European European Urology 48 (2005) 978–983

Urology

Hydrophilic-Coated Catheters for Intermittent

Catheterisation Reduce Urethral MicroTrauma:
A Prospective, Randomised, Participant-Blinded,
Crossover Study of Three DifferentTypes of Catheters
J. Stensballea,*, D. Loomsb, P.N. Nielsenb, M. Tvedec
a
Department of Anaesthesia and Operating Theatre Services, 4231, Centre of Head and Orthopaedics,
Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark
b
Clinical Documentation, Continence Care Division, Coloplast A/S, Denmark
c
Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Denmark
Accepted 15 July 2005
Available online 2 August 2005

Abstract
Objective: To compare two hydrophilic-coated (SpeediCath1 and LoFric1) and one uncoated gel-lubricated
catheter (InCare1 Advance Plus) concerning withdrawal friction force and urethral micro trauma.
Methods: 49 healthy male volunteers participated in this prospective, randomised, blinded, crossover study of three
different bladder catheters. The withdrawal friction force was measured, and urine analysis of blood, nitrite and
leucocytes, microbiological analysis of urine cultures and subjective evaluation of the catheters were performed.
Results: 40 participants completed the study and were included in the analysis. SpeediCath1 exerted a significantly
lower mean withdrawal friction force and work than the gel-lubricated uncoated catheter, whereas LoFric1 exerted
a significantly higher mean friction force than both of the other catheters. The hydrophilic catheters caused less
microscopic haematuria and less pain than the gel-lubricated uncoated catheter. Furthermore, 93% of the
participants preferred the hydrophilic catheters.
Conclusion: Hydrophilic-coated catheters perform better than uncoated catheters with regard to haematuria and
preference. SpeediCath1, but not LoFric1, exerts less withdrawal friction force than InCare1 Advance Plus.
# 2005 Elsevier B.V. All rights reserved.

Keywords: Intermittent catheterisation; Hydrophilic-coated catheter; Friction force; Haematuria; Urethral trauma

1. Introduction However, catheter surface properties may influence

other aspects of CIC, such as urethral complications,
Since Lapides et al. [1] introduced clean intermittent urinary tract infections as well as patient satisfaction
catheterisation (CIC) as a bladder management and preference. Urethral complications associated with
method, use of the technique has resulted in improved repeated catheterisation range from urethral mucosa
kidney and upper urinary tract status, lessening of irritation over urethral lesions, to strictures and false
vesicoureteral reflux and amelioration of continence passages [3,4].
in patients suffering from neurogenic bladder dysfunc- Hydrophilic-coated catheters are characterised by
tion [2]. These beneficial effects are associated with the having a layer of polymer coating that is bound to the
technique as such and are not influenced by the type of catheter surface. The polymer absorbs and binds water
catheter used. to the catheter, resulting in a thick, smooth and slippery
surface. The coating layer remains intact upon intro-
* Corresponding author. Tel. +45 3545 8269; Fax: +45 3545 2950. duction into the urethra and ensures lubrication of the
E-mail address: jakob.stensballe@rh.hosp.dk (J. Stensballe). urethra in its entire length. Apart from the fact that they
0302-2838/$ – see front matter # 2005 Elsevier B.V. All rights reserved.
doi:10.1016/j.eururo.2005.07.009
 J. Stensballe et al. / European Urology 48 (2005) 978–983 979

