Committee 13

Surgical Treatment of Urinary Incontinence in Men

Chairman

S. HERSCHORN (Canada)

Members

H. BRUSCHINI (Brazil),

C.COMITER (USA),

P.G RISE (France),

T. HANUS (Czech Republic),

R. KIRSCHNER-HERMANNS (Germany)

1121 CONTENTS

I. INTRODUCTION VIII. TRAUMATIC INJURIES OF THE URETHRA AND PELVIC FLOOR II. EVALUATION PRIOR TO SURGICAL THERAPY IX. CONTINUING PEDIATRIC III. INCONTINENCE AFTER RADICAL PROBLEMS INTO ADULTHOOD: THE PROSTATECTOMY FOR PROSTATE EXSTROPHY-EPISPADIAS COMPLEX CANCER

X. DETRUSOR OVERACTIVITY AND IV. INCONTINENCE AFTER REDUCED BLADDER CAPACITY PROSTATECTOMY FOR BENIGN DISEASE

XI. URETHROCUTANEOUS AND V. SURGERY FOR INCONTINENCE IN RECTOURETHRAL FISTULAE ELDERLY MEN

VI. INCONTINENCE AFTER XII. THE ARTIFICIAL URINARY EXTERNAL BEAM RADIOTHERAPY SPHINCTER (AUS) ALONE AND IN COMBINATION WITH SURGERY FOR PROSTATE CANCER XIII. SUMMARY AND RECOMMENDATIONS VII. INCONTINENCE AFTER OTHER TREATMENT FOR PROSTATE CANCER REFERENCES

1122 Surgical Treatment of Urinary Incontinence in Men

S. HERSCHORN, H. BRUSCHINI, C. COMITER, P. GRISE, T. HANUS, R. KIRSCHNER-HERMANNS

high-intensity focused ultrasound, other pelvic I. INTRODUCTION operations and trauma is a particularly challenging problem because of tissue damage outside the lower Surgery for male incontinence is an important aspect urinary tract. The artificial sphincter implant is the of treatment with the changing demographics of society most widely used surgical procedure but complications and the continuing large numbers of men undergoing may be more likely than in other areas and other surgery and other treatments for prostate cancer. surgical approaches may be necessary. Unresolved problems from pediatric age and patients with Basic evaluation of the patient is similar to other areas refractory incontinence from overactive bladders may of incontinence and includes primarily a clinical demand a variety of complex reconstructive surgical approach with history, frequency-volume chart or procedures. Other unique problems encountered are bladder diary, and physical examination. Since most fistulae between the urethra and skin and the prostate of the surgeries apply to patients with incontinence after other operations or trauma, other investigations such and rectum. Surgical reconstructions in experienced as radiographic imaging of the lower urinary tract, hands are usually successful. cystoscopy, and urodynamic studies may provide With extensive worldwide use of the artificial sphincter important information for the treating clinician. in the surgical management of male incontinence, its Although prostatectomy for benign disease has complications and their management are well known. become less frequent in many countries, the Durability of the device is an important aspect that complication of incontinence is a rare but unfortunate impacts on outcome and cost of treatment. occurrence that merits treatment. After a period of Although the literature is replete with well done cohort conservative therapy has been tried, surgical studies, there is a continuing need for prospective treatment, with implantation of the artificial urinary randomized clinical trials. sphincter, has cured or improved 75-80% of sufferers. Injection therapy with agents such as collagen has 1. MATERIALS AND METHODS helped 40-50% of men in the short term but fewer in the long term. New sling techniques have shown The committee was charged with the responsibility of promising results in studies. assessing and reviewing the outcomes of surgical therapy that have been published since the Third Radical prostatectomy for prostate cancer is performed Consultation [1] for non-neurogenic male incontinence. far more frequently now than 10-15 years ago. Articles from peer-reviewed journals, abstracts from Approximately 5-25% of patients will experience scientific meetings, and literature searches by hand incontinence and of those a significant minority will and electronically formed the basis of this review. The require surgical treatment. The artificial sphincter has outcomes were analyzed, discussed among the provided a satisfactory result in most cases with a members of the committee and included in the chapter. positive impact on quality of life. Sling procedures are The incontinence problems were classified according increasingly being reported to have a good outcome. Injectable agents have not shown durable long-term to their etiology, i.e. either primarily sphincter or bladder results but newer technologies such as volume- related, and are listed in Table 1. Treatment of fistulae adjustable balloons have shown reasonably favourable is covered separately. early results in a number of reports. Specific recommendations are made on the basis of published results and determined by the levels of With new data emerging stratification of treatment evidence. Consensus of the committee determined the based on the degree of stress incontinence may recommendations, which are found at the end of the become feasible. chapter. Recommendations for future research are Incontinence following radiation therapy, cryosurgery, also included. 1123 Table 1. Classification of surgically correctable are recommended in incontinent males prior to surgical problems therapy. • SPHINCTER RELATED Blood testing (BUN, creatinine, glucose) is Postoperative recommended only if compromised renal function is Post-prostatectomy for prostate cancer suspected or if polyuria (in the absence of diuretics) Post-prostatectomy for benign disease is documented by the frequency-volume chart [10]. TURP and radiation for prostate cancer Further evaluation should be adapted to the particular Post-cystectomy and neobladder for bladder patient. cancer Post-traumatic Cystourethroscopy is useful to verify integrity of the After prostato-membanous urethral urethral wall (anterior aspect of the distal sphincteric reconstruction mechanism in post-TURP incontinence [11], erosion Pelvic floor trauma by the cuff of the artificial sphincter, voluntary Unresolved pediatric urologic incontinence contraction of the pelvic floor, etc.) and the status of Exstrophy and epispadias the bladder (trabeculation, stone, diverticula, etc).

•BLADDER RELATED Imaging techniques include plain film of the abdomen Refractory urgency incontinence due to detrusor (KUB or Kidneys, Ureters, Bladder), in cases of overactivity incontinence following artificial sphincter implantation Small fibrotic bladder when during the original procedure the hydraulic system was filled with contrast medium. A KUB • FISTULAE Prostatorectal (urethrorectal) immediately following sphincter implantation serves Urethrocutaneous as a reference point for subsequent comparisons [12]. Figure 1 illustrates the case of a young spina bifida patient in whom an artificial sphincter has been implanted with the cuff around the bladder neck. After more than 10 years, he became suddenly incontinent. II. EVALUATION PRIOR TO Second KUB compared to previous one clearly SURGICAL THERAPY demonstrated fluid loss from the system. Contrast studies include cystography which may demonstrate Recommendations for evaluation prior surgery have an open bladder neck when bladder denervation is not changed substantially from the last edition in suspected [13] (e.g.: following abdominoperineal 2005[1]. Before surgical treatment of the incontinent resection of the rectum). Cystourethrography may be male is undertaken, the following evaluations should used to demonstrate a fistula, stricture or urethral be done [2]. Basic evaluation includes history, physical diverticulum eg., following healing of the urethral wall examination (including neuro-urological examination: erosion caused by the cuff of the artificial urinary perineal sensation, anal tone, voluntary contraction and sphincter (Figure 2). Ultrasound is widely used not only relaxation of the anal sphincter, bulbocavernosus to evaluate the upper urinary tract, but also to evaluate reflex [3], urinalysis, and postvoid residual urine. A postvoid residual urine. The sensitivity of 66.7% and frequency-volume chart [4], or bladder diary (indicating specificity of 96.5% when post-void residual is 100 ml daytime and nighttime frequency of micturition, or more is adequate for routine clinical use [14]. It incontinence episodes, voided volumes, 24-hour has been shown to be cost-effective when compared urinary output, etc.) is also helpful. No clear guidelines to catheterization [15]. Other modalities, for example can be found in the literature indicating the minimum transurethral ultrasound [16] and magnetic resonance number of days necessary to furnish reliable data for imaging of the external sphincter are still under a voiding diary. According to Wyman et al. [5] the 7- development. day diary can be considered as the gold standard for 1. URODYNAMIC TESTING voiding diaries. Schick et al.[6] demonstrated that a 4 day frequency-volume chart is the shortest one In the opinion of the Committee a thorough which still gives reliable results, as compared to the urodynamic evaluation to characterize the 7 day diary. The pad test quantifies the severity of underlying pathophysiology is useful prior to incontinence. The 24-hour home test is the most invasive therapy. However, there are factors that accurate pad test for quantification and diagnosis of must be considered. In patients with incontinence urinary incontinence because it is the most secondary to radical prostatectomy who developed reproducible [7]. The 1-hour pad test is widely used bladder neck stenosis, the urethral catheter can create because it is more easily done and standardized. A obstruction giving false values for Valsalva leak point pad test may be helpful in quantifying leak in AUS pressure. Sphincter weakness can be documented by failures. Postvoid residual urine is a good estimation the Valsalva [17] or cough [18] abdominal leak point of voiding efficiency [8,9]. These basic investigations pressure. Peschers et al. suggested that Valsalva

1124 Figure 1 : Young spina bifida patient who had a bladder neck artificial sphincter implanted. After more than 10 years, he became incontinent. Early abdominal plain film, A, shows a full reservoir. After leakage start- ed abdominal plain film, B, demonstrates loss of fluid from the reservoir.

which somewhat limits its usefulness [27]. Measu- rement of leak point volume may also provide information on the functional capacity of the bladder [28]. Retrograde leak point pressure has been used to study incontinence following placement of an artificial sphincter [29,30]. It correlates with the lowest abdominal leak point pressure [31]. The intraoperative use of this technique has been proposed and this allows early recognition of intraoperative urethral injury and mechanical malfunction[32]. Electrophysiologic studies, mainly sphincter electromyography, may be useful to document denervation of the pelvic floor when nerve injury or neuropathology is suspected [33]. Detrusor function is best evaluated by multichannel Figure 2 : Urethrogram of patient who underwent urodynamics. Its main purpose is to detect detrusor cuff removal for erosion into the urethra. overactivity and/or decreased compliance during A. Site of urethral diverticulum . bladder filling. It can be coupled with fluoroscopic B. Tubing plug over tube from pump imaging, video-urodynamics. It has also been C. Scrotal pump proposed by some that fluoroscopy be replaced by transrectal ultrasound [34, 35]. Ultrasound measu- leak point pressure is significantly lower than cough rement of bladder wall thickness was proposed as a leak point pressure [19]. However, its reproducibility better predictor of bladder outlet obstruction than has been studied almost exclusively in women. uroflowmetry [36] but at present is controversial [37]. Catheter size seems to have a significant influence, Non-invasive pressure-flow urodynamic evaluation but the correlation is extremely high between the test- based on Doppler ultrasound seems to have potential retest leak point pressure when the same size of for diagnosing bladder outlet obstruction [38]. However catheter is used [20,21]. In male patients, abdominal invasive pressure-flow studies are still the gold leak point pressure should be evaluated via a rectal standard in the incontinent male to rule out bladder catheter because a urethral catheter is much more outlet obstruction accompanied by detrusor overactivity likely to invalidate Valsalva leak point pressure [39] which in turn can cause incontinence. measurements than it does in female [22]. It has become evident that bladder volume influences In most recently published studies, urodynamic testing Valsalva leak point pressure, i.e. it decreases with has been done prior to surgery [40-44]. Cystoscopy bladder filling [23-25]. However, this observation is is frequently done as well [43, 45-49]. However there not consistent [26]. Unfortunately, there is no agreed are some reports that questioned the value of standardization of the technique at the present time urodynamics studies in predicting outcomes after

1125 surgery. Thiel et al [50] found no evidence that patients tools used to evaluate incontinence vary from validated with detrusor overactivity, low first sensation filling, questionnaires, to interviews from a data manager, to decreased compliance or low bladder capacity had response to the surgeon’s inquiry. worse outcomes after artificial sphincter placement in 86 men. Trigo Rocha et al [51] also found that Recent reports of large cohorts use definitions that preoperative urodynamic findings such as detrusor include “total control/perfect continence”, “occasional overactivity, impaired detrusor contraction, low valsalva leakage but no pad”, and “less than one pad”. Because leak pressure, bladder outlet obstruction, and mildly 1/3 to 1/2 of men who do not wear pads will have reduced compliance did not lead to a bad outcome occasional leakage of urine, it is important to after artificial sphincter implantation. distinguish among those men who leak enough to require pad use and those who do not, as it has been The proposed evaluation of the incontinent male is demonstrated that health related quality of life is summarized in Table 2. strongly correlated with the level of incontinence and wearing one pad more significantly affects the quality Table 2. Evaluation prior to surgical therapy of life than wearing no pad [56]. In addition, not all men who leak will elect to have further treatment. Most • History large cohort studies indicate that between 6% and • Physical examination 9% of patients undergo subsequent surgical treatment • Urinalysis for PPI following prostate cancer surgery [57-60]. • Urine culture Several large cohort studies are listed in Table 3 [55, 61-74]. • Post-void residual (by ultrasound) • Voiding diary (2-7 days) 2. RISK FACTORS - polyuria without diuretics: BUN, Reported risk factors for incontinence following radical Creatinine, Glucose prostatectomy include patient age at surgery, stage • Pad-test of disease, surgical technique including nerve sparing, • Cystourethroscopy preoperative bladder function and urinary continence • Urodynamics : status, prior radiation therapy, preoperative length of - Multichannel urodynamics: the membranous urethra, prior transurethral resection - to characterize the incontinence and to of the prostate (TURP), and vascular comorbidities. detect detrusor overactivity, decreased However, various studies have come to conflicting compliance, and/or outflow obstruction conclusions on specific risk factors. Risk factors for incontinence after TURP have not been as clearly defined, probably because the incidence is so low, making the accumulation of large prospective series of this type of incontinence difficult. However, previous III. INCONTINENCE AFTER RADICAL brachytherapy does predispose to post-TURP PROSTATECTOMY FOR PROSTATE incontinence (Section VII in this chapter). CANCER Pre-operative urinary incontinence has been reported as a risk factor for post-operative SUI. While pre- 1. PREVALENCE operative lower urinary tract symptoms, including urgency incontinence and “overflow incontinence” Urinary incontinence occurring after radical may improve with de-obstruction secondary to prostatectomy (RP) is a significant problem. Although extirpative surgery [75], pre-operative SUI does not its rate has lessened [52] in these last few years improve following RP. Several recent cohort studies primarily due to a better understanding of the have demonstrated that pre-operative sphincteric pathophysiology and improvements in surgical insufficiency (demonstrated either the pre-existing technique, its prevalence has probably increased due clinical sign of SUI or the urodynamic finding of lower to the dramatic increase of RP in developed countries maximal urethral closure pressure) predicts post- which has lead to an overall increase in the number operative SUI [76, 77]. Pre-operative bladder of patients affected. dysfunction can also contribute to post-operative incontinence. Pre-existing abnormalities of detrusor Data from large multicenter studies and prostate function may predispose to leakage following surgery, cancer databases suggest that following RP, 1% to especially in the setting of neurogenic detrusor 40% of patients complain of persistent urinary overactivity due to Parkinson’s disease, dementia or incontinence. The incidence of post prostatectomy spinal cord injury [78]. incontinence (PPI) depends on the definition of urinary incontinence and the length of follow-up [53-55]. In Advancing age as a risk factor is supported by several addition to numerous definitions of incontinence, the studies [60, 75, 79-83]. Steiner, et al found no

