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21 Surgical Options forRefractory Urinary Incontinence inClassic Bladder Exstrophy
333
The social problem of urinary incontinence must not be converted to a medical
problem secondary to the continence procedure. An incompletely emptied bladder
places the upper tracts at risk that is amplied following procedures such as BNR/
closure or continent urinary diversion. Reconstructive strategies that are predicated
on CIC at regular intervals may overwhelm continence mechanisms leading to leakage via continent catheterizable channel (CCC) or bladder/reservoir perforation
[11]. It is important to consider the patient’s cultural background, socioeconomic
situation, and access to medical supplies when determining the surgical treatment
plan. Reliable and uninterrupted access to catheter supplies to perform CIC is
another fundamental part of surgical decision-making. In some circumstances due
to either socioeconomic status, cultural norms, or other factors, the use of catheterindependent procedures such as urostomy or ureterosigmoidostomy may be considered superior to reconstructions reliant upon CIC such as augmentation cystoplasty
(AC) or continent diversion.
The reconstructive surgeries performed in the CBE patients are either aimed at
incompetent bladder outlets and/or insufcient bladder reservoirs. This chapter will
begin with a review of procedures performed to increase bladder outlet resistance.
Surgical procedures to enhance bladder outlet resistance may be done by three basic
surgical categories: procedures with either injection of material under the mucosa or
an external compression device; procedures to recongure the bladder outlet into a
more efcient continence valve and closure of the bladder outlet.
Compression oftheLumen ofBladder Outlet
Bladder Neck Bulking Agent Injection
When surgery is pursued, the least surgically invasive method to improve urinary
continence secondary to an incompetent bladder outlet is endoscopic bulking agent
urethral or bladder neck injection (BNI). The allure of BNI is its simplicity, relatively low risk to the patient compared to open procedure, an opportunity for repetition in the event of failure, and yet not exclude more complex treatment options that
might be needed in the future. BNI can serve as both primary therapy and an adjunct
to reconstructive surgery for achieving urinary continence. Various bulking agents
have been utilized with varying characteristics and success rates. Most studies have
demonstrated that BNI as primary treatment for incontinence in children is often
ineffective and not cost-effective to other surgical treatments
The BNI technique involves cystoscopic visualization of the urethra and bladder neck in either a retrograde or in combination with an antegrade manner via
suprapubic cystotomy or CCC [15]. An injection needle is placed through the
working channel of the cystoscope and multiple injections are performed.
(Fig.21.1) The needle is directed submucosally and a bleb is raised under direct
visualization while injecting the material until submucosal accumulation occurs.
The goal would be material injected until full coaptation is achieved by cystoscopic inspection.
334
Fig. 21.1 Injection of the bladder neck with various materials is accomplished by passing the
needle through the cystoscope. The material is injected submucosally either retrograde through the
urethra or antegrade from suprapubic approach. The material provides passive pressure to help
occlude the bladder outlet. (Used with Permission from Taylor and Francis- Kelalis-King-Belman
Textbook Clinical Pediatric Urology 5E)
B. A. VanderBrink
The original material used for BNI was polytetrauoroethylene (Polytef®/
Teon®) and showed promising results with its rst description in pediatric population in 1985 by Vorstman etal. [16] Dyer etal. reported their experience with
Teon® BNI as primary therapy in 13 CBE patients with 0% success rate of producing continence [17] . The controversy and observations regarding Teon®
particle migration to nonurologic body sites have truncated further use of this
agent [18]. Cross-linked glutaraldehyde bovine collagen (Contigen®) was the
next promoted BNI agent and multiple reports of its use in children [19–22].
Unfortunately, Contigen® was not immune to adverse effects and is associated
with allergic reactions, thus, requiring pre-injection skin testing for a hypersensitivity reaction. The positive effects of Contigen® BNI observed were largely
temporary in durability and putatively secondary to degradation of the material
due to its biodegradability. Burki et al. described their experience with yet
another BNI material, polydimethylsiloxane (Macroplastique®), in a CBE/epispadias population [23]. They reported its use in 52 patients with success in 9
patients (17%) dened as being dry without pads/diapers while another 17 (33%)
signicantly improved. Those patients with a positive outcome comprised just
4/34 (12%) patients with a diagnosis of CBE.Macroplastique®’s continued use
in pediatrics has been tempered by fear of reports of migration and non-biodegradability [24].