lead to a better patient satisfaction [5,6], the hydro-

philic-coated catheters are assumed to reduce the risk
of urethral damage by decreasing the friction exerted
when the catheter is inserted and withdrawn. However,
it is difficult to directly demonstrate reduced urethral
trauma in a clinical setting.
Several indirect approaches have been used to assess
urethral trauma caused by intermittent catheterisation.
One of these is measuring catheter withdrawal friction
force. If a catheter exerts a high level of friction on the
urethral wall, it is assumed that damage to the epithe-
lium will also be increased with long-term use. Another
way of assessing the degree of urethral damage is to
analyse the abrasion of epithelial cells by performing
urethral cytology [4], or to count epithelial cells on the
surface of used catheters [7,8]. Furthermore, haema-
turia is often used as a parameter for evaluating the Fig. 1. Standardised measurement of withdrawal friction force. The parti-
degree of urethral trauma. cipant was seated in a chair with a fixed angle between back and seat of
Previous studies have shown that the degree of 1258. A curtain obstructed the participant’s view of the entire catheterisation
urethral inflammatory response is decreased in spinal process. The research nurse inserted the catheter in its full length, followed
by urine drainage into a bag connected to the catheter. Immediately after
cord-injured patients using hydrophilic-coated cathe- disconnection of the urine bag, a conic stopper was firmly inserted into the
ters for CIC compared to patients using uncoated catheter connector. A string attached to the stopper was connected to the
polyvinyl chloride catheters [4]. In rabbits, it has been loadcell via a guiding wheel to ensure standardised catheter withdrawal.
shown that differences in hydrophilic catheter coating Furthermore, a chute was placed between the legs of the participants at a 458
angle with the seat. Penis and catheter rested on the chute during the entire
can have a significant effect on the withdrawal friction catheter withdrawal process. Once everything was in place, the measure-
and epithelial cell damage [9]. Furthermore, in a ments were initiated by pressing a button. Thus, the actual data collection
clinical study comparing two hydrophilic-coated was performed automatically by the standard software controlling the
catheters, the level of withdrawal friction was sug- tension-testing system.
gested to be linked to the osmolality of the outer layer
(blood, leucocytes and nitrite) at the first visit and had to have given
of the catheter [10]. There have been no reported their verbal and signed, informed consent to participate. Subjects
clinical trials comparing hydrophilic-coated and with experience of recurrent urinary tract infections, known con-
uncoated catheters with regard to withdrawal friction. genital urogenital abnormalities or known urethral strictures were
This study was designed to test the hypothesis that excluded from participation. The study took place at Coloplast A/S
hydrophilic-coated catheters exert less urethral friction Continence Care Division.
and, hence, cause less urethral micro trauma. The catheters tested were: Conveen SpeediCath1 (Coloplast A/
S, Denmark) with a hydrophilic ready-to-use coating, InCare1
Advance Plus (Hollister Inc., U.S.A.) an uncoated silicone/PVC
2. Methods and Materials catheter with gel, and LoFric1 (AstraTech, Sweden) with a hydro-
philic coating where water is added 30 s prior to use. All catheters
used were for single use, size CH12, CE-marked and sold on the
The objective of the study was to compare two hydrophilic-
European market. On the first of the three visits, the participants
coated and one uncoated, lubricated catheter with regard to with-
were randomised to the sequence of catheter type. In a crossover
drawal friction force and urethral micro trauma. The primary
endpoint was the friction force when the catheter is withdrawn, design, each participant was catheterised twice on the same day
measured at 10 mm/s with a LRX tension testing system using a with the same catheter, with at least two days between test visits.
10 N loadcell (Lloyd Instruments Ltd., UK) as shown in Fig. 1. The Only participants who were catheterised twice with all three
secondary endpoints were: (1) incidence of haematuria, leucocytes catheter types were included in the analysis.
and nitrite measured by urine dipsticks, (2) incidence of bacteriuria In a pilot study, an average force difference of 0.07 Newton (N)
measured by urine culture and sensitivity test and (3) subjective was found between SpeediCath1 and LoFric1 with a standard
evaluation of the catheters. deviation of 0.123 N (Coloplast, Clinical Investigation Report
The study was carried out by two specially trained research DK018CC). A sample size of 35 should have 90% power to detect
nurses with experience of more than 1000 intermittent catheteri- a difference in means of 0.07 N, assuming a standard deviation of
sations, supervised by a medical doctor. Study participants were 0.123 N, using a paired t-test with a 0.05 two-sided significance
recruited among healthy volunteers following advertisements on level. Similar calculations showed that a sample size of 10 was
two Danish university bulletin boards and in a Danish online sufficient to detect a difference between SpeediCath1 and the
magazine for medical students. Volunteers included in the study Hollister catheter. In order to detect a difference between Speedi-
had to be at least 18 years old, male, with negative urine dipstick Cath1 and both alternative products, a sample size of 35 was
980 J. Stensballe et al. / European Urology 48 (2005) 978–983