1126 Table 3. Continence rates after radical prostatectomy according definition of continence, Definition 1: total control without any pad or leakage, Definition 2: no pad use but loses a few drops of urine, Definition 3: use no or one pad per day. RRP: radical retropubic prostatectomy; RPP: radical perineal prostatectomy; LRP: Laparoscopic radical prostatec- tomy; Rx: radiotherapy Author No. Mean Continence follow-up at 12 months Type of surgery pts. age (years) def 1 def 2 def 3 Kielb, et al [61] 90 59.6 76% 99% RRP Sebesta, et al [62] 675 <65 43.7% 69.2% 82.2% RRP Lepor and Kaci [63] 92 58.7 44.6% 94.6% RRP Olsson, et al [55] 115 65.2 56.8% 78.4% 100% LRP Madalinska, et al [64] 107 62.6 33% 65% RRP Deliveliotis, et al [65] 149 66.5 92.6% RPP Harris, et al [66] 508 65.8 96% RPP Maffezzini, et al [67] 300 65.5 88.8% RRP Hofmann, et al [68] 83 74.7% 88% RRP+/-Rx Ruiz-Deya, et al [69] 200 63 93% RPP Augustin, et al [70] 368 63.3 87.5% RRP Anastasidis, et al [73] 70 65 67 RRP 230 64 72 LRP Sacco, et al [74] 985 65 83 92 93 RRP Jacobsen, et al [72] 172 64 87 88 RRP 67 61 83 50 LRP Rassweiler, et al [71] 219 65 89.9% RRP 219 64 90.3% LRP correlation between age and continence status, but responsible for the age-related increase in post- only 21 of the 593 patients were 70 years or older [84]. operative SUI, and successfully demonstrated a Others have found advancing age and the number of progressive reduction in sphincter striated muscle co-morbidities to have a negative impact on the cells with age [16]. recovering time for continence during the first year afer Most large series have found no correlation between radical prostatectomy [85] although the rate at one and the stage of disease and incontinence rates [80, 81, two years did not seem to be significantly affected 89-91] Loeb and colleagues specifically demonstrated [86] Mohamad and colleagues reviewed 16,524 excellent continence rates even in high risk (high local patients who underwent RRP in public hospitals, stage) patients [92]. However, in certain cases, the covering 95% of all procedures in Austria between stage of disease may affect the surgical technique 1992 and 2003. They found that increasing age was (i.e. nerve sparing) and incontinence rates may be associated with an increased risk of future AUS higher, but this appears to be a reflection on surgical implantation. In those aged 45-49, 0.5% were bothered technique and not disease stage [82]. enough by PPI to merit AUS placement, while those age 70-74 were five times as likely to undergo AUS Regarding surgical technique, the many parameters placement for PPI. [87] Similarly, Rogers, et al involved in continence may explain difficulties in demonstrated that age affected post-operative understanding the benefit of certain technical points. continence status following laparoscopic RRP. In those Bladder neck preservation has been reported to < 50 years old, 100% achieved 0-1 pad per day improve continence at 3 months [90] no difference continence at 1 year, which decreased to 91% and was found at 6 and 12 months [93, 94]. Nerve sparing 81% for those age 50-59 and > 60 yrs, respectively has no significant impact according to Steiner et al. (p<0.01) [88]. Strasser and colleagues hypothesized [84] and Lepor and Kaci [66] recently confirmed this. that age related sphincteric changes may be Others did find benefit [76]. In particular, Nandipati and

1127 colleagues reported that in a cohort of 152 patients compliance, however this parameter is difficult to followed prospectively, bilateral nerve sparing surgery measure [102]. Scarring may lead to an anastomotic was associated with a shorter time to regain continence stricture evidenced by endoscopy or urethrography, as well as improved long-term continence rates and is clinically suspected when both incontinence compared to non-nerve sparing surgery. They and decreased force of stream coexist. additionally found that increased age was a risk factor The pre-operative length of the membranous urethra for post-prostatectomy incontinence.[95] Burkhard, determined on MRI has been shown to be significantly et al. similarly demonstrated a positive effect of nerve- related to time to post-operative continence. When sparing surgery on post-operative continence. In a urethral length was greater than 12 mm, 89% of the prospective cohort study of 536 patients, PPI patients were continent at one year, versus 77% with developed in 1/75 (1.3%), 11/322 (3.4%), and 19/139 or less than this length [105]. Urodynamic studies (13.7%) with attempted bilateral, attempted unilateral revealed that a reduced functional urethral length was and without attempted nerve sparing, respectively. a predictive parameter of incontinence [76, 106, 107]. Attempted nerve sparing was in fact the only Different components of the urethra may also be statistically significant factor influencing urinary involved. The urethral intrinsic component responsible continence after RRP in this cohort. [96] for passive continence as well as the extrinsic Within the last decade, laparoscopic and robotic- component responsible for active continence may be assisted laparoscopic radical prostatectomy have involved as has been demonstrated in a urodynamic become standard treatments for men with prostate alpha blockade test [108]. This may explain passive cancer. At this time the body of available data on post- incontinence despite a high voluntary urethral pressure operative continence is limited, but it would appear that or that measured during an active squeeze by the incontinence rates are similar between open and patient. Post-operative disruption of the innervation of laparoscopic/robotic approaches. Several studies the posterior urethra may also be involved and can have compared the techniques either prospectively in affect both motor and sensory functions [109, 110]. In non-randomized fashion, [72, 73] retrospectively, [97] clinical practice, urodynamic evaluation of a urethral or via limited meta-analysis [71, 98] and similar weakness may be assessed by resistance to continence rates were found. Further prospective antegrade leakage (ALPP or VLPP), retrograde comparative studies with open surgery are needed. leakage, or profilometric measurement (MUCP) [111]. However no such parameters have been correlated Perineal prostatectomy is done by only a limited to outcomes of treatments for the correction of post number of urologists but is still advocated for obese prostatectomy incontinence. patients and the continence rate was reported as similar to the retropubic route [66, 99, 100]. The state of a patient’s pelvic floor may also influence continence or return to continence after RP. 3. PATHOPHYSIOLOGY Physiotherapy and pelvic floor rehabilitation have Post-prostatectomy incontinence, like any urinary been shown to improve or enhance continence incontinence, may be caused by bladder dysfunction, (decreased time to final continence level) in the post sphincter dysfunction or a combination of both. operative period in two randomized studies, but only Urodynamic investigations are helpful to rule out if such measures are instituted before or immediately bladder outlet obstruction or significant bladder after catheter removal [112, 113]. Maximum difference dysfunction. In addition to incontinence symptoms, between physiotherapy and no treatment is achieved storage and voiding symptoms may be associated at 3 months, with almost no difference at 12 months. [99, 101]. Urodynamics demonstrated that the Another study showed that providing patients with sphincter incompetence occurs as the sole cause in instructions for pelvic floor muscle exercise alone was more than two thirds of patients, while isolated bladder equivalent to biofeedback or electrical stimulation dysfunction (detrusor overactivity, poor compliance, [114]. A randomized study in which randomization detrusor underactivity during voiding) is uncommon, occurred 6 weeks after surgery showed no difference occurring in less than 10% [102, 103]. However, in continence at 6 months [115]. On the same note, sphincter and bladder dysfunction can coexist in at studies in which physiotherapy was used as a least one third of incontinent patients. Bladder treatment modality for established incontinence have dysfunction may occur de novo after prostatectomy shown more variable results [116-119]. perhaps induced by bladder denervation; may be 4. SURGICAL AND MINIMALLY INVASIVE caused by outlet obstruction, or may be related to TREATMENTS pre-existing factors such as the age. Impaired detrusor contractility and poor compliance resolved in the a) Urethral bulking agents majority of patients within 8 months [104]. Urethral bulking is a minimally invasive treatment Decreased sphincter resistance may be due to tissue proposed for post prostatectomy incontinence, and scarring in some cases and reflected by a low urethral theoretically works by adding bulk and increasing

1128 coaptation at the level of the bladder neck and distal are under investigation for female stress urinary sphincter. It can be done in an office or outpatient incontinence, although there is minimal data on the setting in a retrograde or antegrade fashion. Several use of these agents in men with post RP incontinence, different agents have been used for urethral bulking it is certainly hoped that their effect will be better than in men including bovine collagen (Contigen®), and those of currently available agents. These agents silicone macroparticles (Macroplastique®). All agents include carbon coated zirconium oxide beads share the similar problems including the need for (Durasphere®), hyaluronic acid dextranomer multiple injections, deterioration of effect over time, and (Zuidex®), dimethyl sulfoxide/ethylene vinyl alcohol very low cure rates. copolymer (Tegress®, Uryx™), hydoxylapatite spheres in carboxylmethylcellulose carrier (Coaptite), and For collagen, “success rates” for post-prostatectomy autologous muscle cells, stem cells, and fibroblasts. incontinence range from 36-69%, with 4-20% of In a single institution series of 18 patients followed for patients reporting being dry [120-127]. Unfortunately, an average of 4.2 months, injection of ethylene vinyl the end points in most of these studies are subjectively alcohol copolymer, (Tegress, C.R. Bard, Inc., based, making comparisons difficult; however, it is Covington, GA) 41.1% of patients achieved at least clear that cure rates (total dryness) are low, and a 50% improvement, but the complication rate was multiple injections are required to achieve modest 58.8%. Accordingly, this compound is no longer rates of subjective improvement. There is no available as an injectable agent [133]. advantage of delivery technique (retrograde vs. antegrade). Several authors have identified factors Transurethral injection of living muscle stem cells to which negatively affect results include extensive reconstitute the deficient urethral sphincter has recently scarring or stricture formation, previous radiation, and been introduced. Mitterberger and colleagues high grade stress incontinence and low ALPP [121, demonstrated a 67% continence rate at an average 123, 124, 127]. One study reported more favorable of 1 year follow-up in a cohort of men suffering from results for collagen in treating incontinence after PPI who were treated with transurethral ultrasound transurethral prostatectomy as opposed to radical guided injections of autologous fibroblasts and prostatectomy (35.2% ‘social continence’ versus myoblasts obtained from skeletal muscle biopsies 62.5%) [124]. It appears that collagen injection does [134]. An earlier report from the same group not adversely affect outcomes of artificial sphincter demonstrated that men with PPI achieved a 52% dry implantation and does not increase the complication rate with injection of adult autologous stem cells, rate [128]. Nor does collagen injection adversely affect which was superior to a similar cohort of men treated the outcome of the bone-anchored male sling (BAMS). with collagen injection [135]. However, it must be [129, 130] The cost efficacy of injections remains to pointed out that there was a retraction issued by the be determined. editors of The Lancet [136] for a previous article on Other bulking agents such as polydimethylsiloxane the treatment of female SUI with autologous cells (Macroplastique®) have shown some initial success, published by the same group [137]. The project was but results also deteriorate over time. Bugel and co- investigated by the AGES PharmMed, a department workers treated 15 patients. They noted rapid of the Austrian Government’s Agency for Health and deterioration after initial improvements with success Food Safety. The editors stated that in their view “the rates of 40%, 71%, 33%, and 26% at 1,3,6, and 12 conclusions of the official investigation pinpoint so months respectively [131]. They also noted that a many irregularities in the conduct of their work that, taken together, the paper should be retracted from the urethral closure pressure of at least 30 cmH2O was essential for success. Kylmala et al. prospectively published record.” studied 50 patients with mild to moderate SUI (average Conclusion: Bulking agents remain the most minimally 48 cc on 1 hour pad test), with 12% achieving short- invasive treatment for post RP incontinence after term continence following 1 injection, and an additional conservative measures. All agents for which there is 20%, 18%, and 10% achieving continence with 2, 3, peer-reviewed data available, show only modest and 4 injections respectively. Follow-up, however, success rates with very low cure rates. Effects tend was limited to 3 months [132]. In a randomized trial to deteriorate over time. It remains to be seen if of AUS versus Macroplastique injection in patients improvements in outcomes can be achieved with with minimal SUI (the vast majority had SUI following alternative agents, or if the concept of urethral bulking BPH surgery, with greater than1/3 of the cohort has achieved its maximal benefit with the agents suffering from SUI following RRP), Imamoglu and available now. (Level of evidence 3; Grade of colleagues demonstrated no difference in success recommendation C) with AUS versus Macroplastique. However, in patients with more severe incontinence, AUS was superior, b) Male sling with minimal improvement following transurethral The male sling procedure is based upon the concept Macroplastique [47]. of passive external urethral compression, and has Several other bulking agents are currently used or recently emerged as a treatment for PPI. The male