Dextranomer hyaluronic acid (Deux®) has been utilized for BNI and has not
been implicated in particle migration [17, 25–28, 30–32]. It has been described as
primary therapy by Dyer etal. in a CBE population and the authors described, as
they observed with their using Teon® uniformly no improvement in continence or
bladder capacity following Deux® BNI [17]. Several other authors have described
Deux® BNI in either primary or adjunct following BNR in CBE pediatric patients
21 Surgical Options forRefractory Urinary Incontinence inClassic Bladder Exstrophy
335
[25–28]. The characteristics of Deux® show that the implant volume decreases in
size due to a reduction in the aqueous volume of the implant and/or displacement of
the implant from its injection site before its consolidation by endogenous collagen
[29]. This property of Deux® can result in some patients following BNI showing
improvement in urinary continence followed by a rapid deterioration in continence
parameters depending on when they were assessed. Caione etal. showed that after
the rst 3months continence results remained relatively stable and they advocated
that it may be difcult to judge Deux® BNI success within the rst 3months and
repeat BNI should be reserved until after 3months [25].
The Paris, France group has published the most on Deux® BNI in peer-reviewed
literature [26, 30–32]. Fiorenza etal. reported their experience in 22 patients with
CBE (18 males, 4 females) using Deux® BNI [30]. Modern staged reconstruction
was performed in all patients except one. Previous BNR had been performed in the
majority of patients, but not in all patients with ve patients who had undergone
previous AC.Dryness was observed in 7 patients (32%), improvement was observed
in 3 patients (14%), and no change was observed in 12 patients (55%) with
CBE.Patients with previous BNR tended to have longer failure-free survival. The
authors concluded that BE patients are unlikely to benet from Deux® BNI without previous BNR.This same institution shared its observations with outcome of
further continence procedures after failure of Deux® BNI [31]. In their series, 24
patients had a subsequent bladder neck procedure: articial urinary sphincter (AUS,
7—all dry), bladder neck plasty (9–7 dry, 1 improved, and 1 still incontinent), bladder neck closure (BNC, 1—dry), and fascial sling (3–2 dry and 1 improved). At the
time of surgery, the authors state that the Deux® paste was easily identied with
minimal surrounding tissue inammatory reaction. This group from Paris, France,
has advocated that even if the success rate is limited in the long term, due to its relative simplicity Deux® BNI should be proposed to manage major incontinence in
children as a primary procedure or as a salvage procedure with a failed bladder neck
procedure [32]. The authors advocate information that is not over-optimistic should
be provided to the patient and parents regarding the expected success rate of
Deux® BNI.
Artificial Urinary Sphincter
One of the benets of BNI is the high likelihood of maintenance of the ability for
continued volitional voiding; however as previously described, one drawback is the
relatively low success rate in achieving urinary dryness in CBE patients. The AUS
is another surgical intervention where spontaneous bladder emptying with voiding
can be preserved but confers a much higher continence rate compared to a single
BNI.The AUS is a hydraulic device that is composed of three parts: an inatable
cuff that surrounds and compresses the bladder neck or bulbous urethra; a pressuregenerating balloon; and a pump control module. (Fig.21.2) The AUS gives the
patient the ability to deate the cuff and reduce the compression of the bladder neck
at will. The pressure exerted on the urethra is regulated by the balloon/reservoir. The
336
B. A. VanderBrink
b
b
a
a
c
c
Fig. 21.2 The articial urinary sphincter is a mechanical device composed of three components:
(a) an inatable cuff, (b) a pressure-regulating reservoir balloon, and (c) a control pump. It functions by using hydraulic pressure to inate the cuff, which compresses the urethra and provides
continence. By squeezing the pump (implanted in the scrotum or labia), the patient can manually
deate the cuff and allow voiding or catheterization through the urethra. The pressure in the balloon then restores pressure throughout the system and reinates the cuff in 3 minutes. (Used with
Permission from Taylor and Francis- Kelalis-King-Belman Textbook Clinical Pediatric Urology 5E)
ab
21 Surgical Options forRefractory Urinary Incontinence inClassic Bladder Exstrophy
Fig. 21.3 (a) Articial urinary sphincter components in a female with the pump implanted in the
labia. (b) Articial urinary sphincter components in a male with the pump implanted in the scrotum. Both examples demonstrate the cuff implanted around the bladder neck. (Used with
Permission from Taylor and Francis- Kelalis-King-Belman Textbook Clinical Pediatric Urology 5E)
bladder neck is the preferred site of placement of inatable cuff in children
(Fig.21.3). The pump is placed in the scrotum or labia, and the entire device is
contained within the body.
