Curr Bladder Dysfunct Rep (2013) 8:351–357 DOI 10.1007/s11884-013-0209-4

RECONSTRUCTED BLADDER FUNCTION AND DYSFUNCTION (L WESTNEY, SECTION EDITOR)

Vaginal Reconstruction in the Neobladder Patient: Fistula and Prolapse Cory D. Harris & Angelo E. Gousse

Published online: 28 September 2013 # Springer Science+Business Media New York 2013

Abstract Approximately 25 % of all new bladder cancers were diagnosed in women in 2010. Initially concerns of continence and oncologic outcomes prevented widespread use of orthotopic neobladder (ONB) in women. These concerns have been addressed in recent investigations and ONB diversion in women has been advocated by many surgeons. One of the most feared complications of ONB in women is fistula formation between neobladder and vagina. Rates of fistula formation range between 3-5 %. Damage to vaginal wall and lack of vascularized tissue is associated with fistula formation. Other complication specific to the female patient include anterior vaginal wall prolapse (neocystocele). This finding has been associated with urinary retention in female ONB patient. Herein, we described the etiology, diagnosis, and, management of the issues surrounding ONB use in female patient.

Keywords Female . Postoperative complications . Vaginal fistula . Review . Urinary fistula . Surgery . Cystectomy . Adverse events . Cystocele . Etiology . Urinary diversion . Urinary reservoir

C. D. Harris (*) Harlem Hospital, 12th Floor Room 12118, 506 Lenox Avenue, New York, NY 10037, USA e-mail: [email protected] A. E. Gousse Herbert Wertheim College of Medicine – Female Urology,Voiding Dysfunction, Memorial Hospital Miramar, South Broward Hospital District 1951 SW 172 Avenue, Suite 305, Miramar, FL 33029, USA e-mail: [email protected]

Introduction While orthotopic urinary diversion has been available to male patients for several decades, routine usage in female patients is a recent development [1]. Classically, radical cystectomy in women involved en bloc removal of the bladder, uterus, fallopian tubes, ovaries, anterior vaginal wall and urethra. Lack of outcome data related to secondary urethral tumors and insufficient knowledge about the functional anatomy of the isolated female urethra and its sphincter were the biggest obstacles in the development and common use of orthotopic intestinal reconstruction of the lower urinary tract in women. This line of inquiry has been addressed by several recent investigators. Coloby et al. [2] and Stein et al. [3] in retrospective analyses step-sectioned urethrocystectomy specimens of female bladder cancer patients and found respective urethral tumor involvement in 7 of 65 (10.7 %) and 3 of 47 (6.4 %) patients. In both studies, a strong correlation was seen between urethral involvement and bladder cancer at the bladder neck. Based in part on this information, orthotopic neobladder replacement has now been established as an acceptable and desirable type of urinary diversion in female patients without compromising oncologic outcomes. Orthotopic neobladder (ONB) offers the potential benefit of a better quality of life as compared to ileal conduit urinary diversion [4]. In addition to oncologic concerns, anatomical and technical considerations unique to female cystectomy have contributed to its relatively slow acceptance in the urological community. Currently there is debate on the optimal technical approach. Notwithstanding excellent clinical outcomes in the majority of women undergoing neobladder reconstruction, the functional complications of the neobladder include hypercontinence requiring intermittent catheterization, pouch calculus formation, persistent urinary incontinence, prolapse formation and neobladder-vaginal fistula (NVF).

