Trauma/Reconstruction/Diversion

A Prospective, Randomized Trial Evaluating

the Use of Hydrogel Coated Latex Versus All Silicone
Urethral Catheters After Urethral Reconstructive Surgery
Bradley A. Erickson, Neema Navai, Mukul Patil, Allen Chang and Chris M. Gonzalez*
From the Northwestern University Feinberg School of Medicine, Department of Urology, Chicago, Illinois

Purpose: The superiority of silicone over latex based catheters following urethral reconstructive surgery for stricture disease
has been theorized, and yet data comparing their use in this group of patients are lacking. We present our findings from a
prospective, randomized trial comparing silicone to hydrogel coated latex catheters in patients following urethral reconstruc-
tive surgery.
Materials and Methods: From February 2004 to August 2006 men undergoing urethral reconstructive surgeries were
randomized to receive an all-silicone or a hydrogel coated latex urethral catheter for postoperative bladder drainage. Patient
demographics and the various reconstructive procedures used were analyzed. Complications and stricture recurrence were
evaluated in the 2 groups.
Results: A total of 85 men were randomized to receive a silicone (43) or a latex (42) catheter following reconstructive surgery.
Median followup was 20 months (range 10 to 36). Mean patient age, urethral stricture length, complication rate and type of
reconstructive procedure did not significantly differ between the 2 groups. Five patients (11%) per group required repeat
instrumentation for stricture recurrence (p ⫽ 0.97). Median time to stricture recurrence was not statistically different
between the 2 groups.
Conclusions: The theoretical benefit of silicone catheters over hydrogel coated latex catheters does not appear to translate
into a clinical advantage after urethral reconstructive surgery since we found no difference in the rate of recurrence or
operative complications at intermediate term followup. It appears that the 2 types of catheter are appropriate for urethral
stenting following urethral reconstructive surgery.

Key Words: urethra, catheterization, hydrogel, silicones, urethral stricture

he use of a urethral catheter after reconstructive sur- they continue to advocate the exclusive use of silicone cath-

T gery for urethral stricture disease is almost universal.

The catheter serves 3 purposes, that is to provide a
template for the urethra to heal in the appropriate cir-
cumferential fashion, hasten the approximation of grafts
to the underlying vascular bed and drain the bladder of
urine, preventing turbulent, high pressure, intraurethral
urine that could potentially disrupt new suture lines and
cause urinoma.1
Urethral catheters have undergone significant material
and design improvements in the last decade.2 The newer
generations of urethral catheters generate lower contact
friction and cause less urethral and periurethral inflamma-
tion than traditional all-latex catheters.3,4 It is hypothesized
that these new catheters, including all-silicone and latex
based models, may lead to fewer problems with stricture
recurrence, although to our knowledge this theory has yet to
be tested in a clinical study. Because of historical concerns
with all-latex catheters,5–7 many reconstructive urologists
are reluctant to use the newer, coated latex catheters and
Submitted for publication June 12, 2007.
Study received institutional review board approval.
* Correspondence: Department of Urology, Northwestern Univer-
sity Feinberg School of Medicine, 303 East Chicago Ave., Tarry
16-703, Chicago, Illinois 60611 (telephone: 312-908-0494; FAX: 312-
908-7275; e-mail: CGonzalez@nmff.org).
eters after urethral reconstruction.1,8
However, the new generation of coated latex urethral
catheters may offer potential advantages over silicone cath-
eters. These new catheters appear to have inertness similar
to that of silicone2 but they are less expensive and generally
preferred by patients over traditional catheters.9,10 To eval-
uate the safety and efficacy of the newer urethral catheters
on urethral reconstructive surgery we performed a single
institution, prospective, randomized trial of the use of sili-
cone and hydrogel coated latex catheters after urethral re-
constructive cases for stricture disease.
MATERIALS AND METHODS
Randomization/Demographics
All men undergoing urethral reconstruction from February
2004 to August 2006, as performed by 1 surgeon (CMG),
were included in the study. During this period these patients
were randomized to receive a hydrogel coated latex based
catheter or an all-silicone catheter after the reconstructive
procedure. Randomization was achieved by alternating the
use of latex based or all-silicone catheters after each respec-
tive case unless there were concerns about latex sensitivity,
in which case an all-silicone catheter was used. Periopera-
tive and followup data were kept in a prospectively main-
tained, institutional review board approved database.