The AUS was originally only placed in patients who could void as there were
concerns that performing CIC through the implanted sphincter could cause damage
to the tissue compressed by the cuff and lead to erosion. However, as previously
mentioned, the use of CIC is frequently seen in children with CBE [3, 8]. Barrett
and Furlow reported a series of children who could not void after AUS implantation
and found that CIC could be performed safely if the cuff was deated prior to passage of the catheter [33]. Continence was good and no patients suffered erosion due
to catheterization. The AUS device is not activated immediately after implantation,
as cuff pressure immediately after surgery may cause erosion of the cuff into the
bladder. The sphincter may be activated after 6–8weeks with less risk of erosion.
Eventually, all AUS will wear out and fail, requiring replacement, but if complications can be avoided the mean survival of the new devices in children well over
10+ years.
Light and Scott, as pioneers of the AUS implantation procedure, published the
rst series of CBE patients with AUS in 1983 [34]. Surgical implantation with the
AS792 model of AUS in 10 CBE patients resulted in a reported continence in 90%.
Removal of the device occurred in one patient secondary to bladder neck obstruction and resulting upper tract dilation, which resolved after explanation. Concerns
over the placement of the cuff around the previously operated bladder neck were not
observed in this original case series; however, as experience grew with the AUS
device erosion of the cuff was observed. Decter etal. reported their experience with
the AMS 800 device in 11 patients with CBE and 5 patients with epispadias [35]. A
total of 13 patients had failed prior BNR.Of these 16 patients, 10 currently have an
active device in place and 9/10 continent. To accomplish these results, however,
337
338
B. A. VanderBrink
these 10 patients required 10 additional procedures, including 6 revisions and 4
other operations for complications associated with the procedure. Three patients
had erosion and the device was removed (1 underwent successful reimplantation).
Ruiz etal. described the use of AUS in 23 non-neurogenic patients (19 males)
where 12 had extrophy epipspadias complex (EEC) with mean follow-up of
80months [36]. Three sphincters in patients with exstrophy were removed because
of erosion and/or infection at 5, 49, and 60months after initial surgery. CBE patients
and those with previous bladder procedures were exposed to more complications
such as erosion compared with patients with epispadias or anorectal malformation.
Hafez etal. reported their experience with AUS in ve CBE patients as a small subset of larger pediatric cohort (n=89) patients [37]. The authors noted that a history
of CBE was the only signicant factor with detrimental effect on AUS survival as
four of the ve patients (80%) had their AUS removed secondary to erosion relative
to a total of 12/84 (14%) erosions in the remaining cohort. Castera etal. reported in
a small series of seven patients with EEC that ve patients were continent, with two
of the ve patients had epispadias only and two CBE patients underwent concomitant AC [38]. AUS cuff erosion developed 2years later in one of these two CBE
patients and the device was removed. These authors argued that patients who
undergo bladder neck or urethral surgical procedures before AUS placement may
benet from the lowest balloon pressures (51–60cm. water) capable of maintaining
closure of the bladder neck to minimize further ischemia to the compromised bladder neck substrate.