1129 sling is actually based on the concept similar to that and additional 6% improvement in 19 patients, with described by Kaufman and associates in the early a mean follow up of 14 months. Eight intraoperative 1970’s [138-140]. At that time a high rate of failure, bladder perforations healed without complication. septic complications and pelvic pain as well as the Xu and colleagues described a bulbourethral advent of the mechanical artificial urinary sphincter composite suspension utilizing a suburethral polyester (AUS) led to the abandonment of the Kaufman patch plus a narrow polypropylene tape passed from prosthesis. Now with the higher prevalence of PPI a perineal incision to a suprapubic incision. At an and patient desire for less invasive surgery and a average of 28 months, 22 (85%) of 26 patients were non-mechanical device the concept has been revisited. successfully treated [149]. Procedures have been developed based on principles used to treat female stress urinary incontinence using The most common method of sling fixation involves biological and synthetic graft materials. These use of bone anchors. The bone anchored male sling procedures rely on compression from the ventral side (BAMS) has increased in popularity, as bone anchor of the urethra rather than the circular compression fixation obviates the need for any suprapubic incision caused by a natural or artificial sphincter. Therefore, for suture passage and fixation. Since 2001, reports most successful sling surgeries rely on a device that of the BAMS have become more prevalent in the is placed under tension, occluding the urethra at rest, literature. In 2001, Madjar, et al reported on 14 patients and during stress manoeuvres [141-143]. with post RP incontinence that underwent the Schaeffer and Stamey described the bulbourethral procedure with a synthetic or cadaveric fascial sling sling which uses Dacron bolsters placed under the [150]. At a mean follow up of 12.2 months, 86% were urethra, which are suspended to the anterior rectus “cured” wearing none or 1 pad. Comiter reported a 76% fascia by sutures [144]. Data on this procedure are cure and 14% “substantially improved” rate in 21 men limited to retrospective analyses from the two authors with post prostatectomy incontinence using who described the procedure: it has never gained polypropylene mesh with a mean follow up of 12 widespread popularity. In the initial report from 2 months [129]. In a 2005 update, the same author centers, 64 patients were included and 56% were reported that with a median of 48 months follow-up, “dry” and 8% “improved” at a mean follow up of 22.4 65% of patients remained pad free and 15% required months [144]. Almost one-third needed secondary 1 pad per day [151]. Urodynamic follow up in 22 men, retightening procedures and patients with radiation revealed that the sling had no significant effects on fared poorly. Subsequently, Clemens, et al reported voiding function and no man was obstructed a questionnaire-based study of 66 men from a single postoperatively [152]. Onur and colleagues reported institution and 41% were cured and 51% improved but on 46 men with a mean follow-up of 17 months (6-26) mean follow up was only 9.6 months [145]. They also [153]. They used different materials for the sling reported that the bulbourethral sling did not cause (allograft dermis, allograft fascia lata, porcine small significant outlet obstruction [146]. intestine submucosal (SIS) graft, synthetic mesh, and a composite of synthetic and dermis). Overall they The long-term efficacy of the bulbourethral sling was reported 41% of patients dry and 35% improved (50% evaluated in 2005, where 95 patients were followed reduction in the number of pads). All patients in whom retrospectively at an average of 4 years post- allograft or xenograft alone were used failed. A 24- operatively. With follow-up questionnaires returned month update from that group revealed a patient by 71 patients, the authors found that in patients who satisfaction rate of 70% and a 74% improvement in had undergone radiation, had worse outcomes with leakage at a median of 24 months [154]. 14% dry and 43% requiring 1 or 2 or fewer pads daily. Those patients who had not had radiation treatment Several new slings have been introduced, with a had a cure rate of 42% and 72% used only 0-2 pads common objective of overcoming the potential problem per day for mild leakage [147]. Others have described of overcorrection or undercorrection of continence. a bulbourethral sling using a polypropylene mesh Transobturator slings have been introduced, [44, 155, graft with or without a porcine dermis backing 156] which rely more on rotation of the dorsal surface of the proximal bulbous urethra and indirect support (presumably to reduce the risk of erosion) [48]. In two of the sphincteric urethra, rather than direct small studies of 9 [148] and 16 [48] patients cure rates compression of the urethral lumen [157]. However, range from 56-69% and failure rates from 22-25% at small numbers of patients, with limited follow-up do a mean follow up of 14 months. Recently, John not allow for adequate assessment of this new described the bulbourethral composite suspension technique enjoying early popularity. where porcine dermis is secured to the bulbospongiosus muscle and a 1 cm wide poly- In an effort to overcome the problem of under- propylene sling is placed over this and passed through correction, two “adjustable” slings have been the retropubic space to emerge from two suprapubic introduced — the readjustable sling procedure incisions (similar to the tension free vaginal tape (REMEEX), [158], and the “Argus” [159] In 48 patients procedure in women) [48]. He reported a 69% cure reported in a Phase III multicenter trial of the Argus

1130 sling, a 73% continence rate and additional 10% incontinence questionnaires. Success was determined improvement rate was realized at an average of 7.5 by the Patient Global Impression of Improvement. months. Erosion and infection necessitated sling Overall, 36/62 (58%) of surgeries were successful at removal in 10% of patients. Adjustments were indicated a mean follow-up of 15 months. The only preoperative for persistent incontinence as well as for urinary predictive factor was 24-hour pad weight. If pad weight retention. In a prospective multicenter Phase II trial was less than 423 gm, there was a 6-fold greater of the Male Remeex System (MRS) adjustable sling, success rate compared to those with a pre-operative 51 patients were followed for an average of 32 months pad weight of greater than 423 gm. (range: 16-50). With 90% of patients requiring at least Finally, previous AUS placement and explantation 2 adjustments, a continence rate of 64.7% was predict sling failure [152, 163]. However, it is not clear achieved, with an additional 19.6% realizing if this is directly due to the urethral fibrosis and poor improvement over baseline [160]. urethral coaptability, and/or if those patients simply Sling results are shown in Table 4 [40, 41, 48, 144, suffer from more severe incontinence, which interferes 147-154, 158-165]. with successful sling surgery.

1. COMPLICATIONS CONCLUSION Due to the small size of most reported cohort series In the intermediate term, the male sling appears to of male sling patients, and due to the limited body of perform reasonably well. In the UK as well, the literature on the subject, the precise complication rate National Institute for Health and Clinical Excellence is [163] not known. However, reports from the largest (NICE) has stated that current evidence on the cohorts of patients reveal an infection rate ranging safety and efficacy of slings appears adequate to from 0-6%, and a urethral erosion rate of 0-2% [41, support their clinical use [167]. 151, 163]. Bothersome scrotal pain or numbness The best candidates appear to be those with lower affects 16%-72% of patients post-operatively, but has and moderate degrees of incontinence, who have been reported to resolve in all patients by 3 months not had previous radiation. While reported revision [151, 165]. Reported rates of recurrent incontinence rates due to recurrent incontinence are quite low, following sling surgery, amenable to revision surgery, longer follow-up is obviously needed before definitive are low (<5%) [41, 151, 154]. But the small sizes of comparisons to the AUS can be made. Nevertheless, the cohorts, and the limited follow-up of < 5 years in men with adequate detrusor contractility and mild prevent meaningful comparisons to the AUS at this to moderate degrees of SUI, or for patients time. Urinary retention is uncommon with male sling demanding a less invasive procedure or non- surgery, and may be avoided by excluding those mechanical device, a sling procedure is a reasonable patients with detrusor underactivity on pre-operative alternative to artificial sphincter, although longer urodynamics [165, 166]. term outcome is unknown. (Level of evidence 3; Grade of recommendation C) 2. PREDICTORS OF SUCCESS

Several cohort studies have demonstrated that prior 3. ADJUSTABLE BALLOONS radiation therapy is associated with diminished efficacy of the male sling, probably due to urethral fibrosis The adjustable balloon procedure is based upon the and inadequate urethral coaptation [147, 153, 165]. concept of passive compression of the urethra utilizing In addition, the use of organic (resorbable) material two balloons located on either side of the urethra. is less efficacious than synthetic (permanent) sling Balloons may be progressively inflated until there is material [153, 163, 165]. The treatment of male ISD optimal coaptation, thereby achieving continence. with a suburethral sling requires tension which can only The biomaterial name ACT™ (Adjustable Continence be maintained with the use of synthetic material. Pre- Therapy) was originally conceived and developed for treatment severity of incontinence measured by the female stress urinary incontinence, and subsequently degree of leakage also appears to influence sling was applied to male incontinence. The proACT™ results. Several reports indicate that those with more device was developed and reported in 2000 [168]. severe leakage do not achieve similar continence The device consists of a silicone elastomer balloon rates when compared to those with milder leakage attached to an injectable titanium port via a silicone [153, 163, 165]. Fischer and colleagues were able to tube. A balloon is implanted on either side of the quantify, in prospective fashion, that leakage greater urethra, either under the bladder neck for post-radical than 423 gm on pre-operative pad weight predicted prostatectomy incontinence, or under the veru an inferior outcome, compared to those men with less montanum for post TURP-incontinence. The ports leakage on pre-operative pad weight test [41]. In their are located subcutaneously in the scrotum, allowing report, 62 patients with SUI were followed pros- simple access for percutaneous adjustment of the pectively. All patients were rigorously evaluated with balloon volume. The implantation is performed under 24-hour pad test, urodynamics and validated general or spinal anesthesia through a short perineal

1131 Table 4. Results of sling procedures in males with stress urinary incontinence

Authors No. Mean Follow Sling type Cured (%) Improved (%) Failed(%) Patients -up (months) Thüroff [161] 22 10.3 Fascia sling with supra- 63.6 9 27.3 pubic and perineal approaches Madjar, et al[150] 16 12 Synthetic or organic 86 14 0 Dikranian et al[40] 36 12 Organic 56 87 31 20 12 Synthetic 13 13 0 Ullrich & Comiter 36 25 Perineal (Invance®) 67 25 8 [152] Onur et al [153] 46 18 Synthetic or organic 41 35 24 John [48] 16 14 Polypropylene suspen- 69 6 25 ded suprapubically plus porcine skin collagen Stern et al[147] 75 48 Bulbourethral 36 32 32 suspension Rajpurkar et al 46 24 Synthetic 37 37 26 [154] or organic Comiter [151] 48 48 Synthetic 65 20 15 Castle et al [163] 42 18 Synthetic 16 24 60 Migliari et al. [148] 9 14 Polypropylene needle 55.6 22.2 22.2 suspension Cespedes & 9 13 Perineal 66.7 11.1 22.2 Jacoby [162] (Invance®) Schaeffer et al. 64 18 Vascular graft bolsters 56 8 36 [144] with needle suspension Gallagher et al 24 15 Synthetic 38 37 25 [164] Sousa-Escandon 6 18 Readjustable synthetic 83.3 16.7 - et al. [158] suprapubic and perineal Moreno-Sierra 48 7.5 Argus -adjustable 73 10 17 et al. [159] Romano et al.[160] 51 32 REMEEX- adjustable 64.7 19.6 15.7 Fischer et al.[41] 62 15 Perineal (Invance®) 34 24 42 Xu et al. [149] 26 28.3 Bulbourethral composite 73 19 8 suspension Giberti et al[165] 36 41 Synthetic or organic 62 8 30

1132 incision. A trocar covered with a U-shaped sheath is early in their series, but a lower urethral perforation inserted up to the site of implantation, and then the rate in the most recent cases – illustrating a relatively balloon is pushed along inside the sheath. Fluoroscopic short learning curve for optimal balloon placement and urethroscopic guidance are used for the near the urethral/bladder wall. Temporary urinary procedure. Transrectal ultrasound guided implantation retention from presumed obstruction was reported at [169] is a possible option. An isotonic medium with 5% [43]. Voiding was restored by removing fluid from sterile water and contrast medium is prepared to fill the balloon. the balloons with 2 ml during the initial procedure. Device explantation related to balloon failure, infection, Then, after a period of time, approximately one month, erosion, or migration. The explantation rate ranged the balloons are refilled with 1 ml of this solution at from 12 to 58% [43, 46, 170-173], but decreased with each period (maximum filling is 8 ml) until continence experience [43]. Device removal is straight-forward, is achieved. The adjustment of the filling are volume as a deflated balloon can be explanted transperineally. limited and are carried out step by step in order to The only reported risk factor for failure and obtain a pseudo-capsule surrounding the balloons complications was prior external beam radiotherapy and therefore to minimize the risk of urethral erosion [46]. Kocjanic et al. [173] demonstrated a continence or migration. Results from 6 prospective studies [43, rate of 67% in non-radiated patients compared to 46, 170-173] reported are shown in Table 5. Of 170 36% in radiated patients. patients reported by Hubner [170] and Lebret [46], one-third became pad free. In other studies 70% of CONCLUSION patients utilized 0-1 pads daily [46, 170-172]. Mean procedure time of 35 minutes was reported. Along The proACT™ balloon technique appears to be a with this improvement in pad use, there were parallel feasible procedure to improve the continence in improvements in I-Qol quality of life score [46, 170, short and median term, with better results occurring 171]. Based upon theses trials, the mean number of with more operator experience. Similar to the male post-operative adjustments of the balloon was 3 to 5, sling procedure, appropriate candidates include with some patients requiring 6 to 8 refillings. those with mild to moderate leakage due to intrinsic 4. COMPLICATIONS sphincter deficiency, and no previous radiation. The benefit of an adjustable system should be weighed The most common peri-operative complications are against the need for multiple sessions of refilling urethral or bladder perforation, necessitating the balloon, and with reported rate of peri-operative termination of the implant on the perforated side. and post-operative complications. Longer follow- However, contralateral implantation was not adversely up is needed before definitive comparison to male affected, and repeat ipsilateral implantation was sling or artificial sphincter can be made. No invariably achieved after healing of the urethral or recommendation is possible due to variable data on bladder wall. Lebret et al. [46] reported a perforation complication rates (12-58%). (Level 3, Grade D). rate of 10% and Hubner [43] reported a rate of 18%

Table 5. Results and complications of six prospective series of Adjustable Balloons (proACT) in post- prostatectomy urinary incontinence Authors Number Follow- Number of Postoperative Continence Complete of patients up (mo) adjustments Complications 0 or 1 pad/day Continence (balloon with explantation refilling) (uni or bilateral) Hubner [170] 117 13 (3-54) 3 (1-15) 46 % 68 % (46/63) 35 % (22/63) (idem at 1 and 2 years) Trigo-Rocha 23 22 (6-48) 5 (1-6) 17 % 65 % (15:23) [171] Hubner [43] 50 versus 20 vs 23 5 vs 4 58 % vs 24 % 52% vs 60 % 50 (first pts /last pts) Cansino Alcaide [172] 69 22 (3-48) 2 12 % 70 % 14 % Kocjancic 64 20 (12-62) 3 (0–8) 17 % 67 % [173] Lebret [46] 62 6 4 31 % 71 % 30 %