0022-5347/08/1791-0203/0 203 Vol. 179, 203-206, January 2008

THE JOURNAL OF UROLOGY® Printed in U.S.A.
Copyright © 2008 by AMERICAN UROLOGICAL ASSOCIATION DOI:10.1016/j.juro.2007.08.174
204 HYDROGEL COATED OR SILICONE CATHETERS AFTER URETHRAL SURGERY

Catheter Type
TABLE 2. Stricture etiology
The 2 types of catheters used during the study were a hy-
drogel coated, latex based Bardex® Lubricath® Foley cath- Etiology No. Silicone No. Latex Total No. (%)
eter and a 100% silicone Kendall-Dover® catheter. An 18Fr Unknown 18 20 38 (45)
catheter was used in 73% of cases in the series with a 16Fr Hypospadias repair failure 6 9 15 (17)
Instrumentation 9 4 13 (15)
catheter reserved for complicated distal or penile reconstruc- Erosion 2 4 6 (7)
tive cases. The number of patients in each cohort requiring Lichen sclerosis 5 1 6 (7)
a 16Fr catheter was similar (silicone in 10 and latex in 13). Trauma 2 3 5 (6)
Infection 1 1 2 (2)
Totals 43 42 85

Surgical Procedures
All patients were confirmed to have culture negative urine
before the procedure. Surgery included EPA, buccal mucosal RESULTS
substitution urethroplasty and 2-stage urethral repair. Buc-
A total of 85 men were prospectively randomized to receive
cal grafts in the bulbar urethra were placed dorsal and used
a silicone (43) or a latex (42) catheter following reconstruc-
only when the length or location of the pathological condi-
tive surgery. Median followup was 20 months (range 10 to
tion did not make it amenable to EPA. One-stage penile
36). Mean patient age, urethral stricture length and the
urethroplasty involved ventral placement of a buccal mucosa
specific type of reconstructive procedure did not significantly
or skin graft with buccal mucosa being our preferred graft
differ between the 2 groups (table 1). Stricture etiology was
tissue, especially in men with lichen sclerosis or those with
also similar in the 2 groups with most men reporting the
failed hypospadias repair. Two-stage repairs involved dorsal
cause of the stricture to be unknown (table 2). The compli-
placement of buccal mucosa or other graft material sur-
cation rate for each type of repair showed no significant
rounding the urethral plate at stage 1 with stage 2 closure 4
differences. There were 6 perioperative complications (14%)
to 6 months later. Patients who underwent 2-stage repair
in the silicone group and 5 (12%) in the latex group (p ⫽ 0.9,
were included in analysis only if stage 2 was completed.
table 3). No patients in the latex group experienced a prob-
lem with latex sensitivity and there were no catheter related
incidents in either group. Five patients per group required
Postoperative Management
repeat instrumentation for stricture recurrence (p ⫽ 0.97).
All catheters were removed at postoperative visit 2, gener-
Stricture length was the only factor appearing to affect
ally 2 to 3 weeks after the procedure. Patients were moni-
stricture recurrence, although statistical significance was
tored postoperatively by determining post-void residual
not seen (6.7 vs 5.4 cm, p ⫽ 0.32). Subanalysis of repair type
urine on noninvasive bladder ultrasound and by monitoring
revealed modestly higher success rates for EPA vs substitu-
urinary symptoms. Routine retrograde urethrogram and
tion urethroplasty (94% vs 89%, p ⫽ 0.44), although there
cystoscopy were not performed unless there was a return of
was no difference with regard to catheter type (p ⫽ 0.97).
preoperative symptoms (as demonstrated by a worsening
Median time to stricture recurrence was not statistically
International Prostate Symptom Score), urinary tract infec-
different between the silicone and latex groups (85.1 vs
tion was noted or the patient had increased post-void resid-
112.5 days, range 37 to 219, p ⫽ 0.83). Four of the 10
ual urine compared to preoperative values. If a recurrent
patients confirmed to have recurrence required a single
stricture was found, the initial management was DVIU.
DVIU for short segment ring-shaped recurrences in the bul-
Repeat urethroplasty was reserved for large segment stric-
bar urethra. One patient with a longer segment, ischemic-
ture recurrence or for patients in whom initial DVIU failed.
appearing recurrence in the bulbar urethra was also treated
with a single DVIU but he currently requires weekly cath-
Statistical Analysis eterization to remain patent and has refused repeat urethro-
Patient demographics, perioperative complications and plasty. Two patients with long segment recurrences in the
stricture recurrence rates were compared between the 2 membranous urethra elected urinary diversion after initial
groups. Chi-square and t test analyses were done when DVIU failed, including a man with a history of radical pros-
appropriate with p ⱕ0.05 considered significance. Statistical tatectomy and adjuvant chemotherapy/pelvic radiation for
analysis was performed using Microsoft® Office Excel® 11.0 prostatic rhabdomyosarcoma as a child, and a patient with a
