat and smooth muscle are hyperin-
agent (ultrasound gel or mashed potatoes, gadolinium-based MR contrast tense. The prominent pelvic floor structures of the posterior compartment
agent) to study the actual act of defecation. The use of reference lines for visualized at MRI are: • Perineal body and superficial perineal muscles; • Anal
image evaluation is helpful. The most used reference line is the pubococ- sphincters: the IAS is easily recognized as a circular hyperintense structure.
cygeal line (PCL),which is defined on mid-sagittal images as the line joining It is approximately 2.9mm thick on endoluminal MRI. The inter-sphincteric

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space is seen as a bright line on T2-weighted MRI. The EAS has a thickness Although long term data are lacking, some studies have shown significant
of 4.1mm on endoluminal imaging; • Puborectalis muscle and levator ani; • improvements in subject symptoms of vaginal dryness, burning, itching,
Superficial perineal muscles; • Rectum and rectal support. and dyspareunia as well as quality of life.

Female Orgasmic Disorder Female Sexual Dysfunction - Non-pharmacological treatments - Vaginal di-
Diagnosis lators
Presence of either of the following on all or almost all (75% - 100%) occa- Conservative Management – Female
sions of sexual activity: (i) Marked delay in, marked infrequency of, or ab- Vaginal forms or inserts, dilators are medical devices of progressively in-
sence of orgasm; (ii) Markedly reduced intensity of orgasmic sensations creasing lengths or girths designed to reduce vaginal adhesions after pel-
vic malignancy treatments or in treatment of vulvar/vaginal pain. Can be
Female Sexual Dysfunction useful for perineal pain or introital narrowing following pelvic reconstruc-
Symptom tive repairs. However, routine use after surgery not supported. Dilators can
Complaint of dyspareunia or impairment of sexual desire, arousal, or or- also be used for pelvic floor muscle stretching (ie, Thiele massage) and was
gasm. found helpful in women with interstitial cystitis and high-tone pelvic floor
dysfunctions.
Female Sexual Dysfunction - Conservative treatments - Lifestyle modifica-
tion Female Sexual Dysfunction - Non-pharmacological treatments - Vaginal ex-
Conservative Management – Female ercising devices
Alterations of certain behaviors may improve sexual function. These include Conservative Management – Female
weight loss, appropriate sleep, adequate physical fitness, and management Pelvic muscle strengthening tools in form of balls, inserts or biofeedback
of mood disorders. Vulvo-vaginal pain may be treated by dietary changes monitors. May improve pelvic floor muscle tone and coordination by im-
and perineal hygiene (avoiding irritant soaps, detergents, and douches), proving ability to contract and relax. Studies are lacking assessing their use
although data are conflicting. Dietary modifications may be disorder spe- without concurrent physical therapy.
cific including low oxalate diet as reduction in dietary levels of oxalate may
improve symptoms of vulvodynia, or a bladder friendly diet with reductions
in acidic foods and bladder irritants may treat bladder pain and associated
sexual pain.
Female sexual dysfunction - Non-pharmacological treatments - Vaginal vi-
Female Sexual Dysfunction - Conservative Treatments - Topical Therapies brators
Conservative Management – Female Conservative Management – Female
Lubricants and moisturizers - Application of vaginal lubricant during sexu- Vaginal vibrators, external and internal: May be associated with improved
al activity or vaginal moisturizers as maintenance may assist with atrophic sexual function, data controversial. Possibility that use of vibrators for
symptoms and dyspareunia. Examples of some lubricants are described be- self-stimulation may negatively impact sexual function with partner related
low, although no one lubricant or moisturizer has been adequately studied activity.
to recommend it over others. Additionally, not all products are available in
all countries. Female Sexual Dysfunction - Physical therapy
1: Essential arousal oil: Feminine massage oil applied to vulva prior to ac- Conservative Management – Female
tivity. Some evidence to support efficacy in treatment of sexual dysfunction, Manual therapy: Techniques that include stretching, myofascial release,
including arousal and orgasm, compared with placebo. 2: Vulvar soothing pressure, proprioceptive neuromuscular facilitation, and massage applied
cream: Non-hormonal cream containing cutaneous lysate, to be applied externally on the perineum and internally to increase flexibility, release
twice daily. Study shows improvement in vulvar pain with use compared muscle tensions and trigger points in the pelvic floor muscles. It was found
to placebo. 3: Prostaglandin E1 analogue, may help increase genital vasodi- to be effective to improve sexual function in women with pelvic floor dis-
lation. Ongoing trials to determine efficacy in arousal or orgasmic dysfunc- orders in recent meta-analysis and systematic review. These therapies have
tion. also been found helpful in women with genito-pelvic pain.
1: Pelvic muscle exercises with or without biofeedback: May improve sexual
Female Sexual Dysfunction - Non-pharmacological treatments - Clitoral suc- function in women with pelvic floor disorders or pain. 2: Dry needling: Place-
tion devices ment of needles without injection in myofascial trigger points. 3: Trigger
Conservative Management – Female point injections i. Anesthetic: Injection of local anesthetics, often Lidocaine,
This is a battery-operated hand held device, designed to be placed over the directed by trigger point palpation, can be external or transvaginal. ii. Botox:
clitoris. It provides a gentle adjustable vacuum suction with low-level vibra- Injection of Botulinum toxin type A, a potent muscle relaxant, into refractory
tory sensation. Intended to be used three or more times a week for approx- myofascial trigger points to reduce pelvic pain.
imately 5min at a time. This therapy has been shown to increase blood flow
to the clitoral area as well as to the vagina and pelvis. Small non-blinded Female sexual dysfunction - Prescription treatments - Hormonal
studies have shown it may significantly improve arousal, orgasm, and over- Conservative Management – Female
all satisfaction in patients with sexual arousal disorder. 1: Estrogen: Available via prescription for both systemic use (oral or transder-
mal preparations); or locally use (creams, rings ,or tablets). May assist with
Female Sexual Dysfunction - Non-pharmacological treatments - Fractional overall well-being, sexual desire, arousal and dyspareunia. Role for topical
CO2 Laser use in treatment of post-surgical atrophy or mesh extrusion. 2: Ospemifene:
Conservative Management – Female Selective estrogen receptor modulator for treatment of moderate to se-
Use of thermoablative laser to vaginal mucosa may improve microscopic vere dyspareunia related to vulvar and vaginal atrophy, in postmenopausal
structure of epithelium. This results in increased thickness, vascularity, and women. Acts as an estrogen agonist/antagonist with tissue selective effects
connective tissue remodeling, which can improve climacteric symptoms. in the endometrium. 3: Testosterone: Not approved for use in women in

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the USA or UK, may be available in other countries. Variety of preparations Female sexual dysfunction - the effect of pelvic reconstructive surgery for
including transdermal, oral, or pellet administration. Long term safety un- prolapse and incontinence on sexual health
known, studies suggest improvements in satisfying sexual events, sexual Surgery – Female
desire, pleasure, arousal, orgasm and decreased distress. 4: Tibolone: Syn- Women with pelvic floor dysfunction commonly report impaired sexual
thetic steroid with estrogenic, progestogenic and androgenic properties. function, which may be associated with the underlying pelvic floor disor-
It is not currently available in the USA. Studies have suggested a positive der. Treatment of the underlying disorders may or may not impact sexual
effect on sexual function with use. 5: Prasterone: dehydroepiandrosterone function. While both urinary incontinence and pelvic organ prolapse affect
suppository available as a vaginal insert. It has been shown to be efficacious sexual function, prolapse is more likely than urinary incontinence to result
when compared to placebo in decreasing vulvovaginal atrophy. in sexual inactivity. Prolapse is also more likely to be perceived by women
as affecting sexual relations and overall sexual satisfaction. This perception
Female Sexual Dysfunction - Prescription treatments - non-hormonal is independent of diagnosis or therapy for urinary incontinence or prolapse.
Conservative Management – Female Very little is known about the impact of fecal incontinence on sexual func-
1: Bremelanotide; formerly PT-141- Melanocortin agonist, initially devel- tion. The effect of pelvic reconstructive surgery on sexual function has in-
oped as a sunless tanning agent, utilizes a subcutaneous drug delivery sys- creased but there is need for more focused research. Overall, randomized
tem. Treatment significantly increased sexual arousal, sexual desire and the trials are lacking, varied outcome measures are used among studies. There
number of sexually satisfying events with associated decreased distress in is a lack of reporting per DSM-IV/DSM 5 categories and a lack of long-term
premenopausal women with FSD. 2: Serotonin receptor agonist/antago- follow-up. Level of Evidence (LOE) is poor in many studies and sexual dys-
nist; Flibanserin-5-hydroxytryptamine (HT)1A receptor agonist and 5-HT2A function is usually reported as a secondary outcome measure. While any
receptor antagonist, initially developed as antidepressant. Challenges in surgery can impact sexual function postoperatively, most commonly per-
FDA applications, dueto possible long term risks. Studies show improved formed pelvic floor surgeries were not designed with the intent to improve
sexual desire, satisfying sexual events, and reduced distress. 3: Dual control sexual function. In general, successful surgical treatment of incontinence
model in differential drug treatments for hypoactive sexual desire disor- or prolapse may improve sexual symptoms associated with the underlying
der and female sexual arousal disorder: i. Testosterone in conjunction with disorder. For example, coital incontinence improves after sling surgery, but
phosphodiesterase type 5 inhibitor (PDE-5); ii. Testosterone in conjunction whether it impacts other aspects of sexual function such as orgasm, desire,
with a 5-HT1A agonist. May be able to target physiologic and subjective or arousal is unclear. Surgery for prolapse may improve underlying symp-
measures of sexual functioning in a more specific manner. Premise of two toms of laxity or embarrassment from bulge, which in turn may improve
types of HASDD subjects: low sensitivity to sexual cues, or prone to sexual sexual function, but does not seem to have a direct impact on other aspects
inhibition. Tailoring on demand therapeutics to different underlying etiolo- of sexual function. A small but significant number of patients will develop
gies may be useful to treat common symptoms in women with lack of sexual pain or other sexual disorders following surgery. These pain disorders spring
interest and provide the appropriate therapy. Testosterone is supplied as a from a variety of causes including those caused by the use of grafts. Predic-
short acting agent 4 h prior to sexual event to lessen the side effect/risk tion of who will develop these pain disorders is challenging. A recent paper
profile. 4: Apomorphine: Nonselective dopamine agonist that may enhance which evaluated the effect of vaginal surgery on sexual function reported
response to stimuli. 5: Antidepressants and Neuropathics: Include tricyclic that women overall reported improved function, decrease in dyspareunia
antidepressant and anticonvulsants, may be useful in treating sexual pain, rates, and that de novo dyspareunia rates were low at 5% at 12 months and
and vulvar pain. 6: Bupropion: Mild dopamine and norepinephrine reuptake 10% at 24 months. Nonetheless, assessment of sexual activity and partner
inhibitor and acetylcholine receptor antagonist, it may improve desire and status and function prior to and following surgical treatment is essential in
decrease distress or modulate Selective Serotonin Reuptake Inhibitor (SSRI) the evaluation of surgical outcomes. Because of the negative impact of pain
induced FSD. on sexual function, assessment of sexual pain prior to and following proce-
dures should also be undertaken.
Female Sexual Dysfunction - Psychological intervention
Conservative Management – Female Female Sexual Dysfunction Diagnoses - Female Orgasmic Disorder (Ameri-
Counseling and therapy are widely practiced treatments for female sexual can Psychiatric Association)
dysfunction. Even when a sexual problem’s etiology and treatment is pri- Diagnosis
marily urogenital, once a problem has developed there are typically psy- Presence of either of the following on all or almost all (75-100%) occasions
chological, sexual, relationship, and body image consequences and it may of sexual activity: 1: Marked delay in, marked infrequency of, or absence of
be tremendously validating and helpful for these women to be referred to orgasm; 2: Markedly reduced intensity of orgasmic sensations
counselors or therapists with expertise in sexual problems. Psychological
interventions include cognitive behavioral therapy (CBT), sex therapy, and Female sexual dysfunction diagnoses - Female Sexual Interest/Arousal Dis-
mindfulness training. While there is insufficient evidence with regard to order (American Psychiatric Association)
controlled trials studying the efficacy of psychological treatment in wom- Diagnosis
en with sexual dysfunction, the available evidence suggests significant im- Lack of, or significantly reduced, sexual interest/arousal as manifested by
provements in sexual function after intervention with traditional sex thera- 3 of the following: 1: Absent/reduced interest in sexual activity; 2: Absent/
py and/ or cognitive behavioral therapy. Specific techniques include: 1: Sex reduced sexual/erotic thoughts or fantasies; 3: No/reduced initiation of
therapy: Traditional treatment approach with aim to improve individual or sexual activity and unreceptive to partner’s attempts to initiate; 4: Absent/
couple’s sexual experiences and reduce anxiety related to sexual activity; reduced sexual excitement/pleasure during sexual activity in almost all or
2: Cognitive-behavioral therapy: Incorporates sex therapy components but all (75-100%) sexual encounters; 5: Absent/reduced sexual interest/arousal
with larger emphasis on modification of thought patterns that may inter- in response to any internal or external sexual/ erotic cues (written, verbal,
fere with sexual pleasure; 3: Mindfulness: An ancient eastern practice with visual) 6: Absent/reduced genital or non-genital sensations during sexual
Buddhist roots. The practice of “relaxed wakefulness,” and “being in the mo- activity in almost all or all (75-100%) sexual encounters.
ment,” has been found to be an effective component of psychological treat-
ments for sexual dysfunction. Female Sexual Dysfunction Diagnoses - General comments
Diagnosis

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6. ICS Glossary
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The Diagnostic and Statistical Manual of Mental Disorders fifth edition Female Sexual Interest/Arousal disorder
(DSM-5), the International Classification of Diseases 10th edition (ICD-10), Diagnosis
and the Joint Terminology from the fourth International Consultation of Lack of, or significantly reduced, sexual interest/arousal as manifested by 3
Sexual Medicine (ICSM) all have proposed diagnoses for sexual disorders of the following: (i) Absent/reduced interest in sexual activity; (ii) Absent/
in women. Many of the diagnoses from the various societies overlap; ICS reduced sexual/erotic thoughts or fantasies; (iii) No/reduced initiation of
have chosen the diagnoses from the DSM 5, as well as the diagnosis of gen- sexual activity and unreceptive to partner’s attempts to initiate; (iv) Absent/
itourinary syndrome of menopause as these diagnoses seem most relevant reduced sexual excitement/pleasure during sexual activity in almost all or all
to the population of women with pelvic floor dysfunction. The DSM 5 has (75% - 100%) sexual encounters; (v) Absent/reduced sexual interest/arousal
combined disorders that overlap in presentation and reduced the number in response to any internal or external sexual/erotic cues (written, verbal,
of disorders from six to three. Hypoactive sexual desire disorder (HSDD) and visual); (vi) Absent/reduced genital or non-genital sensations during sexual
female sexual arousal disorders (FSAD) have been combined into one disor- activity in almost all or all (75% -100%) sexual encounters.
der, now called Female Sexual Interest/Arousal Disorder (FSIAD), based on
data suggesting that sxual response is not always a linear, uniform process, Female Sexual Interest/Arousal Disorder (FSIAD)
and that the distinction between certain phases, particularly desire and Diagnosis
arousal, may be artificial. Although this revised classification has not been Hypoactive sexual desire disorder (HSDD and female sexual arousal disor-
validated clinically and is controversial, it is the new adopted standardiza- ders (FSAD)) have been combined into one disorder, now called Female Sex-
tion. One reason offered for the new diagnostic name and criteria were clin- ual Interest/Arousal Disorder (FSIAD), based on data suggesting that sexual
ical and experimental observations that sexual arousal and desire disorders response is not always a linear, uniform process and that the distinction be-
typically co-occur in women and that women may therefore experience dif- tween certain phases, particularly desire and arousal, may be artificial.
ficulties in both.The DSM-IV categories of vaginismus and dyspareunia have
been combined to create“genito-pelvicpain/penetration disorder” (GPPPD). Filling cystometry
Female Orgasmic Disorder remains its own diagnosis. The DSM 5 has also Investigation
changed the relevant specifiers of these disorders with the goal of increas- Pressure-volume relationship of the bladder during bladder filling. It begins
ing objectivity and precision and to avoid over-diagnosis of transient sexual with the commencement of filling and ends when a “permission to void” is
difficulties. In particular, all diagnoses now require a minimum duration of given by the urodynamicist or with incontinence (involuntary loss) of the
approximately 6 months and are further specified by severity. Genitourinary bladder content.
syndrome of menopause (GSM) is a new term introduced by the Interna-
tional Society of Sexual Medicine to describe a variety of symptoms which Filling cystometry - intrinsic sphincter deficiency (ISD)
may be associated with sexual health. Although not validated, this diagnosis Investigation
was introduced in an effort to improve communication between providers Very weakened urethral closure mechanism.
and patients regarding symptoms which may be difficult to discuss. While
not a sexual dysfunction diagnosis, given the age of women who typically Filling cystometry - abnormal sensations
develop pelvic floor dysfunction, symptoms associated with GSM may be Investigation
relevant to the assessment of the sexual health of women with pelvic floor Awareness of sensation in the bladder, urethra or pelvis described with the
dysfunction. For each of the DSM-5 diagnoses, providers should indicate words like “tingling”, “burning” or “electric shock” in the setting of a clinically
whether or not the condition is lifelong or acquired, generalized of situa- relevant neurologic disorder (e.g. incomplete spinal cord lesion).
tional, and rate the severity as mild, moderate or severe in terms of the dis-
tress it causes. All of the diagnoses, except for the pain diagnoses, need to
meet the criterion that it has been present for 6 months, causes significant Filling cystometry - absent bladder sensation.
distress, and are not a consequence of non-sexual mental disorder, severe Investigation
or primarily attributable to a medication or underlying illness. For genitouri- No bladder sensation during bladder filling, at least to an expected capacity
nary syndrome of menopause, not all signs and symptoms need be present, of 500mLs.
but the symptoms must be bothersome and not better accounted for by
another diagnosis. Filling cystometry - aims
Investigation
Female Sexual Dysfunction Diagnoses - Genito-Pelvic Pain/Penetration Dis- These are to assess bladder sensation, bladder capacity, detrusor activity
order (American Psychiatric Associoation) and bladder compliance as well as to document (the situation of and detru-
Diagnosis sor pressures during) urine leakage.
Persistent or recurrent difficulties with 1 or more of the following: 1: Vagi-
nal penetration during intercourse; 2: Marked vulvovaginal or pelvic pain Filling cystometry - bladder (detrusor) compliance (mL/cm H2O)
during intercourse or penetration attempts; 3: Marked fear or anxiety about Investigation
vulvovaginal or pelvic pain in anticipation of, during, or as a result of vaginal Relationship between the change in bladder volume (Vol) and change in
penetration; 4: Marked tensing or tightening of the pelvic floor muscles dur- detrusor pressure (pdet) as a measure of the distensibility of the bladder.
ing attempted vaginal penetration. Compliance = Change Vol / change Pdet. Compliance reflects the amount
of fluid in the bladder to increase the bladder pressure by 1cm H2O (mL per
Female Sexual Dysfunction Diagnoses - Genitourinary syndrome of meno- cm H2O)
pause
Diagnosis Filling cystometry - bladder oversensitivity
The genitourinary signs and symptoms of menopause that arise from de- Investigation
creasing level of estrogens and other steroids. This includes burning and irri- Increased sensation during bladder filling with: early first desire to void; ear-
tation of reproductive organs and structures, dryness, pain with intercourse ly strong desire to void, which occurs at low bladder volume; lower cysto-
and urinary urgency, dysuria and recurrent infections. metric bladder capacity; no abnormal increases in detrusor pressure.

Terms F
886

Filling cystometry - bladder sensation In an individual with normal sensation, this is the volume during filling
Investigation cystometry when voiding can no longer be delayed.
Usually assessed by questioning the individual in relation to the fullness of
the bladder during cystometry. Filling cystometry - Neurogenic (secondary) detrusor overactivity
Investigation
Filling cystometry - cystometric capacity Detrusor overactivity and evidence (history; visible or measurable deficit) of
Investigation a relevant neurological disorder.
Bladder volume at the end of filling cystometry, when ‘‘permission to void”
is usually given by the urodynamicist. This endpoint and the level of the Filling cystometry - non-specific bladder awareness
woman’s bladder sensation at that time, for example, ‘‘normal desire to void’’, Investigation
should be noted. Perception of bladder filling as abdominal fullness, vegetative symptoms
(nausea, vomiting, faintness), spasticity or other “non-bladder”awareness,
Filling cystometry - cystometric capacity (mL) in the setting of a clinically relevant neurologic disorder (e.g. incomplete
Investigation spinal cord lesion).
Bladder volume at the end of filling cystometry, when a “permission to void”
is usually given by the urodynamicist. Filling cystometry - normal detrusor activity/function.
Investigation
Filling cystometry - detrusor overactivity There is little or no change in detrusor pressure with filling or any provoca-
Investigation tive activities.
The occurrence of detrusor contraction(s) during filing cystometry. These
contractions, which may be spontaneous or provoked, produce a waveform Filling cystometry - normal urethral closure mechanism.
on the cystogram, of variable duration and amplitude. Symptoms, e.g. ur- Investigation
gency and/or urgency incontinence or perception of contraction may or A positive urethral closure pressure is maintained during bladder filling,
may not occur. even in the presence of increased abdominal pressure, although it may be
overcome by detrusor overactivity.
Filling cystometry - filling rate (male)
Investigation Filling cystometry - pain
The filling rate, including any changes during testing, should be noted on Investigation
the urodynamic report. A medium fill rate (25-50 mL/min) should be appli- The complaint of pain during filling cystometry is abnormal. Its site, charac-
cable in most routine studies. Much slower filling rates (under 25 mL/min) ter and duration should be noted.
are appropriate in men where there are concerns for poor compliance or
with a bladder diary showing low bladder capacity or those with neuropath- Filling cystometry - Position of female patient
ic bladder. A higher filling rate is greater than 50mL/min. Investigation
Sitting position is more provocative for abnormal detrusor activity than the
Filling cystometry - first desire to void supine position. At some point in the test, filling might desirably take place
Investigation with the woman standing.
The first feeling that the individual may wish to pass urine. The volume at
which this occurs should be noted. Filling cystometry - position of male patient
Investigation
Filling cystometry - first sensation of bladder filling Sitting (standing) position is more provocative for abnormal detrusor activi-
Investigation ty (i.e. overactivity) than the supine position. At some point in the test, filling
The feeling when the individual first becomes aware of bladder filling. might desirably take place with the patient standing (in those patients able
to do so). Many men will void standing.
Filling Cystometry - First sensation of bladder filling
Investigation Filling cystometry - reduced bladder sensation.
Investigation
Filling cystometry - Idiopathic (primary) detrusor overactivity Bladder sensation perceived to be diminished during filling cystometry.
Investigation
No identifiable cause for the involuntary detrusor contraction(s) Filling cystometry - temperature of fluid
Investigation
Filling cystometry - incompetent urethral closure mechanism Fluid at room temperature is mostly used. It can be warmed to body temper-
Investigation ature but without evidence that this influences results.
Leakage occurs during activities which might raise intra-abdominal pres-
sure in the absence of a detrusor contraction. Filling cystometry - urgency.
Investigation
Filling cystometry - Initial bladder volume Sudden, compelling desire to void which is difficult to defer.
Investigation
Bladder should be empty. Filling cystometry - urodynamic stress incontinence (USI)
Investigation
Filling cystometry - maximum cystometric capacity (mL) Involuntary leakage of urine during filling cystometry, associated with in-
Investigation creased intra-abdominal pressure, in the absence of a detrusor contraction.

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Filling cystometry: first sensation of bladder filling. Flexible sigmoidoscopy

Investigation Investigation
The feeling when the individual first becomes aware of bladder filling. Filling This refers to the inspection of the distal colonic mucosa, typically up to the
volume when this occurs can be noted/recorded. splenic flexure, with a 60 cm flexible endoscope following enema prepara-
tion.
Filling cystometry: normal desire to void.
Investigation Flow delay (unit: s) - pressure flow studies
The feeling that leads the individual to void at the next convenient moment, Investigation
but voiding can be delayed if necessary The time elapsed from initial rise in pressure to the onset of flow. This is the
initial isovolumetric contraction period of micturition. It reflects the time
Filling cystometry: strong desire to void. necessary for the fluid to pass from the point of pressure measurement to
Investigation the uroflow transducer.
The persistent desire to void without the fear of leakage.
Flow time (FT - unit: s)
First desire to void - filling cystometry Investigation
Investigation Time over which measurable flow actually occurs.
The first feeling that an individual may wish to void. Volume when this oc-
curs may be noted/recorded. Frequency-volume chart (FVC)
Sign
First morning void Frequency-volume chart (FVC): The recording of the time of each micturi-
Sign tion together with the volume voided for at least 24 hours. Ideally a mini-
The first void after waking with the intention of rising. mum of three days of recording (not necessarily consecutive) will generally
provide more useful clinical data. It is relevant to discriminate daytime and
First sensation of bladder filling - filling cystometry night-time micturition.
Investigation
The feeling when the individual first becomes aware of bladder filling. Functional Anal Length - Anal Manometry
Investigation
First sensation of bladder filling - Filling cystometry Functional anal canal length is defined as the length of the anal canal over
Investigation which resting pressure exceeds that of the rectum by greater than 5mmHg
The feeling when the individual first becomes aware of bladder filling. Filling or, alternatively, as the length of the anal canal over which pressures are
volume when this occurs can be noted/recorded. greater than half of the maximal pressure at rest.

Fistula in ano Functional profile length - Urethral pressure profile - female

Sign Investigation
An anal fistula is an abnormal connection between the anal canal epithe- The length of the urethra along which the urethral pressure exceeds intra-
lium (or rarely rectal epithelium) and the skin epithelium. Patients may vesical pressure in women.
complain of pain, swelling, intermittent discharge of blood or pus from the
fistula and recurrent abscesses formation. Functional profile length (on stress) - urethral pressure profile (female)
Investigation
Flatal incontinence. The length over which the urethral pressure exceeds the intravesical pres-
Symptom sure on stress.
Complaint of involuntary loss of flatus (gas).

Flaturia
Symptom
Complaint of passage of gas per urethra.

G
Genital skin signs
Generalised Vulvar Pain Syndrome Sign
Symptom Excoriation, redness, irritation secondary to urinary incontinence
i. Diffuse vulvar pain perceived to be in the vestibule or beyond. ii. Dyspare- and the effect of pads or diapers. (ii) Mycotic infections (balan-
unia. iii. Provocation of pain with touch, pressure or friction. oposthitis, intertrigo, or scrotal): moist, red pruritic skin usually
in men with urinary or fecal incontinence, immune suppression
Genital hiatus or poorly controlled diabetes mellitus; (iii) Skin pigmentation:
Sign balanitis xerotica obliterans (BXO – syn. lichen sclerosus) and
This is measured from the middle of the external urethral meatus to the pos- vitiligo may cause depigmentation (penile skin, scrotum, glans);
terior margin of the hymen. (iv) Cutaneous manifestations of sexually transmitted diseases:
vesicles, ulcers.

Terms F - G
888

Genito-Pelvic Pain/Penetration Disorder Good Urodynamic Practice - Key Elements

Diagnosis Investigation
Persistent or recurrent difficulties with 1 or more of the following: (i) vaginal A Good Urodynamic Practice comprises three main elements: . A clear in-
penetration during intercourse; (ii) marked vulvovaginal or pelvic pain dur- dication for and appropriate selection of relevant test measurements and
ing intercourse or penetration attempts; (iii) marked fear or anxiety about procedures; Precise measurement with data quality control and complete
vulvovaginal or pelvic pain in anticipation of, during, or as a result of vaginal documentation; Accurate analysis and critical reporting of results.
penetration; (iv) marked tensing or tightening of the pelvic floor muscles
during attempted vaginal penetration. Graft
Surgery – Female
Genito-pelvic pain/penetration disorder” (GPPPD) Any tissue or organ for transplantation. This term would be used to refer
Diagnosis to biological materials inserted. (i) Autologous grafts: From patient’s own
The categories of vaginismus and dyspareunia have been combined to cre- tissues e.g. rectus sheath or fascia lata. (ii) Allografts: From post-mortem tis-
ate “genito-pelvic pain/penetration disorder” (GPPPD) sue banks. (iii) Xenografts: From other species e.g. modified porcine dermis,
porcine small intestine and bovine pericardium. Terminology for grafts has
Genitourinary syndrome of menopause (urogenital aging) not been separated into the different applications for POP and continence
Sign surgery.
(i) Pallor/erythema: Pale genital mucosa; (ii) Loss of vaginal rugae: vaginal
rugae flush with the skin; (iii) Tissue fragility/fissures: genital mucosa that Granulation
is easily broken or damaged; (iv) Vaginal petechiae: a petechia, plural pete- Surgery – Complication related
chiae, is a small (1–2 mm) red or purple spot on the skin, caused by a minor Fleshy connective tissue projections on the surface of a wound, ulcer or in-
bleed (from broken capillary blood vessels); (v) Urethral eversion: urethral flamed tissue surface.
epithelium turned outside the lumen; (vi) Urethral prolapse: complaint of
a lump at the external urethral meatus; (vii) Loss of hymenal remnants: ab-
sence of hymenal remnants; (viii) Prominence of urethral meatus vaginal
canal shortening and narrowing: Introital retraction.

H
Hesitancy
Halban procedure Symptom
Surgery – Female Complaint of a delay in initiating voiding (when the individual is ready to
Obliteration of the cul-de-sac by using successive sutures placed sagittally pass urine).
between the uterosacral ligaments.
Hispareunia
Hematospermia Symptom
Symptom Male partner pain with intercourse after female reconstructive surgery.
Complaint of the appearance of visible blood in the seminal fluid. Colour of
the seminal fluid may be red or brown. Hormonal assessment in female sexual dysfunction
Investigation
Hematuria Hormones such as estrogen, progestin, and androgen influence sexual
Symptom function and imbalance may lead to various symptoms including decreased
Complaint of passage of visible blood mixed with urine. This may be initial libido, lack of arousal, vaginal dryness and dyspareunia. Depending on the
(at the beginning), terminal (at the end) or total (throughout bladder emp- underlying suspected conditions associated with sexual dysfunction, hor-
tying). monal investigations such as estradiol (or FSH if symptoms of deficiency),
serum testosterone, dehydroepiandrosterone acetate sulphate (DHEAS),
Hemorrhoids free testosterone, dihydrotestosterone, prolactin, and thyroid function test-
Sign ing may be considered. Moreover, the evaluation of vaginal pH and vaginal
Abnormality of the normal cushion of specialized, highly vascular tissue in maturation index (ie, percentage of parabasal cells, intermediate cells, and
the anal canal in the submucosal space. Hemorrhoids can be divided into superficial cells) can be helpful in women with vulvovaginal atrophy as it
those originating above the dentate line which are termed internal and has been shown to be correlated with patient’s symptomatology.
those originating below the dentate line which are termed external. Internal
hemorrhoids are graded as follows: (I) Grade I bleeding without prolapse; (II) Hygiene
Grade II prolapse with spontaneous reduction; (III) Grade III prolapse with Conservative Management – Female
manual reduction; (IV) Grade IV incarcerated, irreducible prolapse. Grade Bladder hygiene: Bladder hygiene prevents UTI by using techniques such
II and Grade III hemorrhoids will become evident on asking the patient to as wiping the urethral meatus with clean wipes in an anterior-to-posterior
bear down and grade IV hemorrhoids are obvious at the time of the exami- direction after voiding, wearing clean underwear, keeping the genital area
nation. A proctoscopy is essential in examining for hemorrhoids unless they clean, and emptying the bladder before and after sexual intercourse. Vulval
are completely prolapsed. hygiene: involves maintaining a clean perineum by means of washing the
area on a regular basis, and wearing cotton underwear. To avoid vulval irrita-
tion, shampoo, perfumed creams or soap should be avoided. Anal hygiene:

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6. ICS Glossary
 889

involves keeping the perianal region clean, which is especially important and/or passive tension in the muscle. This term is used to describe increased
when fecal seepage is present. Advice includes using soft toilet paper or muscle tone of neurogenic origin.
moist wipes (avoiding any with an alcohol base), always wiping from front to
back, washing after a bowel movement, then gently patting dry. To avoid ir- Hypospadias
ritation from products, the vulval hygiene advice above should be followed. Sign
Urethral meatus sited on ventral surface of the penis, either congenital or
Hypersensitivity acquired, proximal to its normal position at the tip of the glans. Types: glans
Symptom penis (glandular hypospadias); sulcus (coronal hypospadias); shaft (penile
Increased nerve activity from a standardized stimulus with an expected hypospadias); scrotum (scrotal hypospadias); perineum (perineal hypospa-
tissue/clinical response. The underlying mechanism remains to be defined. dias).