chosen. To compensate for non-evaluable patients, it was planned Table 2

to include approximately 50 participants. Average withdrawal friction force for the three catheter brands
The randomisation list was produced electronically by compu-
Catheter Brand n Average Force (Newton)
ter using software Medstat version 2.1. Consecutively numbered
randomisation envelopes were delivered to the research nurses. On Mean SD
all three test day’s participants were blinded with a curtain so that 1
SpeediCath 80 0.142 0.029
they could not see which catheter brand they were testing. The
InCare1 Advance Plus 80 0.204 0.055
research nurses were not blinded, as it was impossible to conceal
LoFric1 80 0.284 0.129
the type of catheter. The microbiologist analysing the urine samples
was blinded.
Average friction force and average work needed for withdrawal
were analysed using a two-sided ANOVA test (with catheter and Pair-wise comparison of the products was also signifi-
participant as factors). The Bonferroni test was used subsequently cant (p < 0.05, Bonferroni test) with SpeediCath1
for pair-wise comparison. The level of haematuria and the sub- exerting a lower mean friction force on withdrawal
jective evaluation by the participants of insertion and withdrawal of
than both InCare1 Advance Plus and LoFric1,
catheters were analysed using the Friedman test with subsequent
Wilcoxon test for pair-wise comparison. Assessments of discom- whereas InCare1 Advance Plus exerted a lower force
fort during micturition following catheterisation were analysed than LoFric1. The difference between the catheters
using the Cochran’s Q test with subsequent McNemar test for with regard to average work needed for withdrawal of
pair-wise comparison. Data were entered twice into a data manage- the catheters (Table 3) was also statistically significant
ment system (Medloc, SAS Institute A/S, Denmark). The statistical (p < 0.0001, ANOVA analysis). Pair-wise comparison
analysis was performed using SAS version 8.2 with a 5% level of
significance. of the catheters showed a statistically significant dif-
ference (p < 0.05, Bonferroni test) in favour of Spee-
diCath1 when compared to InCare1 Advance Plus and
3. Results LoFric1, and a significant difference in favour of
InCare1 Advance Plus when compared to LoFric1.
3.1. Participants
A total of 50 men volunteered to participate in the 3.3. Urine analyses
study. Forty-nine participants were included in the One of the secondary endpoints with regard to safety
study, one did not show up. Of the 49 participants, was the incidence of haematuria, leucocytes and nitrite
nine stopped before completing the study as shown in measured by using urine dipsticks. The results of the
Table 1. Thus, 40 participants completed the study and analyses performed after the catheterisations with
were included in the analyses. Participants were regard to haematuria are shown in Table 4. The dif-
recruited from January 2005 to March 2005. The mean
age was 24 years (range 18–42). None of the partici- Table 3
pants received any concurrent medication. Average work needed for withdrawal of the three catheter brands, calculated
as the area under the curve of the friction force measured versus length of
withdrawal
3.2. Withdrawal friction force Catheter Brand n Average Work (Joule)
The primary endpoint of the study was to compare
Mean SD
the withdrawal friction force for the three catheters
tested. The average withdrawal friction force is shown SpeediCath 1
80 0.037 0.009
in Table 2. The difference between the products was InCare1 Advance Plus 80 0.061 0.015
LoFric1 80 0.076 0.035
statistically significant (p < 0.0001, ANOVA analysis).