Others have not reported as high a rate of erosion in the CBE population. Bosco
etal. and Levesque etal. reported the Boston children’s 5- and 10-years of experience, respectively, with AUS in children with varying causes of incompetent bladder outlet with the majority being from neurogenic causes [39, 40]. In Levesque’s
study, 32 of 39 (82%) of the patients with sphincters in place were dry [39]. The
authors demonstrated that the AUS was a viable and successful option for the incontinence associated with CBE in a very small sample size (n=4). Bosco etal. demonstrated that the risk of cuff erosion in girls and boys was similar if they have not
had prior bladder surgery [40]. Herndon etal. and the Indiana group had 20+ years
of experience published with over 100 children with AUS implantation and 10 had
CBE within the 21 patients having EEC [41]. Risk factors for erosion were evaluated but in their series placement of the AUS directly on the segment of bowel used
to create the neourethra was the only signicant clinical factor, while previous bladder neck repair or use of CIC in this large series did not signicantly increase the
erosion rate. Patients in whom the latest model of AUS (AMS 800) was implanted
had a much lower revision rate than those with a previous model and almost 60%
had no mechanical complications.
Increasing the outlet resistance with the AUS, as with any bladder outlet procedure, can potentially alter the bladder storage dynamics in a manner deleterious to
the upper urinary tracts. This delayed clinical phenomenon after AUS implantation
has been reported by several authors [42–45]. This deterioration has been hypothesized to be secondary to two factors: a failure to void efciently in some patients
and the new development of detrusor hypertonicity in others. Deterioration of
21 Surgical Options forRefractory Urinary Incontinence inClassic Bladder Exstrophy
detrusor function after AUS placement occurs in as many as 20% of patients, and
there is currently no reliable method to predict which patients will undergo these
changes or the timetable for risk [45]. Because of this threat, it is necessary to
closely follow patients with AUS with upper tract imaging and urodynamics, as
needed indenitely after placement of the sphincter.
AC has been performed in a signicant number of CBE patients for a variety of
indications to create a low-pressure, adequate-volume reservoir [PUMA].
Augmentation may be performed at the same time as AUS placement but has been
associated with an increased risk of device infection if the colon and small bowel
are the substrates used for the augmentation [46]. At the current time, the use of the
AUS in patients who require AC and CIC may offer little advantage over other surgical methods to increase bladder outlet resistance.
339
Procedures toSurgically Reconfigure theBladder Outlet into
aContinence Valve
Bladder Neck Reconstruction
Due to the congenital exstrophic bladder and bladder outlet in CBE, the primary
repair to close the bladder, bladder neck, and urethra may not result in urinary continence. Hugh Hampton Young of Johns Hopkins University in 1922 described a
procedure in epispadias to reconstruct the bladder outlet by excising redundant dorsal tissue and then both narrowing and lengthening the bladder outlet to narrow it
using “Boomerang Needle Holder” that Young himself created [47]. John Dees of
Duke University in 1949 expanded upon Young’s procedure by describing a posterior urethral ap to lengthen the neourethra [48]. He removed the mucosa from the
muscle on the lateral aspect of this ap and, after closing the central ap of mucosa
into a tube, he closed the muscle over the mucosa in a second layer. This provided
additional muscle around the neourethra. Guy Leadbetter of Massachusetts General
Hospital in 1964 further improved upon the Young–Dees bladder neck repair by
moving the ureters to a new location higher along the posterior bladder wall and
away from the urethra [49]. This maneuver allowed the posterior bladder strip to be
even longer and produce a long neourethra and a much higher bladder neck. This
last modication of these prior techniques is currently known as Young-DeesLeadbetter (YDL) BNR.
The Johns Hopkins team has published extensively on the use of YDL in CBE
patients and typically performs BNR when a patient is 5–8years of age and has a
strong desire to be continent [3, 50–52]. As previously mentioned, they advocate
that the patient must be mentally prepared to commit to an intense voiding program
and, in addition, must have adequate bladder capacity as BNR may result in loss of
capacity [12]. The Johns Hopkins group state contraindications to BNR alone
include a prior failed exstrophy closure, small bladder capacity, or unfavorable urodynamic parameters such as poor compliance, elevated detrusor pressure, or low
contractility that would suggest poor emptying [52].