Hypertonicity
Sign
An increase in muscle tone related to either elevated contractile activity

I
symptom and bother score(s) and medication list), relevant clinical exami-
ICS STANDARD nation, (3 days-) bladder diary, representative uroflowmetry with post-void
Investigation residual (PVR) and a complete ICS standard urodynamic test, is referred to as
Best practice, based on evidence, with the use of standard terms and stand- having had the ‘ICS standard urodynamics protocol (ICS-SUP).
ard techniques, evaluated and reported clinically or scientifically, in a com-
plete and validated manner. ICS Standard Urodynamic Test
Investigation
ICS Standard Urodynamic Information Leaflet Free uroflowmetry, postvoid residual, cystometry and pressure-flow study
Investigation are termed ICS standard urodynamic test (ICS-SUT).
Overview of the content of an ICS Standard Information Leaflet for Urody-
namics. ICS Standard Urodynamics Report
• What is a urodynamic investigation? Investigation
• That the tests involves insertion of catheters into the bladder and • Overall judgement of the technical quality and the clinical relia-
rectum, and relevant technical issues. bility of the test to represent the lower urinary tract function ‘as usual’, to be
• What is the usefulness of urodynamics? Why is the testing done? evaluated by the person who performed the tests.
• What are the different steps of urodynamic investigation and • Uroflowmetry: Voiding position, urge (before the test) and repre-
how they are performed (e.g. uroflowmetry, cystometry, urethral pressure sentativeness, as reported by the patient.
measurement and pressure-flow) • Introduction of catheters: sensation; (if occurring; pain), muscu-
• How dignity, communication and comfort during the investiga- lar (pelvic or adductor) defence and -perceptibly unusual- obstruction(s)
tion are maximized (What you do or offer in this regard). during insertion.
• The symptoms that may occur following the investigation, what • Position(s) during cystometry and pressure flow study.
they indicate and how can they be handled or prevented, e.g. the fact that • Patient’s ability to report filling sensations and/ or urgency and/
mild discomfort, frequency, dysuria and haematuria may be experienced, or urine loss.
and a urinary tract infection may occasionally develop. • Method of urodynamic stress test (if applicable).
• Additional information including length of the investigation, ste- • Pressure-flow: position and representativeness as reported by
rility of relevant parts of equipment, lack of ‘injections’. the patient.
• That the test is done interactively and that communication with • Accessory tests or measurements (if applicable -no further stand-
the patient is a necessary part of the test. ard).
• What the patient should do before the test (e.g. arrive if possible • Representativeness of the tests to reflect the ‘usual LUT behav-
with a full bladder for uroflow, and also with an empty bowel if possible). iour’ as reported by the patient.
• Whether the patient should continue medication before the test, • Filling sensation (with volumes) -diagnosis or urodynamic condi-
or whether there are specific medications that the patient should not take tion.
in (a defined period) before the test. Note: This should be individual- • Cystometry (detrusor) pressure pattern -diagnosis.
ized, e.g. with a tick box or a written instruction of the requester. • Pressure-flow -diagnosis (compared with uroflowmetry) in-
• What the patient should do after the test. cludes:
o e.g.: Immediately drink one portion of ½ - 1L extra fluid to ensure • Bladder outflow function, or obstruction (and the
prompt voiding again, in order to relieve urethral irritation rapidly. method for assessment)
o All usual activities are permitted after the test. • Detrusor contraction, (and the method for assess-
o Symptoms and signs of urinary tract infection and what steps to ment)
take if these arise.
Idiopathic (primary) detrusor overactivity (DO) - filling cystometry
ICS STANDARD URODYNAMIC PROTOCOL (ICS-SUP) Investigation
Investigation No identifiable cause for involuntary detrusor contraction(s).
A patient undergoing collection of a clinical history (should include (a) valid

Terms G - I
890

Impaired cognition urinary incontinence is more persistent to that previously experienced. Can be (I) first sensation;
Symptom (ii) urge sensation; (iii) maximum tolerated volume.
Complaint of periodic urinary incontinence that the individual with cogni-
tive impairment reports to have occurred without being aware of it. Increased Urinary Frequency
Symptom
Impaired mobility urinary incontinence Complaint that voiding occurs more frequently than deemed normal by the
Symptom man or woman. Time of day and number of voids are not specified.
Complaint of inability to reach the toilet on time for voiding because of
physical or medical disability (similar to “disability associated urinary incon- Increased urinary frequency
tinence”). Symptom
Complaint that voiding occurs more frequently than deemed normal by the
Implant individual (or caregivers). Time of day and number of voids are not specified.
Surgery – Female
A surgically inserted or embedded prosthesis or graft. Indwelling catheterization
Conservative Management – General
Inability to void An indwelling catheter remains in the bladder, urinary reservoir or urinary
Symptom conduit for a period longer than one emptying.
Complaint of inability to initiate voiding despite an intensive effort (by ab-
dominal straining, Valsalva or suprapubic pressure).

Incompetent urethral closure mechanism - filling cystometry Inflammatory Bowel Disease (IBD)
Investigation Diagnosis
Leakage occurs during activities which might raise intra-abdominal pres- Inflammatory Bowel Disease (IBD)—Complaint of recurrent abdominal pain
sure in the absence of a detrusor contraction. and discomfort of at least 3 days per month in the last 3 months. The major-
ity of IBD patients experience periods of flares and remission.
Incompetent urethral closure mechanism (female) i. Abdominal and anal pain, diarrhea which may be associated with blood,
Investigation suggestive of ulcerative colitis. ii. Abdominal pain, fatigue, prolonged diar-
Leakage of urine occurs during activities which might raise intra-abdominal rhea with crampy abdominal pain, weight loss, and fever, with or without
pressure in the absence of a detrusor contraction. gross bleeding. Irregular bowel habits, with possible blood in the stool, are
suggestive of Crohn’s disease.

Increased bladder filling sensation Infrasacral (cauda equina or peripheral nerves) lesion (CEPNL)
Symptom Diagnosis
Complaint that the sensation of bladder filling occurs earlier or is more This is a neurological lesion affecting the cauda equine and/or peripheral
intense or persistent to that previously experienced. n.b. This differs from nerves. Neurogenic lower urinary tract dysfunction in CEPNL: an acontrac-
urgency by the fact that micturition can be postponed despite the desire tile detrusor and/or stress urinary incontinence may be present. In diabet-
to void. ic neuropathy, detrusor overactivity can be seen in combination with the
above.
Increased daytime defecation (female)
Symptom Inguinal protrusion
Complaint that defecation occurs more frequently during waking hours Sign
than previously deemed normal by the woman. Examination and differentiation of hernia from hydrocele or cyst of spermat-
ic cord or groin lymph nodes.
Increased daytime urinary frequency
Symptom Insensible urinary incontinence
Complaint that voiding occurs more frequently during waking hours than Symptom
previously deemed normal by the individual (or caregivers). Complaint of urinary incontinence where the individual is aware of urine
leakage but unaware of how or when it occurred.
Increased (high) semen volume
Symptom Insertion
Complaint of higher amount of seminal fluid than normal or previously ex- Surgery – Complication related
perienced. Putting in.

Increased libido (male) Intercurrent pathology - ultrasound imaging (male)

Symptom Investigation
Complaint of increased interest in sexual activity in comparison with previ- Prostate volume (transrectal), tumor, hydronephrosis, scrotal abnormalities.
ous experience.
Intermittency (Intermittent stream)
Increased rectal sensation (rectal hypersensitivity) Symptom
Symptom Complaint of urine flow that stops and starts on one or more occasions dur-
Complaint of a desire to defecate (during rectal filling) that occurs earlier or ing one voiding episode.

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 891

Intermittent catheterization (IC) Intravesical prostatic protrusion (IPP) - ultrasound imaging (male)
Conservative Management – General Investigation
Drainage of the bladder or a urinary reservoir with subsequent removal of The distance from the bladder base until the tip of the prostate in the blad-
the catheter mostly at regular intervals. der lumen. It is recommended to fill the bladder with 100-200mLs of fluid in
order to receive representative measurements; bladder filling over 400 mL
Interpretation of Normality of Free Uroflowmetry (Female) will lower IPP values. The IPP measurement can be divided into three grades:
Investigation grade I = 0-4.9 mm; grade II = 5-10 mm; grade III = > 10 mm. IPP grade III is
Because of the strong dependency of urine flow rates on voided volume, associated with prostate-related BOO.
they are best referenced to nomograms where the cutoff for abnormally
slow (MUFR, AUFR) has been determined and validated, as under the 10th Intrinsic sphincter deficiency (ISD)
centile of the respective Liverpool nomogram. References to a specific Diagnosis
urineflow rate as the lower limit of normal provided a specific volume has Very weakened urethral closure mechanism.
been voided require further validation studies.
Intrinsic sphincter deficiency (ISD) - Filling cystometry
Interpretation of normality of free uroflowmetry (men) Investigation
Investigation Very weakened urethral closure mechanism.
Because of the strong dependency of urine flow rates in men on voided vol-
ume and age, they are best referenced to nomograms where the cutoff for
normality has been determined and validated. Ideally, abnormal uroflowm-
etry studies should be repeated. Intusseption
Diagnosis
Interstitial Cystitis Full thickness invagination of the upper rectum without extrusion through
Diagnosis the anus leading to interruption of flow of the fecal stream.
As for Bladder Pain Syndrome (BPS), i.e. Persistent or recurrent chronic pel-
vic pain, pressure or discomfort perceived to be related to the urinary blad- Invagination
der accompanied by at least one other urinary symptom such as an urgent Surgery – Complication related
need to void or urinary frequency, though with a known Hunner’s lesion Vaginal muscosa folded and entrapped on itself, characterized by a fixed
present. Pain, pressure or discomfort often increases with bladder filling. and tight area on examination.

Intravaginal Devices Invasive Urodynamics

Conservative Management – Female Investigation
Intravaginal devices are intended to provide some support to the bladder Any test that is invasive, as it involves insertion of one or more catheters or
neck and possibly some compression to the urethra, to correct urinary stress any other transducers into the bladder and/ or other body cavities, or inser-
incontinence. These can be traditional tampons, pessaries, and contracep- tion of probes or needles, for example for EMG measurement.
tive diaphragms and devices designed specifically to support the bladder
neck (removable, reusable intravaginal ring or single-use disposable devic- Irritable Bowel Syndrome (IBS) - Functional (non-inflammatory)
es). Diagnosis
i. Recurrent episodes of abdominal pain. ii. Changes in frequency, form or
Intravenous urography (IVU) consistency of the stool. iii. Sensation of incomplete evacuation, straining,
Imaging fecal urgency. iv. Sensation of nausea, fatigue, fullness, vomiting. v. Re-
This provides an anatomical outline of the urinary tract including a nephro- current abdominal pain or discomfort at least 3 days/month in the last 3
gram prior to passage of the contrast to the calyces, renal pelvis, ureter and months associated with two or more of the following: 1. Improvement of
bladder. pain with defecation. 2. Onset associated with change in frequency of stool.
3. Onset associated with a change in the form (appearance) of stool
Intravesical pressure (Pves - cm H20)
Investigation
The pressure within the bladder (as directly measured by the intravesical
catheter)

Joint therapies
Conservative Management – Female
1. Mobilization: skilled passive movement of a skeletal joint including grad-
ed passive oscillations at the joint to improve joint mobility, e.g., movement
of the coccyx. 2. Manipulation: a passive (for the patient) therapeutic move-
ment, usually of small amplitude and high velocity, at the end of the avail-
able joint range. Manipulation is a sudden small thrust that is controlled by
the clinician.

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L
1. Fluid consumption/restriction: fluid consumption is the intake of fluid
Labial thermistor over 24h. Fluid restriction is the limitation of fluid to a prescribed amount
Investigation over a period of 24h.These measures are often undertaken as part of a blad-
Temperature measurement evaluated with a small metal clip attached to der training process. 2. Dietary modification: an alteration or adjustment of
the labia minorum and equipped with a sensitive thermistor. food to treat bowel disorders (e.g., constipation and fecal incontinence) or
urinary disorders (e.g., incontinence or urgency), for example, increasing
Laparoscopic Assisted Vaginal Hysterectomy fiber to treat constipation. The specifics of the dietary changes should be de-
Surgery – Female scribed. 3. Elimination diet: a form of dietary modification. A diet designed
A laparoscopic approach is used to divide the three uterine pedicles (broad to detect what ingredient in the food causes symptoms in the patient, food
ligament, uterine vessels and uterosacral/cardinal). The uterus is removed items to which the patient may be sensitive are withdrawn separately and
vaginal with the vaginal vault oversewn laparoscopically. successfully from the diet until the item that causes the symptoms is dis-
covered.This is used frequently in patients with fecal incontinence, urinary
Laser Doppler imaging of genital blood flow urgency and urinary urgency incontinence (bladder diet). Physical activity:
Investigation any body movement produced by the skeletal muscles that results in a sub-
An imager positioned close to the vulva allows the assessment of skin/mu- stantial increase above resting energy expenditure. Physical activity can be
cosae microcirculation at a depth of up to 2-3 mm. This method has been done at work, as transportation, as household and other chores, and as lei-
used to assess response to sexual stimulation and correlated with subjec- sure time/sport and fitness activities.
tive arousal. It has also led to a better understanding of microvascular differ-
ences in women with provoked vestibulodynia compared to asymptomatic Localised Vulvar Pain Syndrome
controls. Symptom
i. Vestibular pain syndrome—pain localized to one or more portions of the
Leak point pressure vulvar vestibule. ii. Clitoral pain syndrome—pain localized to or perceived
Investigation in the clitoris.
The leak point pressure is the pressure (spontaneous or provoked) that has
caused fluid to be expelled from the bladder at the moment that it is visible Low backache related to POP
outside the urethra (may also be used for extra-urethral urine loss or stoma). Symptom
This may be Abdominal, Cough or Valsalva LPP or Detrusor LPP. Provocation Complaint of low, sacral (or “period-like”) backache associated temporally
and pressure recording site (‘type of LPP’) should be reported. with pelvic organ prolapse (POP)

Levator defects/ trauma Lower urinary tract symptom (LUTS)

Sign Symptom
Per-vaginal palpation for levator injury/defect/ “avulsion”. A symptom related to the lower urinary tract. It may originate from the blad-
der, urethra, prostate (men) and/or adjacent pelvic floor or pelvic organs,
Lifestyle Modification for Pelvic Floor Dysfunction or at times be referred from similarly innervated anatomy e.g. lower ureter.
Conservative Management – Female
Lifestyle modification is the application of interventions in the management
of lifestyle-related health problems, e.g., change to a healthy diet and reg-
ular participation in physical activity and smoking cessation. The following
lifestyle modifications may be applied to treat pelvic floor dysfunctions,
either in combination with other therapies or as “stand alone” treatments.

M
MRI provides the opportunity to examine the soft tissue structures of the
Magnetic resonance imaging - male - general comments pelvic support apparatus in toto. It is non-invasive, has excellent soft tissue
Imaging contrast resolution without exposure to ionizing radiation and allows the
MRI provides the opportunity to examine the soft tissue structures of the study of function of pelvic floor structures under different dynamic condi-
pelvic support apparatus. It is non-invasive, has excellent soft tissue con- tions such as increased abdominal pressure during Valsalva. Several ana-
trast resolution without exposure to ionizing radiation and allows the study tomical landmarks used for pelvic measurements are also easily identified
of function of pelvic floor structures under different dynamic conditions. in MRI and most measurements are thus highly reproducible. Currently the
Several anatomical landmarks used for pelvic measurements are also eas- clinical value of these examinations is still under investigation with its im-
ily identified in MRI and most measurements are thus highly reproducible. pact on therapeutic decisions not yet fully evaluated.
T-weighting assists enhancement of fluid-filled structures.
Magnetic Resonance Imaging in Urogynecology - Current Possible Meas-
Magnetic resonance imaging - uses in female urements
Imaging Imaging

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Bladder neck and cervical descent/mobility: . Position of bladder neck and Magnetic resonance imaging (MRI -male) - Urethral abnormalities
cervix at rest and on Valsalva. Pubo-coccygeal line: A line extending from Imaging
the inferior border of the pubic symphysis to the last joint of the coccyx. Excellent soft tissue contrast resolution looking for urethral diverticula, pa-
Bladder neck or cervical descent >2 cm below this line with straining indi- ra-urethral cysts, recto-urethral fistulae.
cates weakness of the pelvic floor. If alternative landmarks are used in sci-
entific papers they should be clearly described. Magnetic Resonance Imaging (MRI) of the Pelvic Floor
(b) Intercurrent pelvic pathology: For example, fibroids, ovarian pathology. Imaging
(c) Uterine version :Anteverted or retroverted; flexion at the isthmus. (d) Magnetic resonance imaging (MRI) of the pelvic floor: MRI allows the de-
Bladder abnormalities: For example, tumor; foreign body. (e) Urethral ab- tection of ligamentous and muscular pelvic floor structures in fine detail.
normality: For example, diverticulum. (f ) Postoperative findings: For exam- Although it does not use ionising radiation, it is a high cost technique. Static
ple, bladder neck mobility. (g) Pelvic floor measurements/levator defects: MRI relies on static sequences and high spatial resolution images, to delin-
Assessment of the configuration of pelvic floor muscles, in particular, the eate the passive and active elements of the pelvic organ support system.
levator ani. (h) Descent of pelvic organs Most commonly, images are acquired in axial, sagittal and coronal planes.
MRI has been proposed to be a useful method for diagnosing and staging
Magnetic resonance imaging (MRI) - current female applications POP. Several lines and levels of reference have been described inthe litera-
Imaging ture.The most commonly used ones are either a line drawn from the inferior
(i) Bladder neck and cervical descent / mobility: position of bladder neck and margin of the pubis symphysis to the last coccygeal joint (pubococcygeal
cervix at rest and on Valsalva; (ii) Intercurrent pelvic pathology: e.g. fibroids, line—PCL). in the sagittal plane, noted as midpubic line (MPL). Other appli-
ovarian pathology; (iii) Uterine version: anteverted or retroverted; flexion at cations of MRI are the assessment of the LAM morphology (size, thickness
the isthmus; (iv) Bladder abnormalities: e.g. tumor; foreign body; (v) Urethral volume) and detection of LAM injuries/ defects/ (‘‘avulsion’’).
abnormality: e.g. diverticulum; (vi) Postoperative findings: e.g. bladder neck
mobility; (vii) Pelvic floor measurements / levator defects: assessment of the Magnetic resonance imaging (MRI-male)
configuration of pelvic floor muscles, in particular, the levator ani; (ix) De- Imaging
scent of pelvic organs: Excellent soft tissue contrast resolution looking for detection of mullerian
remnants, aberrantly inserted ureters and duplicated pelvic structures.
Magnetic resonance imaging (MRI - male)
Imaging Magnetic resonance imaging of the vulvar area
Excellent soft tissue contrast resolution looking for benign enlargement, Imaging
cancer, cysts, prostate-rectal fistulae. Evaluation of the increase in clitoral structure volume related to tissue en-
gorgement occurring during arousal.
Magnetic resonance imaging (MRI) - (male) - current possible measurements
Imaging Magnetic stimulation
(1) Bladder abnormalities: e.g. tumor; foreign body, bladder wall abnor- Conservative Management – Female
malities, intestine-vesical fistulae; (2) Urethral abnormality: e.g. divertic- Magnetic stimulation (or extracorporeal magnetic innervation): a pulsed
ulum, recto-urethral fistulae. (3) Urethral sphincter length: prediction of magnetic technology developed for the transmission of nerve impulses that
post-prostatectomy incontinence; (4) Prostate abnormalities: e.g. benign is aimed at causing PFM contraction. Patients receive therapy by sitting in a
enlargement, cancer, cysts, prostato-rectal fistulae; (5) Intercurrent abnor- chair, which contains the device that produces the pulsing magnetic fields.
malities: e.g. rectum - rectal dynamics are assessed during evacuation after
adding ultrasound gel to the rectum. Anorectal and pelvic floor motion can Main (Chief) complaint
be imaged providing pelvic images at rest and when the subject strains; (6) Symptom
Congenital abnormalities: Detection of Mullerian duct remnants, aberrantly The primary symptom that an individual states in the main reason for seek-
inserted ureters and duplicated pelvic structures; (7) Standardized MRI pros- ing medical advice.
tate imaging: PI-RADS – prostate imaging reporting and data system.
Main sleep period
Magnetic Resonance Imaging (MRI) in Urogynecology Sign
Imaging The period from the time of falling asleep to the time of rising for the next
MRI provides the opportunity to examine the soft tissue structures of the day (as recorded on chart or diary).
pelvic support apparatus in toto. It is noninvasive, has excellent soft tissue
contrast resolution without exposure to ionizing radiation, and allows the Male Chronic Genital Pain Syndromes
study of function of pelvic floor structures under different dynamic condi- Diagnosis
tions such as increased abdominal pressure during Valsalva. Several ana- Male genital pain syndromes are often associated with symptoms sugges-
tomical landmarks used for pelvic measurements are also easily identified tive of lower urinary tract and sexual dysfunction. Common complaints:
in MRI and most measurements are thus highly reproducible. Currently, the genital pain, uncomfortable urination, dysuria, sensation of residual urine,
clinical value of these examinations is still under investigation with its im- increased daytime frequency, slow stream, urgency, dyspareunia. Absence
pact on therapeutic decisions not yet fully evaluated. of infection, previous operations, or other obvious pathology.

Magnetic resonance Imaging (MRI -male) - Bladder abnormalities Male examination - General principles.
Imaging Sign
Excellent soft tissue contrast resolution looking at bladder tumor, foreign A comprehensive physical examination is done to seek potential influences
body, bladder wall abnormalities, intestinal-vesical fistulae. on symptoms. It should include abdominal examination, focussing on the
suprapubic area to detect an enlarged bladder, or other abdominal mass,
and digital examination of the rectum (prostate) as well as examination of

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the external genitalia, the perineum and lower limbs. The hernia orifices Maximum urine flow rate (MUFR - mL/s) - Qmax
should also be evaluated. Penile lesions including meatal stenosis, phimosis Investigation
and penile cancer must be excluded. If a neurological diagnosis is suspect- Maximum measured value of the urine flow rate (corrected for artefacts).
ed, then a focused neurological examination with evaluation of perianal
crude and pinprick sensations need to be tested. Also, the anal muscle tone Maximum voided volume
can be assessed with finger in the rectum and asking the patient to squeeze. Sign
Highest voided volume recorded during an assessment period of a frequen-
cy-volume chart (FVC).
Male foreskin abnormalities
Sign Mean maximum voided volume (functional capacity)
. Tumor or infection (balanoposthitis i.e. inflammation of the glans penis and Sign
overlying foreskin). Mean maximum voided volume in everyday activities (as recorded in chart
. Phimosis: Partial or complete inability to retract the prepuce due to adhe- or diary).
sion between the glans and the prepuce or a preputial ring.
Paraphimosis: Entrapment of the prepuce behind the glans. Measurements of labial and vaginal oxygenation
Investigation
Male general (visual) observations A heated electrode and oxygen monitor are used to evaluate the arterial
Sign partial pressure of oxygen (PO2) transcutaneously. The temperature of the
(I) Mobility: generalized muscle strength and ability to ambulate inde- electrode is kept at a constant elevated temperature by an electric current.
pendently or with assistance. Increase in blood flow under the electrode results in more effective temper-
(ii) Skin: jaundice or pallor or skin irritation due to urinary loss. ature dissipation (heat loss) with the result that more current is needed to
(iii) Nutritional Status: cachexia (possible underlying malignancy); obesity maintain the electrode at its prefixed temperature. The changes in current
(possible endocrine abnormality including metabolic syndrome). provide an indirect measurement of blood flow during sexual stimuli. The
(iv) Edema of genitalia and lower extremities: Possible cardiac decompen- electrode also monitors oxygen diffusion across the skin.
sation, renal failure, nephrotic syndrome, or pelvic and/or retroperitoneal
lymphatic obstruction. Measuring Outcome in POP Surgery
Surgery – Female
Manual defecatory assistance: External - perineal pressure or buttock sep- Measuring Outcome in POP surgeries: As per IUGA-ICS Report on outcome
aration. measures for POP surgery, every study evaluating POP surgery should re-
Symptom port. (i) Perioperative data: i.e. blood loss, operating time, length of hospi-
Complaint of the need to press on the perineum or separate the buttocks tal stay, return to normal activities and complications. (ii) Subjective (pa-
to assist defecation. tient-reported) outcomes: At its simplest level this can be reported as the
presence or absence of vaginal bulge. Patient satisfaction and quality of
Manual defecatory assistance: Internal - anorectal digitation life can be measured by validated instruments that cover prolapse, urinary,
Symptom bowel and sexual function. (iii) Objective outcomes: POP-Q measurement
Complaint of the need to use of fingers in the rectum to manually assist generally and should be tabulated with absolute values and percentages to
in evacuation of stool contents by scooping, stretching and/or stimulation. allow other studies to compare results. (iv) Secondary outcomes (e.g. low-
er urinary tract symptoms, stress urinary incontinence or bowel and sexual
Manual Therapy (female) dysfunction) in their studies whenever possible.
Conservative Management – Female
Manual therapy is a clinical approach utilizing skilled, specific hands-on Median functional bladder capacity
techniques, including but not limited to, massage, manipulation or mobi- Sign
lization. Median maximum voided volume in everyday activities (as per frequen-
cy-volume chart -FVC)
Maximum cystometric capacity - filling cystometry (mL)
Investigation Mesh
In individuals with normal sensation, this is the volume during filling Surgery – Female
cystometry when voiding can no longer be delayed. A (prosthetic) network fabric or structure; open spaces or interstices be-
tween the strands of the net. The use of this term would be for POP surgery
Maximum detrusor pressure (Pdet-max – unit: cm H20) - pressure flow stud- with synthetic materials.
ies
Investigation
Maximum registered detrusor pressure during voiding. Mesh kit
Surgery – Female
Maximum urethral closure pressure (MUCP) - female A set of articles or equipment utilised for POP surgery containing mesh with
Investigation a system of trocars designed to achieve mesh fixation or allow mesh pas-
Maximum pressure in the UCPP, i.e. the maximum difference between the sage to or through specific areas within the pelvis.
urethral pressure and the intravesical pressure.
Mesh, Tape & Graft Surgery Complication - CTS Classification - Category (C)
Maximum urethral pressure (MUP) - female 1A - 3A
Investigation Surgery – Complication related
Maximum pressure in the UPP. 1A–3A: Asymptomatic—Abnormal mesh finding These are generally phy-

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sician-diagnosed at any episode of clinical care. It can be argued that the Mesh, Tape and Graft Surgery Complication - CTS Classification - Category
“abnormal prosthesis or graft finding” aspects of category 1A, in particular, (C) 4
aren’t really complications as the patient isn’t bothered by the potential Surgery – Complication related
problem. It may be, however, that the woman may not have engaged in an Category 4: Urinary tract compromise or perforation. This category class has
activity that is likely to provoke symptoms for herself, e.g. pain or bleeding been subdivided into:
during sexual intercourse (or for her partner), which would convert these 4A: Small intraoperative defect: For example, bladder perforation. Such
complications to category 1B. 1Aa–3Aa: Asymptomatic—Abnormal mesh a complication does not generally create longer-term compromise for
finding —No pain. The addition of an “a” specifies that the patient experi- the bladder if recognized, prosthesis (graft) removed as indicated, defect
ences no pain in association with the abnormal finding. oversewn (if necessary), and some minor precautions are taken, for exam-
ple, short-term bladder drainage, with suitable antibiotics commenced. 4B:
Mesh, Tape & Graft Surgery Complication - CTS Classification - Category (C) 2 Other lower urinary tract (bladder or urethral) complication or compromise:
Surgery – Complication related This division would incorporate injuries causing longer-term bladder issues,
Vaginal complication—(smaller) exposure: A smaller (1 cm or less) degree of for example, ongoing prosthesis or graft perforation, fistula, calculus around
vaginal epithelial separation is involved. the prosthesis, or graft. This category also incorporates urinary retention di-
rectly related to the procedure requiring subsequent surgical intervention
Mesh, Tape & Graft Surgery Complication - CTS Classification - Category (C) 3 (apart from any form of bladder drainage). The time and site divisions relates
Surgery – Complication related to those for the surgical intervention. 4C: Ureteric or upper tract complica-
Vaginal complication—(larger) exposure or extrusion: A larger degree (more tion or compromise: This division is self-explanatory.
than 1 cm) of vaginal epithelial separation or prosthesis or graft extrusion
is involved. Mesh, Tape and Graft Surgery Complication - CTS Classification - Category
(C) 5
Mesh, Tape & Graft Surgery Complications - CTS Classification - Category (C) Surgery – Complication related
1 Category 5: Rectal or Bowel compromise or perforation. This category class
Surgery – Complication related has been subdivided into:
Vaginal complication—no epithelial separation: This incorporates the terms 5A: Small intraoperative defect: Such a complication may not generally be
prominence (e.g. due to wrinkling or folding) or contraction (shrinkage). expected to cause compromise if the defect is recognized, prosthesis (graft)
Also incorporated here is the palpation of mesh fibres. removed as indicated, defect oversewn (as necessary) with appropriate pre-
cautions taken, for example, short-term bowel rest is instituted with suita-
Mesh, Tape and Graft Complication - CTS Classification - Category (C) 1B - 3B ble antibiotics commenced. 5B: Rectal injury or compromise: This division
Surgery – Complication related would incorporate injuries causing longer-term rectal issues, for example,
1B–3B: Symptomatic—Unusual discomfort or pain; dyspareunia (for either ongoing prosthesis (graft) perforation, fistula. 5C: Small or large bowel inju-
partner). Bleeding or discharge may be possible symptoms. 1Bb–3Bb: Symp- ry or compromise: This division would incorporate injuries causing longer-
tomatic—Provoked pain only (during vaginal examination) The addition of term bowel issues, for example, ongoing prosthesis (graft) perforation, fistu-
a “b” to the category code specifies that pain, provoked only during vaginal la, obstruction. 5D: Abscess formation from bowel injury/compromise.
examination, is associated with the abnormal finding. 1Bc–3Bc: Symptomat-
ic—Pain during sexual intercourse The addition of a “c” to the category code Mesh, Tape and Graft Surgery Complication - CTS Classification - Category
specifies that pain, provoked during sexual intercourse (patient only), is as- (C) 7
sociated with the abnormal finding. 1Bd–3Bd: Symptomatic—Pain during Surgery – Complication related
physical activities The addition of a “d” to the category code specifies that Category 7: Patient compromise. This category recognizes that the patient
pain, provoked during physical activities, is associated with the abnormal might be brought into systemic danger with some of the complications in
finding. 1Be–3Be: Symptomatic—Spontaneous pain: The addition of an “e” addition to any localized issue. 7A: Bleeding complication including hemat-
to the category code specifies that pain, spontaneously present (i.e. without oma: This division refers to any clinically diagnosed hematoma as well as
physical activity), is associated with the abnormal finding. those where blood transfusion or surgical intervention is a consideration.
7B: Major degree of resuscitation or intensive care: This division refers to
Mesh, Tape and Graft Surgery Complication - CTS Classification - Category 6 significant hemodynamic or cardiopulmonary resuscitation directly related
Surgery – Complication related to the procedure, and/or patient transfer for management in intensive care
Category 6: Skin and/or musculoskeletal complications: 6A: Asymptomatic: facilities. 7C: Mortality: The insertion of the prosthesis, whilst not necessarily
Physician-diagnosed complication at any episode of care. 6B: Symptomatic: fatal at the time, has set in train further morbid events leading to mortality.
For example, discharge, pain, lump. 6C: Infection from skin or musculoskel- N.B. Because of their systemic nature, 7B and 7C will not have a specific site
etal complication: Including sinus tract formation 6D: Abscess formation division. They will be denoted S0.
from skin or musculoskeletal complication.
Mesh, Tape and Graft Surgery Complication - CTS Classification - Time Di-
Mesh, Tape and Graft Surgery Complication - CTS Classification - Category visions
(C) 1C - 3C Surgery – Complication related
Surgery – Complication related The time (T) for the complication is when it is clinically diagnosed. This sec-
1C–3C: Clinical Infection: This is always a possibility with a synthetic prosthe- tion incorporates four time periods, all of the possible episodes where clin-
sis or graft. Signs of local tenderness are suggestive with the combination ical care might be given by the physician or sought by the patient. It might
of redness and a purulent discharge being more conclusive. 1C–3C (b–e): not always be possible to predict with any prosthesis or graft when compli-
Infection—Pain. The addition of the letters “b” through to “e” specifies that cations might be more frequently seen. This would depend on the results
pain (as defined in Table 3) is part or all of the infected abnormal finding. of a procedure-specific surgical audit using the classification. The earliest
time division (T1) might involve more insertion issues, whilst later divisions
(T2–T4) might be biased towards healing abnormality issues. T1: Intraoper-