and universally available, web based software (http://www. history of prostatic urethral injury after pelvic trauma.
stat.uiowa.edu/⬃rlenth/Power). Three patients required repeat urethroplasty for fossa na-
vicularis stricture failures, of whom 1 presented with a
distal urethral fistula. Median followup after secondary pro-
cedures was 23 months (range 9.5 to 30).
TABLE 1. Demographics
Silicone Latex
TABLE 3. Perioperative complications
Mean age (range) 43 (17–75) 40 (20–75)
No. previous stricture endoscopic 39 (90.1) 37 (88) Complication No. Silicone (%) No. Latex (%) Total No. (%)
dilation/incision (%)
Urinary tract infection 3 (7) 1 (2) 4 (5)
Median cm length stricture (range) 5.5 (1–21) 4.9 (1.5–22)
Hematoma 1 (2) 2 (5) 3 (4)
No. surgical procedure:
Thromboembolic 2 (5) 1 (2) 3 (4)
EPA 16 16
Fistula 0 1 (2) 1 (1)
Substitution urethroplasty 18 15
2-Stage repair 9 11 Totals 6 5 11
 HYDROGEL COATED OR SILICONE CATHETERS AFTER URETHRAL SURGERY
DISCUSSION
Our prospective, randomized study found no differences in
postoperative complications or the recurrence rate of ure-
thral strictures between the 2 cohorts of patients at a me-
dian followup of 20 months, indicating that each catheter
type can be safely used in patients after urethroplasty. The
2 catheters also appear to be durable for postoperative ure-
thral stenting since none malfunctioned or needed replace-
ment during the study course. These data are similar to
those in previous urological studies of catheter use after
radical prostatectomy and transurethral prostate resection,
in which the rates of postoperative bladder neck contracture
and urethral stricture formation were unrelated to the spe-
cific type or diameter of urethral catheter used, or the time
that the catheter was left in place.11,12
Before the commencement of our study it was our practice
to use only silicone catheters after urethral reconstructive
surgery for stricture disease. This practice was in place due
to historical concerns with latex catheters, which have been
implicated in complications ranging from iatrogenic panure-
thral strictures to systemic toxic shock.5,7,13 Traditional la-
tex catheters, which we considered for study purposes to be
latex catheters without a protective coating, generate a large
periurethral inflammatory reaction that is capable of dra-
matically decreasing local urethral blood flow.13 While the
likely culprit of these pathological inflammatory reactions
was later found to be an impurity in the latex that has since
been eliminated,5 concerns about latex catheters have right-
fully persisted.
A new class of coated latex catheters claiming to be as
safe as silicone catheters was developed to prevent these
complications with the added benefits of being slightly less
expensive and with the potential to be more comfortable for
patients.14 Because of these benefits, these catheters were
rapidly embraced by the general medical community and
they are now used in more than 90% of patients requiring
urethral catheterization in a hospital setting.15 Their accep-
tance in the urological community has not been as prompt,
especially as pertains to their use after urethral reconstruc-
tive surgery for stricture disease. Accordingly we thought
that a study designed to test the safety of these newer latex
catheters after urethral reconstruction was warranted.
The Kendall-Dover silicone catheter used in the study
has many characteristics that make it attractive for use
after urethroplasty. Silicone is entirely biocompatible and
its use as a urethral catheter generates little urethral epi-
thelial inflammation,2,16 an important attribute when trying
to minimize scar formation and suture line contracture after
urethroplasty. Silicone is also an inherently strong material
compared to latex. This intrinsic strength allows for the
silicone catheter to have a thinner wall relative to a circum-
ference matched latex catheter, which effectively increases
lumen size for urinary drainage.17 Studies directly compar-
ing silicone catheters to traditional latex catheters showed
that silicone models cause less iatrogenic urethral stric-
tures,7 are less prone to kinking and have better flow prop-
erties, allowing them to drain the bladder more efficiently
than sized matched latex catheters.18 However, despite
their larger lumen size and better flow parameters studies
indicated that silicone catheters are more susceptible to
encrustation, blockage and other catheter related problems,
eg balloon malfunction requiring reinsertion, compared to
205
the newer generation of coated latex catheters.2 The in-
creased strength of silicone catheters also tends to make
them stiff, causing more patient related discomfort than
latex catheters.2
The Bardex Lubricath latex based Foley catheters used in
the study were coated with hydrogel, a class of cross-linked
macromolecular polymers with unique properties, making
them hydrophilic and inert.2,15 In an aqueous environment
the hydrogel molecule absorbs a large amount of water,
resulting in a thin aqueous film on the outside of the cath-