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Epidemiology/Symptoms/Diagnosis Neobladder-vaginal fistula occurs in 3-5 % of patients [5–7]. The main presenting symptom in NVF is continuous urinary drainage from the vagina and or incontinence once suprapubic and urethral Foley catheters are removed post-operatively. Although urinary incontinence is often reported after female ONB construction, the incontinence is usually mild. In a series of 25 women undergoing ONB construction, Chang et al. [5] reported that 71 % required less than one pad/day, with none requiring more than two pads per day. Patients presenting with severe and immediate urinary incontinence after cystectomy and ONB construction warrant aggressive investigation to exclude the presence of a NVF. Similar to vesico-vaginal fistulas, larger NVFs are easy to identify, as they may be large enough to accommodate the index finger. However, if the fistula is very small, the urine leakage may be intermittent which renders endoscopic identification much more difficult. In these cases, the neo-bladder can be filled with Methylene blue-stained normal saline with the patient in lithotomy position while performing a tampon test or while directly inspecting the vagina for leakage with a vaginal speculum. Vaginoscopy after intravesical dye instillation may also be useful [8]. A combination of neobladder endoscopy and vaginoscopy with an attempt at cannulation of the fistulous tract with a 0.038 Glide or Sensor wire can be quite informative. Alternatively, a CT urogram without and with IV contrast can yield useful radiographic information. In the authors opinion, a combination of exam under anesthesia, vaginoscopy, neobladder endoscopy with cannulation of the fistulous tract is the most useful and comprehensive diagnostic testing to plan a possible repair (Fig. 1).

Prevention The most important factor in the prevention of NVF during radical cystectomy is technical considerations. Compared to

Fig. 1 Successful cannulation of neobladder-vaginal fistula tract identified after with vaginoscopy and endoscopy of the neobladder

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the native bladder, the wall of the neobladder is much thinner, and thus vulnerable to fistula formation. The reservoir’s proximity to the vagina and the thin bowel wall creates an added risk of a potential fistulization. Fistula formation can occur due to inadvertent injury to the vaginal wall during radical cystectomy, overlapping suture lines, disturbed tissue planes between the posterior bladder neck and vagina, and compromised tissue vascularity between the urethra and anterior vaginal wall caused by surgical dissection [5, 9]. Surgical precautions should be taken during dissection of the vesicovaginal plane. Development of NVF after injury to the vaginal wall has been described despite primary repair and use of omental interposition flap [5, 9]. Poor tissue vascularity after radiotherapy and local tissue recurrence are also other contributing etiologies [9–11]. Fistulization between neobladder and vagina can also occur as a complication following collagen injections for stress incontinence after cystectomy and orthotopic bladder replacement. Pruthi et al. [10] described two patients who developed NVF after collagen injections for treatment of urinary incontinence following orthotopic neobladder substitution. In both cases, NVF developed at the level of the bladder neck. One should be cautious using bulking agents for post-neobladder stress urinary incontinence, as it may not be as effective and innocuous as in those with a native bladder. Fistulization may be avoided by using smaller volumes of collagen localized away from the neobladder neck and directed more anteriorly toward the 12 o’ clock position [10]. Surgical techniques designed to minimize both the risk of inadvertent vaginal injury and local inflammation are important in preventing potential fistula development. Modifications to traditional technique of cystectomy and neobladder creation have been designed to minimize fistula formation. Mills and Studer [12] advocated excision of a portion of the anterior vaginal wall with the specimen in an attempt to improve the urethral recurrence rate. Later descriptions of their technique maintained partial vaginal wall resection with meticulous attention to the rhabodosphincter and the autonomic nerve supply. Other groups have focused on preserving the integrity of the vaginal wall for improvement of sexual function and concomitant decreased fistula with the advantage of eliminating an additional suture line [13]. Chang et al. [5] described preservation of the anterior vaginal wall during radical cystectomy with cephalad elevation of the vaginal vault to identify the apex and anterior vaginal wall. The bladder specimen is elevated cephalad out of the pelvis and the posterior plane is continued to the level of the bladder neck. The proximal urethra is circumferentially incised from anterior to posterior to connect the previously developed posterior plane preserving the endopelvic fascia. Following cystectomy, the posterior bed of resection is inspected to ensure that no defects in the anterior vaginal wall are created. Any incidental incisions are closed primarily [14].