1133 c) Artificial urinary sphincter urethral atrophy, infection and erosion vary considerably among studies with respectively reports The artificial urinary sphincter remains the most of 8-45% and 7-17% [192]. In a large cohort reported effective long term surgical treatment for post RP by Lai and colleagues [187], non-mechanical failure incontinence due to sphincteric insufficiency. However, has decreased from 17% to 9% and mechanical failure due to the cost of the device, patient reluctance to have decreased from 21% to 8% following introduction of or inability to use a mechanical implant, and fear of complications, it is not ideal for all patients. In addition the narrow back cuff and mean time to reoperation was the development of less invasive techniques (as 26.2 months (mean 2-68 months). With a Kaplan- described above) potentially gives patients new options Meier analysis, the overall 5 year expected product for treatment. Ultimately the choice of AUS will be survival was 75%. Only 6% of devices failed based upon patient dexterity, economics, degree of mechanically, at an average of 68.1 months, with 75% incontinence and patient expectations from surgery. of patients requiring no revisions at 5 years. Actuarial freedom from revision at 5 years was estimated at The AUS has the longest track record of success in 50%-75%. the treatment of PPI. Two studies have reported that about half of the patients with severe incontinence The long term efficacy of the AUS was demonstrated will undergo AUS implantation [174, 175]. However, by Fulford et al who reported that at 10-15 year these studies were conducted before male slings and followup, [193] 75% of patients with an implanted bulking agents became popular. The success rates for AUS either still had or died with a functioning device. AUS as defined by a continence status of zero to one Revisions include replacement of the malfunctioning pad per day range from 59% to 90% [176, 177], as part, cuff replacement, repositioning or downsizing shown in Table 6 [51, 176, 178-187]. Just as with due to urethral atrophy, a second or tandem cuff [194, reported rates of incontinence following prostate 195] or transcorporal cuff placement [196]. cancer surgery depend on the definition of Transcorporal cuff placement, which involves inserting incontinence, continence rates with the AUS can vary the cuff through the corporal bodies to avoid perforating with the definition of continence, the method of the dorsal aspect of the urethra, can be particularly evaluation, and the length of follow-up. The lowest useful for patients with prior radiation or urethral rates are from patient administered questionnaires erosion; however potency if present may be when pad free rates range from 10-72% [179, 188- compromised. Some have advocated tandem cuffs not 192]. Nevertheless, high satisfaction rates of 87% to only as a salvage procedure, but also as a primary 90% are consistently reported, even without total procedure for men with severe incontinence [197, continence [180, 184, 188]. 198]. However, O’Connor et al. recently reported no One potential downside of the AUS is the need for difference in continence outcome and a higher revision periodic revisions in a number of patients. Revision rate in patients undergoing double-cuff implant versus and explantation rates due to mechanical failure, single-cuff after longer follow up [199].

Table 6. Results of the artificial urinary sphincter in post-radical prostatectomy incontinence. Author No. pts. Follow-up (yrs.) 0-1 pad/day Montague [178] 66 3.2 75% Perez and Webster [176] 49 3.7 85% Martins and Boyd [179] 28 2 85% Fleshner and Herschorn [180] 30 3 87% Mottet, et al [181] 96 1 86% Madjar, et al [182] 71 7.7 59% Klijn, et al [183] 27 3 81% Haab, et al [184] 36 7.2 80% Trigo Rocha, et al [51] 40 4.5 90% Kim, et al. [186] 124 6.8 82% Lai, et al. [187] 218 3.1 69% Goldwasser [185] 42 1.2 82%

1134 An increased revision rate has been reported for mean of 26 months post-operatively. It could not be patients who received pelvic radiation [179, 200] but demonstrated, however, that long term continence is was not found in a recent series [177]. The results for improved by early injection of bulking agent. Similarly, continence for radiated patients are variable with Jones and colleagues [204] demonstrated in a some studies showing lower success rates [176, 200] comparative cohort study of RRP patients treated while others do not [191]. It has been recommended either with or without a simultaneous suburethral sling, that such patients have a lower pressure reservoir that sling placement at the time of RRP resulted in an and/or longer period of deactivation time [179]. earlier return to continence. There was no difference after 24 months. (Level of evidence 4; Grade of CONCLUSION recommendation C) The AUS remains the gold standard for the treatment of PPI secondary to sphincteric insufficiency in IV. INCONTINENCE AFTER patients with severe incontinence, and in those who PROSTATECTOMY FOR BENIGN have had external beam radiation treatment. It has the largest body of literature reporting long-term DISEASE success. The long term success rates and high patient satisfaction seem to outweigh the need for 1. INCIDENCE AND RISK FACTORS periodic revisions in some patients. Intermediate The incidence of urinary incontinence after term data with the male sling demonstrates that the prostatectomy for benign disease has been reviewed sling is an alternative to the AUS in patients with mild- moderate SUI, provided that those patients have and described in the AHCPR “Benign Prostatic not failed previous AUS surgery, have not had Hyperplasia” linical Practice Guidelines [205]. The radiation treatment, and have normal bladder following percentages for stress incontinence and contractility. Overall, the AUS remains the reference total incontinence, respectively, were reported: standard to which all other treatments must be • Open surgery (retropubic or transvesical compared. (Level of evidence 2; Grade of prostatectomy): 1.9% and 0.5%. recommendation B) • TUIP (transurethral incision of the prostate): 1.8% 5. TIMING OF SURGICAL INTERVENTION and 0.1%. There are no clear data on timing of a surgical • TURP (transurethral resection of the prostate): intervention for the treatment of PPI, either with benign 2.2% and 1.0%. or malignant disease. Therefore, at present guidelines These figures were based on studies reported before as to timing of the surgery cannot be formulated. A 1990. Several other series were published after 1990. certain period of watchful waiting supplemented with These series were reviewed for the 1st, 2nd, and 3rd conservative measures, particularly pelvic floor International Consultations on Incontinence [1, 206, physiotherapy, seems to be a reasonable option. 207]. A clear description of the method of follow-up and Thus, conservative management may be tried for assessment of the continence status was indicated in periods of up to 6-12 months depending on whether only about one third of these studies. The incidence there is any progress noted by the patient. In a of incontinence after open surgery, TURP, TUIP and prospective cohort study of men undergoing RRP, HoLEP is low: the reported percentages ranged 63 Lepor and Kaci demonstrated continued recovery between 0 and 8.4%. Since the method of assessment of continence up to 24 months post-operatively, from of the continence status and the definition of 80.6% at 3 months to 95.2% at 12 months, plateauing incontinence is rarely stated it is actually not possible at 98.5% at 24 months. Other cohort studies have to make a distinction between simple stress demonstrated a plateau in continence rates at 12 incontinence and total incontinence. There is no clear months [201, 202]. Since continence may improve indication that the incidence is affected by patient age up to 12 months post-operatively, and possibly even or (resected) prostatic volume [206]. In a retrospective until 24 months, it is generally recommended that chart review from Wendt-Nordahl and colleagues behavioral/conservative management be utilized [208], the incidence of incontinence following TURP during the first year after prostate cancer surgery. was reported to have decrease over 17 years, from There have been some studies evaluating the effect 3.3% in 399 patients operated on between 1987 and of early interventional treatment for incontinence. 1997, compared to 1.3% in 550 patients operated on Schneider and colleagues [203] demonstrated a from 1997-2004. Whether this statistically significant beneficial effect on the earlier return to continence (p< 0.05) difference was due to improvement in with early injection of periurethral bulking agent. surgical technique or patient characteristics is not Results were better in the subgroup of 34 patients clear, however both the earlier and later incontinence that were injected early (mean 23 days post- rates are consistent with those in the AHCPR and operatively) compared to 10 patients treated at a AUA guidelines reports. 1135 In 2003, the AUA published guidelines for the In summary, the AUS is a successful surgical treatment management of “benign prostatic hyperplasia” [209]. option for post-prostatectomy incontinence. It is the The estimated frequency of incontinence following most commonly performed surgery for post- TURP was 3% (from 19 trials that included > 5000 prostatectomy incontinence, with the longest follow- patients). However, the Veterans Affairs Coope-rative up and therefore longest record of success. Level of Study, reported an incontinence rate of only 1% in evidence 2; Grade of recommendation B) TURP patients, which was not different from the watchful waiting arm [210]. The AUA conducted meta- b) Injectable agents analysis of RCTs comparing TURP with TUIP or Most series include post-prostatectomy incontinence transurethral electrovaporization did not reveal any after treatment for benign and malignant disease, with statistically significant differences in incontinence the majority after prostate cancer surgery. For collagen, rates [209, 211-214]. “success rates” range from 36-69%, with 4-20% of Over the past decade, transurethral holmium laser patients reporting being dry [120-127]. Study results enucleation of the prostate (HoLEP) has become a are inconsistent with both TURP [224] and radical standard treatment for BPO. Review of RCTs by the prostatectomy [225] showing better outcomes. AUA as well as a meta-anlaysis of RCTs comparing Other bulking agents such as polydimethylsiloxane TURP with HoLEP did not reveal any significant PDMS (Macroplastique®) have shown some initial differences in incontinence rates [209, 215-221]. success, but results also deteriorate over time. Bugel In summary, the incidence of urinary incontinence and co-workers treated 15 patients. They noted rapid after open surgery, transurethral resection of the deterioration of initial improvements with success prostate, transurethral incision of the prostate, and rates of 40%, 71%, 33%, and 26% at 1,3,6, and 12 holmium laser enucleation of the prostate is low, and months respectively [131]. As mentioned previously does not differ significantly among the various in the section on post-radical prostatectomy techniques. incontinence Kylmala et al. prospectively studied 50 2. TIMING OF SURGICAL INTERVENTION patients with mild to moderate SUI (average 48 cc on 1 hour pad test), with 12% achieving continence There are no clear data on timing of a surgical following 1 injection, and an additional 20%, 18%, intervention for the treatment of incontinence, as and 10% achieving continence with 2, 3, and 4 mentioned above in the section on post-radical injections respectively [132]. Follow-up, however, was prostatectomy. Therefore, at present guidelines as to only 3 months. In a randomized trial of AUS versus the timing of surgery cannot be formulated. A certain Macroplastique injection in patients with minimal SUI period of watchful waiting supplemented with (the vast majority had SUI following BPO surgery, conservative measures, particularly pelvic floor with less than1/3 of the cohort suffering from SUI physiotherapy, seems to be a reasonable option. following RP), Imamoglu and colleagues demonstrated Thus, conservative management may be tried for no difference in success with AUS versus periods of up to 6-12 months depending on whether Macroplastique. However, in patients with more severe there is any progress noted by the patient. (Level of incontinence, AUS was superior, with minimal evidence 4; Grade of recommendation C) improvement following transurethral Macroplastique [47]. There has also been some initial work with 3. SURGICAL TREATMENT OPTIONS sphincteric injections of muscle stem cells [134, 135]. a) Artificial sphincter Bulking therapy fails in up to 75% of men. Of those The literature on this subject was reviewed for the who are improved only a minority actually becomes 1st, 2nd, and 3rd International Consultations on dry with short-term follow-up. Although bulking therapy Incontinence [1, 206, 207]. Candidates for treatment may be slightly more efficacious in treating SUI with the artificial urinary sphincter (AUS) are patients following TURP compared to SUI following prostate with incontinence due to intrinsic sphincter deficiency cancer surgery, bulking is of limited value in those that have normal bladder compliance [222]. Detrusor men with all but minimal SUI. (Level of evidence 3; overactivity is not an absolute contraindication but Grade of recommendation C) the response to medical treatment should be assessed c) Male sling procedures before implantation of an AUS. The AUS has been placed around the bulbar urethra via a perineal route Since Frangenheim described his first successful or transverse scrotal routes [223] or around the bladder urethral sling suspension for post-traumatic stress neck [1, 206, 207]. The above mentioned review of the urinary incontinence in 1914, various sling materials results obtained with the AUS indicated that more and surgical methods have been reported [226]. than 70% of the men treated with the AUS for this Rectus fascia, as described by Frangenheim, has indication are dry or almost dry after a follow-up of more distinct advantages over alloplastic materials with than 2-3 years. However, most series on the AUS respect to erosion and infection risks. Allograft off- include both post-prostatectomy incontinence for the-shelf-materials like lyophilized fascia lata have a benign and malignant disease [206]. higher infection risk than does autologous fascia, 1136 whereas the use of synthetic materials like polypropylene mesh or polytetrafluoroethylene slings V. SURGERY FOR INCONTINENCE IN are associated with a higher incidence of urethral ELDERLY MEN erosion [227]. According to various published techniques, the sling can be placed either underneath With an increase in the aging population and the bladder neck, the urethral bulb or the membranous improvements in anesthesia, availability of less portion of the urethra. The principle of continence invasive and shorter surgical procedures, reduced support is similar for all sling procedures and comprises blood loss and reduced infection risk more aged passive compression of the urethra, which is patients are candidates for surgical treatment. Although dependent on the applied sling tension [161]. This every surgeon should be aware of those special risks mode of action favours sling procedures as a treatment in elderly patients which might require special peri- option for intrinsic sphincter deficiency. operative care, even in the very old well planned However, the sling tension needed for restoration of surgical procedures can be safe, and are justifiable, continence has not been standardized, with tensioning if it helps to improve continence and besides benefiting techniques ranging from perfusion sphincterometry, general health status leads to a better quality of life to a cough test, to visual approximation, [153, 228] and for the individual. Many studies have documented therefore the success of the procedure probably that the frequency of peri-operative complications depends heavily to the surgeon’s experience and the increases with age [229]. This finding is not surprising degree of sphincteric incompetence. Overcorrection given that the prevalence of significant co-morbid with consequent urinary retention (especially in the conditions is increased in the elderly [230]. It is however setting of detrusor underactivity) and undercorrection unclear whether the increased frequency of with persistent or recurrent incontinence are certainly complications can be attributed to these co-morbid possible, which may adversely affect continence, conditions or whether advanced age itself is an bladder emptying, and patient satisfaction. Published independent risk factor [231]. success rates are shown in Table 4 [40, 41, 48, 144, PubMed and Medline searches were conducted in 147-154, 158-165]. May 2008 covering the time frame from 01.01.2004 Several new slings have been introduced, with a to the present. The terms ‘surgery, male and urinary common objective of overcoming the potential problem incontinence’ were used and the search was limited of overcorrection or undercorrection of continence. to English articles to update the previous Transobturator slings [44, 155, 156] rely more on comprehensive literature search done for the third rotation of the dorsal surface of the proximal bulbous edition of the ICI. urethra and indirect support of the sphincteric urethra, Data available are still sparse, since the search did rather than direct compression on the urethral lumen not differentiate between fit and frail elderly. Since [157]. However, small numbers of patients, with limited the latter are defined as patients with continuous follow-up do not allow for adequate assessment of this severe impairment and/or co-morbidity, they are usually new technique which is enjoying early popularity. not candidates for surgical treatment. In an effort to overcome the problem of under- Conflicting data are reported on age as an independent correction, two “adjustable” slings have been risk factor for incontinence after radical prostatectomy. introduced — the readjustable sling procedure In most reports, the patient’s age and preoperative (REMEEX), [158], and the “Argus” [159]. In 48 patients urine leakage are predictive of postoperative urinary reported in a Phase III multicenter trial of the Argus incontinence, whereas some came to the opposite sling, a 73% continence rate and additional 10% conclusion [232]. Advancing age as a risk factor is improvement rate was realized at an average of 7.5 supported by a number of studies [60, 79-83]. Steiner, months. Erosion and infection necessitated sling et al [84] found no correlation between age and removal in 10% of patients. Adjustments were indicated continence status, but only 21 of the 593 patients for persistent incontinence as well as for urinary were 70 years or older. However, Mohamad and retention. In a prospective multicenter Phase II trial colleagues reviewed 16,524 patients who underwent of the Male Remeex System (MRS) adjustable sling RP in public hospitals in Austria. They found that [160], 51 patients were followed for an average of 32 increasing age was associated with an increased risk months (range: 16-50). With 90% of patients requiring of future AUS implantation[87]. Similarly, Rogers, et at least 2 adjustments, a continence rate of 64.7% was al demonstrated that age affected post-operative achieved, with an additional 19.6% realizing continence status following laparoscopic RP [88]. As improvement over baseline. mentioned above, Strasser and colleagues hypo-