340
B. A. VanderBrink
Reports of urethral continence using the YDL BNR alone have been observed in
25–70% of CBE patients with variable follow-up periods from different institutions
[3, 4, 50–57]. However this continence rate post-BNR can be challenging for the
reader to discern at rst glance for a number of reasons due to variable reporting
metrics [58]. Is continence after BNR dened as dry without the use of any incontinence protection? Is continence after BNR dened as dry within 2-h or 3-h or 4-h
intervals? Is continence after BNR with spontaneous voiding or via CIC or
AC.Bladder capacity has been reported to be a predictor of continence after BNR
alone [13, 14]. A minimum bladder capacity of 100cc has been advocated as a metric to assist in surgical decision-making between BNR or CCC with or without
AC [59].
Early series reported continence rates with voiding alone in 80% with modern
staged reconstruction with YDL BNR [60, 61]. In the most recent review from
Johns Hopkins, 350 CBE patients with continence data known at least 3months
postoperatively and 7years median follow-up. In those who underwent BNR
alone, the continence rate was 91 of 142 (64.1%) with 80 of the 91 voiding spontaneously per urethra and 11 of 91 performing CIC [3]. One of the disadvantages
of the YDL BNR includes the loss of bladder capacity that results from the reallocation of bladder wall tissue to the urethral continence mechanism. The neourethra following YDL, as most BNR, may be tortuous and difcult to catheterize.
Such extensive bladder neck surgical reconguration with YDL BNR, as with all
BNR techniques, carries the potential for postoperative neuromuscular dysfunction. Therefore, it may be difcult for CBE patients following YDL BNR to
exhibit normal voiding characteristics. Yerkes et al. examined 27 patients with
EEC who had undergone YDL without AC with 2 or more years of follow-up [57].
Dry intervals of at least 2h were achieved by 18 patients and all were considered
by parents to void well. Despite near or total subjective continence and “good”
voiding, 13 of these 18 patients (72%) had clinical problems related to emptying,
which included recurrent urinary tract infections in 10, epididymitis in 2, and
bladder calculi in 4. Objective urodynamic parameters conrmed poor voiding in
most patients.
Other surgeons have modied the YDL BNR in a quest to improve urethral continence. Mollard in 1980 described his results using a BNR technique in 15 patients
with CBE [62]. (Fig.21.4) On one side, the trigonal muscle is cut in the transverse
direction at the level of the new bladder neck. On the other side, the trigone is cut
parallel to the urethra, thus leaving a triangle attached to the bladder by its base and
tubularized. The muscular triangle, still attached to the urethra, is turned inward and
sutured to the other side of the urethra. The muscular triangle on the other side is
pulled upward in front of the new bladder neck and the lowest part of the detrusor.
This will reconstitute a muscular loop in front of the new bladder neck and a clear
urethrovesical angle. A long-term follow-up (mean 11years) from this center in
Lyon, France, using the Mollard BNR technique in 80 CBE patients showed that 36
(45%) patients presented with a dry interval of >3h with 18 patients using CIC (16
via Mitrofanoff) after one BNR [63]. Twenty-two patients (27%) underwent
AC. Fifty-one percent of all patients required an endoscopic procedure within
a
c
21 Surgical Options forRefractory Urinary Incontinence inClassic Bladder Exstrophy
341
b
a
d
b
b
a
Fig. 21.4 Mollard bladder neck reconstruction. Molalrd’s variation of the Young-Dees-Leadbetter
procedure is similar in the construction of the neourethra from a long posterior strip of urethra and
bladder. It differs in that one of the triangular aps is incised vertically and parallel to the neourethra. This ap is then rotated horizontally across the midline to create an angle of the anterior
bladder neck. (a) The bladder is opened in the midline (b) The mucosa lateral to the central urethra
strip is excised. (c) The two lateral muscle aps are incised, one vertically and one horizontally. (d)
Flap [A] is wrapped around the neourethra like Young-Dees-Leadbetter operation while Flap [B]
is rotated horizontally across the repair to create an anterior bladder neck. (Used with Permission
from Taylor and Francis- Kelalis-King-Belman Textbook Clinical Pediatric Urology 5E)
3months after the BNR either in the form of dilation of BNR for urine retention or
BNI (n=3) for persistent urethral leakage.