n/a

Combined abdominal and vaginal approach in (3) patients. Continent diversion after failed Rectus and subsequent gracilis interposition (1) Obturator interposition (1) Conversion to ileal conduit Failed primary two layer closure Failed initial transvaginal repair with 2nd repair with Martius flap (1) 2nd repair with transvaginal repair with dermal graft pubo-vaginal sling (1) 19.5 months

n/a n/a

6 months

3 months 20.2 months

Follow-up after ONB

Management

Risk of injury to the vagina was reported to be greatest during the most distal dissection of the vesico-vaginal plane in the region of the urethra [8, 15]. Rapp et al. report decrease fistula formation by minimizing blunt dissection in the vicinity of the bladder neck and sharply dissecting the posterior urethra [8]. Ghoneim et al. [6] present a modified technique to prevent NVF which includes vaginal transection such that the anterior flap is longer than that posterior vaginal flap. The vaginal stump is embedded after the posterior flap is closed to ensure stump suture line is facing posterior away from the urethra–ileal anastomosis. The peritoneal edge from the anterior rectal wall is then sutured to the top of the vaginal stump, and a generous omental flap is placed between the vaginal stump and pouch to provide interposition tissue and to fill dead space in the pelvis [6]. The overarching technical pearl is that NVF formation is decreased by taking steps to ensure suture lines do not overlap.

Transvaginal repair in multiple layers+ cadaveric fascia pubovaginal sling (1), Transvaginal repair+ Martius flap interposition+ cadaveric fascia pubovaginal sling (1) Continent diversion failed repair x 3. (1) n/a

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Ileal conduit urinary diversion Transvaginal repair

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Neo-Bladder Fistula (2) Enterocutaneous fistula (1) Radical cystectomy+ T-pouch ileal neobladder

Rapp et al. [8] (n=37)

Quek ML et al. [22] (n=101)

Neo-Bladder vaginal fistula (4)

Neo-Bladder vaginal fistula (1) Neo-Bladder vaginal fistula (1)

Radical cystectomy+ileal Neobladder Radical cystectomy (anterior vaginal wall preservation)+ileal neobladder Vaginal sparing cystectomy with ileal neobladder Horenblas et al. [23] (n=3) Chang et al. [5] (n=25)

Pruthi et al. [9] (n=2)

Nerve sparing cystectomy+ileal neobladder Radical cystectomy+ileal W-neobladder Radical cystectomy and ileal Neobladder+ trans-urethral injection of collagen Hautmann et al. [24] (n=13) Ali-El-Dein et al. [20•] (n=60)

Neo-bladder vaginal fistula (2) Neo-bladder vaginal Fistula (3) Neo-Bladder vaginal fistula (2)

Surgery Author

Table 1 Review of neobladder vaginal fistula literature

Although the development of NVF is a benign event, its social significance is great because of the associated total and continuous incontinence in these women. The impact in quality of life is significant in patients who are, often concurrently dealing with the oncologic aspects of their disease. Understandably, the patients are desirous of a rapid resolution to their incontinence. The standard surgical challenges of fistula repair are augmented by the fact that the neobladder wall is much thinner than the bladder wall, which theoretically renders the neobladder more vulnerable to fistulization [14]. The techniques that might be used to repair a NVF are based on the principles of repair of all urinary fistulas. Care needs to be taken when dissecting out the planes of the neobladder due to it its comparative delicacy in comparison to native detrusor. Another concern is the pouch/intestinal mesentery, which can be easily violated during dissection resulting in troublesome bleeding and tissue ischemia. Successful outcomes using omental, peritoneal or labial (Martius) flaps augmented repairs are commonly reported [16, 17]. For more complex and/or failed cases of fistula repair, usage of pedicled rectus abdominus muscle flap, myocutaneous gracilis and obturator flap have been described [8, 18, 19]. Current publications report mixed outcomes associated with NVF repair (Table 1). Ali-el-Dein et al. [20•] reported on repair of eight patients with NVF. Repair was performed transvaginally in six patients and abdominally in two patients. The authors describe using a circumferential vaginal wall incision encircling the fistulous opening with 2 mm margin. Limited dissection between the vagina and pouch is performed circumferentially with subsequent excision of the fistula. The dissection intentionally limited distally to avoid sphincteric damage. The defect in the pouch was closed in a