1137 thesized that age related sphincteric changes may therapy with botulinum toxin has been extended to the be responsible for such age-related increase in post- treatment of non-neurological detrusor overactivity of operative SUI, and successfully demonstrated a the bladder after other treatment failed. These options progressive reduction in sphincter striated muscle are discussed in the section on Refractory Overactive cells with age [16]. Bladder (see below). No data were found on how these techniques work in aging bladders. Since Others have found that advancing age and number detrusor contractiliy decreases with age [239] the of co-morbidities have a negative impact on the speed incidence of bladder emptying problems might be of recovery of continence during the first year post expected to be higher in the elderly. radical prostatectomy [52, 85], but the rate at one or two years does not seem to be significantly affected CONCLUSION [63]. Comparison of studies dealing with peri-operative risk of surgery in the elderly is complicated by the Age by itself should not preclude any patients from use of different definitions of diseases and outcomes, treatment. Although bulking agents are less invasive different modes of clinical care and diversity in the they have not yet been shown to be very effective. type of clinical procedure examined. Furthermore sub If co-morbidtiy, mental status and dexterity of the clinical diseases might not be detected and still may patient permit an invasive approach the implantation impose a risk factor. Although the overall frequency of an artificial sphincter, or a sling, should be offered of peri-operative complications is increased in the to the patient. (Level of evidence 3; Grade of elderly, it is still relatively low [233, 234]. recommendation C) Two frequently used options for incontinence in men after prostatectomy are injection therapy with bulking agents such as collagen and the placement of an VI. INCONTINENCE AFTER artificial urinary sphincter. O’Connor et al. [235] EXTERNAL BEAM RADIOTHERAPY concluded after having examined the outcome of ALONE AND IN COMBINATION WITH primary artificial urinary sphincter in 29 men aged 75 SURGERY FOR PROSTATE CANCER years and older, that implantation of AMS Sphincter should not been denied to a patient simply on the The risk of incontinence after external beam basis of age. Thiel et al [50] found in their study of 86 radiotherapy (EBRT) for prostate cancer is variable and men with artificial urinary sphincter surgery that older ranges from 0 to 18.8%. Lawton et al. [240] reported men conceived their improvement as less significant a risk of urinary complications of 7.7% in more than than younger men although the age difference between 100 patients, proportional to dose. Perez et al. [241] patients rated as ‘success’ and ‘failure’ was only two found incontinence in only 5 of 738 patients. Shipley to three years and thus might not be clinically relevant. et al. [242] reviewed more than 2500 cases with an (Level of evidence 2 and 3; Recommendation incontinence rate of 0.5%. Similar incidences have Grade B) been reported in more recent series. Madalinska et Before implanting an artificial sphincter in a fit aged al. [64] reported an incidence of 6-7%. With three- patient, mental status and dexterity have to be dimensional conformal radiotherapy, Weil and evaluated and discussed with the patient. No data colleagues [243] reported no incontinence in 168 could be found on how aging patients are able to consecutive patients and Hanlon et al. [244], in a manually operate and remember to use the artificial series of 195 men, found that post treatment urinary sphincter. symptoms were no different from a control group without cancer. With conformal radiotherapy, Sandhu Most studies looking at these options for incontinence et al. [245] reported a 9% incidence of stress after treatment of localized prostate cancer did not look incontinence in 110 patients. the impact of EBRT at age as an independent factor associated with certain followed by prostatic boost, for a total of 66-70 Gy, was complications [125, 128, 177, 236, 237]. Some investi- evaluated. Scalliet and co-workers [246] reported gators came to the conclusion that age does not urinary incontinence in 16% of 230 patients, however, predict treatment efficacy of bulking agents [126, 238]. Fransson and colleagues [247] reported an increase (Level of evidence 3) in urinary incontinence on a patient-administered Recent series of slings with less than 2-year follow- symptom bother scale 3 years after treatment in 153 up have shown satisfactory improvement rates, with men compared to pretreatment status. The increase results similar to those of the artificial urethral sphincter, was from a mean of 0, at the start to 2 out of 10 at 3 although patient selection may be different. However, years. Ponholzer et al. [248] reported incontinence in no stratification for age is available from the data. 18.8% of a group of 82 men who were surveyed 4.4 year after EBRT for prostate cancer. Furthermore TREATMENT OF DETRUSOR OVERACTIVITY urinary incontinence worsened from year 2 to year 6 Therapy with intravesical neuromodulatory drugs such in a cohort of 147 men treated with 3D conformal RT as capsaicin and resiniferatoxin as well as injection [249]. 1138 Pre-radiotherapy transurethral prostatectomy may be to low risk patients, 38% versus 22%. Although recent a risk factor for incontinence. Jonler et al. [250] reported reports dispute the higher rate [177, 187]. However, an incontinence rate of 11% with pretreatment TURP. generally this is due to a higher incidence of erosion Green et al. [251] and Lee et al. [252] also reported and infection as well as urethral atrophy, possibly a higher risk of incontinence with pretreatment TURP secondary to radiation induced vasculitic fibrosis of the versus those without with 5.4% and 2% respectively. urethra [179]. Radiation may also induce detrusor There are no series reported on the treatment of overactivity or poor compliance leading to urgency patients who only have incontinence after EBRT. incontinence. Recurrence of bladder neck contracture may be more common [187]. Radiation was also Salvage or adjuvant radiotherapy is frequently given after identified as a co-morbidity associated with erosion radical prostatectomy and the impact on continence is [262]. However, good results are reported, and it is controversial. Petrovich et al. [253] reported no generally recommended that the cuff be inserted difference in incontinence in 2 cohorts of patients, one outside the radiated field [263]. with and one without adjuvant radiation. In a follow-up study the same group reported no late toxicity [254]. Collagen injection has also been reported for Fontaine et al. also reported no change in continence incontinence after radical prostatectomy and adjuvant status in 16 of 17 men after salvage radiation [255]. radiation [122, 126, 224, 264-266] or after salvage However, Petroski et al. reported that postoperative radical prostatectomy following radiotherapy [129.267]. radiotherapy worsened continence in 26% of 129 Continence results are poorer compared to those without radiation [225]. Very few patients have been patients followed for a median of 5 years [256]. On the reported on with the use of Macro-plastique following other hand salvage radical prostatectomy following radical prostatectomy and adjuvant radiotherapy. external beam radiotherapy has been has been generally reported to have a high incidence of urinary The male perineal bone-anchored sling has been incontinence [257-259] possibly because of radiation reported in patients following adjuvant RT. In Comiter’s induced fibrosis of the external sphincter [258]. group with the perineal compression sling 3/21 with radiation had no adverse sequelae [129] Similarly in SURGICAL TREATMENT the series of Onur et al. radiation did not cause a Results of surgical treatment of incontinence in this worse outcome [153]. However, Schaeffer et al. setting are based on retrospective clinical series. In reported that prior irradiation was the only identified the past the most commonly published treatment factor that predisposed to failure. Their success rate modality was the artificial urinary sphincter as therapy following a single sling procedure was only 29% (2 of for sphincter damage. As discussed and referenced 7) for irradiated patients, and the corresponding rate in the following paragraphs, the series published for nonirradiated patients was 68% (39 of 57) [144]. contain both patients who had and had not received They postulated that the sling acts by compressing and radiotherapy and collagen injections have also been elevating the urethra, thereby increasing urethral reported in case series. resistance to abdominal pressures. Theoretically, radiation-induced fibrosis of the urethral and There has been a higher reported revision rate for periurethral tissues would make compression and the artificial sphincter following radiotherapy (Table 7 elevation more difficult by reducing tissue compliance [176, 177, 179, 187, 190, 200, 260, 261]) compared and mobility.

Table 7. The artificial sphincter for incontinence after radiotherapy Study Number of patients Revision rate Continence after radiotherapy Martins and Boyd [179] 34/81 38% for whole group 88% Wang and Hadley [260] 16 25% (Infection and 87% Erosion - 12.5%) Perez and Webster [176] 11/75 55% 63% Gundian et al. [261] 15/56 22% 90% Elliott and Barrett [190] 46/313 22% - Manunta et al. [200] 15/72 53% (Infection and Erosion – 20%) 73% Gomha and Boone [177] 28/86 25% (Similar to a non- 64% Radiated control group) Lai et al. [187] 60/176 20% versus 32% for non- 69% radiated group)

1139 In summary, despite the frequently reported higher obstruction, 7 developed some degree of permanent incidence of complications of the artificial sphincter in urinary incontinence. They surmised that the cause post-prostatectomy patients after adjuvant radiation, may be multifactorial and may include physical damage it has provided acceptable treatment benefits. Collagen to the urinary sphincters and the radiation dose to injections have yielded poor results. Although the data the urethral region. Surgical therapy when required has are limited, a perineal compresssion device may also included the artificial sphincter [275]. High dose be acceptable but suprapubic suspension brachytherapy that is administered over a short period bulbourethral slings may be less efficaceous. (Level of time may have reduced toxicity [281]. Urethrorectal of evidence 3; Grade of recommendation D) fistula is another complication that has been reported in 1.8% of patients in a large U.S. medicare retrospective review [275]. Salvage brachytherapy VII. INCONTINENCE AFTER OTHER leads to a higher rate of urinary tract complications TREATMENT FOR PROSTATE [259]. CANCER 2. CRYOSURGICAL ABLATION OF THE PROSTATE 1. BRACHYTHERAPY OF THE PROSTATE Cryosurgical ablation of the prostate is used for Brachytherapy is a form of radiation therapy in which clinically localized prostate cancer either as primary radioactive materials are placed directly into the treatment or after unsuccessful external beam radiation prostate gland. The incidence of incontinence following therapy. The frequency of the main lower urinary tract this modality is given in Table 8 [268-279] and was complications are listed in Table 9 [282-294]. The previously related to the treatment of post- artificial sphincter has been mentioned as one of the brachytherapy retention of urine. Numerous series treatments for incontinence [293] Cryotherapy is an have reported retention to be associated with larger adverse factor for collagen injections. Urethrorectal initial prostate volumes [280]. In a systematic review fistulae can also occur in up to 5% of treated patients. of brachytherapy series, Crook et al. [277] reported Severe incontinence and fistulae that occasionally the incidence of retention to be 1-14%. Many patients results may have to be treated with extirpative surgery require prolonged or permanent alpha blocker or and diversion [295]. TURP. The main risk factor for incontinence after 3. HIGH-INTENSITY FOCUSED brachytherapy is TURP. Hu and Wallner [274] reported ULTRASOUND (HIFU) on the incidence of urinary incontinence after TURP/TUIP following prostate bracytherapy for Transrectal high-intensity focused ultrasound is prostate cancer. Of the 10 patients who underwent the emerging as another minimally invasive treatment for outlet relaxing procedures for refractory urinary prostate cancer. HIFU destroys prostate cells by

Table 8. Incontinence after brachytherapy for prostate cancer Author % Incontinence % Post TURP % No TURP Beyer et al. [268] 1 - - Blasko et al. [269] 6 17 0 Stock et al. [270] 0 - - Wallner et al. [271] 0 - - Kaye et al. [272] 4 11 1 Blasko et al. [273] 13 0 - Hu and Wallner [274] 6 70 - Benoit et al. [275] 6.6 - - Merrick et al. [276] 0 - - Crook et al. [277] 5.6 13 - Talcott et al. [278] 105 83 39 Bottomley et al. [279] 1.5 - -

* Implant plus external beam radiation

1140 Table 9. Lower urinary tract complications after cryosurgery for prostate cancer Author N % Incontinent %Bladder outlet obstruction Shinohara et al. [282] 102 5 23 Bahn et al. [283] 210 3 9 Cox and Crawford [284] 63 27 29 Wieder et al. [285] 83 2.5 13 Cohen et al. [286] 239 4 2.2 Coogan and McKiel [287] 95 3.5 6 Sosa et al. [288] 1467 11 6.8 Long et al. [289] 145 83/2.0* 17.2 Pisters et al. [290] 150 60 43 Derakhshani et al. [291] 48 10.4 22.9 Long et al. [292] 975 7.5 13 De la Taille et al. [293] 43 9 4 Robinson et al. [294] 46 29 (urinary bother) -