Table 1 Table 4
Number of participants included, discontinued and included in analysis Dipstick analysis of blood content in urine from first normal micturition
n after two catheterisations performed with the catheter

Participants included 49 Erythrocytes/mL SpeediCath1 InCare1 LoFric1

Advance Plus
Participants discontinued 9
Not possible to catheterise 4a n % n % n %
Lack of time due to work/study 2
Negative 17 42 13 33 24 60
Level of discomfort too high 3b
10/+/ 9 22 7 17 6 15
Participants included in analysis 40
25/1+ 3 8 4 10 2 5
a
LoFric1 n = 2, InCare1 Advance Plus n = 2. 80/2+ 8 20 8 20 6 15
b
InCare1 Advance Plus n = 2, SpeediCath1 n = 1. 200/3+ 3 8 8 20 2 5
 J. Stensballe et al. / European Urology 48 (2005) 978–983 981

Table 5
Subjective evaluation by the patient of sensation at insertion of the catheter

All in all how do you feel the catheter during insertion? SpeediCath1 InCare1 Advance Plus LoFric1

n % n % n %

I could not feel it 0 0 0 0 0 0

I could feel it, but it was not painful 26 65 10 25 17 43
I could feel it and there was some pain 14 35 21 53 23 57
I could feel it and it was painful 0 0 9 22 0 0
Total 40 100 40 100 40 100

ference between the products was statistically signifi- Table 6

Participants’ preference as to catheter type
cant (p = 0.0006, Friedman test), with less haematuria
in the samples obtained following catheterisation with Catheter brand n %
the hydrophilic-coated catheters. Pair-wise comparison SpeediCath 1
21 53
of LoFric1 and the gel-lubricated uncoated catheter InCare1 Advance Plus 1 2
showed a significant difference in favour of LoFric1 LoFric1 16 40
No preference 2 5
(p = 0.0019, Wilcoxon test). The urine samples taken
before the catheterisations were also found to be
negative for erythrocytes. All urine samples before When the participants were asked whether or not they
and after the catheterisations were negative with regard had experienced any discomfort such as pain or stinging
to nitrite and leucocytes. during micturition after catheterisation, 70%, 45% and
Bacteriuria measured by urine culture and sensitiv- 68% answered ‘‘no’’ after using SpeediCath1, InCare1
ity test was found in six participants, who were Advance Plus and LoFric1, respectively. The difference
included in the analyses. Of these, only three had between the catheters was statistically significant
significant bacteriuria with bacterial counts of (p = 0.0475, Cochran’s Q test). However, there was
103 CFU/mL or more, and only two of these were no significant difference in the pair-wise comparison
symptomatic and received antibiotic treatment. None of the products with regard to this parameter (p = 0.0574
of the remaining participants with positive urine cul- SpeediCath1/InCare1, p = 1 SpeediCath1/LoFric1,
tures had clinical symptoms. The incidence of bacter- p = 0.0768 LoFric1/InCare1; McNemar test).
iuria could not be associated with the use of a specific The results of the assessment of catheter preference
catheter. Furthermore the exclusion of these six parti- are shown in Table 6. Ninety-three per cent of the
cipants from the analysis did not affect the results of the participants preferred the hydrophilic-coated catheters
primary endpoint (withdrawal friction force). SpeediCath1 and LoFric1.

3.4. Subjective catheter evaluation 3.5. Adverse events

The result of the subjective assessment of sensation Two test participants experienced adverse events.
during insertion of the catheter is shown in Table 5. The One test participant experienced eczema on the penis
difference between the catheters was statistically sig- and a urinary tract infection. The other test participant
nificant (p < 0.0001, Friedman test). Pair-wise com- experienced a urinary tract infection. All three adverse
parison of the catheters using the Wilcoxon test was events were considered possibly related to the use of
also significantly in favour of SpeediCath1 when catheters. No serious adverse events were reported in
compared to InCare1 Advance Plus (p < 0.0001) this study.
and LoFric1 (p = 0.049) as well as in favour of LoF-
ric1 when compared to InCare1 Advance Plus
(p = 0.0059). Similarly, there was a statistically sig- 4. Discussion
nificant difference between the three catheters with
regard to the subjective assessment of sensation during This study was designed to test the hypothesis that
withdrawal of the catheter (p = 0.0069, Friedman test). hydrophilic-coated catheters exert less urethral friction
However, the pair-wise comparison was only signifi- and hence cause less urethral micro trauma measured
cantly in favour of SpeediCath1 over InCare1 as withdrawal friction force and haematuria. The
Advance Plus (p = 0.0012, Wilcoxon test). results show that the withdrawal friction force was
982 J. Stensballe et al. / European Urology 48 (2005) 978–983