eter that serves to increase its smoothness and lubricity, and
protect the urethra from the underlying latex.2,17 In vivo
studies of hydrogel coated catheters showed that they gen-
erate only minimal urethral inflammation and have a lower
retention force (an indirect measure of surface friction) than
silicone catheters, which has been postulated to act as a tool
to predict catheter related irritation of the urethral epithe-
lium.14,18 However, as with silicone catheters, there are
conceivable problems with hydrogel coated latex catheters.
Nonuniform hydrogel coating and cracking of the hydrogel
surface after catheter bending have been demonstrated, il-
lustrating that even with the protective coating there re-
mains the potential for the urethral epithelium and new
anastomosis to be exposed to raw latex material.17
Despite their structural differences we found no statisti-
cal differences in terms of the complication or recurrence
rate between the 2 described catheters when used after
urethral reconstruction. While previous studies showed that
it is probable to find more patients with recurrent stricture
disease at a longer time out from surgery,19 we believe that
it is unlikely that differences in stricture rates between the
2 cohorts would begin to emerge at longer followup. We also
recognize that that the study was underpowered to detect
minor differences between the catheters, although it must
be noted that achieving a sufficient power in urethral recon-
struction studies is extremely difficult. For example, when
designing this study, we calculated that to detect a 10%
difference in recurrence rates between the 2 catheters would
require almost 200 study participants per cohort, which is a
population that could not be achieved at our institution in a
reasonable period. We instead elected to enroll consecutive
patients during a 30-month period, knowing that only major
differences would be uncovered. Because none existed, we
are comfortable in concluding that each catheter is relatively
safe for use after urethroplasty, while acknowledging that
only larger, multi-institutional studies would be able to de-
cipher the superiority of 1 type of catheter over another in
regard to recurrence prevention.
We must also recognize that monitoring these men post-
operatively with a more stringent protocol, including routine
retrograde urethrogram and/or cystoscopy, may have re-
vealed more asymptomatic recurrences, which for the inter-
ests of this study might have uncovered nonclinical differ-
ences between the groups. Finally, this study would have
ideally included a complementary patient preference evalu-
ation. However, despite initial attempts at designing an
appropriate questionnaire it proved to be extremely difficult
in a population in which many patients had never before
experienced long-term catheterization. Instead, we are left
to extrapolate findings from other populations that are bet-
ter suited to determine preference. Studies in the chronic
indwelling catheter and intermittent catheterization popu-
lations revealed that the increased softness and superior
206 HYDROGEL COATED OR SILICONE CATHETERS AFTER URETHRAL SURGERY
lubricity of the coated latex catheters led most patients to
prefer this variety over traditional models.9,10 However,
whether we could apply these findings to our population is
conjecture.
Accordingly the findings of this study do not allow us to
conclude that 1 type of catheter is superior to the other.
Rather, the results simply emphasize that the only essential
requirements for urethral catheters after urethral recon-
structive surgery are to be biocompatible, inert and to drain
the bladder adequately. What is interesting to consider is
whether a catheter could be engineered to interact with the
urethral epithelium in a beneficial manner. Could the same
biotechnology that produced these biologically inert cathe-
ters be used to produce a catheter that improves imbibition
or even hastens inosculation of a replacement graft by re-
leasing angiogenic growth factors?20 As our understanding
of wound healing and urethral stricture disease continues to
mature, these uses for urethral catheters may come to fru-
ition. For now it appears that hydrogel coated latex and
silicone catheters are equally well suited for urethral stent-
ing after urethroplasty.
CONCLUSIONS
We compared the use of 2 commonly used catheters after
urethral reconstructive surgery. We found no differences in
the postoperative complication or recurrent stricture rate at
a median followup of 20 months. Based on these findings we
believe that the use of an all-silicone catheter or a hydrogel
coated latex catheter is appropriate after reconstructive sur-
gery for urethral stricture disease.
ACKNOWLEDGMENTS
Dr. John Cashy assisted with statistical analysis and study
design.
Abbreviations and Acronyms
DVIU ⫽ direct visual internal urethrotomy
EPA ⫽ excision and primary anastomosis
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