*Previously radiated/not previously radiated coagulative necrosis of the tissue without damaging bone-anchored sling has been reported for one case the structures intervening between the transrectal [312]. Collagen has only been reported in women probe and the target tissue [296]. Recent reports of following neobladder construction [313]. efficacy also include morbidity. In a systematic review In summary there are not enough data upon which to involving 37 articles/abstracts Rebillard et al. [297]. recommend definitive surgical therapy, although the reported that stress incontinence occurs in 6-28%, artificial sphincter looks reasonable. (Level of urethra/bladder neck stenosis in 1-31%, and evidence 3; Grade of receommendation C-D) rectourethral fistula in 0-3% of treated patients. With improvements in techniques the risk of complications is decreasing [297]. VIII. TRAUMATIC INJURIES OF THE 4. INCONTINENCE AFTER NEOBLADDER URETHRA AND PELVIC FLOOR CONSTRUCTION The incidence of continence after neobladder Incontinence following posterior urethral injuries occurs construction following radical cystectomy for bladder in 0-20% of patients [314, 315] and is thought to be cancer ranges from 85 to 100% during the day and due to the extent of injury rather than to the method 55 to 100% at night (Table 10 [298-310]). Most patients of management. achieve daytime continence after one year and The data on surgical treatment are all retrospective nightime continence after 2 years. Most of the case series and the most commonly published surgical published reports do not comment on specific surgical therapy is the AUS. The series published contain both management and imipramine is mentioned as patients with and without traumatic injuries. Perez treatment only occasionally. Martins and Boyd [179] and Webster [176] reported on 27 patients after reported on 8 patients treated with the AUS for urethral or bladder neck strictures. The revision rate persistent sphincter weakness incontinence. Six of was 41% and the continence rate was 85%. In a these underwent revisions, 3 for infection and/or subsequent report from this centre on reoperations the erosion and 3 for inadequate cuff compression. They patients with traumatic injuries were not discussed cautioned against the use of the AUS and suggested separately [316]. In Montague’s [178] series 22 out alternatives such as intermittent catheterization at of 166 patients had incontinence after trauma. He did night. However, O’Connor and colleagues [311] not separate the results of this group from those of the reported a successful outcome, after AUS, with no other patients. Martins and Boyd [179] reported on only complications in 5/5 men with incontinence after one patient out of 81 with a traumatic urethral injury. neobladder, with a mean follow-up of 22 months. The This patient was dry and required no revisions. Venn

1141 Table 10. Continence after neobladder construction for bladder cancer Author Number of patients Follow-up (mo) Continence (%) Day Night Alcini et al. [298] 34 12 100 83 Cancrini et al. [299] 89 24 97 83 (22% with SUI) Elmajian et al. [300] 266 24 85 85 Studer et al. [301] 100 24 92 80 Benson et al. [302] 32 25 94 74 Abol-Enein and 60 4 90 80 Ghoneim [303] Rogers and 20 24 90 55 Scardino [304] Hautmann et al. [305] 211 36 85 85 Hautmann et al. [306] 363 57 95 95 Steven and Poulsen [307] 166 32.4 100 100 (After 5 years) Abol-Enein and Ghoneim [308] 353 38 93.3 80 Carrion et al. [309] 56 ileum 41 91 68 57 colon 41 86 68 Nieuwenhuijzen et al. [310] 62 >12 90 67 50 (sexuality >12 96 67 preserving) at el. [263] reported on 2 with pelvic trauma out of a total of 70. (Level of evidence 3; Grade of IX. CONTINUING PEDIATRIC recommendation C) PROBLEMS INTO ADULTHOOD: THE Bladder neck reconstruction by excising the scar and EXSTROPHY-EPISPADIAS COMPLEX narrowing the calibre was reported by Iselin and Webster [317] in 6 patients who had incontinence Achieving continence and protecting the upper urinary with an open bladder neck on cystourethrography, tract are important goals of reconstruction in patients following urethroplasty for traumatic strictures. Bladder with exstrophy-epispadias complex. However, these neck closure with a Mitrofanoff catheterizable tasks remain formidable challenge for pediatric abdominal stoma has also been reported as treatment urologists. Urinary incontinence [322, 323] and other following severe urethral or bladder trauma [318] voiding problems [324, 325] due to these congenital (Level of evidence 3; Grade of recommendation anatomical abnormalities are continuing problems C) into adulthood. Although quite a few publications on the exstrophy-epispadias complex have appeared in For patients with severe bladder neck strictures and the literature over the past 7 years, the long-term incontinence after prostate surgery Meulen et al. [319] follow-up data into adulthood are still lacking [322, and the group from Baylor [187, 320] reported on the 326], and there have been no significant changes in use of a Urolume stent with a bulbar artificial sphincter. the management of urinary incontinence. Furthermore, Alternative management with perineal urethroplasty the definition of continence differs between studies. and subsequent artificial sphincter placement in 6 Despite the devastating nature of this disease, there patients was reported by Simonato et al. [321] (Level have been few studies addressing quality of life issue of evidence 3; Grade of recommendation C) and psychological assessment in patients with In summary, the AUS provides a reasonable outcome exstrophy-epispadias complex. Lee et al. surveyed 208 in appropriate cases. Since there are so few reports patients of which only 24 were 18 years or older. They of alternative therapies the C recommendations were found that of those older than 20 years all women based primarily on expert opinion as to what is and but only 60% of males had close friendships reasonable surgical therapy in very difficult cases. [327].

1142 Published materials consist mainly of retrospective with bladder exstrophy have also provided excellent reviews of experience at various centers. Even major long-term outcome in continence (100%) and institutions struggle to gather large series of patients. preservation of the upper tract (97%) [339]. However, Thus, we are still left with mainly level 3 evidence. prophylactic alkalization does not prevent the long-term metabolic consequences. Subclinical metabolic The management of the exstrophy-epispadias complex acidosis and decreased linear growth are to be includes 2 principal aspects; initial management anticipated in more than 50% of patients, and (primary treatment) and subsequent management of moreover, significant bone demineralization is to be persisting incontinence. These 2 aspects are discussed expected in all of these patients [339]. Thus, it is separately. Based on the evaluation of the literature, concluded that low pressure rectal reservoirs should recommendations are made at the end of this section. be reserved for failed surgical reconstruction or patients I. INITIAL MANAGEMENT OF THE presenting beyond the age suitable for reconstruction EXSTROPHY-EPISPADIAS COMPLEX [339]. a) Staged repair versus one-stage primary repair b) Bladder neck reconstruction Staged surgical management of the exstrophy- In a staged repair, bladder neck reconstruction is epispadias complex (early closure with or without usually performed at age 4 to 5 years when the bladder pelvic osteotomy, repair of epispadias and bladder gains enough capacity to provide for safe filling with neck reconstruction) has been the standard approach good compliance and the child is ready to be dry and [323, 328-332] although the staged approach has participate in a postoperative voiding program [328, undergone significant changes since first advocated 329]. The classic Young-Dees-Leadbetter technique by Jeffs et al [328]. Success rates for staged functional has been modified in several ways [329, 332, 340]. closure are high with continence rates reaching 75% The success of bladder neck reconstruction in both to 90% [328-330]. However, these results were based continence and emptying is highly dependent on the on highly selected groups of patients and others failed delicate balance between the bladder and outlet. to achieve such results. Continence rates of only 10% Bladder capacity, contractility and outlet resistance to 30% were reported with the staged approach [333, are determinants of continence after bladder neck 334]. Complete primary repair described by Grady reconstruction [325]. A report from the Johns Hopkins and Mitchell combined primary bladder closure with group [329] describes that 77% of patients are epispadias repair in one stage in neonates [335]. The completly dry by day and by night and voiding through idea was to optimize the chance for early bladder the urethra without need for bladder augmentation or cycling and potentiate bladder development. It may clean intermittent catheterization, and that another also obviate the need for multistage repair of bladder 14% have “social continence” (dry more than 3 hours exstrophy including bladder neck reconstruction. during the day but still wet at night). Analysis of bladder Although acceptable short-term results were achieved, capacity measurements under anesthesia, prior to the procedure has been criticized in view of 50% bladder neck reconstruction, revealed that patients incidence of antireflux surgery needed because of with a preoperative bladder capacity of greater than breakthrough urinary tract infections. A recent report 85 cc had a better outcome [329]. However, subjective from another institution has also shown that complete success with continence and emptying does not repair of exstrophy is feasible in neonates and older necessarily correlate with objective findings [325]. children after failed initial closure, with acceptable Despite near or total subjective continence (dry morbidity [336]. Ureteral reflux was noted in 63% of intervals of at least 2 to 3 hours) and “good voiding” renal units but did not require surgery in this series. in 18 patients, there were clinical (recurrent urinary tract There is short-term evidence of favorable outcome in infections, epididymitis and bladder stone) and newborns compared with older children [336]. urodynamic voiding problems in 72%, including flow However, we will have to wait for long-term results from rates of less than 10 ml/sec in 70%, postvoid residual those centers using this one-stage technique to know more than 33% of capacity in 50% and acute urinary whether it is consistent in producing urinary continence retention in 17% [325]. Another report from the Toronto and satisfactory sexual function. group also highlights the extreme difficulty in achieving The Mainz group has recommended primary urinary volitional voiding in an unselected exstrophy diversion (ureterosigmoidostomy, sigmoid rectal pouch, population. Of 43 patients only 3 (7%) were voiding ileocecal pouch) with closure of the abdominal wall spontaneously through the native reconstructed [337, 338]. The posterior urethra is closed as a seminal urethra [341]. Similarly Burki et al. reported redo receptacle. While this approach is hardly used in North bladder neck reconstruction in 30 patients and all America, long-term reports have demonstrated required intermittent catheterization [342]. Thus, excellent continence and upper tract preservation perseverance in the pursuit of volitional voiding is [337, 338]. Low pressure rectal reservoirs in children more likely to result in repeatedly failed bladder neck

1143 reconstruction and delay in the age at which (Mitrofanoff procedure). The overall rate of bladder continence is finally attained. Earlier recognition of augmentation in patients with exstrophy-epispadias the need for other storage improvement procedures complex has been 22% to 40% [323, 325]. such as bladder augmentation and/or appendicove- Preservation of the native bladder template has been sicostomy and bladder neck closure may facilitate emphasized by the Johns Hopkins group and others the timing of achieving continence and self-esteem, [330, 354]. This has two advantages, whether in the and achieve a satisfactory result with fewer operative younger or older patients. First, using the template may procedures [341]. decrease the amount of bowel needed for reconstruction. Second, if ureteral reimplantation is c) Urodynamic evaluation required, the bladder template is a better structure There are several reports on urodynamic evaluation for reimplantation than a subtaenial tunnel of the in patients who underwent bladder neck reconstruction bowel [330]. [343-345]. The majority of closed exstrophy bladders Stomach, ileum or colon can be used for bladder have normal filling dynamics before bladder neck augmentation. Each type of augmentation has reconstruction [344]. However, bladder abnormalities disadvantages that are inherent to the use of are very common after bladder neck reconstruction, gastrointestinal segments, including metabolic with about 50% incidence of poor compliance and derangement, urolithiasis [355], decreased linear detrusor overactivity [343-345]. Detailed urodynamic growth [356], and hematuria-dysuria syndrome (in investigation in patients with bladder exstrophy, after the case of stomach) [357]. A recent paper concludes the first operation to create a functional bladder, is vital that ileocystoplasty is safe and does not impact to guide the next step of management and to compare negatively on the linear growth or bone densities of objectively the surgical outcome of reconstruction patients with bladder exstrophy [358]. Gastrointestinal using different approaches. composite reservoirs, i.e. those made of a combination d) The fate of the upper urinary tract of stomach and other intestinal segments, may be considered to achieve electrolyte neutrality by Preservation of the upper urinary tract is the most contrasting electrolyte movements across the stomach important goal in any form of lower urinary tract and bowel [348]. reconstruction. In several series of exstrophy patients, significant upper tract deterioration was noted in 22% b) Continent stoma to 26% of patients [323, 346, 347]. Because any type There are many surgical procedures, other than of outlet procedure that elevates the outlet resistance bladder neck reconstruction, to increase bladder outlet can be a potential cause of upper tract deterioration, resistance, including injection of bulking agents and upper and lower tracts should be monitored by placement of bladder neck slings and artificial urinary ultrasound to measure the efficacy of bladder emptying sphincter [352]. Unfortunately, these outlet procedures and to look for subtle upper tract changes even in have variable degrees of success with none being patients with a good bladder storage function who successful in all patients. It is not uncommon for some are undergoing any kind of outlet procedure. patients to undergo multiple procedures in an attempt 2. MANAGEMENT OF PERSISTING to achieve continence. When these attempts fail, the INCONTINENCE creation of a catheterizable continent stoma with or without bladder neck closure is the preferred procedure Regarding the management of persisting incontinence, to achieve continence [359]. Continence rate of 100% there still remain considerable differences of opinion was achieved by bladder neck closure compared with [337-339, 341, 347-352]. Various options are shown continence rates of 56% by bladder neck in Table 10. When planning the management of reconstruction only and 67% by bladder neck persisting incontinence, possible causes of reconstruction with augmentation and/or appen- incontinence should be thoroughly evaluated. Bladder dicovesicostomy [341]. However, the success of and outlet storage function should be examined by bladder neck closure is dependent in part upon detailed urodynamic investigation that allows for the patients’ compliance with intermittent catheterization individualization of treatment to optimize the chance [352]. In addition, those who have undergone bladder of a successful outcome [345]. Multiple available neck closure are at an increased risk for bladder reconstructive options may be considered to optimize stones [352]. continence outcome [353]. c) Urinary diversion a) Augmentation cystoplasty Regardless of the type of continent urinary diversion The late 1980s and early 1990s witnessed the more used, most series demonstrate excellent success liberal use of bladder augmentation coupled with the rates around 95% [359]. Based on the excellent option of a catheterizable appendicovesicostomy continence rates achieved by urinary diversion