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ative—48 hr: Insertion complications more likely. T2: 48 hr–2 months: Heal- breathing, toe curling or plantar flexion of the ankle. Double voiding: the
ing or infection complications more likely. T3: 2–12 months: Later healing patient is taught to urinate, relax, and attempt to urinate again. Defecato-
abnormalities more likely. T4: Over 12 months: Late healing abnormalities ry dynamics: is a postural and respiratory technique to aid defecation. The
and other mesh complications more likely. mechanics involves co-ordination of the diaphragm, abdominal and PFM,
with the intent to maintain rectal support whilst releasing the anal outlet
Mesh, Tape and Graft Surgery Complications - CTS Classification - Category with sufficient expulsion to be effective. Bowel habit training: is aimed at
(C) 1D - 3D establishing a regular, predictable pattern of bowel evacuation by patient
Surgery – Complication related teaching and adherence to a routine to achieve a controlled response to
1D–3D: Abscess formation: This is a more serious possibility with a synthetic bowel urgency (modified from NICE guideline).
prosthesis or graft. 1D–3D (b–e): Infection—pain: The addition of the letters
b through to e specifies that pain (as defined in Table 3) is part of the abnor- Mixed bladder outlet obstruction and detrusor underactivity (male -BOO-
mal finding associated with abscess formation. DU)
Diagnosis
Mesh, Tape and Graft Surgery Complications - CTS Classification - Site Divi- Urodynamically confirmed BOO occurring simultaneously with urodynami-
sions cally confirmed DU in pressure-flow analyses.
Surgery – Complication related
The selection of these divisions incorporates the current sites where pros- Mixed detrusor overactivity and bladder outlet obstruction (male - DO-BOO)
thesis or graft complications have been noted: S0: Systemic complications Diagnosis
(no specific site): As mentioned earlier, category divisions 7B and 7C which Detrusor overactivity (filling cystometry) in the presence of bladder outlet
are systemic complications will be denoted S0. S1: Vaginal: area of suture obstruction (pressure-flow studies). This is a relatively common diagnosis.
line: Perhaps the commonest site for prosthesis and graft complications
from vaginal surgery is close to the vaginal suture line. S2: Vaginal: away Mixed detrusor overactivity with detrusor underactivity (male - DO-DU)
from the vaginal suture line: As most suture lines would be midline, this Diagnosis
would generally be lateral in the vagina. S3: Trocar passage: The passage of Urodynamically confirmed detrusor contractions during filling cystometry
any sharp surgical instrument can cause damage along the path of insertion. in combination with detrusor underactivity on pressure-flow.
This division incorporates any extraperitoneal, bladder, or rectal complica-
tion, but not intra-abdominal complications which are S5. S4: Other skin or Mixed neuronal lesion
musculoskeletal site: This division is relevant to any skin or musculoskeletal Diagnosis
complications away from the sites of trocar entry or exit. Included might be This results from lesions of the neural pathway at different levels of the cen-
cutaneous sinus or fistula formation. S5: Intra-abdominal: Included in this tral nervous system concurrently.
section would be bowel perforation or obstruction.
Mixed storage and voiding dysfunction
Micturating cystogram (MCU) - female Diagnosis
Imaging (A) Bladder Outlet Obstruction and Detrusor Underactivity (BOO-DU): Uro-
The principal use is the detection of vesico-ureteric reflux, some fistulae and dynamic BOO occurring synchronous with urodynamic DU in pressure-flow
diverticula. analyses. (B) Detrusor Overactivity and Bladder Outlet Obstruction (DO-
BOO): Urodynamic DO on filling cystometry in the presence of BOO on
Mid-perineal thickness (MPT) pressure-flow studies. (C) Detrusor Overactivity with Detrusor Underactivity
Surgery – Female (DO-DU)
Thickness (cm) of the mid-perineum in the midline. Urodynamic DO on filling cystometry) in combination with urodynamic DU
on pressure-flow studies. This diagnosis is intended to supersede the old
Mid-vaginal laxity (MVL - undisplaced - cm) expression “detrusor hyperactivity with impaired contractility” (DHIC) and
Surgery – Female detrusor overactivity with impaired contractility (DOIC). It is most common
Laxity of the vaginal mucosa (anterior traction) midpoint in the vagina su- in the elderly group.
per-posteriorly and in the midline with the vaginal vault held in an undis-
placed position (similar to that after vault fixation). Mixed urinary incontinence (MUI)
Symptom
Mid-vaginal laxity (MVL - undisplaced) - posterior colporrhaphy Complaints of both stress and urgency urinary incontinence, i.e. involuntary
Surgery – Female loss of urine associated with urgency and also with effort or physical exer-
Laxity (cm) of the vaginal mucosa (anterior traction) midpoint in the vagina tion including sporting activities or on sneezing or coughing.
super-posteriorly and in the midline with the vaginal vault held in an undis-
placed position (similar to that after vault fixation). Modified Manchester (Fothergill) Procedure
Surgery – Female
Miscellaneous Techniques for Bladder and Bowel Control This procedure combines anterior vaginal wall repair with amputation of
Conservative Management – Female the cervix and uterosacral ligament suspension with or without concurrent
Other techniques consist of doing something that takes the patient’s mind vaginal posterior wall repair.
off the condition. Distraction techniques utilized in urgency may include
(but are not limited to) counting backward from 100 in 7s, reciting a poem, (Modified) Manchester repair (Fothergill operation)
doing breathing exercises, reading or working. Urgency suppression tech- Surgery – Female
niques: are methods/maneuvers that are used to decrease the feeling of This procedure combines anterior vaginal wall repair (colporrhaphy) with
urgency, which may include, but are not limited to: distraction, PFM con- amputation of the cervix and uterosacral ligament suspension with or with-
traction, perineal pressure such as sitting on a hard chair, relaxation and out concurrent vaginal posterior wall repair (colporrhaphy).

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Moschovitz procedure Muscle Action Characteristics - Maximum Voluntary Contraction (MVC)

Surgery – Female Investigation
Concentric purse string suture(s) are placed around the cul-de-sac to in- The attempt to recruit as many fibers in a muscle as possible for the purpose
clude the posterior vaginal wall, pelvic side-walls and serosa of the sigmoid. of developing force. MVC of the pelvic floor can be assessed by vaginal pal-
pation, manometers, and dynamometers.
Muscle Action Characteristics
Investigation Muscle Action Characteristics - Motor Control
The decrease in size of muscle fibers as a result of inactivity, illness or aging. Investigation
The ability of the nervous system to control or direct the muscles in pur-
Muscle Action Characteristics - Anatomic Cross-sectional Area poseful movements and postural adjustment by selective allocation of mus-
Investigation cle tension across appropriate joint segments.
For an individual muscle, the largest cross-sectional area along the length of
that muscle and 90° on the muscle length. Muscle Action Characteristics - Muscle Power
Investigation
Muscle Action Characteristics - Antagonistic Contraction The explosive aspect of strength; the product of strength and speed of
Investigation movement (force×distance/time).
Contraction of muscle/ muscle groups with the opposite action to the de-
sired action (activity that hinders the targeted muscle/ muscle group from Muscle Action Characteristics - Muscle Strength
contracting). Investigation
Force-generating capacity of a muscle. It is generally expressed as maximal
Muscle Action Characteristics - Bulk voluntary contraction measurements and as the one repetition maximum
Investigation (1RM) for dynamic measurements.
The absolute volume of a muscle measured using imaging techniques such
as anatomical magnetic resonance imaging and ultrasound. Muscle Action Characteristics - Physiological Cross-sectional Area
Investigation
Muscle Action Characteristics - Co-Contraction The total area of cross-section perpendicular to the muscle fibers.
Investigation
Contraction of two or more muscles at the same time. Co-contraction of Muscle Action Characteristics - Proprioception
muscles can be synergistic (e.g., resulting in an augmentation of motor ac- Investigation
tivity) or it could be counterproductive to normal function (e.g., contraction Sensory information from receptors of muscles, joints, capsules, andliga-
of antagonistic muscles resulting in abnormal movement or training other ments that provides information related to posture and movement.
muscles instead of the targeted ones, e.g., training of gluteal muscles in-
stead of the PFM). Muscle Action Characteristics - Submaximal contraction
Investigation
Muscle Action Characteristics - Coordination All contractions without maximal effort, expressed as a percentage of one
Investigation repetition maximum (1RM).
Property of movement characterized by the smooth and harmonious action
of groups of muscles working together to produce a desired motion. Muscle Action Characteristics - Synergistic Contraction
Investigation
Muscle Action Characteristics - Exteroception The combination of several muscle actions that serve to optimally achieve
Investigation a motor task.
Sensory information from receptors in the skin registering touch, vibration,
heat, and cold. Muscle Action Charcteristics - Local Muscle Endurance
Investigation
The ability to sustain near maximal or maximal force, assessed by the time a
Muscle Action Characteristics - Flexibility patient is able to maintain a maximal static or isometric contraction, or the
Investigation ability to repeatedly develop near maximal or maximal force determined by
The ability of a muscle to lengthen and allow one joint (or more than one assessing the maximum number of repetitions the patient can perform at a
joint in a series) to move through a range of motion. Loss of flexibility is given percentage of 1RM.
defined as a decrease in the ability of a muscle to deform.
Muscle contracture
Muscle Action Characteristics - Hypertrophy Sign
Sign An involuntary shortening of a muscle. Clinically, a muscle cramp and con-
The increase in size (volume) of the muscle fibers. tracture may appear similar; however, contractures are electrically silent.

Muscle Action Characteristics - Maximum Voluntary Contraction (MVC) Muscle Cramp

Investigation Sign
The attempt to recruit as many fibers in a muscle as possible for the purpose A painful involuntary muscle contraction that occurs suddenly and can be
of developing force. MVC of the pelvic floor can be assessed by vaginal pal- temporarily debilitating. Pain is intense and localized. It tends to occur when
pation, manometers, and dynamometers. the muscle is in the shortened position and contracting, is generated by mo-
tor units, and displays a high firing rate (20–150Hz).

Terms M
898

Muscle Fasciculation Muscle Tension

Investigation Sign
A single, spontaneous, involuntary discharge of an individual motor unit. May have a similar meaning to tone and stiffness. Muscle tension can be
The source generator is the motor unit or its axon, before its terminal increased or decreased because of exogenous factors such as the amount of
branches. Fasciculations display an irregular firing pattern of low frequen- pressure applied and endogenous factors such as thickness/cross-sectional
cy (0.1–10Hz). Clinically, fasciculations are recognized as individual brief area of the muscle itself, fluid present within the muscle (swelling, inflam-
twitches. They may occur at rest or after muscle contraction and may last mation), position (e.g., standing versus sitting) or increased neural activity.
several minutes.
Muscle tone
Muscle Hypertonicity Sign
Sign State of the muscle, usually defined by its resting tension, clinically deter-
An increase in muscle tone related to the contractile or viscoelastic compo- mined by resistance to passive movement. Muscle tone has two compo-
nents that can be associated with either elevated contractile activity and/ nents: the contractile component, created by the low frequency activation
or passive stiffness in the muscle. The terms neurogenic hypertonicity and of a small number of motor units, and the viscoelastic component, which is
non-neurogenic hypertonicity are recommended to describe the diagnosis independent of neural activity and reflects the passive physical properties
and inform management. of the elastic tension of the muscle fiber elements and the osmotic pressure
of the cells.
Muscle Hypotonicity (female)
Sign Muscle Tone - Measurement (female)
A decrease in muscle tone related to the contractile or viscoelastic compo- Investigation
nents that can be associated with either reduced contractile activity and/ There is no single tool that is able to measure all components of muscle
or passive stiffness in the muscle. The terms neurogenic hypotonicity and tone. Some tools may be able to measure aspects of tone such as contrac-
non-neurogenic hypotonicity are recommended to describe the diagnosis tility, stiffness or elasticity. Instrumented methods may play a role in the
and inform management. valid and reliable evaluation of muscle tone, e.g., surface electromyography
(sEMG), wire and concentric electromyography, dynamometry, real-time ul-
Muscle spasm trasound, elastometry, myotonometry.
Sign
Persistent contraction of striated muscle that cannot be released voluntar- Myalgia
ily. If the contraction is painful, this is usually described as a cramp. Spasms Symptom
occur at irregular intervals with variable frequency and extent and over days Muscle pain. Pelvic floor myalgia (a symptom) may be present with or with-
or weeks may lead to a contracture. out a change in PFM tone (a sign).

Myofascial Pain
Muscle stiffness Symptom
Sign Pain caused by the presence of trigger points within muscles or their fascia.
Resistance to deformation.Passive elastic stiffness is defined as the ratio of
the change in the passive resistance or passive force (ΔF) to the change in
the length displacement (ΔL) or ΔF/ΔL.The term should only be used if stiff-
ness is measured quantitatively, such as with the use of instruments such as
dynamometry or myotonometry.

N
4A: Small intraoperative defect: e.g., bladder perforation. Such a complica-
Native tion does not generally create longer-term compromise for the bladder if
Surgery – Complication related the defect is recognised and oversewn (if necessary), and some minor pre-
Pertaining to birth; autologous. cautions are taken, e.g., short-term bladder drainage, with suitable antibi-
otics commenced. 4B: Other lower urinary tract (bladder or urethral) com-
Native Surgery Complications (CTS Classification) - Category (C) 1 plication or compromise: This division would incorporate injuries causing
Surgery – Complication related longer-term bladder issues, e.g., ongoing suture perforation, fistula, calculus
Vaginal complication—no epithelial separation: This incorporates the terms around the suture. This category also incorporates urinary retention directly
prominence or excessive degrees of scarring or tethering. related to the procedure requiring subsequent surgical intervention (apart
from any form of bladder drainage). The time and site divisions relates to
Native (tissue) those for the surgical intervention. 4C: Ureteric or upper tract complication
Surgery – Female or compromise: This division is self-explanatory.
Pertaining to birth - “in situ autologous”
Native Tissue Surgery Complications - CTS Classification) - Category (C) 1D
Native Tissue Surgery Complications - CTS Classification - Category 4 - 3D
Surgery – Complication related Surgery – Complication related
Category 4: Urinary tract compromise or perforation: This category class has 1D—3D: Abscess formation: This is a more serious possibility. 1D—3D (b–e):
been subdivided into: Infection—Pain The addition of the letters ‘‘b’’ through to ‘‘e’’ specifies that

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6. ICS Glossary
 899

pain (as defined in Table 3) is part of the abnormal finding associated with facilities. Included in this division is hematoma associated with sepsis, thus
abscess formation. increasing patient compromise. 7C: Mortality: The native tissue surgery,
whilst not necessarily fatal at the time, has set in train further morbid events
Native Tissue Surgery Complications - CTS Classification - Category (C) 1B leading to mortality. N.B. Because of their systemic nature, 7B and 7C will
- 3B generally not have a specific site division. They will then be denoted S0.
Surgery – Complication related
1B—3B: Symptomatic—Unusual discomfort or pain; dyspareunia (for ei- Native Tissue Surgery Complications - CTS Classification - Site Divisions S0
ther partner). Bleeding or discharge may be possible symptoms. 1Bb—3Bb: - S5
Symptomatic—Provoked pain only (during vaginal examination) The addi- Surgery – Complication related
tion of a ‘‘b’’ to the category code specifies that pain, provoked only during SELECTION OF SITE (S) DIVISIONS: The selection of these divisions incorpo-
vaginal examination, is associated with the abnormal finding. 1Bc—3Bc: rates the current sites where complications have been noted: S0: Systemic
Symptomatic—Pain during sexual intercourse The addition of a ‘‘c’’ to the complications (no specific site): As mentioned earlier, category divisions 7B
category code specifies that pain, provoked during sexual intercourse (pa- (septic hematoma a possible exception) and 7C which are generally system-
tient only), is associated with the abnormal finding. 1Bd—3Bd: Symptomat- ic complications will be denoted S0. S1: Vaginal: area of suture line: Perhaps
ic—Pain during physical activities: The addition of a ‘‘d’’ to the category code the commonest site for complications from native tissue vaginal surgery is
specifies that pain, provoked during physical activities, is associated with close to the vaginal suture line. S2: Vaginal: away from the vaginal suture
the abnormal finding. 1Be—3Be: Symptomatic—Spontaneous pain The ad- line: As most suture lines would be midline, this would generally be lateral in
dition of an ‘‘e’’ to the category code specifies that pain, spontaneously pres- the vagina. S3: Adjoining viscus: This division incorporates any extraperito-
ent (i.e., without physical activity), is associated with the abnormal finding. neal, bladder or rectal complication, but not intraabdominal complications
which are S5. S4: Skin or musculoskeletal site: This division is relevant to any
Native Tissue Surgery Complications - CTS Classification - Category (C) 1C skin or musculoskeletal complications away from the sites of the primary
- 3C wound. Included might be cutaneous sinus or fistula formation and deep
Surgery – Complication related muscle pain from suture fixation. S5: Intra-abdominal: Included in this sec-
1C—3C: Clinical Infection/Inflammation: Signs of local tenderness are sug- tion would be bowel perforation or obstruction.
gestive with the combination of redness and a purulent discharge being
more conclusive. The presence of granulation should be accepted as repre- Native Tissue Surgery Complications - CTS Classification - Time (T) - T1 - T4
senting ongoing inflammation. 1C—3C (b–e): Infection Pain: The addition Surgery – Complication related
of the letters ‘‘b’’ through to ‘‘e’’ specifies that pain is part or all of the infected The time (T) for the complication is when it is clinically diagnosed. This sec-
abnormal finding. tion incorporates four time periods, all of the possible episodes where clin-
ical care might be given by the physician or sought by the patient. It might
not always be possible to predict with any particular surgery when particular
Native Tissue Surgery Complications - CTS Classification - Category (C) 5 complications might be more frequently diagnosed. This would depend on
Surgery – Complication related the results of a procedure-specific surgical audit using the classification. The
Rectal or Bowel Perforation or Compromise: this is subdivided into: 5A: earliest time division (T1) might involve more perioperative issues, whilst
Small intraoperative defect: Such a complication may not generally be ex- later divisions (T2–T4) might be biased towards healing abnormality issues.
pected to cause compromise if the defect is recognized and oversewn (as T1: Intraoperative—48 hr: Perioperative complications clearly more likely.
necessary) with appropriate precautions taken, e.g., short term bowel rest T2: 48 hr—2 months: Bleeding, infection or healing complications more like-
is instituted with suitable antibiotics commenced. 5B: Rectal injury or com- ly. T3: 2 months—12 months: Later healing abnormalities more likely. T4:
promise: This division would incorporate injuries causing longer-term rectal Over 12 months: Late healing abnormalities and other suture complications
issues, e.g., ongoing suture perforation, fistula. 5C: Small or large bowel in- more likely.
jury or compromise: This division would incorporate injuries causing longer-
term bowel issues, e.g., ongoing suture perforation, fistula, obstruction. 5D: Native Tissue Surgery Complications (CTS Classification) - Category (C) 1
Abscess formation from bowel injury/compromise. Surgery – Complication related
Vaginal complication—no epithelial separation: This incorporates the terms
Native Tissue Surgery Complications - CTS Classification - Category (C) 6 prominence or excessive degrees of scarring or tethering.
Surgery – Complication related
Category 6: Skin and/or musculoskeletal complications: 6A: Asymptomatic: Native Tissue Surgery Complications (CTS Classification) - Category (C) 1A
Physician-diagnosed complication at any episode of care. 6B: Symptomatic: - 3A
e.g., discharge, pain, lump. 6C: Infection from skin or musculoskeletal com- Surgery – Complication related
plication: including sinus tract formation. 6D: Abscess formation from skin 1A—3A: Asymptomatic - Abnormal finding. These are generally physi-
or musculoskeletal complication. cian-diagnosed at any episode of clinical care. It can be argued that the
‘‘abnormal finding’’ aspects of category 1A, in particular, are not really com-
Native Tissue Surgery Complications - CTS Classification - Category (C) 7 plications, as the patient is not bothered by the potential problem. It may
Surgery – Complication related be, however, that the woman may not have engaged in an activity that is
Category 7: Patient compromise: This category recognizes that the patient likely to provoke symptoms for herself, e.g. pain or bleeding during sexual
might be brought into systemic danger with some of the complications in intercourse (or for her partner), which would convert these complications to
addition to any localized complication. 7A: Bleeding complication including category 1B. 1Aa—3Aa: Asymptomatic—Abnormal finding The addition of
hematoma: This division refers to any clinically diagnosed hematoma as well an ‘‘a’’ specifies that the patient experiences no pain in association with the
as those where blood transfusion or surgical intervention is a consideration. abnormal finding.
7B: Major degree of resuscitation or intensive care: This division refers to
significant hemodynamic or cardiopulmonary resuscitation directly related Native Tissue Surgery Complications (CTS Classification) - Category (C) 2
to the procedure, and/or patient transfer for management in intensive care Surgery – Complication related

Terms M - N
900

Vaginal complication—smaller epithelial separation or ulcer: A smaller (1 cm base pressure with each subsequent contraction occurs during filling
or less) degree of vaginal epithelial separation or ulcer formation is involved. cystometry in the setting of a clinically relevant neurologic disease.

Native Tissue Surgery Complications (CTS Classification) - Category (C) 3 Neurogenic detrusor overactivity - general
Surgery – Complication related Investigation
Vaginal complication—larger epithelial separation or ulcer or suture extru- Involuntary detrusor muscle contractions occur during filling cystometry in
sion: A larger degree (more than 1 cm) of vaginal epithelial separation or the setting of a clinically relevant neurologic disease.
ulcer formation or suture extrusion is involved.
Neurogenic detrusor overactivity - high pressure
Native Tissue Surgery Complications (CTS Classification) - Category (C) 3 Investigation
Surgery – Complication related A phasic, terminal, sustained or compound high maximal detrusor overac-
Vaginal complication—larger epithelial separation or ulcer or suture extru- tivity with high detrusor pressure occurs during filling cystometry in the
sion: A larger degree (more than 1 cm) of vaginal epithelial separation or setting of a clinically relevant neurologic disease. The investigator may con-
ulcer formation or suture extrusion is involved. sider whether such contractions might be potentially detrimental to the
patient’s renal function and/or health.
Native Tissue Surgical Complications (CTS Classification) - Category (C) 1
Surgery – Complication related
Vaginal complication—no epithelial separation: This incorporates the terms
prominence or excessive degrees of scarring or tethering.
Neurogenic detrusor overactivity - phasic
Native Tissue Surgical Complications (CTS Classification) - Category (C) 2 Investigation
Surgery – Complication related Phasic detrusor muscle contractions (characteristic waveform) occur during
Vaginal complication—smaller epithelial separation or ulcer: A smaller (1 cm filling cystometry in the setting of a clinically relevant neurologic disease.
or less) degree of vaginal epithelial separation or ulcer formation is involved. These may or may not lead to urinary incontinence.

Neurogenic detrusor overactivity - sustained

Investigation
Native Tissue Surgical Complications (CTS Classification) - Category (C) 3 Continuous detrusor muscle contractions (without returning to the detru-
Surgery – Complication related sor resting pressure) occur during filling cystometry in the setting of a clini-
Vaginal complication—larger epithelial separation or ulcer or suture extru- cally relevant neurologic disease.
sion: A larger degree (more than 1 cm) of vaginal epithelial separation or
ulcer formation or suture extrusion is involved. Neurogenic detrusor overactivity - terminal
Investigation
Need to immediately re-void (“encore” or “double” voiding) Involuntary detrusor muscle contractions occur near or at the maximum
Symptom cystometric capacity, in the setting of a clinically relevant neurologic dis-
Complaint that further voiding is necessary soon after passing urine (ces- ease. These contractions generally cannot be suppressed resulting in uri-
sation of flow). nary incontinence or even reflex bladder emptying (reflex voiding).

Neural lesions Neurogenic detrusor overactivity incontinence

Diagnosis Investigation
These are described according to the time of onset, risk of neurological pro- Incontinence due to detrusor muscle contractions during filling cystometry
gression, completeness and neurological level. The extent of loss of neuro- in the setting of clinically relevant neurologic disease.
logical function depends on which part(s) of the nervous system is affected.
Relevant diagnoses (see separate descriptions) are (i) Spinal Shock Phase; Neurogenic detrusor overactivity (NDO)
(ii) Suprapontine Lesion (SPL); (iii) Suprasacral cord/pontine lesion (SSL); (iv) Diagnosis
Sacral Spinal Cord Lesion (SSCL); (v) Infrasacral (cauda equine and peripheral In men and women with LUT/PF symptoms (more commonly storage symp-
nerves) lesion (CEPNL); (vi) Mixed Neuronal Lesion. toms) detrusor muscle contractions occur during filling cystometry in the
setting of a clinically relevant neurologic disorder.
Neurogenic
Diagnosis Neurogenic (secondary) detrusor overactivity
Occurs in the presence of relevant neurological pathology ONLY. Investigation
Detrusor overactivity and evidence (history; visible or measurable deficit) of
Neurogenic acontractile detrusor - pressure flow studies a relevant neurological disorder
Investigation
No visible detrusor contraction during voiding attempt in a man with ev- Neurological assessment of female sexual dysfunction
idence of a neurological disorder (either visible or measurable neurologi- Investigation
cal deficit or history of neurological disease). This should replace the term Related to intact sensation, neurological innervation is important for arous-
“areflexia”. al and orgasm. Peripheral neuropathy or central nervous system disorders
(eg, diabetic neuropathy, spinal cord injury) may lead to anorgasmia and
Neurogenic detrusor overactivity - compound decreased arousal. Different approaches can be used to evaluate motor and
Investigation sensory neurological function.
A phasic detrusor contraction with a subsequent increase in detrusor and 1. Functional magnetic resonance imaging: Investigation of neural activa-

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6. ICS Glossary
 901

tion in anatomically localized cerebral regions evaluated through monitor- trical current. Measured in ohms and designated as Z. 8. Evoked potentials:
ing subtle changes in regional cerebral blood flow that occur with activation electrical potentials recorded from the nervous system following a delivered
of the neurons. These patterns of activation and deactivation are used to stimulus.
examine the cerebral and cognitive response to sexual stimulation; 2: Quan-
titative sensory testing: Assessment of the sensitivity by applying different Night-time
stimuli (light touch, pressure, temperature, or vibration) using an ascending Sign
or descending method in order to evaluate the detection threshold. These The individual’s main daily period of sleep. It commences at the time of fall-
methods can be used to evaluate different vulvovaginal sites including the ing asleep and concludes when the individual decides to no longer attempt
clitoris, labia minora, and majora as well as vaginal and anal margins; 3: Re- to sleep and rise for the next day (ideally recorded on chart or diary).
flex examination: Evaluating sacral arc integrity, the bulbocavernosus reflex
can be elicited by squeezing the clitoris and assessing the contraction of Night-time (urinary) frequency
the anal sphincter. The external anal reflex is tested by repetitive pricking Sign
delivered to perianal skin and observing anal sphincter contraction. Laten- Total number of night-time voids irrespective of sleep, i.e. the number of
cies can also be evaluated by stimulating the nerve and evaluating muscle voids recorded from the time the individual goes to bed with the intention
response through a needle electrode. of sleeping till the time the individual wakes with the intention of rising.

Neurological examination (female) Nociceptive pain

Sign Symptom
For patients with possible neurogenic lower urinary tract or pelvic floor dys- Pain which arises from actual or threatened damage to non-neural tissue
function, there should be particular note of those neurological signs related and is due to the activation of nociceptors.
to S2-4, but these should be complemented by a more general neurological
examination as indicated. Nocturia
Symptom
Neurological examination (male) The number of times urine is passed during the main sleep period. Having
Sign woken to pass urine for the first time, each urination must be followed by
. Overall neurological status: abnormalities of speech, gait as well as upper sleep or the intention to sleep. This should be quantified using a bladder
and lower extremity dexterity should be noted as they may indicate a neu- diary.
rological cause for the urological symptoms. Neuropathy may impact also
on management options. Nocturia
. Level of neurologic abnormality: can occasionally be localized by the pat- Sign
tern of sensory or motor deficit noted during physical examination using a The number of times an individual passes urine during their main sleep pe-
dermatome map. riod, from the time they have fallen asleep up to the intention to rise from
. Penile, scrotal, or perianal sensory deficits: may indicate damage or injury that period. This is derived from the bladder diary.
to sacral roots or nerves. Reflex testing in the genital area may also be per-
formed. The most important of these is the Bulbospongiosus reflex (BSR). Nocturia - General Advice
. Bulbospongiosus reflex (BSR) - a reflex contraction of the striated muscle Conservative Management – General
of the pelvic floor (anal sphincter) and the bulbo-spongiosus muscle that General lifestyle advice, e.g. reducing caffeine and alcohol intake, and limit-
occurs in response to various stimuli in the perineum or genitalia. ing excessive liquid/food volume intake before bedtime, can in some cases
. Cremasteric reflex: contraction of the ipsilateral cremaster muscle, draw- be sufficient to elicit a satisfactory response. However, care should be taken
ing the testis upwards, when the upper inner aspect of the thigh is stroked not to impose a general fluid restriction as this could have serious conse-
longitudinally. quences in patients with undiagnosed diabetes insipidus. Patients should
be encouraged to return to their doctor for further evaluation if they are not
Neuromuscular Electrical Stimulation Parameters content with the results after their initial advice.
Conservative Management – Female
Neuromuscular electrical stimulation parameters: 1. Pulse frequency (or Nocturia related to Bladder Storage
rate): the number of pulse cycles that are generated per unit of time (sec- Investigation
onds).This is reported in hertz (Hz). 2. Pulse width: the determined period Reduced functional bladder capacity (e.g. significant post void residual);
of time elapsing from the beginning to the end of one pulse cycle, usually Reduced nocturnal bladder capacity Detrusor overactivity; Neurogenic (e.g.
expressed in microseconds or milliseconds. 3. Current amplitude: the mag- multiple sclerosis); Non-neurogenic Bladder hypersensitivity Bladder outlet
nitude of current relative to the isoelectric baseline, expressed in amperes obstruction with post void residual urine; Urogenital ageing.
(A).The current amplitude of therapeutic electrical stimulators ranges from
micro- to milliamps. 4. Train: the continuous series of pulse cycles over time, Nocturia related to Sleep Disorders
usually lasting seconds. For example, a train of impulses may be the results Investigation
of successive pulse cycles delivered at 50Hz for a duration of 5s. 5. Train Insomnia Obstructive and central apnoea syndrome; Periodic legs syn-
ramp-up time and ramp-down time: ramp-up time is the time elapsed from drome; Restless legs syndrome Parasomnias; Sleep disorders related to
the onset(or baseline) to the plateau current amplitude (or maximum) of medical diseases, e.g. chronic obstructive lung disease, cardiac diseases etc;
the train, whereas ramp-down time is the time elapsed from the plateau Sleep disorders related to neurological diseases, e.g. Alzheimer’s, Parkin-
current amplitude to zero baseline. 6. Duty cycle (D): the ratio of ON time son’s and nocturnal epileptic seizures.
to the summation of ON time+OFF time, expressed as a percentage (duty
cycle=(ON)/(ON+OFFtime)x100, e.g., a duty cycle of 20 % is calculated when Nocturnal
the ON and OFF times equal 10 and 40s respectively. 7. Impedance (electric Sign
resistance): the opposition of our biological tissues to the flow of an elec- Occurring or active at night.