significantly lower for the hydrophilic-coated Speedi- Due to the crossover design we could not associate
Cath1 catheter compared to the other two catheters the bacteriological urine analyses in this study with any
tested. Surprisingly, however, the other hydrophilic- specific type of catheter. Incidence of bacteriuria and
coated catheter, LoFric1, was found to exert a sig- symptomatic urinary tract infection has previously
nificantly higher withdrawal friction force than the gel- been suggested to be decreased in patients using
lubricated uncoated catheter. Thus, there seems to be hydrophilic-coated catheters for intermittent catheter-
no basis for accepting the hypothesis that hydrophilic- isation compared to patients using uncoated catheters
coated catheters, in general, exert lower friction than [2,13,14].
uncoated catheters. Concerning the subjective catheter evaluation, the
Several factors influence the level of friction force hydrophilic-coated catheters performed better than the
exerted by a catheter and may explain why one type of uncoated catheter with regard to all the subjective
hydrophilic-coated catheter performs better than parameters tested, including sensation during inser-
another in this respect. Among these are the smooth- tion and withdrawal of the catheter and discomfort
ness and evenness of the catheter determined by the during micturition after catheterisation. Of the two
outer layer of coating. Other important factors are the hydrophilic catheters, SpeediCath1 obtained better
osmolality of the catheter coating [9,10] as well as the scores than LoFric1. It has previously been shown
adherence of the catheter to the urethral mucosa that patients on a CIC regimen prefer hydrophilic-
[10,11]. Furthermore, it is possible that the shape of coated catheters to uncoated catheters. The main rea-
the drainage eyes has an impact on the level of friction sons for this preference are comfort of insertion,
exerted by a catheter at withdrawal. However, one convenience and ease of handling [5,6]. The ready-
study showed no significant difference in withdrawal to-use concept of the SpeediCath1 catheter has also
friction force measured in rabbits for catheters with and been scored significantly better compared to LoFric1
without drainage eyes but otherwise identical [9]. with regard to ease of use, discretion and speed of
In this study it was shown that both of the tested catheterisation [15].
hydrophilic-coated catheters caused significantly less
haematuria following catheterisation compared to the
uncoated catheter. This result confirms the previous 5. Conclusion
finding that the number of episodes of microscopic
haematuria was significantly (p < 0.05) reduced in The findings in this study indicate that using hydro-
patients using hydrophilic-coated catheters compared philic-coated catheters for intermittent catheterisation
to the patient group using uncoated catheters [5]. This reduces urethral micro trauma as determined by the
may benefit patients on CIC, since 74% of patients level of haematuria. In addition, hydrophilic-coated
experience initial bleeding when starting on a self- catheters were preferred by the participants in this
catheterising CIC regimen, and 28% complain of study. However, the hypothesis that hydrophilic-coated
persistent urethral bleeding 3 months after starting catheters in general exert less urethral friction than
CIC with uncoated catheters [12]. uncoated catheters must be rejected. Although the
To summarise the results of the friction force and SpeediCath1 hydrophilic-coated catheter exerted a
haematuria measurements in this study, it was shown significantly lower mean withdrawal friction force than
that only one of the hydrophilic-coated catheters per- both InCare1 Advance Plus and LoFric1, the other
formed better than the gel-lubricated uncoated catheter hydrophilic-coated catheter, LoFric1, was found to
in terms of withdrawal friction force, whereas both exert a significantly higher withdrawal friction force
hydrophilic-coated catheters performed better than the than the gel-lubricated uncoated catheter.
uncoated catheter with respect to haematuria. Thus,
there is no direct correlation between withdrawal fric-
tion force and haematuria following catheterisation. In Acknowledgments
other words, increased friction does not necessarily
lead to a higher degree of haematuria, but may cause The authors wish to thank research nurse Anne-
urethral damage of a different nature. Haematuria Grethe Rasmussen and research nurse, MSc Karen
measured after catheterisation can be characterised Rene Pape as well as all other persons involved in
as an acute form of urethral trauma, whereas irritation carrying out this study.
of the mucosa caused by friction may be followed by The primary author is funded by a research grant for
subsequent inflammation [4] giving rise to complica- a PhD-study from Coloplast A/S. The study was spon-
tions in the long term. sored by Coloplast A/S.
 J. Stensballe et al. / European Urology 48 (2005) 978–983 983