1144 compared with those by staged or one-stage primary repair, the Mainz group has recommended that all, but X. DETRUSOR OVERACTIVITY AND especially those who have failed previous treatment, REDUCED BLADDER CAPACITY are best served by conversion to a rectal reservoir or ileocecal pouch with a catheterizable stoma [337, 338]. However, taking into account the long-term 1. REFRACTORY URGENCY INCONTINENCE negative impact of a rectal reservoir on the metabolic AND IDIOPATHIC DETRUSOR milieu and bone density [339] and a high risk of OVERACTIVITY neoplasia in those who have been exposed to the mixing of urine and faeces in a colorectal reservoir According to the Terminology Report of the [360], urinary diversion should be reserved as a last International Continence Society the overactive resort after failed surgical reconstruction. bladder (OAB) syndrome refers to the symptoms of urgency, with or without urge incontinence, usually d) Outlet procedures with frequency and nocturia [363]. Detrusor overactivity If the initial bladder neck reconstruction (original or (DO) was redefined to indicate the urodynamic modified Young-Dees-Leadbetter in many cases) fails observation characterized by involuntary detrusor and a low outlet resistance is the only cause of contractions during the filling phase that may be persisting incontinence, another outlet procedure is spontaneous or provoked. Idiopathic Detrusor worth attempting. Option includes Kropp or Pippi Salle Overactivity (IDO) exists when there is no defined bladder neck reconstruction, injection of bulking cause and replaces the term “detrusor instability”. agents, placement of bladder neck slings or an artificial Neurogenic Detrusor Overactivity (NDO) is seen when urinary sphincter [352]. The presence of scarred tissue there is a relevant neurological condition and replaced due to a previous surgery at the bladder neck may the term “detrusor hyperreflexia”. The criterion for compromise the outcome. The value of the artificial considering detrusor overactivity as idiopathic is urinary sphincter in dynamic control of outlet resistance questioned, as Ahlberg et al found that 82% of patients in exstrophy patients is also questioned [323]. A initially considered idiopathic on careful searching vascularized gracilis muscle sling, to wrap around the actually had pathology potentially leading to the compromised bladder neck of incontinent patients problem [364]. has been reported as salvage surgery [350]. Limited Idiopathic detrusor overactivity is a normal situation success has been reported with the use of bulking early in life. Children have urgency incontinence as agents 361, 362]. a stage in acquiring bladder control. The incidence of 3. RECOMMENDATIONS detrusor overactivity during mid-life years (20 to 60) has been estimated as 10% [365]. In the asymptomatic elderly, detrusor overactivity once again becomes The published studies to date are retrospective common, occurring in 50% of men over 70 [366]. In case series with levels of evidence at best 3 with the symptomatic elderly, over 75 years old, it can a grade of recommendation of C. The expert reach 90% in men [367]. Detrusor overactivity may be opinion of the Committee has resulted in the a cause of severe storage symptoms such as following recommendations regarding the frequency, nocturia, urgency and urgency incontinence. evaluation and treatment of persisting incontinence Conservative treatment of these symptoms such as in adulthood. (C) bladder training and pharmacotherapy is discussed • Patients with exstrophy-epispadias complex in other sections. should be evaluated and managed in Magnetic stimulation may play a role in the non- specialized centers invasive treatment of DO [368, 369]. Bradshaw et al. • A universal definition of continence should be demonstrated an effect on cystometry of magnetic established stimulation and found an improvement in urodynamic parameters but no consistent change in OAB • Persisting incontinence should be evaluated symptoms [370]. Almeida et al. [371] in a prospective with urodynamics and its treatment should be urodynamic controlled study of 91 women with UI, individualized based on urodynamic findings found an improvement on DO only in patients with • Life-long follow-up is mandatory in terms of initial bladder contractions <15 cm H2O. There are no other data available on the subject. continence, voiding efficiency, upper tract status and other urological complications For symptoms that are refractory to conventional means, 4 interventional treatments have been • Comparative studies, including quality of life and reported: intravesical resiniferatoxin, botulinun-A toxin psychological assessment, should be detrusor injections, neuromodulation, and bladder undertaken if possible. augmentation.

1145 a) Resiniferatoxin in quality of life of these patients [416], and is likely to be cost-effective [417]. The use of botulinum toxin The use of intravesical neuromodulatory drugs such B is less efficient, with a duration of action of about as capsaicin and resiniferatoxin was extended to DO 10 weeks [418]. of non-neurologic origin after the suggestion that its etiology involved the enhancement of the C-fiber The optimal site of injections, including or not including mediated spinal micturition reflex [372] and emerged the trigone, is still under debate [419]. Kuo in 2007[ as a minimally invasive procedure: the results are 399], published a study comparing the injections into shown in Table 11 [373-380]. In spite of promising the detrusor, suburothelial area, and bladder base, with results, it is still considered experimental and more the last location improving urgency but not increasing clinical studies are necessary for it to be licensed capacity. Most studies on idiopathic overactive bladder [381]. have been done in women [393, 394]. Data are lacking on dose, concentration, site(s), numbers of injections The mechanism of action is still under study. The and long-term efficacy and side effects. Attempts to mean bladder perception threshold is increased only determine whether poor responders could be predicted in patients with clinical improvement [382]. The from preoperative urodynamic parameters showed complexity of the mechanism is demonstrated by the only a very high maximal detrusor pressure over 110 presence of vanilloid receptors not only on sensory cm H O as an unfavorable predictor when using 200 fibers but also in bladder urothelium and smooth 2 units [401]. Studies in women suggest a longer muscle cells [379] and by ineffectiveness in treating duration of action than its mere motor-nerve blocking an overactive bladder from idiopathic causes or potency can explain [394]. Therefore, a dual suprapontine lesions with no vanilloid-sensitive fiber- mechanism of action has been proposed: in addition mediated reflex [383]. It has been suggested that over to binding to cholinergic terminals, it might also affect expression of transient receptor potential vanilloid afferent nerve transmisson, thereby decreasing subfamily 1 in the bladder predicts the response [384]. urgency [420, 421]. A well designed double-blind placebo-controlled study revealed no difference between placebo ethanol 10% There are two commonly marketed forms of botulinum saline solution and 50 nM resiniferatoxin, nevertheless toxin-A (Botox and Dysport) and they require different both treatments showed improvement in symptoms doses to achieve similar results, in a proportion around of women with IDO [380]. Some placebo-controlled 1:3 [422]. The first report using Dysport in refractory studies either did a quasi randomization [385] or did IDO was only recently published with similar results not explain how it was done [379]. Patients with to Botox [393]. In a study using type A neurotoxin, increased bladder sensation without DO presented purified by a procedure using a lactose gel column, some improvement in symptoms in a small non improvements were seen in 89% of patients treated placebo controlled series [386]. (levels of evidence for incontinence due to IDO and NDO [396]. 1 – 4; Grade of recommendation D, two level 1 Many studies with botulinum toxin detrusor injection studies have contradictory conclusions [379, 384] use different outcome measures for results and are b) Botulinum-A toxin injection in the bladder variable for the presence of residual urine and the need for intermittent catheterization, but 6-75% of cases may The minimal invasiveness of this method makes it present high post void residual urine [394, 396, 398, very attractive but long term results in IDO are lacking 401]. Besides being an alternative for treatment of (Table 12 [387-403]). The effects of its use are still not refractory DO, currently available data do not show fully recognized [404], with possible systemic superiority of any specific treatment plan, and therapy consequences [405-407], such as generalized muscle options should be tailored to the specific patient and weakness in two patients treated for neurogenic physician preference [423]. Higher doses such as 200 bladder overactivity, and the development of resistance units in IDO resulted in incomplete emptying, to the drug [408, 409]. The FDA made a public necessitating intermittent catheterization in 6 out of 16 notification of adverse reactions linked to Botox use patients (37.5%) in one study [401]. Sahai suggests a in February 2008, in approved and nonapproved careful follow up of the patients after the injections, usages. The agency is currently reviewing safety data starting IC in symptomatic patients if postvoid residual from clinical studies to further communicate to the urine is more than 100-150 ml [424]. public its conclusions [410]. Most of the initial experience come from its use in neurogenic bladders Many reports do not separate genders and mix [411-414], with favorable results. Information about its neurogenic and idiopathic etiologies. A large number use in children is scarce [415]. A randomized study of publications are reviews of the literature [425-435]. comparing the results of botulinum-A toxin injections There is one randomized double blind placebo to intravesical resiniferatoxin in NDO showed superior controlled trial showing favorable difference against clinical and urodynamic benefit with the use of saline injections for frequency and incontinence, but botulinum-A toxin [414]. The need for reinjections not for urgency [401]. (Most levels of evidence 3, with seems to be overcome by the significant improvement one level 2; Grade of recommendation C)

1146 Table 11. Intravesical capsaicin and resiniferatoxin for detrusor overactivity (males and females) Author No. Improvement Duration of effect Drug and dose Side effects Cruz et al. 3 IDO 71% continence Up to 18 months Capsaicin Intense [373] (total of 16, (overall total of 125 ml of 30% burning including 3 14) and 21% alcohol in saline sensation males) improvement containing 1mM Kuo [374] 13 IDO 5 ( 38,5%) 2 to 9 months RTX 10 ml of 100 nM (41 total ) RTX in 10% ethanol 18 previous 11 ( 61,1%) Average 5 for 40 min TURP months Kuo [378] (23) (11 of 19) (58%) 10nM RTX weekly 4 withdrew (19 ended) 3 to 4 times due to side effects. Significant worsening of emptying Kuo et al. [379] 17 IDO Vehicle 2(9) 22% 6 months Vehicle or 4 weekly Randomized RTX 5 (8) 63% 10 nM RTX double blind placebo controlled 6 withdrew after first instillation Liu and Kuo 28 14 (50%) 10 nM RTX weakly Transient [384] for 4 weeks receptor potential vanilloid subfamily 1 overexpressed in the responders Palma et al 25 females 10 (40%) 1 month evaluation 50 nM RTX No mention of [375] with idiopathic disappearance only retention urgency of urgency incontinence incontinence Rios et al. [380] 58 females 43% RTX 1 month first 50nM RTX or 10% Randomized With IDO 35 % Placebo evaluation ethanol saline double-blind Vehicle solution placebo Improvement - controlled equal (p=0.439) Silva et al. [377] 13 IDO 11 improved (91%) 3 months follow-up 100 ml 50nM RTX No retention (2 men in incontinence solution 10% or other 11 women) 3 (25%) dry ethanol in saline problems (12 incont.) for 30 min Silva et al.[385] 17 IDO Vehicle 9 (39%) Pre-test with vehicle Vehicle followed by No separation (out of 23) RTX 14 (60%) only followed by 100 ml 50nM RTX of NDO and RTX (patients enrolled in IDO 2005) Yokoyama et al. 10 (4 men) 5 (2 dry) [382] 50% 3 months follow-up 100 ml 50nM RTX Neurometer for 30 min before and at 30 days

1147 Table 12. Botulinum-A Toxin detrusor injection Author No. Type of patients Dose No. Results Comments punctures Harper et al. 39 (13 men Neurogenic and 200 idiopath 20 to 30 sparing Increase max 2003 [387] and 26 idiopathic origin the trigone bladder volume Level 3 women) (not described 300 neurog Flex. cysto. 174 to 589 ml evidence separately) Loch et al. 30 Neurogenic and 200 U 20 injections Significant No 2003 [388] idiopathic sparing the improvement description Level 3 trigone in 67% of the of gender evidence patients - > or whether residual urge NDO Radziszewski 12 (6 female Only idiopathic Up to 300 U 10-15 injections 1 months Short follow-up et al. 2002 and 6 male) sparing the follow-up Inexact [389] trigone 100% success criterion of Level 3 no residual success evidence Rackley et al. 18 women IDO 200-300 U Each 100 Improvement 6 months 2004 [402] (Botox) U in 1 cc 40% frequency follow -up Level 3 saline, 0.1 cc 30% urgency evidence injections Rapp et al. 35 6 neurogenic 300 U 30 injections 34% resolution 40% failure 2004 [390] (29 females including trigone 26% improvement Level 3 and 6 males) Kuo, 2004 30 12 neurogenic 200 U 40 injections 26% resolution 26% failure [391] (12 females sparing the 46% improvement Level 3 and 18 males) trigone Chancellor 10 Only idiopathic 100-300 U 20-30 injections 80% Control group et al. 2003 (2 males and only in bladder improvement 11 neurogenic [ 392] 8 females) base and trigone with 73% Level 2/3 improvement Rajkumar et al. 15 women IDO 300 U 30 ml – 93% Not 2005 [398] (Botox) 30 injections improvement randomized Level 3 prospective study 6 patients with PRV >130 ml Popat et al. 31 (18 women 200 U 20 ml – 57 % dry at 19 % needed 2005 [397] and 13 men) IDO (Botox) 20 injections 4 months CISC Level 3 Kessler et al. 11 patients IDO 300 U 30 ml – 30 91% dry Prospective 2005 [403] (no gender (Botox) injections 5 months study Level 3 information – sparing the duration comparing 8 men in total trigone IDO with NDO of 22 patients) 4 high PVR with CSIC (36%) Werner et al. 26 women Only IDO 100 U 30 ml- 30 65 % dry at 36 weeks 2005 [649] (Botox) injections 12 weeks follow-up Level 3 60% dry at 36