Terms N
902

Nocturnal defecation Non-Functioning Pelvic Floor Muscles

Symptom Sign
Complaint of interruption of sleep one or more times because of the need (Modified from Messelink et al, 2005): A situation in which there is no PFM
to defecate. action measurable either on instruction to contract (inability) or as the ab-
sence of an automatic response to an increase in intraabdominal pressure.
Nocturnal enuresis This condition can be based on any pelvic floor symptom and on the sign of
Symptom a non-contracting or non-relaxing pelvic floor.
Complaint of involuntary voiding that occurs at night during the main sleep
period (i.e. bedwetting) Non-functioning Pelvic Floor Muscles
Diagnosis
Nocturnal (night-time) polyuria A situation in which there is no pelvic floor muscle action palpable.This
Sign condition can be based on any pelvic floor symptom and on the sign of a
Increased proportional production of urine during the night-time com- non-contracting, non-relaxing pelvic floor.
pared with the 24 hour urine volume. Nocturnal polyuria index (NPi) is most
commonly used definition (night-time urine volume/24 hour urine volume) Non-functioning pelvic floor muscles (female)
x 100%. Sign
- 33% in elderly e.g. > 65 years. Pelvic floor muscles where there is no voluntary action palpable.
- >20% in younger individuals
- 20 - 33% in “middle age” Non-inflammatory anorectal pain
Symptom
Nocturnal polyuria Complaint of blunted anorectal pain, as opposed to sharp stinging or burn-
Symptom ing type of pain (proctalgia fugax, Levator ani syndrome, pudendal neural-
Complaint of passing large volumes of urine at night-time (during the main gia)
sleep period).
Non-invasive Urodynamics
Nocturnal polyuria Investigation
Sign All urodynamics done without the insertion of catheters: e.g. uroflowme-
Excessive production of urine during the individual’s main sleep period. try, PVR, penile compression-release test, penile cuff, condom catheter, or
Should be quantified using a bladder diary. sonography.

Nocturnal polyuria - Causes Non-neurogenic acontractile detrusor - pressure flow studies

Sign Investigation
Water diuresis: Circadian defect in secretion or action of antidiuretic hor- No visible detrusor contraction during voiding attempt in a man without
mone Primary (Idiopathic). Secondary: (Excessive evening intake of fluid, evidence of a neurological disorder.
caffeine, alcohol); Solute/water diuresis • Congestive heart failure • Auto-
nomic dysfunction • Sleep apnoea syndrome • Renal insufficiency • Oestro- Non-neurogenic (secondary) detrusor overactivity (DO) - filling cystometry
gen deficiency. Investigation
An identifiable possible non-neurological cause exists for involuntary det-
Nocturnal urine volume rusor contraction(s) during bladder filling. e.g. functional (obstruction); pa-
Sign thology stone, tumor (e.g. carcinoma in situ), UTI.
Total volume of urine produced during the individual’s main sleep period.
This includes the first void of the morning. Should be quantified using a Non-specific (atypical) bladder filling sensation (bladder dysesthesia)
bladder diary. Symptom
Complaint of abnormal bladder filling sensation such as the perception of
Non coital sexual pain vague abdominal bloating, vegetative symptoms (nausea, vomiting, faint-
Symptom ness) or spasticity. It differs from normal bladder filling sensation or pain,
Pain induced by non coital stimulation. pressure or discomfort of the bladder.

Non- specific (atypical) bladder filling sensation (bladder dyesthesia) Non-specific bladder awareness
Symptom Symptom
The individual reports no specific bladder filling sensation, but may per- The individual reports no specific bladder sensation, but may perceive, for
ceive, for example, abdominal fullness, vegetative symptoms (nausea, vom- example, abdominal fullness, vegetative symptoms, urethral sensations or
iting faintness), urethral sensations or spasticity as bladder filling awareness. spasticity as bladder filling awareness or a sign of bladder fullness.

Non-coital sexual pain Non-specific bladder awareness - Filling cystometry

Symptom Investigation
Pain induced by non-coital stimulation. Perception of bladder filling as abdominal fullness, vegetative symptoms
(nausea, vomiting, faintness), spasticity or other “non-bladder”awareness,
in the setting of a clinically relevant neurologic disorder (e.g. incomplete
spinal cord lesion).

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 903

Non-Standard (Urodynamic) Tests Normal pelvic floor muscles (female)

Investigation Sign
ICS Standard Urodynamic Testing (ICS-SUT) may be supplemented with Pelvic floor muscles which can voluntarily and involuntarily contract and
EMG, with imaging, with continuous urethral pressure(s) and/ or with ure- relax.
thral pressure profile measurement. Cystometry may be done via a suprapu-
bic catheter (specify supplements). Normal urethral closure mechanism (female)
Investigation
Normal bladder filling sensation. A positive urethral closure pressure is maintained during bladder filling,
Symptom even in the presence of increased abdominal pressure, although it may be
The individual is aware of bladder filling and increasing sensation up to a overcome by detrusor overactivity.
strong desire to void.
Normal urethral closure pressure - Filling cystometry
Normal desire to void - filling cystometry Investigation
Investigation A positive urethral closure pressure is maintained during bladder filling,
The feeling that leads the individual to void at the next convenient moment, even in the presence of increased abdominal pressure, although it may be
but voiding can be delayed if necessary. overcome by detrusor overactivity.

Normal detrusor activity/function - filling cystometry Normal urethral function during voiding - pressure flow studies (male +/-
Investigation VCU, EMG)
There is little or no change in detrusor pressure with filling or any provoca- Investigation
tive activities. The urethra opens and is continuously relaxed to allow micturition at a nor-
mal pressure and urine flow and results in complete emptying. The voiding
Normal detrusor contractile function - pressure flow studies. is prompted by a detrusor contraction and simultaneous relaxation of the
Investigation smooth and striated sphincters of the urethra and pelvic floor muscles.
Normal voiding is achieved by an adequate continuous detrusor contrac-
tion that leads to complete bladder emptying within a normal time span. Normal urethral function during voiding (female)
Investigation
Normal detrusor function (female) The urethra opens and is continuously relaxed to allow micturition at a nor-
Investigation mal pressure, urine flow and PVR.
Normal voiding in women is achieved by an initial (voluntary) reduction in
intraurethral pressure (urethral relaxation). This is generally followed by a No-touch technique intermittent catheterization
continuous detrusor contraction that leads to complete bladder emptying Conservative Management – General
within a normal time span. Many women will void successfully (normal flow This was introduced as an easier way for the patient to perform self-intermit-
rate and no PVR) by urethral relaxation alone, without much of a rise in de- tent catheterization with a ready-to-use catheter (pre-lubricated catheter,
trusor pressure. The amplitude of the detrusor contraction will tend to in- usually a hydrophilic catheter). A pull-in aid or special packages are used
crease to cope with any degree of bladder outflow obstruction. to handle the catheter without directly touching the sliding surface of the
hydrophilic catheter.
Normal Pelvic Floor Muscles
Diagnosis
A situation in which the pelvic floor muscles can voluntarily and involun-
tary contract and relax. Voluntary contraction will be normal or strong and
voluntary relaxation complete. Involuntary contraction and relaxation are
both present.

O
ry, if there is uncertainty regarding the full extent of the injury it should be
Obstetric Anal Sphincter Injuries (OASIS) classified as the greater degree, for example, if one is unsure as to wheth-
Diagnosis er an injury is a Grade 3a or 3b it should be classified as 3b. This classifica-
OASIS are reported to occur in 0.5–14% of vaginal deliveries (2.9–19% of tion also has clinical relevance as it ensures increased vigilance for internal
primiparous vaginal deliveries). It has previously been shown in a prospec- sphincter injuries that are best repaired soon after delivery as persisten tint-
tive study that about one third of OASIS can be diagnosed 8 weeks after ernal sphincter defects are associated with fecal incontinence. Examination
delivery by endoanal ultrasound alone. As these were not identified clini- techniques to improve detection of these injuries and avoiding pitfalls in
cally, the injuries were believed to be ‘‘occult.’’ However, it has subsequently diagnosis have been described in detail.
been proven that such injuries are not necessarily occult but in fact undiag-
nosed due to lack of expertise of midwives and doctors. Training in diagno- Obstructed Defecation Syndrome
sis and management of perineal trauma has been shown to be suboptimal Diagnosis
and dedicated hands-on courses have shown significant improvements in Obstructed defecation: incomplete evacuation of fecal contents from rec-
diagnosis and classification of OASIS.Sultan therefore proposed a more de- tum due to physical blockage of the fecal stream during defecation at-
scriptive classification of OASIS that has now been accepted internationally tempts. It includes symptoms such as straining to defecate, sensation of
to support consistency in reporting. To avoid underestimation of the inju- blockage, digitation, and splinting. Constipation due to slow transit ,irri-

Terms N - O
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table bowel syndrome, Hirschsprung’s disease, megarectum, anismus are Outcomes of Female Pelvic Floor Surgery - Economic Evaluation / Cost Anal-
not within the remit of this standardization document. Associated features ysis
of obstructed defecation are: 1: Rectocele: Bulge in posterior vaginal wall Surgery – Female
associated with herniation of anterior wall of the rectum; 2: Enterocele/ Despite considerable cost, sparse cost-effectiveness data exists related to
sigmoidocele: Bulge of upper wall of vagina associated with herniation POP surgery. Investigators are encouraged to include economic analyses in
of peritoneal sac and small bowel (enterocele) or sigmoid colon (sigmoi- their studies whenever possible. Economic evaluation techniques provide
docele). 3: Intussusception: Full thickness invagination of the upper rectum systematic methods of comparing the costs and consequences of clinical
without extrusion through the anus leading to interruption of flow of the and other health sector interventions. Cost-utility analysis (CUA), a form of
fecal stream; 4: Internal mucosal prolapse: Mucosal prolapse of the anterior, cost-effectiveness analysis (CEA), is by far the most commonly used and re-
posterior, or circumferential mucosal layer. 5: External rectal prolapse: Full quires quantifying the effects of interventions on both morbidity and mor-
thickness rectal prolapse outside the anal canal. tality. In a CUA, benefits are measured in units of health gain (or loss), most
commonly using quality-adjusted life-years (QALYs) and combined with
Obstructed intercourse (female) estimates of cost to create a ratio of incremental costs to incremental con-
Symptom sequences (e.g., ‘‘incremental cost per QALY’’). QALYs are usually calculated
Vaginal intercourse is difficult or not possible due to obstruction by genital using a generic health status measure, such as Short Form (SF)36 or Euro-
prolapse or shortened vagina. QOlEQ-5D, which can be used with a standard set of health state values or
by other measures of utility, such as the standard gamble or time-trade off
Obstructed intercourse (male) technique. These incremental cost effectiveness ratios (ICERs) enable com-
Symptom parison of competing interventions on the basis of the cost at which they
Complaint that vaginal intercourse is not possible due to perceived obstruc- create improvements in health-related quality-of-life. In economic evalu-
tion. Whilst this may be a partner issue, it can occur in cases of penile curva- ations, it is important to consider the perspective (e.g., patients, hospital,
ture (Peyronie’s disease) or penile carcinoma. third-party payer, government and society) of the evaluation, as this will
have significant influence on which costs should be included in the analysis.
“Occult” urodynamic stress incontinence For example, the perspective of the analysis will influence whether it should
Diagnosis include both direct and indirect costs. Direct medical costs typically relate
Where the diagnosis of urodynamic stress incontinence is only made when to the intervention and the immediate impact of the intervention on the
co-existent pelvic organ prolapse (POP) is reduced. health system: e.g., personnel costs/time (physician, nurse, technician), di-
agnostic and laboratory tests, hospital costs, treatment costs (drugs, operat-
Opening Time ing room time, etc.), treatment of side effects and outpatient visits. Indirect
Investigation costs will be of more relevance to a patient and/or societal perspective (e.g.,
The time elapsed from initial rise in pressure to the onset of flow. This is the loss of productivity, time lost from work, loss of service to family and com-
initial isovolumetric contraction period of micturition. It reflects the time munity and premature mortality) and are often more difficult to quantify
taken for the fluid to pass from the point of pressure measurement to the and to put a monetary value on.
uroflow transducer. Flow measurement delay should be taken into account
when measuring the opening time. Outcomes of Female Pelvic Floor Surgery - Patient Reported Outcomes
Surgery – Female
Orgasmic urinary incontinence (female) The primary patient reported outcome should be subjective and would
Symptom usually be the absence of a bulge.This can be regarded as a ‘‘subjective
Urinary incontinence at orgasm. cure’’ and can be recorded as part of a symptom scale. Details of validated
questionnaires for patient reported outcomes can be found on ICI’s website.
Outcome measurement in POP surgeries - objective outcomes To adhere with the SMART criteria, patient/subjective outcomes should be
Surgery – Female defined at a specific time interval and classified on a 7-point Likert scale
POP-Q measurement generally and should be tabulated with absolute val- (i.e. very much better, moderately better, a little better, no change, slightly
ues and percentages to allow other studies to compare results. worse, moderately worse, very much worse) such as the Patient Global Im-
pression of Improvement (PGI-I) scale.
Outcome measurement in POP surgeries - perioperative data
Surgery – Female
These data include blood loss, operating time, length of hospital stay, return
to normal activities and complications. Outcomes of Female Pelvic Floor Surgery - Reporting Complications
Surgery – Female
Outcome measurement in POP surgeries - subjective (patient reported out- Complications specifically related to prostheses and grafts and native tis-
comes) sues should be reported as per the IUGA-ICS classifications of complications
Surgery – Female directly related to the insertion of prostheses and grafts or the use of native
At its simplest level this can be reported as the presence or absence of vag- tissue in female pelvic floor surgery. These classifications both use the CTS
inal bulge. Patient satisfaction and quality of life can be measured by vali- Classification System: (C) Category of complication. (T) Time the complica-
dated instruments that cover prolapse, urinary, bowel and sexual function. tion was diagnosed in relation to primary surgery. (S) Site of the complica-
tion. There are seven Categories with subdivsions of (A–D). For the majority
Outcomes measurement in POP surgeries - secondary outcomes of complications, this would mean: (A) Asymptomatic, (B) Symptomatic, (C)
Surgery – Female Infection, (D) Abscess. For complications involving bowel or bladder injury
For example, lower urinary tract symptoms, stress urinary incontinence or or patient compromise, variations in the pattern of the increasing index of
bowel and sexual dysfunction in their studies whenever possible. severity exist: e.g., Category 5: rectal or bowel injury (both classifications)
(A) Small intraoperative defect; (B) rectal injury or compromise; (C) small

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or large bowel injury or compromise; (D) abscess. Studies, in particular of a expectations. These might have advantages over objective measures of out-
specific surgical procedure, should have a procedure-specific list of compli- come. With this in mind, goals should be reported using SMART criteria. The
cations using the CTS Classification Systems as part of the reporting. Only aim of the SMART criteria is to help clinicians review and confirm the utility
in this way can the nature and chronology of possible complications be de- of the chosen endpoint and how it will relate to other studies and reports.
termined (in relation to time of surgery) and at which sites they might most Criteria comprise: Specific Defining goal (for POP: absence of bulge). Meas-
commonly occur. Note is also made of the generic Clavien-Dindo complica- ureable validated symptom scale or objective measure such as the POPQ
tion classification which consists of four severity grades of complications. appropriate relevant to improving patient lifestyle realistic achievable by
This has been modified to include a fifth category. Grade IV IC/ICU organ treatment Timely For example at 6 months/2 years. The following is an ex-
or system dysfunction (a: single organ; b: multi-organ dysfunction) Grade V ample of good and poor reporting of patient expectations and outcomes,
Death. Grade I requires no treatment; Grade II requires drug therapy; Grade using the SMART Schema: Good example: ‘‘The absence of bother from a
III requires a procedure or intervention (a: in local; b: general anesthesia). vaginal bulge as measured using a defined tool at 2 years.’’ This statement
has Specific, Measurable, Appropriate, Realistic, and Timely attributes. Poor
Outcomes of Female Pelvic Floor Surgery - Reporting Demographics example: ‘‘Feeling perfect’’ when followed-up. ‘‘Perfect’’ is not specific (OB
Surgery – Female compared with absence of bulge), is less measurable (because it is difficult
The reporting of minimum demographics in POP surgery should include: A. to define), has no defined timepoint and is not appropriate or relevant
Age, B. Parity, C. Body mass index (BMI), D. Menopause status, E. Hormone to the surgery as many factors define ‘‘perfect.’’ Definitions relating to the
replacement (HRT) usage, F. Prior hysterectomy, G. Prior POP surgery, H. Pri- SMART criteria should be derived from the symptoms the researchers feel
or continence surgery, I. Chronic cough, J. Chronic constipation, K. Smoking are important. When designing a study, the symptoms should be listed and
then SMART should be applied. Authors should use this as a checklist to
Outcomes of Female Pelvic Floor Surgery - Reporting Objective Outcomes ensure that the methodology is sound and relevant.
Surgery – Female
Objective outcomes (e.g., POPQ) should be tabulated with percentages Outcomes of Female Pelvic Floor Surgery - Reporting of Randomized Con-
achieving each level to allow studies to compare results, as definitions of trolled Trials
success will vary among studies (see below). This report does not attempt to Surgery – Female
provide a definition for success and failure, as these are unknown. However, There are already accepted standards for reporting RCTs such as the CON-
authors should report data on the leading edge of the prolapse for each SORT (Consolidated Standards of Reporting Trials) which requires detailed
site (e.g. patients who achieve points 1and 0 postoperatively having had information provided by authors to reviewers with a checklist added as an
prolapse greater than 1 or 0 before surgery). These data, which may help appendix. However, many studies fail to provide complete descriptions of
identify the level of anatomical restoration that leads to improvement in critical information.
symptoms, should be reported separately. When possible, raw data should
be provided for POPQ, quality of life measures and all primary symptoms. Outcomes of Female Pelvic Floor Surgery - Reporting Patient Satisfaction
These should be reported in separate tables, which can be published as Surgery – Female
supplementary material in the electronic (online) version rather than the Patient satisfaction can be measured using qualitative measures, such as a
printed version. patient-defined measure or a validated instrument (PGI-I scale). Qualitative
assessment can include Expectations, Goal setting, Goal achievement and
Outcomes of Female Pelvic Floor Surgery - Reporting of Methodological Satisfaction (EGGS). Again these should be in accordance with the SMART
Data acronym. The number of pre-specified goals and the number achieved
Surgery – Female post-operatively should be recorded and reported for responsiveness and
General Criteria: The following should be defined: A. Inclusion criteria. B. reliability of goal achievement.
Exclusion criteria. C. Recruitment time span. D. Flow diagram including: (i)
Number of patients evaluated. (ii) Number suitable for inclusion. (iii) Num- Outcomes of Female Pelvic Floor Surgery - Reporting Perioperative Data
ber agreed to participate. (iv) Clear documentation accounting for all pa- Surgery – Female
tients’ progress throughout the study period. Comparative Studies: A. Clear Perioperative data includes blood loss (ml) and/or hemoglobin change, op-
explanation of patient allocation to treatment groups. B. Allocation con- erating time, length of hospital stay, return to normal daily activities and
cealment from surgeon and/or patient. C. Randomized trials: explanation complications.
of randomization process. D. Stratification of associated issues utilized such
as concomitant continence surgery or hysterectomy. Interventions: A. Clear Outcomes of Female Pelvic Floor Surgery - Reporting Postoperative Pain
documentation of interventions performed, experience level of surgeons Surgery – Female
and number of interventions performed prior to study commencement. Pain associated with surgical complications is addressed separately in the
B. Criteria for performing concomitant surgery. Evaluation Process: A. Who IUGA-ICS classifications of complications of female pelvic floor surgery. The
performed the evaluation and the training received. B. Were reviewers and/ addition of a letter (a to e), as part of a subclassification to the CTS Classifi-
or participants blinded. C. Evaluation tools: were validated, patient-com- cation System, specifies the presence of pain as part or all of the abnormal
pleted assessments standardized. D. Evaluation timeline: i. Very early (up to finding or complication and the grade in terms of the presence and severity
3 months). ii. Early (up to 1 year). iii. Intermediate (12–36 months). iv. Late of symptoms.
(3–5 years). v. Very late (>5 years). Power Analysis: Details of the assumptions (a) Asymptomatic or no pain. (b) Provoked pain only (during vaginal exam-
made in the power calculation, estimate of the type 1 error and sample size ination). (c) Pain during sexual intercourse. (d) Pain during during physical
should be reported. activties. (e) Spontaneous pain.
Additional information on pain may include ‘‘permanent or temporary’’ and
Outcomes of Female Pelvic Floor Surgery - Reporting of Patients’ Preopera- ‘‘severity’’ as measured by impact on quality of life and treatment required
tive Goals and Expectations (e.g., simple oral analgesia, compound analgesia, opiates, referral and man-
Surgery – Female agement by pain team or further surgery).
To date, few studies have provided data on patients’ preoperative goals and

Terms O
906

Outcomes of Female Pelvic Floor Surgery - Reporting Quality of Life Outcomes of Female Pelvic Floor Surgery - Timelines for Reporting
Surgery – Female Surgery – Female
Appropriate and fully validated quality of life instruments should be used to Timelines should be described chronologically, as outlined below, using
cover prolapse, urinary, bowel and sexual function. New questionnaires can the classification above. Of note, these timescales are different to those
be included when they have demonstrated good psychometric properties described in the classifications of complications reports related to female
(i.e., validity, reliability and responsiveness) in women with POP. It is impor- pelvic floor surgery using either prosthese and meshes or native tissue. I.
tant to verify that the questionnaire has been validated in the language of Very early (up to 3 months). II. Early (up to 1 year). III. Intermediate (12–36
the trial investigator(s). months). IV. Late (3–5 years). V. Very late (>5 years).

Outcomes of Female Pelvic Floor Surgery - Reporting Secondary Outcomes Overactive bladder (OAB, Urgency) syndrome
Surgery – Female Symptom
Secondary outcomes to be reported include an assessment of other symp- Urinary urgency, usually accompanied by increased daytime frequency
toms known to be associated with prolapse: Lower urinary tract symptoms and/or nocturia, with urinary incontinence (OAB-wet) or without (OAB-dry),
(LUTS): Overactive bladder, stress urinary incontinence (either pre-existing in the absence of urinary tract infection or other detectable disease.
or de-novo) and voiding dysfunction. Bowel dysfunction: Obstructed def-
ecation, feeling of incomplete emptying, constipation and digitation. Sex- Overactive Pelvic Floor Muscles
ual dysfunction: Dyspareunia, loss of libido, abstinence due to prolapse Diagnosis
symptoms and change in sexual satisfaction. Authors should report num- A situation in which the pelvic floor muscles do not relax, or may even con-
bers of all patients who are sexually active with and without pain, pre and tract when relaxation is functionally needed for example during micturition
post-intervention. All participants in trials should be accounted for pre- and or defecation. This condition is based on symptoms such as voiding prob-
post-intervention. De novo/new onset symptoms (if not previously report- lems, obstructed defecation, or dyspareunia and on signs like the absence
ed): LUTS, sexual dysfunction, pain and bowel dysfunction. Backache: Back- of voluntary pelvic floor muscle relaxation.
ache is a common presenting symptom, the resolution of this may be an
important outcome. Overactive pelvic floor muscles (female)
Sign
Outcomes of Female Pelvic Floor Surgery - Reporting Systematic Reviews Pelvic floor muscles which do not relax, or may even contract when relaxa-
and Meta-Analyses tion is functionally needed, for example, during micturition or defecation.
Surgery – Female
Due to the lack of consistent descriptions of critical information reported Overflow fecal incontinence
from RCTs, a new instrument, Preferred Reporting Items for Systematic Re- Symptom
views and Meta-Analyses (PRISMA), has been introduced to evaluate sys- Complaint of involuntary loss of stool due to an overfull rectum or fecal im-
tematic reviews and meta-analyses. The aim of the PRISMA statement is to paction.
give authors an evidence-based minimum set of items to improve the re-
porting of systematic reviews and metaanalyses in POP issues. Other stand- Overflow urinary incontinence.
ards include the Standards for the Reporting of Diagnostic (STARD) accuracy Symptom
studies, and STROBE (STrengthening the Reporting of OBservational studies Complaint of urinary incontinence in the symptomatic presence of an ex-
in Epidemiology). Researchers should quote which standard they adopt and cessively (over-) full bladder (no cause identified).
reference accordingly.

P
A variably unpleasant sensation. It may be described as pressure or discom-
Pad testing fort by the patient. Pain should be characterized by site, type, frequency,
Sign duration, precipitating and relieving factors.
For individuals with urinary (fecal) incontinence symptoms, the quantifica-
tion of the amount of urine (feces) lost over the duration of testing, by meas- Pain
uring the increase in the weight of the pads (weighed pre- and post-test- Symptom
ing) used. This may give a guide to the severity of incontinence. Different A subjective phenomenon described as an unpleasant sensory and emo-
durations from a short (1 hour) test to a 24 and 48-hour tests have been tional experience associated with actual or potential tissue damage, or de-
used with provocation varying from normal everyday activities to defined scribed in terms of such damage. Pain should be characterized by site, type,
regimens. frequency, duration, precipitating and relieving factors. NB: The word pain
comes from the Latin “poena” meaning a fine or a penalty.
Pad testing
Sign Pain - filling cystometry
For individuals with urinary (fecal) incontinence, the quantification of the Investigation
amount of urine (feces) lost over the duration of testing, by measuring the The complaint of pain during filling cystometry is abnormal. Its site, charac-
increase in the weight of the pads (weighed pre-and post-testing). ter and duration should be noted.

Pain Pain - Neurobiology

Symptom Symptom

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 907

Alterations in gut and bladder motility, visceral perception and central pro- Passive fecal incontinence (female)
cessing of pain and motor function due to abnormalities in the visceral and Symptom
central nervous systems may account for the symptoms. Fecal soiling without sensation or warning or difficulty wiping clean.

Pain - psychology Passive fecal leakage (female)

Symptom Symptom
Pain is modulated by cognitive factors and emotional experience, memory, Involuntary soiling of liquid or solid stool without sensation or warning or
attention and context represented in descending modulation of pain, af- difficulty wiping clean.
fecting pain experience from moment to moment and longer term. Pain has
an impact on many aspects of daily life, affecting mood, sleep, relationships Passive (insensible) fecal incontinence.
and activities. Therefore, attention to the psychological aspects of pain is an Symptom
important part of effective assessment and treatment. Complaint of involuntary soiling of liquid or solid stool without sensation
or warning.
Pain (during) - Filling cystometry
Investigation Patient Preparation and Information in advance of Invasive Urodynamics
The complaint of pain during filling cystometry is abnormal. Its site, charac- Investigation
ter and duration should be noted. Although evidence indicates that urodynamics is generally well tolerated,
studies have examined pain and embarrassment, using a variety of ques-
Pain during straining/defecation (female) tionnaire methods. Younger patients have been identified as a group that
Symptom may experience more pain and apprehension associated with depression,
Complaint of pain during defecation or straining to defecate. anxiety and/or bladder pain syndrome. Effectiveness of patient information
leaflets requires comprehensibility and communicative effectiveness. How-
Pain Evaluation and Measurement ever, reports analysing existing information conclude that this is of poor
Investigation quality. Studies to develop a detailed explanatory leaflet, which were used
Pain rating(s) are essential in patient evaluation including: baseline and in a double-blind randomized controlled trial to conclude that ‘leaflet’ or ‘no
ongoing regular evaluation of severity, quality of life, questions about leaflet’ intervention had a disappointing satisfaction outcome. Poor under-
thoughts, emotions and behavior associated with the pain (questionnaires). standing of the test has been associated with lack of satisfaction with care
Pain measurement: one of the most commonly used tools is the visual an- and with, for example, the perception that the investigation in itself is ther-
alogue scale (VAS), which is a 10cm line from ‘‘0’’ no pain to ‘‘10’’ extreme apeutic. Some evidence exists that information leaflets about urodynamic
pain. Pain evaluation involves additional pain mapping by identifying pain investigations are too difficult for patients to understand.
generators through diagnostic procedures. These include EMG, Q-tip touch Young adults and patients with a bladder pain syndrome may have a rel-
sensitivity testing, trigger point injections, nerve blocks and imaging. atively negative experience with urodynamic investigation.Conflicting evi-
dence exists about which precise information is helpful to give to patients
Pain experience before urodynamic testing to reduce distress. Effective communication is
Symptom an expectation in modern healthcare, so that patients become actively en-
According to the most common views, pain constitutes the internal per- gaged in the test and their care delivery. A leaflet with a minimum set of
ception of bodily damage. It is unknown whether chronic pelvic pain syn- items would facilitate informed decision making. Good information before
dromes (CPPS) are primarily an abnormal perception of a normal stimulus or and during the test increases a patient’s acceptance and confidence, and
a normal perception of an abnormal physiologic sensory stimulus. will reduce confusion. Although in the absence of good evidence, that an
explanatory leaflet about urodynamic investigation with sufficient infor-
Painful bladder syndrome mation, which uses clear, unambiguous wording will be appreciated by the
Symptom majority of patients.
Painful bladder syndrome is the complaint of suprapubic pain related to
bladder filling, accompanied by other symptoms such as increased daytime
and night-time frequency, in the absence of proven urinary infection or oth- Pelvic Congestion Syndrome
er obvious pathology. Symptom
i. Pressure, heaviness, dull aching pain in the pelvis and/or in the back. ii.
Paraphimosis Dysmenorrhea.
Sign
Entrapment of the prepuce behind the glans usually due to a preputial ring. Pelvic electrical stimulation
Conservative Management – General
Paravaginal repair - open, laparoscopic, robotic This is the application of electrical current to stimulate the pelvic viscera or
Surgery – Female their nerve supply.
Extraperitoneal bilateral reattachment of the lateral edge of the damaged
fascia to the Arcus Tendineus Fasciae Pelvis (alt: white line). Pelvic Floor
Conservative Management – General
Paruresis (‘bashful” or “shy” bladder) The term pelvic floor relates to the compound structure, which closes the
Symptom bony pelvic outlet. The term pelvic floor muscles refers to the muscular layer
Complaint of the inability to initiate voiding in public (i.e. voiding in the of the pelvic floor. The pelvic floor consists of different layers, the most crani-
presence of other persons) despite there being no difficulty in private. al being the peritoneum of the pelvic viscera and the most caudal being the
skin of vulva, scrotum and perineum. The middle layers of the pelvic floor
are made up of predominantly muscular tissue. Apart from the pure pel-

Terms O - P
908

vic floor muscles, fibro-muscular and fibrous elements, like the endo-pelvic Pelvic Floor Muscle - Pain Assessment (female)
fascia are found in this layer. Different well recognizable muscles together Investigation
form the muscular layer of the pelvic floor: levator ani, striated urogenital Pain evaluation consists of baseline and ongoing regular evaluation of
sphincter, external anal sphincter, ischiocavernosus and bulbospongiosus. severity, quality of life, thoughts, emotions, and behavior associated with
All these muscles are working together to seal the lower aspect of the pelvic the pain (via direct consultation or questionnaires) and investigations to
cavity. Urethra, vagina, and rectum pass through the pelvic floor and are identify well-defined/ confusable/non-pain syndromes. 1. Pain measure-
surrounded by the pelvic floor muscles.The pelvic bones are the structures ment: pain can only be measured subjectively. Patient-reported outcome
to which the muscularlayer is attached. measures include: a) Numerical rating scale (NRS), from 0 (no pain) to 10
(extreme pain), with half-points marked. b) Visual analogue scale (VAS), a 10-
Pelvic Floor - Voluntary Contraction cm line with the same labels at the ends. c) A simple verbal rating scale can
Sign be used, e.g., “none,” “mild,” “moderate,” “severe.” 2. Pain mapping: identify-
Voluntary contraction of the pelvic floor muscles means that the patient is ing pain generators through diagnostic procedures such as questionnaires,
able to contract the pelvic floor muscles on demand. A contraction is felt digital palpation, EMG, quantitative sensory threshold measurement, trig-
as a tightening, lifting and squeezing action under the examining finger. A ger point injections, nerve blocks, and imaging. a) Questionnaires: several
voluntary contraction can be absent, weak, normal or strong. pain questionnaires can be used in the evaluation of musculoskeletal pain
in the pelvis; the choice will be determined by which is most appropriate
Pelvic floor assessment in female sexual dysfunction - Pelvic floor manom- to the presenting pelvic floor dysfunction: McGill Pain Questionnaire, Pelvic
etry Floor Distress Inventory (PFDI), Female Sexual Function Index, Female Sexu-
Investigation al Distress Scale, Pelvic Pain and Urgency/Frequency Questionnaire. b) Pain
Measurement of resting pressure or pressure rise generated during contrac- chart/body map: a simple line drawing of an outline of the front and back
tion of the PFMs using a manometer connected to a sensor which is inserted (or relevant body part) of the human body, onto which the patient sketches
into the urethra, vagina, or rectum. Pelvic floor manometric tools measuring or ticks or marks areas of bodily pain to demonstrate the site and extent of
pressure in either mmHg, hPa, or cmH2O can be used to assess resting pres- perceived pain; c) Pain checklist: a list of anatomical locations from which
sure, maximal squeeze pressure (strength), and endurance. the patient selects sites that are relevant to her complaint.