Complication

Management

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transverse fashion using interrupted 3–0 absorbable polyglactin sutures. The second layer was constituted of the fascia and the fat surrounding the pouch. The integrity of the repair was tested and the vagina was closed in a non-opposing perpendicular layer using interrupted sutures. An abdominal approach was used for patients with high and large fistulas and those with associated vaginal atrophy. In case of patients with vaginal atrophy, some authors recommend peri-operative local estrogen therapy, if not contraindicated, and use of interposing tissue flaps (mostly Martius flaps) to decrease fistula recurrence [20•]. Bestard Vallejo [21] reported an 8 mm fistula at the urethro–ileal anastomosis, closed with a vaginal approach using a two-layer closure with Martius flap interposition, with no recurrence after 1 year. Martius labial flap interposition between the repaired neobladder-vaginal fistula and the anterior vaginal wall is a commonly used technique to supplement a vascularized buffer between the two layers [9, 22]. Complications of Martius flap interposition include pain and physical deformity of the labial harvest site. Operator experience, wide tissue mobilization, and layered and tension-free closure all appear to be factors in successful vaginal repair of vesico-vaginal fistulas, and these concepts are equally applicable to the repair of NVF. Other options include conversion to a non-orthotopic urinary diversion. Rapp [8] described NVF management with urinary diversion in three patients. In the first patient, rectus and gracilis interposition had been individually attempted and failed leading to a third procedure of continent catheterizable urinary diversion. In the second patient, tissue mobilization was limited leading to performance of a primary two-layered closure which failed. The patient then underwent conversion to an ileal conduit. The third patient had local tumor recurrence and subsequent conversion to ileal conduit. The authors recommend a combined abdominal and vaginal approach with high consideration of converting to a continent cutaneous urinary diversion with possible Mitrofanoff technique. Hornblas et al. [23] reported three unsuccessful attempts at repairing a NVF in the same patient, which ultimately resulted in conversion to a continent pouch. Hautmann et al. [24] reported the immediate conversion to incontinent conduit in two patients developing NVF.

Cystocele In contrast to men, urinary retention is a relatively common problem in women who have undergone neobladder substitution [24, 25]. While some patients fail to empty due to dyssynergia, there is also evidence that chronic urinary retention after orthotopic substitution is due to anatomical rather than functional or neurogenic reasons. The primary anatomical culprit is the formation of a pouchocele or neocystocele, in which

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there is caudal migration and posterior prolapse of the reservoir with subsequent urethral kinking. The normal mechanism of voiding in patients with a neobladder consists of coordinated abdominal straining (the Valsalva maneuver) and pelvic floor relaxation [26–28]. Ghoneim [29] described voiding patterns in 100 women who had undergone orthotopic neobladder creation. Sixteen patients were noted to have chronic urinary retention. In women with asymptomatic voiding patterns, dynamic pelvic floor MRI revealed no neobladder descent at rest or during straining in women without voiding dysfunction. In women in chronic retention there was no neobladder descent below the pubococcygeal line at rest, while significant descent below this line was noted during straining. In this study, videourodynamics revealed that retention was mechanical in nature due to the pouch falling posteriorly into the wide pelvic cavity resulting in acute angulation of the posterior pouchurethral junction. In addition, herniation of the pouch wall through the prolapsed vaginal stump was observed in most cases. This herniation was clinically visible with the patient squatting or in the lithotomy position [29]. Finley et al. [30•] analyzed 19 female patients with a neobladder, in which eight (42.1 %) of the cohort experienced obstructive voiding symptoms. Seven patients (36.8 %) required CIC and one who did not require CIC voided to completion by reducing prolapse with a finger in the vagina. Of patients in urinary retention associated findings included neocystocele in six, anastomotic stricture in one and progressive Huntington’s chorea in one. Six patients with complaint of obstructive voiding symptoms were all noted to have neocystoceles. No neocystoceles were recorded in the 11 patients without voiding symptoms. One grade 2, one grade 3 and four grade 4 neocystoceles were identified. Dynamic pelvic MRI was done in four of the six patients with a neocystocele. Neobladder migration was noted into a potential space posterior to the neobladder where the uterus had previously resided. Upon straining, the peritoneocele increased in volume, allowing the neobladder to drop and angulating the urethra. Average neobladder descent in patients with a neocystocele was 1.8 cm (range 1.3 to 2.5). Average change in the neocystourethral angle from resting to straining was 17.8 degrees (range 0 to 28). It is unknown if these changes are actually the cause of the chronic retention or findings noted retrospectively. In a comprehensive review of orthotopic neobladder voiding dysfunction, Steers noted that urinary retention is related to several factors, including urethral angulation caused by inferior displacement of the neobladder neck, the degree of urethral nerve sparing, urethral length, loss of myogenic activity secondary to detubularization and weak abdominal straining [24]. Hautmann [23] observed that urethral angulation and bladder neck elongation contributed to obstruction.