Koff’s variation on the YDL also differs from the original in its use of the periurethral muscle aps [64]. His description involves the initial incision on the lateral
aspect of the bladder neck, rather than the midline, and this produces a single long
muscle ap on one side of the bladder. (Fig.21.5) After ureteral reimplantation in a
cephalotrigonal fashion, the mucosa is stripped from the long muscle ap, leaving a
midline strip of urethra and bladder to tubularize for the neourethra. The long muscle ap is then wrapped around the neourethra, producing what Koff termed ‘the
cinch’. Koff reported results in 10 CBE patients with continence day and night
achieved in 6 patients (3 voiding and 3 on CIC) while daytime-only continence was
achieved in an additional 2 patients for 80% continence rate. Four patients had
underwent AC in this Koff series (3 prior to BNR and 1 concomitantly). Hanna etal.
described a variation of the Cinch procedure but instead of an initial transverse incision, the muscular ap was created in longitudinal fashion [65].
Both Mollard’s and Koff’s BNR techniques use bladder muscle aps to create
more outlet resistance at the expense of making the bladder smaller by reducing the
bladder itself. Jones etal. originally described a series of patients using a modication of the YDL which has been the Mitchell BMR after Michael Mitchell [66]. The
342
ac
bd
Fig. 21.5 Koff’s Cinch bladder neck reconstruction. It is another variation of the Young–Dees–
Leadbetter procedure that creates the neourethra from a posterior ap of urethra and bladder and
covers it with a ap of demucosalized muscle. The construction of this ap is different to other
repairs that rely on two aps. The technique is predicated on lower transverse lateral incision of the
bladder neck instead of opening the anterior midline. This creates a single long ap on one side of
the neourethra. The ap is then wrapped around the neourethra and sewn to itself with permanent
sutures. It acts as a constant compression of the bladder outlet. (a) The bladder outlet is opened on
one side. (b) A midline mucosal strip is tubularized and the mucosa is dissected from the remaining
muscle ap. (c and d) The muscle ap is then rotated around the bladder outlet. (Used with
Permission from Taylor and Francis- Kelalis-King-Belman Textbook Clinical Pediatric Urology 5E)
B. A. VanderBrink
Mitchell BNR technique returned to Hugh Hampton Young’s original concept of a
narrowed neourethra without added muscular support. Mitchell’s BNR does not
decrease bladder capacity as the anterior bladder and urethral ap are incorporated
into the bladder. The technique through low transverse incision mobilizes a triangular full-thickness ap of the anterior urethra and bladder neck and then narrows the
bladder outlet. The ap is then rotated cephalad and integrated into the bladder.
Continence was achieved in 64% of patients who all voided in a mixed group of
children including neuropathic bladders and CBE.DeCambre etal. reviewed another
modication of Mitchell BNR in a series of four CBE patients using a demucosalized
detrusor muscle pedicle to wrap around the bladder neck base [67]. Three of the four
CBE patients underwent simultaneous enterocystoplasty and concomitant
Mitrofanoff channel. Urinary continence rate, dened as no leaking via bladder neck,
was 50% after the rst procedure in the CBE patients and 100% after the BNI injection. The authors advocated for the detrusor wraparound in combination with the
Mitchell modication of YDL BNR to be most useful in difcult redo operations in
which sufcient bladder tissue is available for repair. Burki etal. from Great Ormod
Street, London, described the utility of the Mitchell BNR in just that clinical scenario
[55]. Burki etal. reported on 30 CBE patients with a history of failed prior BNR.Of