Pelvic Floor Dynamometry Pelvic floor muscle assessment in female sexual dysfunction - general com-
Investigation ments
A dynamometer is an instrument that measures power or force. Pelvic floor Investigation
dynamometry: Measurement of PFM resting and contractile forces using Assessment of pelvic floor muscle (PFM) function involves evaluating the
strain gauges mounted on a speculum (a dynamometer), which is inserted tone, strength, endurance, coordination, reflex activation during rises in
into the vagina. Dynamometry measures force in Newton units (N=1kg×m/s intra-abdominal pressure as well as the capacity to properly relax this mus-
(sq)). culature.These muscles are involved in sexual function as PFM contraction
occurs during arousal and intensifies with orgasm and PFM tone is related to
Pelvic Floor Function - General vaginal sensation. Superficial PFMs such as the bulbospongiosus and ischio-
Conservative Management – General cavernous are also involved in erection of the clitoris by blocking the venous
The function of the pelvic floor isto support the pelvic organs.The function escape of blood from the dorsal vein. Thus, reduction in PFM strength and
of the pelvic floor muscles is performed by contraction and relaxation. In its endurance has been related to lower sexual function. Likewise, PFM hypo-
resting state, the pelvic floor gives support to the pelvic organs. Whether tonicity may be related to vaginal hypoesthesia, anorgasmia and urinary in-
the support function is normal depends on the anatomical position of the continence during intercourse while hypertonicity may lead to dyspareunia.
muscles on the activity of the pelvic floor muscles at rest (active support)
and on the integrity of the fascia (passive support). During intra-abdominal Pelvic floor muscle assessment in female sexual dysfunction - Pelvic floor
pressure rise, the pelvic floor muscles must contract to maintain the sup- dynamometry
port function of the pelvic floor. A contraction of the pelvic floor muscles Investigation
results in a ventral and cranial movement of the perineum, and an upward Measurement of PFM resting and contractile forces using strain gauges
movement of the pelvic organs together with an anterior movement caused mounted on a speculum (a dynamometer), which is inserted into the vagi-
primarily by the vaginal and rectal parts of the levator ani. When the pelvic na. Dynamometry measures force in Newton (N). Several parameters such
floor muscles contract the urethra closes, as do the anus and the vagina. as tone, strength, endurance, speed of contraction and coordination can be
This contraction is important in preventing involuntary loss of urine or rectal evaluated.
contents. For women it can also function as a defense mechanism against
sexual intercourse. For maintaining continence, it is also important to realize Pelvic floor muscle assessment in female sexual dysfunction - Pelvic floor
that detrusor activity is inhibited by pelvic floor muscle contraction. electromyography (EMG)
Investigation
Pelvic Floor Manometry The recording of electrical potentials generated by the depolarization of
Investigation PFM fibers. Intra-muscular EMG consists in the insertion of a wire or needle
A manometer is a device for measuring pressure. Pelvic floor manometry: electrode into the muscle to record motor unit action potentials while sur-
measurement of resting pressure or pressure rise generated during contrac- face EMG requires electrodes placed on the skin of the perineum or inside
tion of the PFM using a manometer connected to a sensor, which is inserted the urethra, vaginal or rectum. EMG amplitude at rest and contraction can
into the urethra, vagina or rectum. Pelvic floor manometric tools measure be recorded.
pressure in mmHg, hPa or cmH2O. Conversion of data to the internation-
al standard unit of measurement(hPa) is recommended. Perineometer: the Pelvic floor muscle assessment in female sexual dysfunction - Pelvic floor
first PFM vaginal pressure device connected to a manometer developed by ultrasound imaging
Kegel. Investigation

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6. ICS Glossary
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Evaluation of PFM morphology at rest, during maximal contraction and Val- universally accepted system for the diagnosis and evaluation of the extent
salva. Several parameters pertaining to assess the bladder neck and anorec- of the injury. Essentially, abnormalities are judged to have occurred when
tal positioning and hiatus dimensions can be measured. the morphology of the pubococcygeal portion of the levator ani muscle
deviates from what is seen in normal nulliparous women. Several groups
Pelvic Floor Muscle Contraction - Repetition and Set have studied and defined levator damage on MRI when one or more of the
Conservative Management – Female following is present: absence of pubococcygeal muscle fibers in at least
Repetition: the completion of a whole cycle from the starting position, one 4-mm section, or two or more adjacent 2-mm sections in both the ax-
through the end of the movement, and back to the start e.g. one PFM con- ial and the coronal planes. The degree of injury can be assessed based on
traction with relaxation. Set: the number of times the desired number of the amount of muscle involved in the injury, with reasonable repeatability
repetitions is performed e.g., three sets of 12 PFM contractions among different examiners in a single group. More than half the expected
muscle bulk is associated with the presence of POP.
Pelvic Floor Muscle Dyssynergia
Sign Pelvic Floor Muscle Injury (PFMI) - Ultrasound detection
Incoordination of the PFM and another muscle group during a functional Imaging
activity, for example, the pelvic floor muscles may not relax appropriately PFMI is diagnosed on ultrasound when at least one of the following is pres-
during micturition or defecation. ent: a) Undetected puborectalis-to-ipsilateral sidewall attachment on any
of the three central slices (full avulsion); b) Undetected puborectalis-to-ip-
Pelvic floor muscle endurance (female) silateral sidewall attachment on at least one slice (partial avulsion); c) A le-
Sign vator–urethra gap (LUG) of greater than 2.5cm. PFM position in the pelvis:
The ability to sustain near maximal or maximal force, assessed by the time can be measured in the sagittal plane in relation to defined landmarks, and
one is able to maintain a maximal static or isometric contraction, or ability may be related to PFM dysfunction (elevated or descended pelvic floor). Hi-
to repeatedly develop near maximal or maximal force determined by as- atal dimension: is the cross-sectional area of the pelvic floor/levator hiatus,
sessing the maximum number of repetitions one can perform at a given including anteroposterior and transverse distances.
percentage of 1 RM (one-repetition maximum).
Pelvic floor muscle (PFM) function (male) - contractile function
Pelvic Floor Muscle Exercises - Kegels Sign
Conservative Management – Female . Voluntary contractility: the individual is able to contract the PFM on de-
A PFM contraction or PFM exercise.This term is named after Arnold Kegel, an mand. A contraction is felt as a tightening, lifting and squeezing action un-
American gynecologist who first described the clinical effect of PFMT in the der/around the finger.
late 1940s. ICS recommends the use of the term PFMT (not the word Kegels) . Strength: Force-generating capacity of a muscle. It is generally expressed
to refer to exercises that specifically target the PFM. as maximum voluntary contraction.
. Endurance: the ability to sustain near maximal or maximal force, assessed
Pelvic floor muscle hypertonicity (female) by the time a patient is able to sustain a maximal static or isometric con-
Sign traction.
A general increase in muscle tone that can be associated with either elevat- . Repeatability: the ability to repeatedly develop near maximal or maximal
ed contractile activity and/or passive stiffness in the muscle. As the cause force, determined by assessing the maximum number of repetitions the
is often unknown the terms neurogenic hypertonicity and non-neurogenic patient can perform before detectable decline in force. Record number of
hypertonicity are recommended. contractions in a row.
. Co-contraction: contraction or activation of two or more muscles at the
same time. Identify which muscles are co-contracting and whether the
co-contraction is synergistic.
. Relaxation ability: return of the PFM to its original resting tone following
Pelvic floor muscle hypotonicity (female) the voluntary contraction. Also includes the ability to maintain PFM relaxa-
Sign tion in anticipation of or during any type of touch.
A general decrease in muscle tone that can be associated with either re-
duced contractile activity and/or passive stiffness in the muscle. As the Pelvic floor muscle (PFM) function (male) - Diagnoses related to PFM exam-
cause is often unknown the terms neurogenic hypotonicity and nonneuro- inations
genic hypotonicity are recommended. Sign
. Overactive pelvic floor muscles: Pelvic floor muscles which do not relax,
Pelvic Floor Muscle Injury (PFMI) or may even contract when relaxation is functionally needed, for example,
Sign during voiding or defecation.
On clinical palpation, PFMI is diagnosed when one or more of the following . Underactive pelvic floor muscles: Pelvic floor muscles which cannot volun-
is present: a) A discontinuity of the puborectalis muscle at its attachment to tarily contract when instructed to do so or when required.
the inferior pubic ramus; b) A distance of >3.5 finger widths between the
two sides of puborectalis muscle insertion; c) A gap in the continuity of the Pelvic floor muscle (PFM) function (male) - Examinations at rest
pubovisceral muscle between the pubic rami and the ano-rectum. Sign
. Myalgia: provoked by palpation. Levator muscle pain/tenderness may be
Pelvic Floor Muscle Injury (PFMI) - Detection by Magnetic Resonance Imag- elicited by palpation of these muscles via rectal examination.
ing (MRI) - Tender point: Tenderness to palpation at a specific soft tissue body site.
Imaging . Tone: state of the muscle, usually defined by its resting tension, clinically
PFM injury: can represent a full spectrum, from disruption of a single fas- determined by resistance to passive movement. Muscle tone has two com-
cicle, to complete disruption of the muscle origin. At present, there is no

Terms P
910

ponents, the contractile component and the viscoelastic component. Mus- Pelvic Floor Muscle Training
cle tone may be altered in the presence or absence of pain. Conservative Management – Female
. Increased PFM tone (non-neurogenic hypertonicity): increased tone in a Exercise to improve PFM strength, endurance, power, relaxation or a combi-
patient without an intercurrent neurological diagnosis. nation of these parameters.
. Decreased PFM tone (non-neurogenic hypotonicity): decreased tone in a
patient without an intercurrent neurological diagnosis. Pelvic Floor Muscle Training - Biofeedback Training
. Symmetry: if examining in the left lateral, there will be a gravity effect and Conservative Management – Female
the dependent side will have a different feel to the upper side and appear as Feedback: is sensory information that is available as the result of an activity
asymmetrical. This may affect PFM tone. Not so common in men. that a person has performed. It can be provided by an intrinsic source (from
. PFM injury: e.g. palpable anal sphincter gap though overall not common within the individual), or an extrinsic source (from the clinician), and can
unlike women. occur concurrently with the activity or post-activity, e.g., verbal information
from the clinician to the patient during or following PFM assessment. Bio-
Pelvic floor muscle (PFM) function (male) - General feedback: is the use of an external sensor to give an indication with regard
Sign to bodily processes, usually with the purpose of changing the measured
The following signs of PFM function may be assessed via the perineum quality. It is an adjunctive therapy.
(visual or tactile examination) or per rectum (digital palpation) examination.
Digital rectal examination (DRE) may be less useful in male urinary dysfunc- Pelvic Floor Muscle Training - Detraining
tions where the urethral sphincter, inaccessible to DRE, has a more impor- Conservative Management – Female
tant role. Cessation of training, but also planned or unplanned reduced volume or
intensity of training.
Pelvic floor muscle (PFM) function (male) - Perineal examination
Sign Pelvic Floor Muscle Training - Dilator Therapy
When the patient is asked to cough or bear down, the perineum should only Conservative Management – Female
show limited downward movement; ventral movement may occur because Dilator therapy: a conical or cylindrically shaped device (made of an inert
of the guarding actions of the pelvic floor muscles. material) inserted intravaginally or intra-anally, with the aim of increasing
- Perineal elevation: This is the inward (ventro-cephalad) movement of the the flexibility or elasticity of the soft tissues via application of a prolonged
perineum and anus. Look for testicular lift and penile retraction. These need elongation or stretch. Dilators may also be used as a desensitizer device, to
to be checked against movement of the scrotum and the whole penis. Cor- reduce fear, anxiety or pain associated with vaginal touch and in conjunc-
rect movement occurs with the PFM only: the shaft of the penis draws in tion with vaginismus or sexual pain. When combined with EMG, dilators can
and the testes lift in a cephalad direction. These movements may be better be used to train PFM relaxation during penetration. Dilators may also be
visualized in standing than supine position. used to increase the tolerance of skin to sliding when the dilator is moved
- Perineal descent: This is the outward (dorso-caudal) movement of the per- in and out.
ineum and anus.

Pelvic Floor Muscle Relaxation Pelvic Floor Muscle Training - Dose-response issues related to exercise train-
Conservative Management – General ing
Pelvic floor muscle relaxation following contraction results in a reduction Conservative Management – Female
in the support given to the urethra, vagina and anus.The perineum and the 1. Dose–response: amount/volume of training and its effect on the speed
pelvic organs return to their anatomical resting position.The pelvic floor and degree of the effect of the training program. 2. Frequency of exercise:
muscles must relax in order to remove the passive continence mechanisms, the number of activity sessions per day, week, or month. 3. Duration of ex-
thereby favoring normal micturition. The same is true for relaxation before ercise: the unit of time (number of seconds/ minutes)of activity in each rep-
and during defecation, allowing the anorectal angle to become obtuse, fa- etition or session, e.g., a10-s PFM contraction. It also refers to the length of
voring rectal emptying the whole training period (intervention), e.g., 3/6 months. 4. Intensity: the
amount of resistance used or the effort associated with the physical activity.
Pelvic floor muscle strength (female) For strength training, it is often expressed as a percentage of one repetition
Sign maximum: 1RM (the maximum load a person can lift once), e.g., 70 % of
Force-generating capacity of a muscle. It is generally expressed as maximal maximum. 5. Session/bout: the block of time devoted to the training, e.g.,
voluntary contraction measurements and as the one-repetition maximum a 1-h session.
(1RM) for dynamic measurements.
Pelvic Floor Muscle Training - EMG assessment of PFM
Pelvic floor muscle tenderness (female) Conservative Management – Female
Sign Electromyography assessment of PFM consists of the use and interpreta-
Occurrence of the sensation of pain or painful discomfort of the pelvic floor tion of the surface EMG recording of a muscle for rehabilitation purposes
muscles elicited through palpation. should be done cautiously, recognizing that the main goal is the qualitative
description of the muscle activation pattern, and not a qualitative diagnosis.
Pelvic floor muscle tone (female) 1. Baseline muscle activity: amount of microvolts generated by the target
Sign muscle during rest. 2. Peak microvolts: the highest EMG amplitude achieved.
In normally innervated skeletal muscle, tone is created by “active” (contrac- 3. Slow recruitment: slow initiation of muscle activation contraction. 4. Slow
tile) and “passive” (viscoelastic) components clinically determined by resist- de-recruitment or slow latency to return to baseline: slow relaxation of the
ance of the tissue against stretching or passive movement. muscle contraction. 5. Inconsistent resting baseline: variation of baseline
between contractions, between sets, or between days may be related to a
change in patient symptoms, e.g., hypertonic PFM. 6. Excessive accessory

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muscle contraction: increased amplitude in accessory muscles often result- Pelvic Floor Muscle Training - Isometric/Static Contraction
ing in cross talk and is indicative of poor isolation of target muscle contrac- Conservative Management – Female
tion. A muscular action during which no change in the length of the total muscle
or joint angle takes place.
Pelvic Floor Muscle Training - EMG Biofeedback Unit Instrumentation
Conservative Management – Female Pelvic Floor Muscle Training - Isotonic or eccentric contraction
1. EMG signal amplitude: number of microvolts (µV) a muscle is generating. Conservative Management – Female
EMG biofeedback units can deliver either the actual amount of EMG activity Isotonic contraction: A muscular action during which the tension developed
in µV or an average µV value. 2. Artifact: extraneous information non-recog- by the muscle remains almost constant while the muscle shortens. Eccen-
nizable in the EMG signal from sources other than the target muscle such tric contraction: a muscular action in which the muscle lengthens in a con-
as the environment or other body functions. 3. Cross talk: muscle activity trolled manner.
from nearby muscles that can artificially increase EMG amplitude; a type of
artifact. 4. Dual-channel EMG: use of two channels to monitor two separate Pelvic Floor Muscle Training - Local Muscle Endurance Training
muscles or muscle groups at the same time, such as the PFM and abdominal Conservative Management – Female
muscles, with the goal of either promoting synergist activity or reducing Training with a low load and a high number of repetitions or holding the
EMG activity of one muscle while increasing the other. 5. Band pass: lim- contraction over time.
its muscle fiber frequencies that are monitored and displayed in the EMG
tracing. Pelvic Floor Muscle Training - Maintenance Training
Conservative Management – Female
Pelvic Floor Muscle Training - EMG Training of PFM A program designed to prevent loss of the previous level of functioning.
Conservative Management – Female
1. Up-training: EMG biofeedback training to increase the EMG activity of a Pelvic Floor Muscle Training - Muscle Power Training
hypotonic muscle with low EMG activity. 2. Down-training: EMG biofeed- Conservative Management – Female
back training to decrease EMG activity and relax muscles. All training with the aim of generating power; can be close to maximal con-
traction training and/or rapid contractions.
Pelvic Floor Muscle Training - Facilitation Technique
Conservative Management – Female
Any method of increasing recruitment/response of a non-responding mus-
cle. In the case of non-contractile or very weak PFMs, this may include a
quick stretch of the PFM, with tapping or stretching the PFM digitally. An Pelvic Floor Muscle Training - Overload
overflow effect from a strong contraction of a nearby synergistic muscle Conservative Management – Female
(e.g. external rotators) may also assist facilitation or recruitment of PFMs. A situation in which the body is required to perform exercise beyond that
to which the neuromuscular system is accustomed during routine activities.
Training adaptation occurs in response to a progressive “overload”. Progres-
sive overload: the gradual increase in stress placed upon the body during
Pelvic Floor Muscle Training - Functional Training exercise training.
Conservative Management – Female
Functional training consists of training for tasks of daily living and self-care Pelvic Floor Muscle Training - Relaxation Training
activities, e.g., squatting to train quadriceps and gluteal muscles. 1. Func- Conservative Management – Female
tional PFM training: training and exercises that incorporate a correct PFM Relaxation: the ability to control muscle activity such that muscles not
contraction into activities of daily living such as lifting, transferring out of specifically required for a task are quiet and those that are required are
bed, or sneezing. A PFM contraction before a rise in intraabdominal pres- fired at the minimal level needed to achieve the desired results. Relaxation
sure, e.g., a cough (“the Knack”) is part of functional PFM training. 2. Co- can be considered a motor skill in itself because the ability to reduce mus-
ordination training: the ability to use different parts of the body together cle firing is as important to control as the generation of firing. a) General
smoothly and efficiently. Related to PFM training, coordination training relaxation technique: a technique that involves the whole body, with the
means PFM contraction with other muscles or other muscle groups, e.g. res- aim of effecting a global relaxation, including a decrease in the skeletal and
piratory muscles. 3. Functional mobility training: an intervention directed at smooth muscles, a decrease in the heart rate and respiration rate and an
improving the physical ability to perform a daily task. For voiding/defeca- increase in parasympathetic activity. General relaxation techniques can also
tion, this may include: gait training, transfer training, stair training, and other be used aimed at relaxing local muscles. b) Progressive muscular relaxation
mobility training to improve speed and safety in reaching the toilet. (also known as Jacobsen’s technique): monitoring tension in each specific
muscle group, by contracting, then relaxing the tension, with attention paid
Pelvic Floor Muscle Training - Individualized, Supervised, Group and Home to the contrast between tension and relaxation. This type of relaxation is
Conservative Management – Female also termed “contract–relax.” c) Meditation: a practice of concentrated focus
1: Individualized PFMT: an individual PFM program aimed at improving the upon a sound, object, visualization, the breath, movement, or attention it-
specific deficiencies in PFM structure or function based on assessment of self to increase awareness of the present moment, reduce stress, promote
the woman’s ability to contract the PFM. 2: Supervised PFMT: a PFMT pro- relaxation, and enhance personal and spiritual growth. d) Mindfulness: in-
gram taught and monitored by a health professional/clinician/instructor. 3: tentionally bringing one’s attention to the internal and external experiences
Group PFMT: PFMT conducted in an exercise class. Class participation may occurring in the present moment. Mindfulness is often taught through a
occur with or without previous individualized PFM instruction. Home train- variety of meditation exercises. e) EMG relaxation techniques: techniques to
ing: home PFM exercise program: an unsupervised PFMT program, which decrease EMG muscle activity or activation through a methods, including a
the individual performs at home. conscious effort to relax.

Terms P
912

Pelvic Floor Muscle Training - Resistence able to relax the pelvic floor muscles on demand, after a contraction has
Conservative Management – Female been performed. Relaxation is felt as a termination of the contraction. The
Resistance: the amount of force opposing a movement. Resistance devices: pelvic floor muscles should return at least to their resting state. Avoluntary
any object used to increase resistance to contraction, e.g., hand weights. relaxation can be absent, partial or complete
Vaginal resistance device: objects inserted into the vagina or rectum that
are inflated or spring-loaded devices to increase resistance to contraction. Pelvic floor spasm (female)
Sign
Pelvic Floor Muscle Training - Strength Training The presence of contracted, painful muscles on palpation and elevated rest-
Conservative Management – Female ing pressures by vaginal manometry. This persistent contraction of striated
Training with high resistance (close to maximal contractions) and few rep- muscle cannot be released voluntarily. If the contraction is painful, this is
etitions with the aim of increasing muscle volume and neural adaptations. usually described as a cramp. Pelvic floor myalgia (a symptom) may be pres-
ent with or without a change in PFM tone (a sign).
Pelvic Floor Muscle Training - Stretching
Conservative Management – Female Pelvic organ
Stretching (also referred to as flexibility training when the method is used Surgery – Female
on skeletal muscles where increased range of motion over the joints is the This refers most commonly to the uterus and/or the different vaginal com-
aim): the application of an external force to muscle and connective tissue to partments and their neighboring organs such as bladder, rectum or bowel.
elongate it in the direction opposite to its shortened position. This can be
done parallel or perpendicular to the muscle fiber direction. For the PFM this
can be applied as a widening of the levator hiatus in the axial plane (latero-
laterally) via a digit or use of a dilator, or a caudal movement (via a straining/
bearing down maneuver) in the sagittal plane. Pelvic organ prolapse - definition of sign
Sign
Pelvic Floor Muscle Training - Vaginal Cones The descent of one or more of the anterior vaginal wall, posterior vaginal
Conservative Management – Female wall, the uterus (cervix) or the apex of the vagina (vaginal vault or cuff scar
Weighted vaginal cones: objects of different shapes, sizes, and weights, after hysterectomy). The presence of any such sign should be correlated
which are inserted into the vagina above the level of the PFM with the aim with relevant POP symptoms. Most commonly, this correlation would occur
of providing sensory biofeedback and load on the PFM to increase muscle at the level of the hymen or beyond.
recruitment and strength.
Pelvic organ prolapse - diagnosis
Pelvic Floor Muscles - Involuntary Contraction Diagnosis
Sign This diagnosis (i) by symptoms and clinical examination, assisted by any rel-
Involuntary contractionof the pelvic floor muscles is the contraction that evant imaging, involves the identification of descent of one or more of the
takes place preceding an abdominal pressure rise, such as due to a cough, to anterior vaginal wall (central, paravaginal or combination cystocele), pos-
prevent incontinence. An involuntary contraction can be absent or present. terior vaginal wall (rectocele), the uterus (cervix) or the apex of the vagina
(vaginal vault or cuff scar) after hysterectomy. The presence of any such sign
Pelvic Floor Muscles - Involuntary Relaxation should correlate with relevant POP symptoms.
Sign
Involuntary relaxation of the pelvic floor muscles is the relaxation that takes Pelvic organ prolapse - related radiology
place when the patient is asked to strain as if defecating. An involuntary Imaging
relaxation can be absent or present. Defecography demonstrates normal anatomy of the anorectum as well as
disorders of rectal evacuation. With barium paste inserted rectally prior to
Pelvic Floor Muscles - Non-Contracting Pelvic Floor defecation, measurement of the anorectal angle is allowed with evidence
Sign of the presence, size or emptying of any rectocele. Enteroceles, rectal intuss-
Involuntary relaxation of the pelvic floor muscles is the relaxation that takes susception and mucosal prolapse might be diagnosed as well as a spastic
place when the patient is asked to strain as if defecating. An involuntary pelvic floor (anismus).
relaxation can be absent or present.
Pelvic Organ Prolapse - Signs
Pelvic Floor Muscles - Non-contracting, Non-relaxing pelvic floor Sign
Sign All examinations for POP should be performed with the woman’s bladder
Non-contracting, non-relaxing pelvic floor means that during palpation, empty (and if possible an empty rectum). An increasing bladder volume has
there is neither a palpable contraction nor a palpable relaxation of the pel- been shown to restrict the degree of descent of the prolapse. The choice
vic floor muscles. of the woman’s position during examination, e.g. left lateral (Sims), supine,
standing or lithotomy is that which can best demonstrate POP in that pa-
Pelvic Floor Muscles - Non-relaxing Pelvic Floor tient and which the woman can confirm as the maximal extent she has per-
Sign ceived e.g. by use of a mirror or digital palpation. The degree of prolapse
Non-relaxing pelvic floor means that during palpation, there is no palpable may be worse after a lengthy time in the upright position.
voluntary or involuntary relaxation of the pelvic floor muscles.
Pelvic organ prolapse (anatomical definition of sign of POP)
Pelvic Floor Muscles - Voluntary Relaxation Sign
Sign The descent of one or more of the anterior vaginal wall, posterior vaginal
Voluntary relaxation of the pelvic floor muscles means that the patient is

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6. ICS Glossary
 913

wall, uterus (cervix) or vaginal vault (cuff scar after hysterectomy). The pres- better when gravity is not a factor, e.g. lying supine. Prolapse may be more
ence of any such sign should be correlated with relevant POP symptoms. prominent at times of abdominal straining, e.g. defecation.

Pelvic organ prolapse (POP) - examination Pelvic organ prolapse (POPQ) - stage 0
Sign Sign
All examinations for POP should be performed with the woman’s bladder No prolapse is demonstrated.
empty (and if possible an empty rectum). An increasing bladder volume has
been shown to restrict the degree of descent of the prolapse. The choice Pelvic organ prolapse (POPQ - Stage I)
of the woman’s position during examination, e.g. left lateral (Sims), supine, Sign
standing or lithotomy is that which can best demonstrate POP in that pa- Most distal portion of the prolapse is more than 1cm above the level of the
tient and which the woman can confirm as the maximal extent she has per- hymen.
ceived e.g. by use of a mirror or digital palpation. The degree of prolapse
may be worse after a lengthy time in the upright position
Pelvic organ prolapse (POPQ - Stage II)
Pelvic organ prolapse (POP) surgery - complications Sign
Surgery – Female The most distal portion of the prolapse is situated between 1cm above the
Complications related to POP native tissue repairs and surgeries using pros- hymen and 1cm below the hymen.
theses/grafts/mesh have been classified separately according to joint IUGA/
ICS recommendations. The sorting system used in both documents utilizes Pelvic organ prolapse (POPQ - stage III)
specific category (C), time (T) and site (S) taxonomy together referred to as Sign
the CTS classification system. Classification is aided by on line calculators: The most distal portion of the prolapse is more than 1cm beyond the plane
http://www.ics.org/complication or http://www.ics.org/ntcomplication. of the hymen but everted at least 2cm less than the total vaginal length.

Pelvic organ prolapse (POP) surgery - further surgery Pelvic organ prolapse (POPQ - Stage IV)
Surgery – Female Sign
Any subsequent procedure relating to the primary surgery: (i) primary sur- Complete eversion or eversion at least within 2cm of the total length of the
gery in a different (new) site/compartment; (ii) repeat surgery in the same lower genital tract is demonstrated.
site/compartment for POP symptom recurrence; (iii) surgery for compli-
cations e.g. mesh exposure, pain, infection, hemorrhage; (iv) surgery for Pelvic organ prolapse (POPQ - Stage O)
non-POP-related issues usually urinary incontinence. Sign
.No prolapse is demonstrated
Pelvic organ prolapse (POP) surgery - objective outcomes.
Surgery – Female Pelvic pain - female
POP-Q measurement should be tabulated with absolute values and per- Symptom
centages to allow other studies to compare results. Complaint of pain perceived to arise in the pelvis, not associated with symp-
toms suggestive of lower urinary tract, sexual, bowel or gynaecological dys-
Pelvic organ prolapse (POP) surgery - perioperative data function.
Surgery – Female
Blood loss, operating time, length of hospital stay, return to normal activities Pelvic pain (male)
and complications. Symptom
Complaint of pain, pressure or discomfort related to the pelvis but not clear-
Pelvic organ prolapse (POP) surgery - primary surgery ly related to the bladder, urethra, scrotum or perineum.
Surgery – Female
First procedure required for treating POP in any compartment. Pelvic Pain Syndrome
Symptom
Pelvic organ prolapse (POP) surgery - secondary outcomes Pelvic pain syndrome is the occurrence of persistent or recurrent episod-
Surgery – Female ic pelvic pain associated with symptoms suggestive of lower urinary tract,
Lower urinary tract symptoms, stress incontinence, or bowel and sexual dys- sexual, bowel or gynecological dysfunction. There is no proven infection or
function to be included in studies whenever possible. other obvious pathology.

Pelvic organ prolapse (POP) surgery - subjective (patient-reported) out- Pelvic pressure (female)
comes Symptom
Surgery – Female Complaint of increased heaviness or dragging in the suprapubic area and/
At its simplest level, this can be reported as the presence or absence of a or pelvis.
vaginal bulge. Patient satisfaction and quality of life can be measured by val-
idated instruments that cover prolapse, urinary, bowel and sexual function. Penetration urinary incontinence
Symptom
Pelvic organ prolapse (POP) symptoms Urinary incontinence at penetration (penile, manual or sexual device)
Symptom
Complaints by a woman in reference to the position (descent) of her pel- Penetration urinary incontinence (female)
vic organs. Symptoms are generally worse at the times when gravity might Symptom
make the prolapse worse (e.g. after long periods of standing or exercise) and Urinary incontinence at penetration (penile or sexual device).