References

[1] Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean, intermittent self- cord injured patients: a prospective randomised crossover study. J Urol
catheterization in the treatment of urinary tract disease. J Urol 2001;166:130–3.
1972;107:458–61. [9] Lundgren J, Bengtsson O, Israelsson A, Jönsson A-C, Lindh A-S, Utas
[2] Hedlund H, Hjelmås K, Jonsson O, Klarskov P, Talja M. Hydrophilic J. The importance of osmolality for intermittent catheterisation of the
versus non-coated catheters for intermittent catheterisation. Scand J urethra. Spinal Cord 2000;38:45–50.
Urol Nephrol 2001;35:49–53. [10] Waller L, Telander M, Sullivan L. The importance of osmolality in
[3] Wyndaele J-J, Maes D. Clean intermittent self-catheterization: a 12- hydrophilic urethral catheters: a crossover study. Spinal Cord
year followup. J Urol 1990;143:906–8. 1997;35:229–33.
[4] Vaidyanathan S, Soni BM, Dundas S, Krishnan KR. Urethral cytology [11] Fader M, Moore KN, Cottenden AM, Pettersson L, Brooks R, Malone-
in spinal cord injury patients performing intermittent catheterisation. Lee J. Coated catheters for intermittent catheterisation: smooth or
Paraplegia 1994;32:493–500. sticky? BJU Int 2001;88:373–7.
[5] Sutherland RS, Kogan BA, Baskin LS, Mevorach RA. Clean inter- [12] Webb RJ, Lawson AL, Neal DE. Clean intermittent self-catheterisa-
mittent catheterization in boys using the Lofric catheter. J Urol tion in 172 adults. Br J Urol 1990;65:20–3.
1996;156:2041–3. [13] Vapnek JM, Maynard FM, Kim J. A prospective randomised trial
[6] Diokno AC, Mitchell BA, Nash AJ, Kimbrough JA. Patient satisfac- of the Lofric hydrophilic coated catheter versus conventional
tion and the Lofric catheter for clean intermittent catheterisation. J plastic catheter for clean intermittent catheterisation. J Urol 2003;
Urol 1995;153:349–51. 169:994–8.
[7] Biering-Sørensen F, Nielsen K, Hansen HV. Urethral epithelial cells on [14] Cindolo L, Palmieri EA, Autorino R, Salzano L, Altieri V. Standard
the surface on hydrophilic catheters after intermittent catheterisation: versus hydrophilic catheterization in the adjuvant treatment of patients
cross-over study with two catheters. Spinal Cord 1999;37:299–300. with superficial bladder cancer. Urol Int 2004;73:19–22.
[8] Giannantoni A, Di Stasi SM, Scivoletto G, Virgili G, Dolci S, Porena [15] Pascoe G, Clovis S. Evaluation of two coated catheters in intermittent
M. Intermittent catheterisation with a prelubricated catheter in spinal self-catheterization. Br J Nurs 2001;10:325–9.