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Natural History Pre-operative incontinence and pelvic organ prolapse are considered contraindications to orthotopic bladder replacement to some [29, 30•, 31]. Patients may occasionally present before cystectomy with a preexisting cystocele and vaginal vault prolapse, but most pouchoceles develop after cystectomy. This abnormality appears to gradually develop as the neobladder expands. Studer detected noticeable changes in voiding parameters within 1 year [29]. Finley et al. [30•] observed that voiding disturbances did not manifest until 3 to 6 months after surgery. The authors hypothesized that neocystoceles probably form during months of straining as a consequence of inadequate voiding due to inability to open the urethra. Some groups believe this may be due to parasympathetic denervation of the urethra and advocate nerve-sparing cystectomy. Stenzl et al. [32] reported chronic retention occurred in 11 % of the patients after a mean follow-up of 26 months. They combined autonomic plexus preservation with supporting the neobladder posteriorly either with an omental flap or suturing the pouch to endopelvic fascia and vagina. A statistical association between preserved autonomic innervation and rate of chronic retention was found. In their study, 72 % of women who underwent a non-nerve sparing procedure subsequently required CIC compared to 0 % and 9 % of those who underwent unilateral and bilateral nerve sparing, respectively. In contrast, Ghoneim et al. [29] routinely sacrifices the autonomic innervation during radical cystectomy reports a favorable 16 % retention rate defined as post-void residual urine less than approximately 100 ml (20 % of mean maximal pouch capacity). This group suggests that keeping the urethral-pelvic ligament intact during urethral dissection may predispose to postoperative formation of neocystocele. The immobility of the urethral remnant in relation to the mobile reservoir may lead to angulation of the urethro-intestinal junction with subsequent herniation of the posterior pouch wall (pouchocele) through the anterior vaginal wall, which may worsen with time due to the straining efforts of the patient. Similarly, preservation of adequate urethral length has been emphasized as a factor that may influence neocystocele formation. Attempts to preserve continence by leaving an excessively long urethral segment may result in a fixed, immobile urethra, which exacerbates neocystourethral junction angulation during neobladder descent. Hautmann et al. [23] reported the use of a longer segment of urethra, including a portion of the bladder outlet or bladder neck, resulted in a higher rate of urinary retention.

Repair Finley et al. [30•] reported transvaginal repair of cystocele and/or enterocele in four out of six patients with poor emptying and documented neocystocele. One patient was