Terms P
914

Perineal descent (male)

Sign
Penile glans and shaft examination This is the outward (dorso-caudal) movement of the perineum and anus
Sign (when the individual is asked to cough or bear down).
. Penile plaque: palpation of node or plaque in the tunica usually on the
dorsal aspect (perhaps related to Peyronie’s disease). Perineal elevation (female)
. Lichen sclerosus: tight foreskin, cracking and bleeding. Sign
Inward (ventrocephalad) movement of the vulva, perineum, and anus dur-
Penile pain with intercourse (male dyspareunia) ing, for example, PFM contraction.
Symptom
Complaint of any penile discomfort occurring during intercourse - may be Perineal elevation (male)
caused by penile disease, vaginal anatomy (e.g. vaginal tightening, scarring Sign
or prosthesis exposure), and/or may relate to various positions with inter- This is the inward (ventro-cephalad) movement of the perineum and anus.
course causing impingement on the uterine cervix. Look for testicular lift and penile retraction. These need to be checked
against movement of the scrotum and the whole penis. Correct movement
Percutaneous Electrical Nerve Stimulation occurs with the PFM only: the shaft of the penis draws in and the testes
Conservative Management – Female lift in a cephalad direction. These movements may be better visualized in
Percutaneous electrical nerve stimulation: a therapeutic modality that stim- standing than supine position.
ulates peripheral sensory nerves performed with a (few) needle electrode(s)
that are placed in close proximity to the area to stimulate. Percutaneous Perineal examination (male)
neuromuscular electrical stimulation (e.g. posterior TNS) is a peripheral neu- Sign
romodulation technique, in which the posterior tibial nerve is electrically . This is generally performed with the patient in the lateral supine or in the
stimulated three finger breadths above the medial malleolus, via insertion lithotomy position.
of a percutaneous needle electrode. This is coupled with an adhesive ref- . Perianal dermatitis: Skin infection at the perineum around the anus, usually
erence surface electrode placed near to the needle. This intervention is of- associated with faecal incontinence or diarrhoea.
fered to patients with OAB. . Fissures: A break or tear in the skin of the perineum, anal sphincter or distal
rectum usually associated with anal pain.
Perforation
Surgery – Complication related Perineal gap (PG)
Abnormal opening into a hollow organ or viscus. Surgery – Female
Thinned out medial area (cm) between Moynihan forceps placed bilaterally
Perianal examination (female) where the labia minora meet the perineum.
Sign
(i) Excoriation: perianal excoriation, skin rashes. (ii) Soiling: perianal fecal Perineal length (PL)
soiling or vaginal fecal soiling. (iii) Discharge: perianal or vaginal bloody or Surgery – Female
mucus discharge. (iv) Gaping anus: non-coaptation of anal mucosa at rest. Distance from posterior margin of vestibule to anterior anal verge.
(v) Scars, sinuses, deformities, condylomata, papillomata, hematoma. (vi)
Deficient perineum/cloacal-like defect: A spectrum of tissue loss from the Perineal measurements - perineal length
perineal body and rectovaginal septum with variable appearance. There can Sign
be a common cavity made up of the anterior vagina and posterior rectal Distance from posterior margin of vestibule to anterior anal verge.
walls or just an extremely thin septum between the anorectum and vagina.
(vii) Others described individually: anal fissure, hemorrhoids, anorectal pro- Perineal pain (female)
lapse, fistula-in-ano, recto-vaginal fistula, anorectal/ vaginal/perineal fistula. Symptom
Complaint of pain felt between the posterior fourchette (posterior lip of the
Perianal itching/pruritus ani vaginal introitus) and the anus.
Symptom
Complaint of an itchy anus. Perineal pain (male)
Symptom
Perineal abnormalities (female) Complaint of pain, pressure or discomfort felt on the surface or in the depth
Sign of the tissue between the scrotum and the anus.
Scars, sinuses, deformities, condylomata, papillomata, hematoma.
Perineal Pain Syndrome
Perineal body (PB) Symptom
Sign Perineal pain syndrome is the occurrence of persistent or recurrent episodic
This is measured from the posterior margin of the hymen to the mid-anal perineal pain, which is either related to the micturition cycle or associated
opening. with symptoms suggestive of urinary tract or sexual dysfunction.There is no
proven infection or other obvious pathology.
Perineal descent (female)
Sign Perineocele
Excessive dorsocaudal movement of the vulva, perineum, and anus, for ex- Sign
ample, during coughing, Valsalva or straining. Bulge in the perineum associated with herniation of the anterior wall of the
rectum.

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 915

Perineorrhaphy - commencement position (PCT) Polyuria

Surgery – Female Sign
Where is Level III, the perineorrhaphy is commenced, e.g. hymen, mid-vesti- Excessive production of urine. it has been defined as >40mls urine/kg body
bule, posterior margin of vestibule. weight during 24 hours or 2.8 litres (70 kg individual).

Perineorrhaphy - depth (PD) Polyuria - Causes

Surgery – Female Sign
Depth of the excised perineum. Diabetes mellitus: Insulin dependent (Type I); Insulin independent (Type II).
Diabetes insipidus: Pituitary, Renal, Gestational, Primary polydipsia (psycho-
Perineorrhaphy - mid-perineal thickness (MPT) genic, dipsogenic or iatrogenic).
Surgery – Female
Thickness (cm) of the mid-perineum in the midline. Polyuria (global symptom)
Symptom
Perineorrhaphy - perineal gap (PG) Complaint that the urine excretion volume over 24 hours is noticeably larger
Surgery – Female than the previous excretion.
Thinned out medial area (cm) between Moynihan forceps placed bilaterally
where the labia minora meet the perineum. POP - anteiror vaginal wall (compartment) prolapse
Diagnosis
Perineorrhaphy - width (PW) Clinically evident (symptoms, signs or any relevant imaging) descent of the
Surgery – Female anterior vaginal wall (compartment).
Width of the excised perineum.
POP - posterior vaginal wall (compartment) prolapse
Pessaries - General Diagnosis
Conservative Management – Female Clinically evident (symptoms, signs or any relevant imaging) descent of the
Pessaries are intravaginal devices used to try to restore the prolapsed or- posterior vaginal wall (compartment).
gans to their normal position and hence to relieve symptoms. Vaginal pes-
saries can be broadly divided into two types: support pessaries (ring, ring POP - uterine/ cervical prolapse
with support, Gehrung, Hodge, shelf ) and space-filling pessaries (donut, Diagnosis
Gellhorn, cube, inflatable). Clinically evident (symptoms, signs or any relevant imaging) descent of the
uterus or uterine cervix.
Phimosis
Sign POP - vaginal vault (cuff scar) prolapse
Partial or complete inability to retract the prepuce due to adhesion between Diagnosis
the glans and the prepuce or a preputial ring. Clinically evident (symptoms, signs or any relevant imaging) descent of the
vaginal vault (cuff scar after hysterectomy).
Physiotherapy for Female Pelvic Floor Dysfunction
Conservative Management – Female POPQ - anterior vaginal wall - Point Aa
Physiotherapy involves “using knowledge and skills unique to physiother- Sign
apists” and “is the service only provided by, or under the direction and su- A point located in the middle of the anterior vaginal wall three (3) cm prox-
pervision of, a physiotherapist”. Adherence: is the extent to which a client/ imal to the external urethral meatus. By definition, the range of position of
patient’s behavior corresponds to the agreed treatment protocol and/or Point Aa relative to the hymen is -3 to +3cm.
regime as recommended by their healthcare provider. It does not refer to
the intervention itself; rather, the patient’s commitment to undertaking the POPQ - anterior vaginal wall - Point Ba
behavioral change to adhere to the intervention. Sign
Compliance: is the extent to which a client/patient’s behavior matches, or A point that represents the most distal (i.e., most dependent) position of
complies with their healthcare provider’s recommended treatment protocol any part of the upper anterior vaginal wall from the vaginal cuff or anterior
and/or regime. vaginal fornix to Point Aa. By definition, Point Ba is at -3cm in the absence
of prolapse and would have a positive value equal to the position of the
Pictorial stool chart cuff (Point C) in women with total uterine prolapse or post-hysterectomy
Sign vaginal eversion.
It is a pictorial chart of stool consistencies. The “Bristol stool chart” seems to
have widespread face validity and recognition and is useful in conversations POPQ - defined points
with patients about their stool consistency, despite little validation work. It Sign
has not been validated as an outcome measure and a reported change in The anatomic position of the six defined points (two on the anterior vaginal
category may not represent sufficient degree of precision for use as a trial wall, two in the superior vagina, and two on the posterior vaginal wall) for
end point. measurement should be centimeters (cm) above or proximal to the hymen
(negative number) or cm below or distal to the hymen (positive number)
Pneumaturia with the plane of the hymen being defined as zero (O). For example, a cervix
Symptom that protruded 3 cm distal to the hymen would be + 3 cm. All points are
Complaint of the passage of gas (or air) from the urethra during of after measured on maximal straining (except total vaginal length).
voiding.

Terms P
916

POPQ - fixed point of reference Complaint of vaginal bleeding, discharge or infection related to dependent
Sign ulceration of uterine and/or vaginal prolapse.
The hymen is the fixed point of reference used throughout the POP-Q sys-
tem of quantitative prolapse description. Position-dependent voiding - female
Symptom
POPQ - Genital hiatus Complaint of having to take specific positions to be able to void spontane-
Sign ously or improve bladder emptying, (female) e.g. leaning forwards or back-
The genital hiatus (GH) is measured from the middle of the external urethral wards on the toilet seat or voiding in a semi-standing position.
meatus to the posterior margin of the hymen.
Position-dependent voiding - male
POPQ - Perineal body Symptom
Sign Complaint of having to adopt specific positions to be able to void sponta-
The perineal body (PB) is measured from the posterior margin of the hymen neously or to improve bladder emptying, e.g. needing (men) to void in a
to the mid-anal opening. seated position.

POPQ- Posterior vaginal wall - Point Bp

Sign
A point that represents the most distal (i.e., most dependent) position of any
part of the upper posterior vaginal wall from the vaginal cuff or posterior Possible Intercurrent Diagnoses of POP
vaginal fornix to Point Ap. By definition, Point Bp is at -3 cm in the absence Diagnosis
of prolapse and would have a positive value equal to the position of the cuff (i) Urodynamic stress incontinence: Involuntary leakage of urine during
in a woman with total post-hysterectomy vaginal eversion. filling cystometry, associated with increased intraabdominal pressure, in the
absence of a detrusor contraction. In the circumstances where this diagno-
sis is only made when the POP is reduced, the additional term ‘‘occult’’ is ap-
POPQ - recording measurements propriate. (ii) Detrusor overactivity: The occurrence of involuntary detrusor
Sign contractions during filling cystometry. (iii) Bladder oversensitivity: Increased
Intraoperative measurements with traction can be quite different than perceived bladder sensation during bladder filling with: an early first desire
measurements made during Valsalva in clinic, both in regards to cervical to void; an early strong desire to void, which occurs at a low bladder vol-
location and the vaginal walls. Measurements directly after removing a ume; a low maximum cystometric bladder capacity. No abnormal increases
vaginal pessary are unreliable and will tend to understage the degree of in detrusor pressure are noted. (iv) Detrusor underactivity and Acontractile
prolapse. detrusor.

POPQ - Superior vagina - Point D Possible Prolapse-related Diagnoses

Sign Diagnosis
A point that represents the location of the posterior fornix in a woman who (i) Voiding dysfunction: A diagnosis by symptoms and urodynamic inves-
still has a cervix. It is included as a point of measurement to differentiate sus- tigations is defined as abnormally slow and/or incomplete micturition,
pensory failure of the uterosacral-cardinal ligament “complex” from cervical based on abnormal slow urine flow rates and/or abnormally high post void
elongation. When the location of Point C is significantly more positive than residuals, ideally on repeated measurement to confirm abnormality. Void-
the location of Point D, this is indicative of cervical elongation which may ing cystometry can be required to determine the cause of the voiding dys-
be symmetrical or eccentric. Point D is omitted in the absence of the cervix. function. (ii) Recurrent urinary tract infections(UTI): A diagnosis by clinical
history assisted by the results of diagnostic tests involves the determination
POPQ - Superior vaginal - Point C of the occurrence of at least three symptomatic and medically diagnosed
Sign urinary tract infections (UTI) over the previous 12 months. One possible
A point that represents either the most distal (i.e., most dependent) edge of POP-related cause is a chronically elevated postvoid residual. (iii) Defecatory
the cervix or the leading edge of the vaginal cuff (hysterectomy scar) after dysfunction: A diagnosis by clinical history assisted, at times, by the results
total hysterectomy. of diagnostic tests involving the confirmation of abnormal or difficult func-
tion in the initiation, passage or completion of defecation. (iv) Sexual dys-
POPQ - Total vaginal length function: A diagnosis by clinical history (including specific questionnaires)
Sign involving the confirmation of abnormal function and/or difficulty with sex-
The total vaginal length (TVL) is the length of the vagina (cm) from the ual intercourse.
posterior fornix to hymen when Point C or D is reduced to its full normal
position. Post coital pain (female)
Symptom
POPQ- Posterior vaginal wall - Point Ap Pain after intercourse such as vaginal burning sensation or pelvic pain.
Sign
A point located in the midline of the posterior vaginal wall three (3) cm prox- Post-coital LUT symptoms (female)
imal to the hymen. By definition, the range of position of Point Ap relative to Symptom
the hymen is -3 to +3 cm. Such as acute cystitis, worsened urinary frequency or urgency, dysuria, su-
prapubic tenderness.
POP-related vaginal bleeding, discharge, infection.
Symptom Post-defecatory soiling
Symptom

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Complaint of soiling occurring after defecation. Post-micturition incontinence

Symptom
Posterior colporrhaphy - mid-vaginal laxity (MVL - undisplaced) Complaint of a further involuntary passage of urine following the comple-
Surgery – Female tion of voiding
Laxity (cm) of the vaginal mucosa (anterior traction) midpoint in the vagina
supero-posteriorly and in the midline with the vaginal vault held in an un- Post-micturition leakage
displaced position (similar to that after vault fixation). Symptom
Complaint of a further involuntary passage of urine following the comple-
Posterior colporrhaphy - posterior vaginal vault descent (PVVD) tion of micturition.
Surgery – Female
Descent of the posterior vaginal vault (on traction) towards the anterior
perineum (perineal gap). Subtract from the total posterior vaginal length Postoperative de novo dyspareunia
(TPVL) the distance from the inferiorly displaced vaginal vault to the anterior Symptom
perineum. Dyspareunia first reported after surgery or other interventions.

Postoperative de novo sexual dysfunction symptoms

Symptom
Posterior colporrhaphy - recto-vaginal fascial laxity (RVFL - cm) New onset symptoms of sexual dysfunction (not previously reported before
Surgery – Female surgery).
Laxity in the recto-vaginal fascia (anterior traction) midpoint in the vagina
supero-posteriorly (mucosa opened) and in the midline with the vaginal Postoperative findings - ultrasound imaging (male)
vault held in an undisplaced position. Imaging
Post-prostatectomy (urethral shape), male sling position, artificial sphincter
Posterior vaginal repair (colporrhaphy) - mesh or graft reinforcement - placement of cuff and reservoir, bulking agents.
Surgery – Female
A structural addition or inclusion used to give additional strength in func- Postural urinary incontinence
tion. It should be noted whether the graft is biologic, absorbable synthetic Symptom
or permanent synthetic. Complaint of urinary incontinence during change of posture or position,
e.g. from supine or seated to standing.
Posterior vaginal repair (colporrhaphy) - native tissue
Surgery – Female Post-void residual (PVR)
Repair the vagina by excision and suturing the edges of any defect. Midline Investigation
fascial plication represents the commonest procedure, involving dissection Volume of urine left in the bladder at the completion of voiding.
under the full thickness of the vaginal epithelium followed by central plica-
tion of the pre-rectal fascia over the rectum and excision of “excess” vaginal Post-void residual (PVR - abdominal) - ultrasound imaging
wall skin. Imaging
Volume = width (left to right) x depth (anterior to posterior) x length (cranial
Posterior vaginal vault descent (PVVD) - posterior colporrhaphy to caudal) x 0.52 (mL)
Surgery – Female
Descent of the posterior vaginal vault (on traction) towards the anterior Post-void residual (PVR - female) - assessment of normality
perineum (perineal gap). Subtract from the total posterior vaginal length Investigation
(TPVL) the distance from the inferiorly displaced vaginal vault to the anterior Quoted upper limits of normal reflect accuracy of measurement. Studies
perineum. using “immediate” PVR measurement by ultrasound (within 60 seconds of
voiding) suggest an upper limit of normal of 30ml. Studies using urethral
Posterior Vaginal Vestibule catheterization (generally 5 - 10min delay) quote higher upper limits of
Sign 50ml or 100ml. An isolated finding of a raised PVR requires confirmation be-
Posterior hymenal ring to anterior perineum (posterior margin of vestibule). fore being considered significant.

Posterior vaginal wall (compartment) prolapse Post-void residual (PVR - female - conditions for measurement)
Sign Investigation
Observation of descent of the posterior vaginal wall. Commonly, this would PVR reading is erroneously elevated by delayed measurement due to addi-
represent rectal protrusion into the vagina (rectocele). Higher stage posteri- tional urine production (1-14 mL/min). Ultrasonic techniques (transvaginal,
or vaginal wall prolapse after prior hysterectomy will generally involve some translabial most accurately) allow immediate (within 60 s of voiding) meas-
vaginal vault (cuff scar) descent and possible enterocele formation. Entero- urement and possible repeat measurement. A short plastic female catheter
cele formation can also occur in the presence of an intact uterus. provides the most effective drainage for PVR measurement by catheteriza-
tion.
Posterior vaginal wall (compartment) prolapse
Diagnosis Post-void residual (PVR - male) - assessment of normality
Diagnosis by symptoms and clinical examination, assisted at times by any Investigation
relevant imaging (i.e. clinically evident) descent of the posterior vaginal wall Upper limits in normal community dwelling men without LUTS are age de-
(compartment). pendent with studies reporting a cut-off value of 10-30 mL. There are no
adequate currently available data from which to quote expected/typical

Terms P
918

ranges of PVR in men with symptoms of lower urinary tract dysfunction. Pressure-flow studies - acontractile detrusor
Such studies would need to reflect the accuracy of measurement, includ- Investigation
ing whether the PVR measurement is “immediate” (e.g. by ultrasound) or by The detrusor cannot be observed to contract (i.e. no increase in Pdet) during
urethral catheterization (unless also “immediate”). In the absence of such pressure-flow studies resulting in failure to void. Limited voiding may occur
studies, our consensus view (D’Ancona, Haylen et al.) is that a PVR (ultra- by straining. May be neurogenic (evidence of a neurological disorder) or
sound) over 50mL, following double voiding, might prompt the suspicion non-neurogenic (no evidence of a neurological disorder).
of voiding dysfunction.
Pressure-flow studies - delayed relaxation of the urethral sphincter (? neu-
Post-void residual (PVR - male) - Conditions for measurement rogenic)
Investigation Investigation
PVR reading is erroneously elevated by delayed measurement due to ad- Impaired and hindered relaxation of the urethral sphincter during voiding
ditional renal input (1-14mL/min) into the bladder. Ultrasonic techniques attempt resulting in delay of urine flow.
allow immediate (within 60 seconds of micturition) measurement to min-
imize the error. Immediate insertion of a transurethral catheter for bladder Pressure-flow studies - detrusor pressure at end flow (pdet-ef - cm H2O)
drainage can still provide an effective and accurate PVR measurement. All Investigation
urethral catheters, however, may not be of equal drainage efficacy. Ultra- Detrusor pressure recorded at the end of urine flow.
sound PVR measurement should ideally be repeated at least once if PVR is
present. An overdistended rather than “comfortably full” bladder might lead Pressure-flow studies - detrusor pressure at maximum flow (Pdet.qmax - cm
to a falsely elevated initial PVR, assessed further by repeat voiding/ repeat H2O)
PVR. Investigation
Detrusor pressure recorded at maximum urinary flow rate.
Postvoiding detrusor contraction - pressure flow studies
Investigation Pressure-flow studies - detrusor underactivity (DU)
An increase in detrusor pressure (Pdet) following the cessation of urinary Investigation
flow. Low detrusor pressure or short detrusor contraction time, usually in combi-
nation with a low urine flow rate resulting in prolonged bladder emptying
Post-voiding incontinence and/or failure to achieve complete bladder emptying within a normal time
Symptom span.
Complaint of a further involuntary passage (incontinence) of urine or drib-
bling following the completion of voiding. Pressure-flow studies - flow delay - unit: s)
Investigation
Post-voiding symptom The time elapsed from initial rise in pressure to onset of flow. It reflects the
Symptom time necessary for the fluid to pass from the point of pressure measurement
Lower urinary tract symptom experienced after voiding. to the uroflow transducer.

Post-voiding urgency Pressure-flow studies - initiated reflex bladder emptying (?neurogenic)

Symptom Investigation
Complaint of persistent urgency post-voiding. An artificially elicited LUT reflex comprised of various manoeuvres (exoge-
nous stimuli) performed by the patient or the therapist, resulting in com-
Premature ejaculation plete or incomplete bladder emptying.
Symptom
Complaint of a persistent or recurrent pattern of too rapid achievement of Pressure-flow studies - maximum detrusor pressure (Pdet-max -cm H2O)
ejaculation during partnered sexual activity, i.e. before the individual wishes Investigation
it. Maximum registered detrusor pressure during voiding.

Premicturition pressure Pressure-flow studies - neurogenic detrusor underactivity

Investigation Investigation
The pressure recorded immediately before the initial isovolumetric contrac- Low detrusor pressure or short detrusor contraction time, usually in combi-
tion. nation with a low urine flow rate, resulting in prolonged bladder emptying
and/or failure to achieve complete bladder emptying within a normal time
Pressure flow studies - detrusor opening pressure (cm H2O) span in the setting of a clinically relevant neurologic disease.
Investigation
Detrusor pressure recorded immediately before the initial isovolumetric Pressure-flow studies - non-relaxing urethral sphincter (? neurogenic)
contraction. Investigation
A non-relaxing, obstructing urethral sphincter resulting in reduced urine
Pressure-flow studies flow.
Investigation
Pressure volume (urinary flow) relationship of the bladder during voiding. It Pressure-flow studies - normal detrusor contractile function.
begins when the “permission to void” is given and ends when the individu- Investigation
al considers voiding has finished. Measurements to be recorded should be: Normal voiding in an individual is achieved by an adequate continuous det-
detrusor pressure (Pdet); abdominal pressure (Pabd) with detrusor pressure rusor contraction that leads to complete bladder emptying within a normal
(Pdet) calculated. Urine flow rate (mL/s) should also be recorded. time span.

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 919

Pressure-flow studies - postvoiding detrusor contraction (cm H2O) The following standardized terminology is proposed for surgical trials and
Investigation clinical audit:
An increase in detrusor pressure (Pdet) following the cessation of urinary A. Primary Surgery: This indicates the first procedure required for the treat-
flow. ment of POP in any compartment. B. Further Surgery: Provides a global term
for the number of subsequent procedures the patient undergoes, directly
Pressure-flow studies - urethral opening pressure (Pdet-uo - cm H2O) or indirectly, relating to the primary surgery. Further surgery per se should
Investigation not be interpreted as a measure or failure as the definitions of success and
Detrusor pressure recorded at the onset of measured flow. failure will be defined within the context of the individual study. Further sur-
gery is subdivided into: I. Primary prolapse surgery/different site: a prolapse
Pressure-flow studies (male +/- VCU, EMG) - detrusor sphincter dyssynergia procedure in a new site/compartment following previous surgery (e.g., an-
(DSD) terior repair following previous posterior repair). II. Repeat surgery: a repeat
Investigation operation for prolapse arising from the same site. Where combinations of
Dyscoordination between detrusor and smooth or striated sphincter func- procedures arise, such as new anterior repair plus further posterior repair,
tion during voiding due to a neurological abnormality (i.e. detrusor con- these should be reported separately as primary anterior repair and repeat
traction synchronous with contraction of the urethral and/or periurethral posterior repair. III. Surgery for complications: mesh exposure or extrusion,
striated muscle). pain, or patient compromise such as hemorrhage (see Complications sec-
tion). IV. Surgery for non-POP related conditions: subsequent surgery for
Pressure-flow studies (male +/- VCU, EMG) - dysfunctional voiding stress urinary incontinence or fecal incontinence.
Investigation
This is characterized an intermittent and/or fluctuating urine flow due to Primary enuresis
inadequate or variable relaxation generally of the external sphincter during Symptom
voiding in neurologically normal men. Complaint of intermittent incontinence that occurs during periods of sleep
that has been present lifelong.
Pressure-flow studies (male +/- VCU,EMG) - abnormal urethral function dur-
ing voiding. Procidentia
Investigation Sign
The urethral sphincter(s) do not relax completely or they are (temporarily) Complete eversion of the vagina and uterus (Stage IV utero-vaginal pro-
contracted during voiding, resulting in increased detrusor pressure. Bladder lapse)
emptying may be incomplete (PVR present).
Proctoscopy (anoscopy)
Pressure-flow studies (male +/- VCU,EMG) - bladder outlet obstruction (BOO) Investigation
Investigation The inspection of the anal canal to identify anal fissure, fistula, or hemor-
The generic term for mechanical obstruction during voiding. It is a reduced rhoids as a cause of anal symptoms.
urine flow rate with an increased detrusor pressure. PVR can be present.
Prolapse
Pressure-flow studies (male +/- VCU,EMG) - normal urethral function during Symptom
voiding. A falling, slipping or downward displacement of a part or organ (Latin: Pro-
Investigation lapsus - “a slipping forth”)
The urethra opens and is continuously relaxed to allow micturition at a nor-
mal pressure and urine flow and results in complete bladder emptying. The Prolapse (pelvic organ) symptoms
voiding is prompted by a detrusor contraction and simultaneous relaxation Symptom
of the smooth and striated sphincters of the urethra and pelvic floor mus- A departure from normal sensation, structure or function experienced by
cles. the woman in reference to the position of her pelvic organs. Symptoms are
generally worse at the times when gravity might make the prolapse worse
Prevention of Pelvic Floor Dysfunction (e.g. after long periods of standing or exercise) and better when gravity is
Conservative Management – Female not a factor e.g. lying supine. Prolapse may be more prominent at times of
Prevention is the act of preventing or decreasing the risk of disease or disa- abdominal straining e.g. defecation.
bility. Activities that are directed toward slowing or stopping the occurrence
of both mental and physical illness and disease, minimizing the effects of a Prominence
disease or impairment on disability, or reducing the severity or duration of Surgery – Complication related
an illness. 1. Primary prevention: prevention of the development of disease Parts that protrude beyond the surface (e.g. due to wrinkling or folding with
in a susceptible or potentially susceptible population through such specific no epithelial separation).
measures as general health promotion efforts. 2. Secondary prevention:
efforts to decrease the duration of illness, reduce the severity of diseases, Prosthesis
and limit the sequelae through early diagnosis and prompt intervention. 3. Surgery – Female
Tertiary prevention: efforts to limit the degree of disability and promote re- A fabricated substitute to assist a damaged body part or to augment or sta-
habilitation and restoration of function in patients/clients with chronic and bilise a hypoplastic structure.
irreversible diseases.
Provocative Manoeuvres
Primary and Further Surgery Investigation
Surgery – Female Provocative manoeuvres are defined as techniques used during urodynam-

Terms P
920

ics in an effort to provoke detrusor overactivity, for example, rapid filling, Pudendal pain (neuralgia)
use of cooled or acid medium, postural changes and hand washing. Symptom
Complaint of pain, pressure or discomfort in one or more areas innervated
Pudendal neuralgia by the pudendal nerve (possible inflammation or entrapment of the puden-
Sign dal nerve and involving its dermatome).
Elicited or described by the patient as burning vaginal and vulva pain (any-
where between the anus and the clitoris) with tenderness over the course
of the pudendal nerve.

Q
Measurement of urethral axial mobility at rest and straining to assess degree
Q-Tip Testing of mobility.
Sign

R
Receptive anal intercourse
Radiological imaging (male) - defecography (evacuation proctography) Symptom
Imaging Having a penis penetrating one’s anus.
This demonstrates the anatomy of the anorectum as well as disorders of rec-
tal evaluation. Barium paste is inserted prior to defecation over a translucent Receptive urethral intercourse
commode. Symptom
Having a penis penetrating one’s urethra (urethral coitus).
Radiological imaging (male) - intravenous urography (IVU)
Imaging Rectal (and prostate) examination (male)
Conventional X-ray or CT, this study provides an anatomical outline of the Sign
upper urinary tract, ureters and bladder as well as an evaluation of renal Digital rectal examination (DRE) is recommended as part of the physical
function by excretion of contrast media. Calcification may be shown in kid- examination. Generally done with the patient standing and bent over the
neys, ureter, bladder, seminal vesicles or vasa. examining table, or with the patient in the left lateral knees bent position,
or in the lithotomy position. DRE is usually pain-free.
Radiological imaging (male) - retrograde +/- antegrade urethrography . Anal examination: This can detect the following findings in the anal sphinc-
Imaging ter or distal rectum:
Unidirectional or combined contrast imaging is used to visualize the ure- - Benign diseases: hemorrhoids, fissure, anal sphincter injury, levator dis-
thral lumen, to diagnose strictures and diverticula and to stage urethral comfort or pain.
trauma. - Possible malignant diseases: anal, distal rectal and prostate carcinoma.
- Anal tone: increased or decreased anal sphincter tone might suggest sim-
Radiological imaging (male) - videocystourethrography (VCU) ilar changes in the urinary sphincter and may indicate neurologic disease.
Imaging - Anal stricture: a circumscribed narrowing or stenosis of the anal canal.
Synchronous radiological screening of the bladder and urethra allowing di- . Prostate gland characteristics: size, symmetry, firmness, nodules, and its re-
rect observation of bladder events, the position and conformation of the lation to the pelvic sidewall and rectum can be assessed. The gland is about
bladder neck in relation to the pubic symphysis, diverticula of the bladder the size of a walnut and has a consistency similar to that of the contracted
and urethra, recto-urethral fistulae and vesico-ureteric reflux. thenar eminence of the thumb.
. Prostate nodularity and/or firmness – May indicate possible abnormality
Radiological imaging (male) - Videourodynamics (pressure-flow studies) requiring further investigation.
Imaging . Prostate tenderness: prostate palpation, as part of a DRE, is usually pain-
A functional test of the lower urinary tract in which pressure, capacity and free. Pain with prostatic palpation is variable though if present, it may be
flow data are simultaneously combined with real-time imaging of the lower helpful in differentiating prostate/pelvic pain syndromes.
and upper urinary tract. . Rectal examination (circumferential): this might lead to the detection of
non-urological diseases such as rectal carcinoma, fistula and fecal impac-
Radiological imaging (male) - voiding (micturitional) cystourethrography tion.
Investigation
Imaging of the bladder neck, urethra and prostate during voiding looking Rectal bleeding/mucus
for vesico-ureteric reflux, vesical or urethral fistulae, vesical or urethral diver- Symptom
ticulae, strictures and the level of obstruction e.g. bladder neck or prostate. Complaint of the loss of blood or mucus per rectum.

Rate of Nocturnal Urine Production Rectal digitation

Sign Symptom
Nocturnal urine volume / time asleep (i.e. night). Measured in mL/min.

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6. ICS Glossary
 921

Use of fingers in the rectum to manually assist in the evacuation of stool of the external anal sphincter run anteriorly from the perineal body to the
contents. coccyx posteriorly.
(4) Puborectalis - is formed from the most anterior fibres of the pubococcy-
Rectal Dynamics - Attempted defecation and balloon expulsion geus muscle. This forms a sling pulling the rectum forward.
Investigation
Patients with symptoms of prolapse and elderly patients with a history of Rectal prolapse
constipation who present with passive incontinence should be thoroughly Symptom
examined for the presence of a full thickness rectal prolapse. Patients are Complaint of external protrusion of the rectum (differentiation on subse-
asked to strain as they would to pass stools whilst on a toilet or commode quent examination between rectal mucosal prolapse and full thickness rec-
and given enough time to reproduce the prolapsing lump before examina- tal wall prolapse which includes muscle and serosal layers.
tion. Expulsion of a water-filled balloon can be used in the assessment of
constipated patients. The ability to expel the balloon within 1min may be a Rectocele
useful tool in demonstrating the absence of pelvic floor dyssynergia. Sign
Bulge in posterior vaginal wall associated with herniation of anterior wall
Rectal Dynamics - Rectal Impedance Planimetry of the rectum. An aspect of posterior vaginal wall (compartment) prolapse.
Investigation
These studies are the preserve of research institutions rather than clinical Recto-vaginal fascial laxity (RVFL - cm) - posterior colporrhaphy
practice. The rationale is to calculate the diameter or cross sectional area Surgery – Female
of an intra rectal bag during a distension sequence. Impedence planimetry Laxity of the rectovaginal fascia (anterior traction) midpoint in the vagina
measures the cross sectional area which enables the circumferential wall super-posteriorly (mucosa opened) and in the midline with the vaginal vault
tension to be calculated. held in an undisplaced position.

Rectal dynamics (female) - Rectal Compliance Rectovaginal fistula

Investigation Sign
Rectal compliance is the term that describes the relationship between pres- Is a communication from the rectum to the vagina.
sure and volume, reflecting the ability of the rectum to act as a reservoir
and is assessed using a barostat, Inflating the bag within the rectum prior to Recurrent urinary tract infection - diagnosis (female)
the recording inflation protocol, known as conditioning, has been shown to Diagnosis
improve the precision of compliance testing. Typically, compliance figures This diagnosis by clinical history assisted by the results of diagnostic tests
between 4 and 11 mmHg/ml are quoted as the normal range. involves the determination of the occurrence of at least three symptomatic
and medically diagnosed urinary tract infection (UTI) over the previous 12
Rectal examination (female) months.
Sign
Observations can include: (i) Anal sphincter tone and strength: Assessment
on digital examination, as good or poor in the absence of any quantitative Recurrent Urinary Tract Infections (female)
assessment; (ii) Anal sphincter tear: May be recognized as a clear “gap” in the Diagnosis
anal sphincter on digital examination; (iii) Confirm presence or absence of This diagnosis by clinical history assisted by the results of diagnostic tests
rectocele: and if possible, differentiate from enterocele. Diagnose perineal involves the determination of the occurrence of at least three symptomatic
body deficiency; (iv) Confirm presence or absence of fecal impaction; (v) and medically diagnosed UTIs over the previous 12 months.
Other rectal lesions: Intussusception, rectovaginal fistula or tumor; (vi) Anal
lesions; Hemorrhoids, fissure; vii) Other perianal lesions: Anocutaneous fis- Recurrent urinary tract infections (UTI - female)
tula. Symptom
A history of at least three symptomatic and medically diagnosed UTI in the
Rectal Irrigation previous 12 months. The previous UTI(s) should have resolved prior to a fur-
Conservative Management – Female ther UTI being diagnosed.
Rectal irrigation is the use of liquid solutions given by enema to remove
material from the rectum. Recurrent urinary tract infections (UTIs - male)
Symptom
Rectal musculature - Endoanal ultrasonography A history of at least two symptomatic and medically diagnosed UTIs in the
Imaging previous 12 months. The previous UTI(s) should have resolved prior to a fur-
(1) Internal anal sphincter - The caudal continuation of the circular smooth ther UTI being diagnosed.
muscle of the rectum forms the internal anal sphincter, which terminates
caudally in a clearly defined edge, at a variable distance from the anal verge. Reduced bladder filling sensation
(2) Longitudinal muscle - Comprises smooth muscle cells continuous with Symptom
the outer layer of the rectal wall, and striated muscle from various pelvic Complaint that the sensation of bladder filling is less intense or occurs later
floor muscles. The longitudinal muscle lies between the internal and exter- in filling than previously experienced.
nal anal sphincters in the inter-sphincteric space.
(3) External anal Sphincter – It is made up of striated muscle and surrounds Reduced bladder sensation - Filling cystometry
the longitudinal muscle forming the outer border of the inter-sphincteric Investigation
space. The external sphincter is divided into deep, superficial and subcuta- Bladder sensation perceived to be diminished during filling cystometry.
neous parts, with the deep and subcutaneous parts of the sphincter form-
ing rings of muscle. Between them, elliptical fibres from the superficial part

Terms P - R
922

Reduced bladder sensation - filling cystometry answered the clinical question. ICS recommends immediate repetition of
Investigation the test when doubt exists as to whether the test has answered the clinical
Bladder sensation perceived to be diminished during filling cystometry. question. ICS recommends repetition of a urodynamic test when technical
errors and artefacts have been observed at immediate post test analysis.
Reduced compliance (storage dysfunction - RCSD) incontinence
Diagnosis Retention with overflow
Urinary incontinence directly related to the RCSD. Diagnosis
Involuntary loss of urine directly related to an excessively full bladder in re-
Reduced compliance storage dysfunction (RCSD) tention.
Diagnosis
In individuals with lower urinary tract symptoms, more commonly storage Retrograde urethrocystography and voiding cystourethrography
symptoms, when there is a non-phasic (at times linear or exponential) rise in Imaging
detrusor pressure during filling cystometry with generally reduced capacity Unidirectional or combined contrast imaging of the urethra in a patient in
indicating reduced compliance. the 30 degree oblique position to visualize the lumen, mainly to diagnose
urethral strictures or diverticula. It is also of use to diagnose and stage ure-
Reflex bladder triggering thral trauma.
Conservative Management – General
This comprises various manoeuvres performed by the patient or the ther- Retroverted uterus
apist to elicit reflex bladder emptying by exteroceptive stimuli (relating to, Sign
being, or activated by stimuli received from outside the bladder). The axis of the uterus is directed backwards towards the hollow of the sa-
crum, away from its anteverted position overlying the bladder. Cervix is
Related noted in/towards the anterior fornix with fundus perhaps palpable in the
Surgery – Complication related posterior fornix.
Connected
Rigid sigmoidoscopy
Repeat Cystometry Investigation
Investigation This is a bedside test to inspect the rectal mucosa with no bowel prepara-
There is no convincing evidence that the clinical diagnosis on the basis of tion.
the first cystometry is often changed on repetition of the test. There is no
definite evidence that immediate repetition of an adequately performed
urodynamic test ‘for confirmation’ is required. ICS does not recommend rou-
tine immediate repetition of invasive urodynamics ‘for confirmation’ if the
test was technically adequate, has been considered representative, and has

S
level of the sacral promontory. This tends to be performed for women who
Sacral spinal cord lesion (SSCL) are keen to preserve their uterus.
Diagnosis
This is a neurological lesion in the sacral spinal cord. Neurogenic lower uri- Sacrospinous Colpopexy (SSC)
nary tract dysfunction in SSCL: findings include acontractile detrusor with or Surgery – Female
without decreased bladder compliance and usually with impaired sphincter Fixation of the vaginal vault to the sacrospinous ligament: (a) Unilateral or
activity. bilateral procedure. (b) Anterior or posterior approach. (c) Permanent or ab-
sorbable suture and number of ‘bites’ taken. (d) Type of suture placement
Sacrocervicocolpopexy - open, laparoscopic, robotic device employed. (e) Direct vision or with the use of a specific instrument
Surgery – Female (tactile feedback).
Suspension of the cervix (and usually vagina) utilizing mesh or graft to the
anterior longitudinal ligament usually at the level of the sacral promontory. Sacrospinous hysteropexy
This procedure tends to be performed as an adjunct following subtotal hys- Surgery – Female
terectomy for advanced utero-cervical prolapse. Fixation of the uterus to the sacrospinous ligament (SSL). Variations: (i) uni-
lateral or bilateral; (ii) anterior or posterior approach; (iii) permanent or ab-
Sacrocolpopexy - open, laparoscopic, robotic sorbable stitches; (iv) number of sutures;(v) direct vision or with use of a
Surgery – Female specific instrument (tactile feedback).
Suspension of the vagina utilizing mesh or graft to the anterior longitudinal
ligament usually at the level of the sacral promontory. Scarred vagina - postoperative
Symptom
Sacrohysteropexy - open, laparoscopic, robotic Perception by the partner of a “stiff“ vagina or a foreign body (stitches, mesh
Surgery – Female exposure, mesh shrinkage).
Suspension of the cervix (with or without additional vaginal attachment)
utilizing mesh or graft to the anterior longitudinal ligament usually at the Scheduled Voiding Regimes in Female Pelvic Floor Dysfunction
Conservative Management – Female

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6. ICS Glossary
 923

Toileting on a fixed schedule around the patient’s normal voiding pattern, Separation
which includes a progressive voiding schedule using relaxation and distrac- Surgery – Complication related
tion techniques for urgency suppression. Scheduled voiding regimes have Physically disconnected (e.g. vaginal epithelium).
been categorized as: bladder training, timed voiding, habit training, and
prompted voiding. Sexual activity urinary incontinence
Bladder training: In the past, bladder training has also been referred to as Symptom
bladder drill, bladder discipline, bladder re-education, and bladder retrain- Complaint of urinary incontinence associated with or during sexual activi-
ing. It consists of a program of patient education, along with a scheduled ty (nb coital urinary incontinence [female] and sexual arousal incontinence
voiding regimen with gradually adjusted voiding intervals. Specific goals [male]).
are to correct faulty habit patterns of frequent urination, improve control
over bladder urgency, prolong voiding intervals, increase bladder capacity, Sexual arousal (female) - vascular assessment
reduce incontinent episodes, and restore patient confidence in controlling Investigation
bladder function. Timed voiding: is a passive toileting assistance program, Sexual arousal results in increased blood flow allowing genital engorge-
initiated and maintained by caregivers for patients who cannot participate ment, protrusion of the clitoris and augmented vaginal lubrication through
in independent toileting. It is a fixed voiding schedule. secretion from the uterus and Bartholin’s glands and transudation of plasma
Habit training: consists of a toileting schedule matched to the individual’s from engorged vessels in the vaginal walls. Several instruments are available
voiding patterns based on their voiding diary.The toileting schedule is as- to measure blood flow during sexual stimulation. Inadequate vasculogenic
signed to fit a time interval that is shorter than the person’s normal voiding response may be related to psychological factors as well as vascular com-
pattern and precedes the time period when incontinent episodes are ex- promise due to atherosclerosis, hormonal influence, trauma or surgery.
pected.
Prompted voiding: is used to teach people to initiate their own toileting Sexual arousal incontinence
through requests for help and positive reinforcement from caregivers, often Symptom
done in combination with a scheduled voiding regimen, typically every 2h. Complaint of involuntary loss of urine during sexual arousal, foreplay and/
or masturbation.
Scrotal examination
Sign Sexual diaries (female)
Normal: The scrotum is a loose sac containing the testes and spermatic cord Investigation
structures. The epididymis is palpable applied to the posterior surface of the A daily log of sexual thoughts, activities; supported by the US FDA as a pri-
testis as a ridge although occasionally it is sited on the anterior surface. mary outcome measure for the efficacy of interventions to improve sexual
. Inflammation: The epididymis may be swollen and tender, and if severe, the function.
inflammatory process may involve the whole scrotal content (i.e. testis and
epididymis [epididymo-orchitis]) and the scrotal skin as well. Sexual dysfunction (female)
. Cystic dilatations of the epididymis: (epididymal cysts or spermatocele) Diagnosis
and hydroceles (fluid collections between the visceral tunica albuginea and A diagnosis by clinical history (including specific questionnaires) and exam-
parietal layer of the testicular peritoneum) - usually benign. The examina- ination, involving the confirmation of abnormal function and/or difficulty
tion of these structures would be generally non-tender and without pain. with sexual intercourse.
. Inguinal bulge: Examination and differentiation of hernia from hydrocele or
cyst of spermatic cord or groin lymph nodes. (Use of transillumination may Sexual event logs
assist though ultrasound is generally diagnostic). Investigation
Record individual sexual events or activities. Each event is classified as a
Scrotal pain “sexually satisfying event (SSE)” or not. Event logs record individual events
Symptom rather than activities on a daily basis.
Complaint of pain, pressure or discomfort felt in and around the scrotum.
It may be localized to the testis, epididymis, cord structures or scrotal skin. Sexual Function Questionnaires - (SFQ)
Investigation
Scrotal pain syndrome 1. Pelvic floor condition specific sexual function measures: A validated sex-
Symptom ual function measure which is developed to include concepts relevant to
Scrotal pain syndrome is the occurrence of persistent or recurrent episodic women with pelvic floor dysfunction. 2. Generic sexual function measures:
scrotal pain which is associated with symptoms suggestive of urinary tract A validated measure that was developed to evaluate sexual function but
or sexual dysfunction. There is no proven epididimo-orchitis or other obvi- does not contain items relevant to pelvic floor dysfunction such as coital
ous pathology. incontinence or vaginal looseness.
EXAMPLES:
Sensation of anorectal blockage - female . ICIQ-FLUTSsex (BFLUTS) (International Consultation on Continence Ques-
Symptom tionnaire Female Lower Urinary Tract ICIQ-VS (International Consultation of
Complaint suggestive of anorectal obstruction. Incontinence Questionnaire -Vaginal Symptoms).
. GRISS (The Golombok-Rust Inventory of Sexual Satisfaction);
Sensory symptoms (female) . ICIQ-VS (International Consultation of Incontinence Questionnaire -Vaginal
Symptom Symptoms);
A departure from normal sensation or function, experienced by the woman . PISQ (Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire;
during bladder filling. Normally, the individual is aware of increasing sensa- . PISQ-12 (short form version of the PISQ-31;
tion with bladder filling up to a strong desire to void. . PISQ IR (IUGA- revised version of the PISQ;
. FSFI (Female Sexual Function Index);

Terms R - S
924

. SFQ (Sexual Function Questionnaire); sue. 9. Thiele’s massage: per-rectal digital massage of the levator ani, sweep-
. SQOL-F (Sexual Quality Of Life-Female). ing lengthwise along the muscle fibers. Massage is begun lightly, and pres-
sure is increased as tenderness decreases. 10. TrP treatment: (sometimes
Shortened vagina called myofascial trigger point treatment): soft-tissue mobilization specifi-
Symptom cally targeting trigger points and may include ischemic pressure, massage,
Perception of a short vagina expressed by the woman or her partner. myofascial release, electrotherapy, ultrasound , laser, spray and-stretch, in-
jection (a variety of chemicals including local anesthetic, botox or steroids),
Shortened vagina (postoperative) dry needling (insertion of a solid needle into the TrP), and stretching.
Symptom
Perception of a short vagina expressed by the women or her partner (follow- Soiling (female)
ing surgical intervention). Sign
Perianal fecal soiling or vaginal fecal soiling.
Simplified POPQ
Sign Somatic pain
This is based on the POP-Q with similar ordinal staging but with only four Symptom
points measured instead of nine. There is no Stage 0; it is combined with Pain which arises from bone, joints, muscles, skin or connective tissue and is
Stage 1. It is performed in the dorsal lithotomy position with patient force- normally achy or throbbing and well localized.
fully bearing down, performing Valsalva or coughing: (i) Four points used: (i)
Anterior vaginal segment: point Ba (estimated around 3cm proximal to hy- Spinal shock phase
menal remnants); (ii) Posterior vaginal segment: point Bp (estimated around Diagnosis
3cm proximal to hymenal remnants); (iii) Cervix point C; (iv) Apex/posterior This is usually temporary following acute neurologic insult or SCI that is
fornix: point D (non-hysterectomized); point C (hysterectomized). Staging characterized by loss of sensory, motor and reflex activity below the level of
I, II, III, IV. injury. Neurological lower urinary tract dysfunction in Spinal Shock is usual-
ly a temporary complete painless urinary retention.
Sinus tract formation
Surgery – Complication related Splinting (female)
(Localized) formation of a fistulous tract towards vagina or skin, where there Symptom
is no visible implant material in the vaginal lumen or overlying skin. Support perineum or buttocks manually (usually with thumb or fingers) to
assist in evacuation of stool content.
Situational types of urinary incontinence - neurogenic
Symptom Splinting/digitation due to POP
Giggle incontinence or incontinence associated with epileptic seizures, Symptom
sphincter denervation in cauda equina and in the Onuf’s nuclei lesions in Complaint of the need to digitally replace the prolapse or to otherwise ap-
multiple system atrophy. ply manual pressure e.g. to the vagina or perineum (splinting), or to the va-
gina or rectum (digitation) to assist voiding or defecation.
Slow (urinary) stream
Symptom Spraying (splitting) of urinary stream
Complaint of a urinary stream perceived as overall slower than previous per- Symptom
formance or in comparison with others. Complaint that the urine passage is a spray or split rather that a single di-
rectional stream.
Soft-tissue Therapies
Conservative Management – Female Sterile intermittent catheterization
1. Touch desensitisation: the manipulation of the soft tissues of the body for Conservative Management – General
the purpose of affecting the nervous, muscular, respiratory, and circulatory Complete sterile setting including genital skin antisepsis, sterile gloves, for-
systems. 2. Massage: the manipulation of the soft tissues of the body for ceps, gown and mask.
the purpose of affecting the nervous, muscular, respiratory, and circulatory
systems 3. Abdominal massage: therapist or self-directed massage of the Storage dysfunction (SD)
abdominal wall with the aim of stimulating peristalsis and relieving the Diagnosis
symptoms of constipation. Generally, the technique follows the ascending, Those diagnoses related to abnormal changes in bladder sensation, detru-
transverse, and descending colon to aid emptying. The effect may be me- sor pressure or bladder capacity during filling cystometry.
chanical or sensory. 4. Myofascial release techniques: the use of deep fric-
tion and stroking of the fascia of the body to improve the ability of the fascia Storage symptom
to deform and move within the body. 5. Skin rolling: a manual technique Symptom
in which skin is pulled away from the underlying structures and elongated A lower urinary tract symptom during the bladder storage phase.
in various directions. 6. Scar massage: a specific application of soft-tissue
mobilization to an adherent scar. 7. Perineal massage: intravaginal massage Storage symptoms
by the woman, her partner or the clinician. Technique includes alternating Symptom
downward and sideward pressure, using thumb and forefinger and a natu- Lower urinary tract symptoms occurring during the bladder storage phase.
ral oil, with the aim of stretching and elongating the tissue in preparation for
vaginal childbirth, or for treatment of adherent scarring in the perineum. 8. Straining to defecate
Transverse friction: the operator’s fingertip is placed on the exact site of the Symptom
lesion and rubbed firmly across the direction of the fibers of the affected tis- Complaint of the need to make an intensive effort (by abdominal straining

ICS Standards 2019

6. ICS Glossary
 925

or Valsalva) or to use abdominal massage to either initiate, maintain or im- the detrusor with impaired cerebral regulation and central inhibition and
prove defecation. usually synergistic voiding/bladder emptying.

Straining to void Suprasacral spinal cord/ pontine lesion (SSL)

Symptom Diagnosis
Complaint of the need to make an intensive effort to either initiate, maintain This is a neurological lesion in the suprasacral spine and/or pons. Neurogen-
or improve voiding or the urinary stream. ic lower urinary tract dysfunction in SSL: detrusor overactivity (DO) and DO
incontinence are common, with or without detrusor-sphincter dyssynergia
Stranguria (DSD), often resulting in a significant post-void residual (PVR) and a “high
Symptom pressure” bladder.
Complaint of voiding which is slow, difficult and spasmodic (at times “drop
by drop”), usually associated with pain. Surgery Type and Operated Compartment
Surgery – Female
Stress fecal incontinence (SFI) (a) Primary surgery: indicates the first procedure required for treating POP in
Symptom any compartment. (b) Further surgery: provides a term for any subsequent
Complaint of involuntary loss of feces on effort or physical exertion includ- procedure relatingto primary surgery. Further surgery is subdivided into:
ing sporting activities, or on sneezing or coughing. Primary surgery in a different (new) site/compartment. Repeat surgery in
the same site/compartment for POP symptom recurrence. Surgery for com-
Stress incontinence on prolapse reduction (occult or latent stress inconti- plications e.g. mesh exposure, pain, infection or hemorrhage. Surgery for
nence) non-POP-related conditions usually urinary or fecal incontinence.
Sign
Stress incontinence only observed after reduction of co-existent pelvic or- Suture hysteropexy - laparoscopic, robotic
gan prolapse (POP). Surgery – Female
The plicated uterosacral ligaments are resutured to the cervix.
Stress urinary incontinence
Symptom Symptom
Complaint of involuntary loss of urine on effort or physical exertion includ- Symptom
ing sporting activities, or on sneezing or coughing. Any morbid phenomenon or departure from the normal in structure, func-
tion or sensation, possibly indicative of a disease or health problem. Symp-
Stress urinary incontinence (clinical stress leakage) toms are either volunteered by, or elicited from the individual, or may be
Sign described by the individual’s partner or caregiver.
Observation of involuntary leakage from the urethral orifice synchronous
with effort or physical exertion, or on sneezing or coughing. Symptoms of sexual dysfunction
Symptom
Strong desire to void - Filling cystometry Complaint of abnormal sensation and/or function experienced by the indi-
Investigation vidual during sexual activity.
The persistent desire to void without the fear of leakage.
Symptoms of sexual dysfunction (female)
Superficial (introital) dyspareunia Symptom
Symptom A departure from normal sensation and/or function experienced by a wom-
Complaint of pain or discomfort on vaginal entry or at the vaginal introitus. an during sexual activity.

Suprapontine lesion (SPL)

Diagnosis
This is a neurological lesion above the pons (forebrain or midbrain). Neuro-
genic lower urinary tract dysfunction in SPL: there is a reflex contraction of

T
Tenderness
Tape (Sling) Sign
Surgery – Female Sensation of discomfort with or without pain; discomfort elicited through
A flat strip of synthetic material. The use of this term would be for inconti- palpation indicates unusual sensitivity to pressure or touch.
nence surgery with synthetic materials.
Tenesmus
Tender Point Symptom
Sign Complaint of an urgent desire to evacuate the bowel accompanied by invol-
Tenderness to palpation at soft-tissue body sites. untary straining and the passage of little fecal matter.

Terms S - T
926

Tenesmus (female) Total excision of the vagina in a woman with no uterus and vaginal eversion.
Symptom
A desire to evacuate the bowel, often accompanied by pain, cramping, and Total vaginal length (TVL)
straining, in the absence of feces in the rectum. Sign
This is the length of the vagina (cm) from posterior fornix to hymen with the
Terminal dribbling (dribble) posterior fornix reduced to its full normal position.
Symptom
Complaint that during the final part of voiding there is noticeable slowing of Transcutaneous electrical nerve stimulation (TENS)
the flow to drops or a tricking stream. Conservative Management – General
This is electrical stimulation of the nerves through intact skin to modulate
Thermal Modalities function and induce therapeutic response of the LUT.
Conservative Management – Female
Cold treatment/cryotherapy: Cold treatment is the application of ice for Transurethral Catheter for Urodynamics
therapeutic purposes. It is used in the initial management of acute musculo- Investigation
skeletal injuries, to decrease edema through vasoconstriction and to reduce ICS standard invasive urodynamics is done with the thinnest possible (6-7F)
secondary hypoxic injury by lowering the metabolic demand of injured tis- transurethral double or triple lumen catheter or a suprapubic catheter.
sues. Heat treatment (moist or dry): Heat treatment consists of the applica-
tion of heat to a body part, with the aim of relieving pain and/or stiffness. It Trigger Point (TrP)
is usually applied when an injury is older than 48h. Sign
A tender, taut band of muscle that can be painful spontaneously or when
Thermography or thermal imaging of the genital area stimulated. The taut band is electrically silent.
Imaging
Evaluation of genital temperature using a camera detecting infrared radia-
tion from the skin during sexual stimulation. This method has been correlat- Trocar
ed with subjective arousal. Surgery – Female
A surgical instrument with either a pyramidal, conical or needle-type cut-
Tight vagina ting or dissecting point.
Symptom
Introital narrowing: vaginal entry is difficult or impossible (penis or sexual Trophic
device). Vaginal narrowing: decreased vaginal calibre. Sign
Promoting cellular growth, differentiation, and survival. This is the normal
Tight vagina (postoperative) status of an organ, tissue or cell with regard to nutrition, size, number, form,
Symptom and function. Atrophic urogenital tract is usually well-estrogenized.
(i) Introital narrowing: vagina entry is difficult or impossible (penis or sexual
device). Twenty-four (24) hour (urinary) frequency
(ii) Vaginal narrowing: decreased vaginal calibre. These are de novo postop- Sign
erative findings. Total number of daytime and night-time micturitions during a specified 24-
hour period.
Time to maximum urine flow rate (tQmax - unit: s)
Investigation Twenty-four (24) hour urine volume
Elapsed time from the onset of urine flow to maximum urine flow. Sign
Summation of all urine volumes during a specified 24-hour period. The first
Tissue void after rising is discarded and the 24-hour period begins at the time of
Surgery – Female the next void and is completed by including the first void, after rising, the
A collection of similar cells and the intercellular substances surrounding following day.
them.
Twenty-four (24) hour voided volume
Tissue Sign
Surgery – Complication related Total volume of urine voided in a 24 hour period. (1st void to be discarded;
A collection of similar cells and the intercellular substances surrounding 24 hours begins at the time of the next void).
them.

Total colpectomy
Surgery – Female

U
A lesion through the skin or a mucous membrane resulting from loss of tis-
Ulcer sue, usually with inflammation.
Surgery – Complication related

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6. ICS Glossary
 927

Ultrasound applications in male LUT/PF dysfunction Ultrasound imaging (female) - prolapse related - 3D (modalities)
Imaging Imaging
(1) Post void residual (see separate heading); (2) Intercurrent abnormali- (i) Endovaginal ultrasound imaging may inadvertently compress tissues
ties: prostate volume (transabdominal, intraabdominal, retroperitoneal or thus distorting the anatomy; (ii) Transanal ultrasound approach requires an
intrapelvic tumor, hydronephrosis); (3) Bladder abnormalities: tumor, for- expensive and dedicated transducer, and it is a more uncomfortable and
eign body, overdistension, stones; (4) Detrusor wall thickness (see separate embarrassing test for the woman. Its most common clinical indication is the
heading); (5) Ultrasound estimated bladder weight (UEBW); (6) Intravesical assessment of sphincter integrity following obstetric trauma. (iii)Translabi-
prostatic protrusion (IPP): See separate heading; (7) Urethral abnormality: al/transperineal approach overcomes the limitations of endovaginal and
diverticulum, urethral stenosis, degree and depth of spongiofibrosis; (8) transrectal techniques providing minimal pressure on local structures and
Postoperative findings: post-prostatectomy (urethral shape), male sling po- it is least likely to alter surrounding anatomy.
sition, artificial urinary sphincter placement of cuff and reservoir, bulking
agents; (9) Prostate ultrasound: determination of prostate and transition
zone volume, prostate shape and visualization of the prostate parenchyma Ultrasound imaging (female) - prolapse related 3D evaluations
for calcifications, cysts, abscesses or enlargement. Imaging
The following pelvic floor abnormalities can be evaluated: (i) trauma (inju-
Ultrasound imaging - post-void residual (PVR - abdominal) ry/damage) of the levator ani muscle (LAM); (ii) excessive distensibility of
Imaging the puborectalis muscle and levator hiatus (“ballooning”); (iii) pathologies
Volume = width (left to right) x depth (anterior to posterior) x length (cranial of the anterior vaginal compartment like urethral diverticula; (iv) bladder
to caudal) x 0.52 (mL) tumours or foreign bodies (sling, mesh, bulking agents); (v) Polypropylene
meshes: highly echogenic and thus easily identified in the coronal and axial
Ultrasound imaging - uses (female) plane, unless they are obscured by vaginal prolapse; (vi) Periurethral bulking
Imaging agents, used as a continence procedure, can also be depicted with 3D pelvic
(i) Bladder neck descent / mobility/ opening including position of bladder floor ultrasound.
neck at rest and on Valsalva; (ii) Post void residuals; (iii) Intercurrent pelvic
pathology: e.g. Uterine and adnexal pathology; (iv) Uterine version: Ante- Ultrasound imaging (female) - prolapse related clinical applications
verted or retroverted; flexion at level of isthmus; (v) Bladder abnormalities: Imaging
e.g. tumor; foreign body; (vi) Urethral abnormality: e.g. diverticulum; (vii) (i) Bladder neck descent/mobility. The position of the bladder neck at rest
Postoperative findings: e.g. bladder neck position and mobility, position of and on Valsalva; (ii) Urethral funnelling: i.e., opening of the proximal third
meshes, tapes or implants; (viii) Pelvic floor / levator defects: Bladder neck of the urethra during coughing or on Valsalva; (iii) Post void residual: Sev-
elevation during pelvic floor contraction; (ix) Descent of pelvic organs: Vis- eral formulas have been described in the literature to measure the bladder
ualization of descent of the bladder, uterine cervix and rectum during Vals- volume by ultrasound. An early formula [(h x d x w) x 0.7] has been demon-
alva and coughing. strated to give reproducible results with a percentage error of 21%; (iv) Blad-
der abnormalities: e.g. tumor, foreign body; (v) Urethral abnormality: e.g.
Ultrasound imaging (female) - 3D imaging of ballooning of the genital hi- diverticulum; (vi) Intercurrent uterine and/or pelvic abnormality: depend-
atus ent on probe range; (vii) Postoperative findings: e.g., bladder neck position
Imaging and mobility, position of meshes, tapes, or implants; (viii) Descent of pelvic
The presence of ballooning of the genital hiatus (= excessive distensibility organs: visualization of descent of the bladder, uterine cervix, and rectum
of the levator hiatus) on Valsalva manoeuvre has also been associated to the during Valsalva and coughing;
severity of urogenital prolapse. An area of more than 25 cm2, 30 cm2, 35 (ix) Assessment of voluntary pelvic floor muscle contractility; (x) Pelvic floor/
cm2 and 40 cm2 has been defined as mild, moderate, marked and severe levator ani muscle defect and hiatal ballooning; (xi) Ultrasound measure-
ballooning respectively. ments of bladder and detrusor wall thickness, and ultrasound estimated
bladder weight (UEBW) are potential noninvasive clinical tools for assessing
Ultrasound imaging (female) - 3D imaging of levator ani trauma the lower urinary tract. UEBW is higher in women with overactive bladder
Imaging and detrusor overactivity.
The presence of levator ani trauma has been postulated to be associated
to an increased risk of pelvic organ prolapse. This can be evaluated using Ultrasound imaging (male) - anal endosonography (AES)
a tomographic ultrasound imaging assessment of the levator ani muscles. Imaging
Looking for: Anal sphincter defects
Ultrasound imaging (female) - 3D of female urethra
Imaging Ultrasound imaging (male) - bladder abnormalities
3D imaging of the rhabdosphincter overcomes the limits of MRI and two-di- Imaging
mensional (2D) ultrasound imaging that incorrectly measure the urethral Tumor, foreign, overdistension, stones, diverticulum.
sphincter volume using mathematical formulas based upon assumptions
that the shape of the urethra is similar to that of an ellipse. Since the urethral Ultrasound imaging (male) - bladder wall thickness (BWT)
shape is neither elliptical nor spherical, but rather an atypical geometric Imaging
shape, equations should not be used. Distance from outer border of the mucosa to the outer border of the ad-
ventitia on the anterior bladder wall with a linear 7.5MHz linear array in a
Ultrasound imaging (female) - combined with urodynamics bladder filled over 250ml.
Imaging
Synchronous ultrasound screening of the bladder and/or urethra and meas- Ultrasound imaging (male) - detrusor wall thickness (DWT)
urement of the bladder and abdominal pressure during filling and voiding Imaging
cystometry. Measured from the inner border of the mucosa to the inner border or the

Terms T - U
928

adventitia at the anterior bladder using linear 7.5MHz array in bladder filled is, opening of the proximal third of the urethra during coughing or on Val-
over 250ml. Over 2mm points to BOO. salva. Urine loss: full urethral opening during coughing, Valsalva, bladder
contraction, or micturition.
Ultrasound imaging (male) - intercurrent pathology (b) Postvoid residuals; (c) Intercurrent pelvic pathology: for example, uter-
Imaging ine and adnexal pathology. (d) Uterine version: Anteverted or retroverted;
Prostate volume (transrectal), tumor, hydronephrosis, scrotal abnormalities. flexion at level of isthmus; (e) Bladder abnormalities: for example, tumor,
foreign body; (f ) Urethral abnormality: for example, diverticulum;(g) Postop-
erative findings: For example, bladder neck position and mobility, position
Ultrasound imaging (male) - intravesical prostatic protrusion (IPP) of meshes, tapes, or implants; (h) Pelvic floor/levator defects: Bladder neck
Investigation elevation during pelvic floor contraction. (i) Descent of pelvic organs: Visual-
The distance from the bladder base until the tip of the prostate in the blad- ization of descent of the bladder, uterine cervix, and rectum during Valsalva
der lumen. and coughing.