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augmented with polypropylene mesh and three were augmented without mesh. Two patients underwent concurrent transvaginal urethrolysis for a fixed, immobile urethra. One patient underwent transurethral bladder neck incision. Two patients required a transvaginal vault suspension procedure (sacrospinous fixation) for symptomatic pelvic organ prolapse. Transvaginal repair of pelvic organ prolapse restored normal voiding in two of four patients, obviating the need for CIC. CIC was still required in the remaining two patients in whom repair failed; one of these patients who underwent a concomitant bladder neck incision had persistent outlet obstruction at the bladder neck. One patient who underwent repair showed stress incontinence, which was successfully treated with a transurethral Coaptite® injection and required no further treatment. Several groups have suggested prophylactic maneuvers at cystectomy to prevent downward migration of the neobladder, including urethral suspension, posterior omental or peritoneal flap interposition, anterior pouch fixation to the pubis or Cooper’s ligament, fixation of the vaginal fornices to Cooper’s ligament, and maximal preservation of paravaginal tissue, levator muscles and pelvic floor fascia [12, 25, 31, 32]. Stein et al. recommended leaving the anterior vaginal wall and pubourethral suspensory ligaments intact to maintain an intrapelvic neobladder [33]. Mills and Studer noted that chronic retention may develop due to a relative lack of support in the capacious female pelvis. They described fixation of the anterior pouch to the posterior aspect of the pubic symphysis to prevent reservoir wall collapse onto the urethral outlet [12]. Stanzel described a Jomental flap, which was brought down around the bottom of the pouch like a hammock [31].Puppo et al. [31] developed a similar technique by harvesting a thick flap of peritoneal and extraperitoneal tissue, and suturing it to the endopelvic fascia antero-laterally, effectively keeping the cul de sac intact. During a median followup of 25 months, PVR was less than 100 ml in all 25 patients and none required CIC with this technique. The same group also described pelvic reconstruction before neobladder creation in a patient with pre-operative pelvic organ prolapse (stage III cystocele with vaginal vault prolapse). After radical cystectomy, pelvic floor integrity was restored with use of a rectangular polypropylene mesh fixed posteriorly to the periosteum of the sacral promontory and anteriorly to the posterior vaginal wall and then covered with peritoneum as described above. After one year follow-up, physical examination did not reveal any pelvic prolapse and continence was reached without chronic retention [34]. Ghoneim [29] also attempted to restore posterior support by suspending the closed vaginal stump at its angles by the medial ends of the preserved round ligaments and

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suturing the peritoneum covering the anterior rectal wall to the vaginal stump. The pouch was suspended near its dome to the back of the rectus muscle at cystectomy. Reportedly the incidence of chronic retention decreased from 18.7 % (14 of 75 cases) to 8 % (2 of 25) after modifications. Chang et al. [5] report no cases of pouch prolapse with only one patient using intermittent catheterization. They believe by preserving the anterior wall and pubo-urethral ligaments the likelihood of anterior vaginal wall descent and pelvic prolapse is decreased. In addition, much of the pelvic support, including the pubo-cervical fascia and cardinal ligaments, is less likely to be injured by limiting dissection around the vaginal apex and lateral vaginal margins.

Conclusions Neobladder-vaginal fistula formation is an uncommon but disappointing complication. The most important aspect in the prevention of NVF during radical cystectomy is technical in nature. The reservoir’s proximity to the vagina and the thin bowel wall creates an added risk for potential fistulization. Surgical techniques designed to minimize both the risk of inadvertent vaginal injury and local inflammation are both important in preventing potential fistula development. Inadvertent injury to the vaginal wall during cystectomy is commonly cited as a cause of NVF formation. Therefore, surgical precautions should be taken during dissection of the vesicovaginal plane. Preservation of the anterior vaginal wall during radical cystectomy may decrease the likelihood of pouchvaginal fistula. Omental flap interposition between the vaginal stump and neobladder at cystectomy, although a sound practice may not always prevent fistulization if the anterior vaginal wall is violated or overlapping suture lines are not avoided. Neocystoceles frequently cause urethral kinking leading to urinary retention. Causes of neocystocele formation include urethral dysfunction due to denervation, excessive urethral length, or lack of posterior support. Prevention may be accomplished with the use of techniques to reduce downward migration. Outcomes are mixed in regards to the effect nervesparing cystectomy has on decreasing incidence of prolapse formation. Compliance with Ethics Guidelines Conflict of Interest Angelo E. Gousse has received research grant support and received honoraria from Allergan. Cory D. Harris declares that he has no conflict of interest. Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors.

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