Ultrasound imaging (male) - postoperative findings Ultrasound in Urogynecology - Modalities in Current Routine Clinical Use
Imaging Imaging
Post-prostatectomy (urethral shape), male sling position, artificial sphincter (a) Perineal: Curved array probe applied to the perineum. This term incor-
- placement of cuff and reservoir, bulking agents. porates transperineal and translabial ultrasound. (b) Introital: Sector probe
applied to the vaginal introitus. (c) Transvaginal (T-V): Intravaginal curvilin-
Ultrasound imaging (male) - prostatic volume (transrectal) ear, linear array, or sector scanning. (d) Transabdominal (T-A): Curvilinear
Imaging scanning applied to the abdomen.
Prostatic volume = Anteroposterior (cm) x transverse (cm) x transrectal (cm)
Ultrasound in Women - 3D and 4D
Ultrasound imaging (male) - urethral abnormality Imaging
Imaging The potential of 3D ultrasound in urogynecology and female urology is
Diverticulum, stenosis, degree and depth of spongiofibrosis. currently being researched with validated applications likely to be includ-
ed in future updates of this report and/or separate ultrasound reports. Ap-
Ultrasound imaging modalities (female) plications with the most current research include: (i) major morphological
Imaging abnormalities such as levator defects and (ii) excessive distensibility of the
(i) Perineal: Curved array probe applied to the perineum. This term incor- puborectalis muscle and levator hiatus (‘‘ballooning’’40). The additional di-
porates transperineal and translabial ultrasound; (ii) Introital: Sector probe agnostic potential of 4D (i.e., the addition of movement) ultrasound awaits
applied to the vaginal introitus; (iii) Transvaginal (T-V): Intravaginal curvi- clarification by further research.
linear, linear array or sector scanning; (iv)Transabdominal (T-A): Curvilinear
scanning applied to the abdomen. Underactive Pelvic Floor Muscles
Diagnosis
Ultrasound imaging modalities (Male) A situation in which the pelvic floor muscles cannot voluntarily contract
Imaging when this is appropriate. This condition is based on symptoms such as uri-
Transrectal (linear array or sector); transabdominal (curved or linear array); nary incontinence, anal incontinence or pelvic organ prolapse, and on signs
perineal (curved array); scrotal (curved array). like no voluntary or involuntary contraction of the pelvic floor muscles.

Ultrasound imaging sites (male) Underactive pelvic floor muscles (female)

Imaging Sign
Renal, bladder, prostate, scrotum urethra, ano-rectum Pelvic floor muscles which cannot voluntarily contract when this is appro-
priate.
Ultrasound in Urogynecology
Imaging Urethral caruncle
Ultrasound has become an increasingly frequent adjunct investigation in Sign
urogynecology and female urology both in the office and in the urodynamic Small eversion of the urethral urothelium, generally involving the posterior
laboratory. lip.

Ultrasound in Urogynecology - Current Routine Possible Uses Urethral closure mechanism - incompetent (female)
Imaging Investigation
(a) Bladder neck descent/mobility/opening: Position of bladder neck at rest Leakage of urine occurs during activities which might raise intra-abdominal
and on Valsalva. pressure in the absence of a detrusor contraction.
N.B: Ideally the Valsalva should be standardized but it is appreciated that at
present a reliable non-invasive method is lacking. Consensus has not been Urethral closure mechanism - normal (female)
reached on criteria for excessive bladder neck mobility nor the relationship Investigation
of this finding to a diagnosis of urodynamic stress incontinence. Position A positive urethral closure pressure is maintained during bladder filling,
of bladder neck during pelvic floor contraction. Retrovesical angle (RVA): even in the presence of increased abdominal pressure, although it may be
that is, angle between proximal urethra and trigonal surface of the bladder. overcome by detrusor overactivity.
Urethral rotation: that is, rotation of the proximal urethra on Valsalva. Angle
gamma: that is, angle defined by lines from the infero-posterior symphyseal
margin to the bladder neck at rest and on Valsalva. Urethral funneling: that

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Urethral closure mechanism - urethral relaxation incompetence (“urethral contraction of the urethral and/or periurethral striated muscle). This is a
instability”) - female feature of neurological voiding disorders. Neurological features should be
Investigation sought. Videocystourethrography is generally valuable to conclude this di-
Leakage due to urethral relaxation in the absence of raised abdominal pres- agnosis.
sure or a detrusor contraction.
Urethral function during voiding (voiding urethrocystometry) - female
Urethral closure mechanism - urodynamic stress incontinence (female) Investigation
Investigation This technique may assist in determining the nature of urethral obstruction
This is the involuntary leakage of urine during filling cystometry, associat- to voiding. Pressure is recorded in the urethra during voiding. This may be at
ed with increased intra-abdominal pressure, in the absence of a detrusor one specific point e.g. high pressure zone or it may be measured as a profile.
contraction. A voiding urethral pressure profile (VUPP) uses a similar technique to that
described above for the UPP measured during bladder filling. Simultaneous
Urethral closure pressure profile (UCPP) - female intravesical pressure measurement is required. Localization of the site of the
Investigation intraurethral pressure measurement is desirable.
The relevant pressure is the urethral closure pressure (urethral pressure mi-
nus the intravesical pressure). Urethral meatal abnormalities (male)
Sign
Urethral discharge . Hypospadias: Refers to the urethral meatus sited on ventral surface of the
Symptom penis, either congenital or acquired, proximal to its normal position on the
Seepage of mucus, pus or blood from the urethral meatus. tip of the glans. External urethral meatus may be on the glans penis (glandu-
lar hypospadias), sulcus (coronal hypospadias), shaft (penile hypospadias),
Urethral diverticulum scrotum (scrotal hypospadias) or perineum (perineal hypospadias).
Sign . Epispadias: Refers to the urethral meatus sited on dorsal surface of the pe-
The presence of a sac opening from the urethra. It might be suspected by nis, either congenital or acquired, proximal to its normal position on the tip
a lump or tenderness along the line of the urethra or external urethral dis- of the glans.
charge on urethral massage. . Neoplastic or inflammatory lesions within the fossa navicularis.
. Post-hypospadias/epispadias repair: including post-urethroplasty urethral
Urethral examination (male) fibrosis: palpated near the meatus or in the penile shaft.
Sign . Postoperative fistula: Urine is visible at or near the incision lines.
Palpation: along the ventral aspect of the penis and inferiorly into the per-
ineum to detect fibrosis, lumps or tenderness along the shaft. Tenderness: Urethral mucosal prolapse
suggestive of urethral or periurethral inflammation, often secondary to a Sign
urethral stricture or sexually transmitted disease. Meatal stenosis: narrowing Prolapse, generally circumferential and larger, of the distal urethral urothe-
changes of the distal urethra; post-infection, post-surgery. lium.

Urethral function during voiding - dysfunctional voiding Urethral opening pressure (Pdet-uo – unit: cm H2O) - pressure flow studies
Investigation Investigation
This is characterized by an intermittent and/or fluctuating flow rate due to Detrusor pressure recorded at the onset of measured flow (consider time
involuntary intermittent contractions of the peri-urethral striated or levator delay – usually under 1 s).
muscles during voiding in neurologically normal women. This type of void-
ing may also be the result of an acontractile detrusor (abdominal voiding) Urethral pain
with electromyography (EMG) or video-urodynamics required to distinguish Symptom
between the two entities. Complaint of pain, pressure or discomfort felt in the urethra before, during
and/or after voiding and the individual indicates the urethra as the site.
Urethral function during voiding - normal (female)
Investigation
The urethra opens and is continuously relaxed to allow micturition at a nor- Urethral pain syndrome
mal pressure, urine flow and PVR. Symptom
Urethral pain syndrome is the occurrence of recurrent episodic urethral pain
Urethral function during voiding (female) - bladder outlet obstruction usually on voiding, with daytime frequency and nocturia, in the absence of
Investigation proven infection or other obvious pathology.
This is the generic term for obstruction during voiding. It is a reduced urine
flow rate and/or presence of a raised PVR and an increased detrusor pressure Urethral Plugs
. It is usually diagnosed by studying the synchronous values of urine flow Conservative Management – Female
rate and detrusor pressure and any PVR measurements. A urethral stricture Urethral plugs are containment products aimed at blocking urine leakage.
or obstruction due to higher degrees of uterovaginal prolapse or obstructed
voiding after stress incontinence procedures are amongst possible causes. Urethral pressure - intraluminal (female)
Investigation
Urethral function during voiding (female) - detrusor sphincter dyssynergia This is the fluid pressure needed to just open a closed urethra.
Investigation
This is incoordination between detrusor and sphincter during voiding due Urethral pressure measurement (female)
to a neurological abnormality (i.e. detrusor contraction synchronous with Investigation

Terms U
930

Urethral pressure and urethral closure pressure are idealized concepts which Urgency - filling cystometry
represent the ability of the urethra to prevent leakage. Urethral pressure is Investigation
currently measured by a number of different techniques which don’t tend Sudden, compelling desire to void which is difficult to defer.
to have consistent results, either between methods or for a single method.
For example the effect of catheter rotation will be relevant when urethral Urgency urinary incontinence
pressure is measured by a catheter mounted transducer. Urethral pressure Sign
might, nonetheless, be measured: (i) at rest, with the bladder at a given vol- Observation of involuntary leakage from the urethral orifice associated with
ume; (ii) During coughing or straining; (iii) During the process of voiding. the individual reporting the sensation of a sudden, compelling desire to
void.
Urethral pressure profile - functional profile length (female)
Investigation Urgency urinary incontinence (UUI)
The length of the urethra along which the urethral pressure exceeds intra- Symptom
vesical pressure in women. Complaint of involuntary loss of urine associated with urgency.

Urethral pressure profile - functional profile length (on stress) - female Urinary Catheters
Investigation Conservative Management – Female
The length over which the urethral pressure exceeds the intravesical pres- Urinary catheters are small tubes inserted via the urethra or into the bladder
sure on stress. suprapubically, to allow the drainage of urine. Catheters are made of plastic,
latex, teflon or silicone, and may be impregnated with antiseptic or antibi-
Urethral pressure profile - pressure “transmission” ratio (female) otic solution. 1. Self-catheterization: a procedure performed intermittently
Investigation to empty the bladder by inserting a catheter into the urethra when normal
This is the increment in urethral pressure on stress as a percentage of the si- voiding is not possible or if the bladder cannot be emptied completely. If a
multaneously recorded increment in intravesical pressure. For stress profiles caregiver undertakes this procedure it is usually a sterile procedure; if a pa-
obtained during coughing, pressure transmission ratios can be obtained at tient undertakes it, it is termed “self-catheterization” and is generally a clean
any point along the urethra. If single values are given, the position in the rather than a sterile procedure.
urethra should be stated. If several transmission ratios are defined at differ-
ent points along the urethra, a pressure transmission “profile” is obtained. Urinary incontinence
During “cough profiles”, the amplitude of the cough should be stated if pos- Symptom
sible. Complaint of involuntary loss of urine.

Urethral pressure profile (UPP) - female Urinary incontinence

Investigation Sign
This is a graph indicating the intraluminal pressure along the length of the Observation of involuntary loss of urine on examination.
urethra: (i) Resting UPP: The bladder and subject are at rest; (ii) Stress UPP:
Defined applied stress (e.g. cough, strain, Valsalva). Urinary incontinence signs
Sign
All examinations for the evaluation of urinary incontinence are best per-
formed with the individual’s bladder comfortably full.

Urethral pressure profile (UPP) - methodology (female) Urinary incontinence symptoms

Investigation Symptom
All systems are zeroed at atmospheric pressure. For external transducers, Involuntary loss of urine experienced during the bladder storage phase.
the reference point is the superior edge of the symphysis pubis. For catheter
mounted transducers, the reference point is the transducer itself. Intraves- Urinary retention
ical pressure should be measured to exclude a simultaneous detrusor con- Symptom
traction. Methodology should be noted including: patient position; catheter Complaint of the inability to empty the bladder completely.
type; transducer orientation; fluid and rate of infusion (if fluid-filling system);
bladder volume; rate of catheter withdrawal. Urinary Tract Infection
Symptom
Urethral prolapse Scientific diagnosis of a UTI is the finding of microbiological evidence of
Symptom significant bacteriuria and pyuriaxii usually accompanied by symptoms
Complaint of a “lump” at the external urethral meatus. such as increased bladder sensation, urgency, frequency, dysuria, urgency
urinary incontinence, and/or pain in the lower urinary tract.
Urethral relaxation incompetence (“urethral instability”) - female
Investigation Urine flow
Leakage due to urethral relaxation in the absence of raised abdominal pres- Investigation
sure or a detrusor contraction. Urethral passage of urine. Pattern of urine flow may be: continuous - no in-
terruption to urine flow; intermittent - urine flow is interrupted.
Urgency
Symptom Urine flow rate (UFR - mL/s)
Complaint of sudden, compelling desire to pass urine which is difficult to Investigation
defer. Volume of urine expelled via the urethra per unit time.

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Urodynamic clinical sequence of testing (female) Uroflowmetry (male) - ideal conditions

Investigation Investigation
This generally involves a woman attending with a comfortably full bladder Ideally, all free uroflowmetry studies should be performed in a completely
for free (no catheter) uroflowmetry and post-void residual (PVR) measure- private uroflowmetry room. Most modern uroflowmeters have a high de-
ment prior to filling cystometry and pressure-flow studies. gree of accuracy (+/- 5%) though regular calibration is important.

Urodynamic clinical sequence of testing (male) Uroflowmetry (male) - interpretation of normality

Investigation Investigation
This generally involves a man attending with a comfortably full bladder for Because of the strong dependency of urine flow rates in men on voided vol-
free (no catheter) uroflowmetry and post-void residual urine volume (PVR) ume and age, they are best referenced to nomograms where the cutoff for
measurement prior to filling cystometry and pressure-flow study. normality has been determined and validated.

Urodynamic stress incontinence - Filling cystometry Urogenital aging: genitourinary syndrome of menopause
Investigation Sign
Involuntary leakage of urine during filling cystometry, associated with in- (i) Pallor/erythema: pale genital mucosa; (ii) Loss of vaginal rugae: vaginal
creased intra-abdominal pressure, in the absence of a detrusor contraction. rugae flush with the skin; (iii) Tissue fragility/fissures: genital mucosa that
is easily broken or damaged; (iv) Vaginal petechiae: is a small (1–2 mm) red
Urodynamic stress incontinence (female) or purple spot on the skin, caused by a minor bleed (from broken capillary
Diagnosis blood vessels); (v) Urethral eversion: urethral epithelium turned outside the
Involuntary leakage of urine during filling cystometry, associated with in- lumen; (vi) Urethral prolapse: complaint of a lump at the external urethral
creased intra-abdominal pressure, in the absence of a detrusor contraction. meatus; (vii) Loss of hymenal remnants: absence of hymenal remnants; (viii)
Prominence of urethral meatus vaginal canal shortening and narrowing: In-
Urodynamic Stress Incontinence (female) troital retraction.
Diagnosis
The diagnosis by symptom, sign, and urodynamic investigations involves Uterine / cervical prolapse
the finding of involuntary leakage during filling cystometry, associated with Diagnosis
increased intra-abdominal pressure, in the absence of a detrusor contrac- Clinically evident (symptoms, signs or any relevant imaging) descent of the
tion. uterus or uterine cervix.

Urodynamic stress incontinence (USI) - filling cystometry Uterine / cervical prolapse

Investigation Diagnosis
Involuntary leakage of urine during filling cystometry, associated with in- Clinically evident (symptoms, clinical examination, assisted at times by any
creased intra-abdominal pressure, in the absence of a detrusor contraction. relevant imaging) descent of the uterus or uterine cervix.

Urodynamic studies Uterine retroversion

Investigation Sign
These usually take place in a special clinical room (urodynamic laboratory) The axis of the uterus is directed backwards towards the hollow of the sa-
and involve (artificial) bladder filling with a specified liquid (ICS recom- crum, away from its anteverted position overlying the bladder. Cervix is not-
mends physiological saline solution or X-ray contrast if video studies) at a ed in/towards the anterior fornix with the fundus perhaps palpable in the
specified rate. posterior fornix.

Urodynamics Uterine/cervical prolapse

Investigation Sign
Measurement of physiological parameters relevant to the function of the Observation of descent of the uterus or uterine cervix.
lower urinary tract.
Uterosacral ligament plication - open, laparoscopic, robotic
Uroflowmetry (female) - ideal conditions Surgery – Female
Investigation Transverse plication of the uterosacral ligaments to obliterate the cul-de-
For free (or spontaneous - no catheter) uroflowmetry, all studies should be sac. Successive sutures are placed into the medial portion of one ligament,
performed in a completely private uroflowmetry room. Most modern uro- into the back wall of the vagina and into the medial border of the opposing
flowmeters have a high degree of accuracy (+/- 5%) though regular calibra- ligament.
tion is important.
Uterosacral (USL) Ligament vaginal vault fixation - intraperitoneal
Uroflowmetry (female) - interpretation of normality Surgery – Female
Investigation Intraperitoneal USL ligament plication to support the vaginal vault. This is
Because of the strong dependency of urine flow rates in women on void- usually associated with posterior wall fascial reconstruction and possible
ed volume, they are best referenced to nomograms (e.g. Liverpool nomo- excision and closure of enterocele.
grams) where the cutoff for abnormally slow maximum (MUFR) and average
(AUFR) urine flow rates has been determined and validated as under the Uterosacral (USL) vaginal vault fixation - extraperitoneal
10th centile. Surgery – Female
Extraperitoneal plication of the uterosacral ligaments to support the vaginal

Terms U
932

vault. This is usually combined with posterior vaginal wall fascial reconstruc-
tion with or without enterocele closure and/or excision.

V
Vaginal hysterectomy
Vaginal agglutination Surgery – Female
Sign Removal of the uterus and cervix vaginally.
Where the walls of the vagina are stuck together.
Vaginal hysterectomy - with adjunctive McCall culdoplasty
Vaginal Anatomical Levels Surgery – Female
Sign Culdoplasty sutures incorporate the uterosacral ligaments into the posterior
(i) Level I: Uterine cervix (if present) and/or upper 2.5cm of vagina. (ii) Level vaginal vault to obliterate the cul-de-sac and support and suspend the vag-
II: Mid-vagina from distal end of Level I to hymen. (iii) Level III (vaginal ves- inal vault after vaginal hysterectomy.
tibule): Vaginal entrance (Latin: ‘‘vestibulum’’- ‘‘a space at the entrance of a
canal’’) from hymenal ring to just below the clitoris anteriorly (anterior ves- Vaginal laxity
tibule), labia minora laterally and anterior perineum posteriorly (posterior Symptom
margin of vestibule). Feeling of vaginal looseness.

Vaginal and clitoral duplex doppler ultrasound. Vaginal length - anterior vaginal length
Investigation Sign
The anatomical integrity of clitoral structures and the changes in clitoral Anterior hymenal ring to anterior vaginal vault (anterior cervicovaginal
and labial diameter associated with sexual stimulation can be evaluated in B junction or anterior cuff post-hysterectomy).
mode. Movement of the blood relative to the transducer can be expressed
as measurement of velocity, resistance, and pulsatility. Blood flow in arteries Vaginal length - total posterior vaginal length
irrigating the clitoris and the vagina are more commonly assessed during Sign
sexual stimulation. Posterior vaginal vault to posterior margin of vestibule (anterior perineum -
cm), i.e., Levels I, II and III posteriorly.
Vaginal bulging
Symptom Vaginal length - total vaginal length
Complaint of a “bulge” or “something coming down” towards or through the Sign
vaginal introitus. The woman may state she can either feel the bulge by di- Posterior vaginal vault to hymen (cm), i.e., Levels I and II posteriorly.
rect palpation or see it with the aid of a mirror.
Vaginal Levels - Level I
Vaginal digitation Sign
Symptom Uterine cervix (if present) and/or upper 2.5 cm of vagina.
Use of thumb or fingers in the vaginal to assist in evacuation of stool.
Vaginal Levels - Level II
Vaginal dryness Sign
Symptom Mid-vagina from distal end of Level I to hymen.
Complaint of reduced vaginal lubrication or lack of adequate moisture in
the vagina. Vaginal Levels - Level III (vaginal vestibule)
Sign
Vaginal eversion Vaginal entrance (Latin: “vestibulum” = “space at the end of the canal”). From
Sign hymenal ring to just below the clitoris anteriorly (anterior vestibule), labia
Complete version of the vagina is Stage IV vaginal prolapse. minora laterally and anterior perineum posteriorly (posterior margin of ves-
tibule).
Vaginal examination
Sign Vaginal Lubricants
Examination for vaginal length and mobility, presence of scarring and/or Conservative Management – Female
pain, and estrogenization. The location of any vaginal pain should be noted. Vaginal lubricants are pharmacological preparations aimed at reducing
friction during coital or any other sexual activity and thereby alleviating
dyspareunia, or at reducing discomfort associated with a clinical (per vagi-
Vaginal feces num or per rectum) examination. Pharmacological preparations and natural
Symptom plant-based oils may be used.
Complaint of passage of feces per vagina.
Vaginal Pain Syndrome
Vaginal flatus Symptom
Symptom Vaginal pain syndrome is the occurrence of persistent or recurrent episodic
Complaint of passage of flatus per vaginam. vaginal pain which is associated with symptoms suggestive of urinary tract

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 933

or sexual dysfunction. There is no proven vaginal infection or other obvious Vaginal wind
pathology. Symptom
Passage of air from vagina (usually accompanied by sound).
Vaginal pessary - general
Conservative Management – Female Vaginismus
A device that is inserted into the vagina to provide structural support to one Symptom
or more of the descending vaginal compartments, i.e. the uterus, anterior Recurrent or persistent spasm of vaginal musculature that interferes with
vaginal wall (and bladder), posterior vaginal wall (and rectum) and/or vagi- vaginal penetration.
nal vault (with or without small intestine) after a prior hysterectomy.
Vascular assessment of female sexual dysfunction - labial thermistor
Vaginal pessary - space filling pessaries Investigation
Conservative Management – Female Temperature measurement evaluated with a small metal clip attached to
Doughnut; cuboid; Gellhorn; inflatable; shelf (similar to a Gellhorn but the labia minora and equipped with a sensitive thermistor.
asymmetric).
Vascular assessment of female sexual dysfunction - Laser Doppler imaging
Vaginal pessary - support pessaries of genital blood flow
Conservative Management – Female Investigation
Ring pessary with or without central support; Gehrung, Hodge pessaries. An imager positioned close to the vulva allows the assessment of skin/mu-
cosae microcirculation at a depth of up to 2-3mm. This method has been
Vaginal photoplethysmography used to assess response to sexual stimulation and correlated with subjec-
Investigation tive arousal. It has also led to a better understanding of microvascular differ-
A tampon shape intravaginal probe equipped with an incandescent light ences in women with provoked vestibulodynia compared to asymptomatic
that projects toward the vaginal walls is inserted; the amount of light that controls.
reflects back to the photosensitive cell provides a measure of vaginal en-
gorgement which can be expressed as vaginal blood volume or vaginal Vascular assessment of female sexual dysfunction - Magnetic resonance im-
pulse amplitude depending on the mode of recording. Likewise, labial and aging of the genito-pelvic area
clitoral photoplethysmography can also be evaluated. Investigation
Evaluation of the increase in clitoral structure volume related to tissue en-
Vaginal tracelectomy for cervical stump prolapse (previous subtotal hyster- gorgement occurring during arousal.
ectomy)
Surgery – Female Vascular assessment of female sexual dysfunction - Measurements of labial
The cervical stump is removed in an identical fashion to the initial steps of and vaginal oxygenation
a vaginal hysterectomy. Investigation
A heated electrode and oxygen monitor are used to evaluate the arterial
Vaginal Trachelectomy for Cervical Stump Prolapse partial pressure of oxygen (PO2) transcutaneously. The temperature of the
Surgery – Female electrode is kept at a constant elevated temperature by an electric current.
(Previous subtotal hysterectomy) The cervical stump is removed in an iden- Increase in blood flow under the electrode results in more effective temper-
tical fashion to the initial steps of a vaginal hysterectomy. ature dissipation (heat loss) with the result that more current is needed to
maintain the electrode at its prefixed temperature. The changes in current
Vaginal vault (cuff scar) prolapse provide an indirect measurement of blood flow during sexual stimuli. The
Sign electrode also monitors oxygen diffusion across the skin.
Observation of descent of the vaginal vault (cuff scar after hysterectomy).
Vascular assessment of female sexual dysfunction - Thermography or ther-
Vaginal vault (cuff scar) prolapse mal imaging of the genital area
Diagnosis Investigation
Clinically evident (symptoms, signs or any relevant imaging) descent of the Evaluation of genital temperature using a camera detecting infrared radia-
vaginal vault (cuff scar after hysterectomy). tion from the skin during sexual stimulation. This method has been correlat-
ed with subjective arousal.
Vaginal vault (cuff scar) prolapse
Diagnosis Vascular assessment of female sexual dysfunction - vaginal and clitoral du-
Diagnosis by symptoms and clinical examination, assisted at times by any plex Doppler ultrasound
relevant imaging (i.e. clinically evident) descent of the vaginal vault (cuff Investigation
scar after hysterectomy). The anatomical integrity of clitoral structures and the changes in clitoral
and labial diameter associated with sexual stimulation can be evaluated in B
Vaginal vestibule - Anterior mode. Movement of the blood relative to the transducer can be expressed
Sign as measurement of velocity, resistance, and pulsatility. Blood flow in arteries
Vaginal entrance from the hymenal ring to just below the clitoris anteriorly. irrigating the clitoris and the vagina are more commonly assessed during
sexual stimulation.
Vaginal vestibule - posterior
Sign Vascular assessment of female sexual dysfunction - vaginal photoplethys-
Posterior hymenal ring to anterior perineum (posterior margin of vestibule). mography
Investigation

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934

A tampon shape intravaginal probe equipped with an incandescent light Voiding cystometry
that projects toward the vaginal walls is inserted; the amount of light that Investigation
reflects back to the photosensitive cell provides a measure of vaginal en- This is the pressure volume relationship of the bladder during micturition.
gorgement which can be expressed as vaginal blood volume or vaginal It begins when the ‘‘permission to void’’ is given by the urodynamicist and
pulse amplitude depending on the mode of recording. Likewise, labial and ends when the woman considers her voiding has finished. Measurements to
clitoral photoplethysmography can also be evaluated. be recorded should be the intravesical, intra-abdominal, and detrusor pres-
sures and the urine flow rate.
Videocystourethrography (VCU - female)
Imaging Voiding cystourethrography - male
Synchronous radiological screening of the bladder and measurement of Imaging
the bladder and abdominal pressure during filling and voiding cystom- Imaging of the bladder neck, urethra and prostate during voiding. The prin-
etry. When indicated for complex cases, VCU allows direct observation of cipal use is determining the site of any obstruction e.g. bladder neck or pros-
the effects of bladder events, the position and conformation of the bladder tate. It can detect vesico-ureteric reflux, vesical or urethral fistulae, vesical or
neck in relation to the pubic symphysis, bladder neck closure during rest urethral diverticula and strictures.
and stress, diverticula of the bladder and urethra, vesico-vaginal and ure-
thro-vaginal fistulae, vesico-ureteric reflux and voiding events. Voiding dysfunction - acute on chronic retention
Diagnosis
Videourodynamics An individual with chronic retention goes into acute retention and is unable
Investigation to void.
Functional test of the lower urinary tract where filling cystometry and press-
flow studies are combined with real-time imaging of the lower urinary tract.
Voiding dysfunction - retention with overflow
Diagnosis
Involuntary loss of urine directly related to an excessively full bladder in re-
Videourodynamics tention.
Imaging
A functional test of the lower urinary tract in which pressure, capacity and Voiding dysfunction (female)
flow data are simultaneously combined with real-time imaging of the upper Diagnosis
and lower urinary tract. It is a dynamic study with function, during bladder (A diagnosis by symptoms and urodynamic investigations is defined as)
filling and emptying. It is a kinetic technique that records morphological abnormally slow and/or incomplete micturition, based on abnormally slow
and functional changes of the lower urinary tract as a function of time. This urine flow rates and or abnormally high post-void residuals, ideally on re-
feature distinguishes this technique from the static images obtained by cys- peated measurement to confirm abnormality. Pressure-flow studies can be
tography. It is a technique that is applied simultaneously with conventional required to determine the cause of the voiding dysfunction.
urodynamic studies.
Image acquisition for the urinary tract can be performed with X-rays (fluor- Voiding dysfunction (male)
oscopy) or by ultrasound. Although in a strict sense, the “video” prefix refers Diagnosis
to the recording of the images and not to their acquisition. Abnormally slow and/or incomplete emptying, manifest as an abnormally
slow urine flow rate and/or an abnormally high post-void residual, with con-
Visceral pain firmation by pressure-flow studies (including any related imaging).
Symptom
Pain which arises from visceral organs, with involvement of the organ cap- Voiding dysfunction (male) - acute urinary retention
sule with aching, and is localized. There is obstruction of hollow viscus, caus- Diagnosis
ing intermittent cramping, which is poorly localized. No urine is able to be passed despite the man having a full bladder, which
i. Nociceptive: direct injury or lesion of an internal organ such as: on examination is painfully distended, and readily palpable or percussible.
bladder stone, surgical injury.
ii. Inflammatory: acute/chronic inflammation of an internal organ Voiding dysfunction (male) - chronic retention of urine
such as urinary tract infection, pelvic inflammatory disease, colitis, endome- Diagnosis
triosis. Generally (but not always) painless and palpable or percussible bladder,
iii. Neuropathic: primary lesion of visceral nerves such as neuritis where there is a chronic high postvoid residual and the man experiences
following mesh placement. slow urine flow and the sense of incomplete bladder emptying. Overflow
incontinence and impaired renal function and/or hydronephrosis can occur
Voided Percentage (Void%) in advanced cases.
Investigation
The numerical description of the voiding efficacy or efficiency which is the Voiding symptoms
proportion of bladder content emptied. Calculation: [(volume voided/vol- Symptom
ume voided + PVR) *100]. Lower urinary tract symptoms experienced during the voiding phase (expe-
rienced during micturition).
Voided volume (VV - mL)
Investigation Voiding time (VT - unit: s)
Total volume of urine expelled via the urethra during a single void. Investigation
Total duration of micturition, i.e. included interruptions. When voiding is
completed without interruption, voiding time is equal to flow time.

ICS Standards 2019

6. ICS Glossary
 935

Voiding urethrocystometry - urethral function during voiding (female)

Investigation
This technique may assist in determining the nature of urethral obstruction
to voiding. Pressure is recorded in the urethra during voiding. This may be at
one specific point e.g. high pressure zone or it may be measured as a profile.
A voiding urethral pressure profile (VUPP) uses a similar technique to that
described above for the UPP measured during bladder filling. Simultaneous
intravesical pressure measurement is required. Localization of the site of the
intraurethral pressure measurement is desirable.

Vulval agglutination
Sign
Labial lips fused.

Vulval examination
Sign
Possible abnormalities include cysts, other tumours, atrophic changes, or
lichen sclerosis.

Vulval gaping
Sign
Non-coaptation of vulva at rest, commonly associated with increased size
of genital hiatus.

Vulval pain
Symptom
Complaint of pain felt in and around the vulva.

Vulval pain syndrome

Symptom
Vulval pain syndrome is the occurrence of persistent or recurrent episod-
ic vulval pain, which is either related to the micturition cycle or associated
with symptoms suggestive of urinary tract or sexual dysfunction. There is no
proven infection or other obvious pathology.

Vulvar agglutination
Sign
Labial lips stuck together.

Vulvar gaping
Sign
Non-coaptation of vulva at rest, commonly associated with increased size
of genital hiatus.

Vulvar pain
Symptom
Complaint of pain felt in and around the vulva.

Vulvodynia
Symptom
Vulvar pain of at least 3 months’ duration, without clear identifiable cause,
which may have potential associated factors

Vulvo-vaginal hyperaesthesia
Sign
Increased vulvo-vaginal sensitivity to touch, pressure, vibration or temper-
ature.

Vulvo-vaginal hypoesthesia
Sign
Reduced vulvo-vaginal sensitivity to touch, pressure, vibration or temper-
ature.

Terms V