1148 c) Electrical stimulation and neuromodulation Some studies do not specify the etiology of the DO and neurogenic and non-neurogenic causes are Electrical stimulation of the genital area was first used grouped together [456]. Some reports focus on to control incontinence due to DO on an empirical technical or specific aspects of the procedure and basis for different etiologies [436]. Later, it was the same patients may be included in different suggested that reflex sphincteric contraction induced publications [458, 461, 462]. Implantation in children by electrical stimulation can promote an inhibitory may be feasible in selected cases [463, 464] and effect on detrusor activity, thus suppressing detrusor poorer results are expected in older women [102]. overactivity [437]. Many studies of external electrical The outcome in older men is unknown since there stimulation for bladder inhibition of idiopathic urgency are no reports. incontinence have been published, mainly in female patients [438-445]. The results vary from 45% to 85% Table 13 [403, 453, 465-472] shows some recent success, with a mean of 38%, and 26% improved. studies. Electrodes implanted in the pelvic floor, have not Some reports are literature reviews [449, 473-475] yielded good results [443]. or detail technical modifications [476, 477]. There is Neuromodulation of sacral nerves has been reported one systematic review on efficacy and safety of sacral as alternative therapy for urgency incontinence, urinary nerve stimulation for urgency incontinence, but 13 of retention, and chronic pelvic pain. Good results have the articles analyzed are abstracts and it is also difficult been published in treating neurogenic bladder to ascertain whether the same patients are included dysfunction [446, 447]. The working mechanism of in different publications [478]. neuromodulation in the treatment of lower tract dysfunction is still unknown [448, 449]. A suggested There are some publications with level 1[465, 466] or mechanism is somatic afferent inhibition of sensory 2 [455, 468, 469] evidence and with a grade of processing in the spinal cord [450, 451], therefore it recommendation of B. However, due to relatively few may be a centrally acting treatment modality different men in the clinical trials, and poor results in one of the from botulinum toxin, which is an end-organ therapy prospective trials, its general applicability to men with that specifically targets the bladder [452]. urgency incontinence may be limited. Level of evidence 3. Grade of recommendation D (due to Long-term results suggest a sustained effect on lack of evidence) restoring voiding in appropriately selected cases, but a revision rate of 42% at 5-year follow up remains a d) Surgical treatment by detrusor myectomy problem [453]. Its use in refractory idiopathic urgency and augmentation incontinence has been limited to few patients, mostly Previously used treatments of surgical bladder women. Bosch and Groen [454] presented results of denervation, open bladder transection, cystolysis, chronic implantation in 15 women and 3 men, with an endoscopic phenol injections, hydrostatic bladder average age of 46 years. Significant improvements in distention did not produce good results. voiding frequency, average voided volume, number of incontinence episodes and number of pads used were Bladder autoaugmentation or detrusor myectomy has found, with no deterioration in response to stimulation been reported as an alternative to augmentation in with time. However, with subsequent experience in 14 neurogenic and non-neurogenic dysfunction. Table 14 men only 2 patients had a partial response and the [479-481] shows results of this treatment in patients rest ultimately failed [455]. Shaker and Hassouna with non-neurogenic detrusor overactivity. There are [456] implanted 18 patients with refractory urinary few long term results available [481]. Additional and urgency incontinence, but only 2 were in men. Groen, longer term experience is still required to properly Bosch and van Mastrigt reviewed 33 implanted women assess this procedure. (Level of evidence 3; grade and found no effect on urethral resistance and bladder of recommendation C-D) contraction strength as consequence of the depressant Enterocystoplasty results are detailed in Table 15 effect of sacral (S3) nerve neuromodulation on detrusor [480, 482-488], which includes both male and female overactivity [457]. Groenendijk et al. in a retrospective patients. Some publications are not clear about the study for the Sacral Nerve Stimulation Study Group, type of surgery specifically done in IDO and about reported urodynamic aspects of 111 patients implanted, the gender [488]. Good results vary from 58% to 88%, but only 8 men were included [458]. They found a with an average of 77%. Approximately 10 to 75% of better result on urgency incontinence in patients patients require intermittent catheterization for bladder without DO. The difference was not significant. This emptying. Ileum was the most frequently used bowel tendency was also found by South et al. in 67 women segment followed by sigmoid colon, although no implanted [459]. Clinical or urodynamic values to scientific reason for the use of any particular segment predict the outcome of sacral nerve stimulation has was given. The surgery, as reported in other sections, been difficult do define. Evaluation of 19 women has a significant complication rate and should be suggested that urethral instability seemed to be a considered carefully when applying it to these patients. good parameter to predict a favourable outcome [460]. (Level of evidence 3; grade of recommendation C)

1149 Table 13. Neuromodulation for treatment of refractory urgency incontinence due to detrusor overactivity (males and females) Authors N Success(dry) Improved Control group Study and comments Schmidt et al. [465] 34 47% 29% 42 prospective randomized Weil et al. [466] 21 56% 19% 23 prospective randomized Bosch et al. [467] 34 38%16% 21%16% prospective longitudinal (females) 6 (males) Siegel et al. [468] 41 46% 19% prospective cohort van Kerrebroeck 105 at 58% for UI 5 –year follow up et al. [453] 5-years 40% for (non randomized) (do not Frequency discriminate gender) Grunewald et al. [469] 18 39% 33% prospective Aboseif et al. [470] 43 77% not clear about etiology (5 males) Hedlund et al. [471] 13 61,5% 2 men included, both dry Roupret et al. [472] 6 17% 67% (all female) Kessler et al. [403] 71 with 70% average follow up 2 years urgency Gender not specifically incontinence discriminated (about 13% (in total of 91) of all are males)

Table 14. Detrusor myectomy for treatment of refractory urgency incontinence due to detrusor overactivi- ty (both sexes) Author Idiopathic detrsor overactivity Good results Swami et al. [479] * 17 12 Kumar et al [481] ** 24 19 Leng et al. [480] 8 7 TOTAL4938 (77.6%)

*short term followup **longer term follow-up of the same series, 45% required IC

1150 Table 15. Enterocystoplasty for treatment of refractory urgency incontinence due to detrusor overactivity (males and females) Authors Detrusor overactivity Good or moderate result Bowel segment Hasan et al. [482] 35 19 46 ileum 2 colon McInerney et al. [483] 50 44 13 colon Bramble [484] 15 13 2 ileum Sethia et al. [485] 11 9 ileum Mundy and Stephenson [486] 40 30 ileum Leng et al. [480] 2 2 Edlund et al. [487] 25 19 Blaivas et al. [488] 9 9 Ileocaecal segment and ileum Total 187 145 (78%)

2. REDUCED BLADDER CAPACITY segments or separate males from females in reporting results. Therefore, it is not possible to correlate any Fibrosis of the wall produces a low-volume low- particular aspect with the chance of success or failure. compliant bladder, leading to diminished functional However, overall the results seem reasonably good capacity. Symptoms of frequency and nocturia occur with the exception of patients who have undergone as a result of progressive decrease in bladder volume, radiation. (Level of evidence 3; Grade of but urinary incontinence may also be the consequence recommendation C) of a very small capacity, especially if accompanied by urethral weakness. The diagnosis can be suggested by the micturition chart, and confirmed by urodynamics. XI. URETHROCUTANEOUS AND The causes can be congenital or acquired. Acquired RECTOURETHRAL FISTULAE causes include multiple surgeries, inflammatory processes (chronic cystitis, interstitial cystitis, tuberculosis, schistosomiasis, and chemical cystitis) Urethrocutaneous or rectourethral fistula may have or following radiation. congenital, inflammatory, neoplastic or traumatic origin. It is important to recognize the varying etiology Bilharzial contracted bladder is a problem that is because each type may require different surgical primarily limited to endemic areas in Africa and the strategy. All reports except one are retrospective case Middle East. Schistosoma haematobium migrates to series. The report by Shakespeare et al. [517] is from the veins of the vesical and pelvic plexuses, where the a prospectively collected data base of patients treated female begins to lay eggs, promoting a initial with radiotherapy for prostate cancer. (Level of inflammatory response. As a result, granulomatous evidence 3; grade of recommendation C). lesions form in the lamina propria. Mucosal reactions vary from hyperplasia to polypoid cystitis. A contracted 1. URETHROCUTANEOUS FISTULA (UCF) bladder occurs in 2 % of cases [489]. Bladder augmentation seems to offer reasonable results in a) Acquired UCF these cases. Hidden foreign bodies have been described as a rare Similarly, small fibrotic bladders due to other etiologies cause of both strangulation of the glans penis and can be treated successfully with enterocystoplasty. urethrocutaneous fistula. Tash and Eid [518] presented The results of this surgery are presented in Table 16 the case of a 30-year-old man who developed a urethrocutaneous fistula and penile shaft necrosis [488, 490-516]. The results are similar in all etiologies after a condom broke during intercourse. Neither the except for radiation. The poorer results after radiation patient nor several physicians could identify the may be due to other tissue damage in the surgical retained ring of condom, which had been buried under area. New conformal techniques for radiotherapy may newly epithelialized skin. He underwent removal of the improve results in the future, so that the need for foreign body under general anaesthesia, followed 5 augmentation cystoplasty decreases. months later by a formal urethrocutaneous fistula Almost all of these studies do not distinguish bowel repair.

1151 Table 16. Enterocystoplasty results for reduced bladder capacity Authors Bilharziasis Tuberculous Radiation Unknown cause cystitis cystitis cystitis Total Success Total Success Total Success Total Success Smith et al.[490] - - 7 4 9 3 12 7 Kerr et al. [491] - - 12 12 - - - - Zinman and - - 2 2 1 ? 1 1 Libertino [492] Dounis et al. [493] - - 31 27 - - 1 1 Lunghi et al. [494] - - 15 15 4 4 3 3 Shawket and 8 8 ------Muhsen [495] Whitmore and - - 7 7 - - 2 1 Gittes [496] Chan et al. [497] ------10 9 Shirley et al. [498] - - 10 10 4 2 - - Goodwin et al. [499] - - 3 2 - - 3 3 Winter and - - 1 1 3 1 - - Goodwin [500] Fall and Nilsson [501] - - 1 1 - - 1 1 Goldwasser and ------7 7 Webster [502] Weinberg et al. [503] - - 2 2 1 1 1 1 Novak [504] - - 11 11 - - - - Sayegh and 2 0 ------Dimmette [505] Beduk et al. [506] ------1 1 Kuo [507] - - - - 1 1 - - Kawamura et al. [508] ------1 1 Hradec [509] - - - - 27 23 - - El Otmany et al. [511] - - 1 1 - - - - Yamada et al. [512] - - 1 1 - - - - Miyano et al. [513] ------1 1 Blaivas et al. [488] - - - - 3 2 3 3 de Figueiredo et al. [514] - - 25 20 - - - - Yashi et al. [515] - - - - 1 1 - - Lima et al. [516] - - 7 7 - - - - TOTAL108 (80%) 136 123 (90%) 54 39 (72%) 48 40 (85%)

1152 Urethroperineal fistula, as a complication of open determine the relative incidence of specific types of perineal prostate cryosurgery, occurs as an immediate these anomalies in Japan. They included discussion perioperative complication in 10.7% [519]. Thomas et of RUF regarding the relationship between the fistula al. [520] retrospectively evaluated 250 patients after levels and the blind end of the rectum, low type radical perineal prostatectomy and revealed only 1 deformity, rare types, and associated anomalies. A total (0.4%) urethroperineal fistula. Fahal et al. [521] of 1,992 patients (1,183 boys and 809 girls) registered published an unusual complication of mycetoma. from 1976 to 1995 were analysed according to the The patient had an infection with Actinomadura pathogenesis of anorectal malformation in the field of madurae that involved abdominal wall, perineum and molecular genetics. They reported that more than urethra. This resulted in urinary extravasation with a 20% of RUF should be categorized as intermediate urethrocutaneous fistula. or low deformity from the position of the rectal pouch. A significant preponderance of Down´s syndrome in c) Management of UCF the deformities without fistulae suggests that The diagnosis of UCF is made by physical investigation of associated anomalies and congenital examination, retrograde urethrography (Figure 3), diseases may provide further insights. urethroscopy, fistulography, urethral ultrasound or The purpose of Rintala’s study was to compare the color Doppler imaging. Urethral sonography provides long-term outcome of sacroperineal-sacroabdo- additional information about any involvement of the minoperineal pull-through (SP-SAP) to that of posterior surrounding tissue, location of vessels and associated sagittal anorectoplasty (PSARP). In boys with high abnormalities such as a periurethral abscess [522]. anorectal anomalies, PSARP was superior to SP- Treatment of UCF usually requires urethroplasty SAP pullthrough in terms of long-term bowel function techniques with modifications involving fistula excision and faecal continence [526]. and multiple layer closure [523]. (Level of evidence b) Acquired RUF 3; Grade of recommendation C) Acquired RUF may occur after pelvic trauma, surgery 2. RECTOURETHRAL FISTULAS (RUF) of the prostate or rectum, pelvic cancer, radiation Culp and Calhoon described five basic groups of RUF (either external beam or brachytherapy), cryosurgery, according to the etiology [524]: congenital, iatrogenic, prostatic hyperthermia, prostatic high intensity traumatic, neoplastic, and inflammatory. focussed ultrasound (HIFU), inflammatory bowel disease affecting rectum, or rarely prostatis a) Congenital RUF inflammation. Endo et al. [525] described the results of the Japanese Benchekroun and co-workers [527] report a series of Study Group of Anorectal Anomalies (JSGA) to 11 RUF observed over a 25-year period. The etiologies were surgical trauma (5 cases), fracture of the pelvis (2 cases), inflammatory lesions (3 cases), and one fistula was congenital. Colostomy was performed in 2 patients, surgical closure of the fistula was performed in 7 patients: abdominoperineal (3 cases), perineal (2 cases), transperitoneal (1 case) or by transano- sphincteric incision (1 case). In 1972 Smith and Veenema [528] reported their 20- year experience with 160 patients undergoing radical retropubic prostatectomy (RRP) with an incidence of 15 rectal injuries. Only 4 fistulas developed in this group. The most common single cause of RUF in the series of 23 male patients published by Tiptaft et al. [529] was a fracture of the pelvis and iatrogenic causes (two cases after transurethral prostatic surgery, two cases after open prostatectomy, and three cases after urethral instrumentation (Table 17). Noldus et al. [530] reported 23 (3.9%) rectal injuries during 589 RRP and cystoprostatectomy procedures. Eastham and Scardino [531] summarized the incidence of rectal injury during RRP in 3834 patients with an average of 0.7% (range 0.2-2.9%). The incidence of RUF, as Figure 3 : Urethrocutanous fistula (Black Arrow) an immediate perioperative complication of open is demonstrated during voiding cystourethrogram perineal prostate surgery, is 1.4 %. after incision of paraurethral collection.

1153 Table 17. Causes of Rectourethral fistulae in 23 advanced prostatic cancer after multiple treatment patients (Tiptaft [529]) sessions. The fistula was cured after a urethral catheter Fractured pelvis with ruptured urethra 11 was left in place for one month. Direct trauma 2 Kleinberg et al. [537] summarized results of 31 patients with stage T1 or T2 prostatic carcinoma following CT Secondary to urethral stricture and sepsis 3 guided transperineal I125 implants and reported that Tuberculosis 1 only one patient developed a prostatorectal fistula that was managed with an ileal conduit. Iatrogenic 12 Fengler and Abcarian [538] published their experience Iatrogenic causes of eight patients with RUF in the course of treatment Urethral instrumentation 3 of prostate cancer (3 fistulae after radiation therapy alone, 3 after prostatectomy and 2 after both surgery Transurethral prostatic surgery 2 and radiation therapy). Larson et al. [539] evaluated Open prostatectomy 2 5719 patients after radiation for prostate cancer. Ten had documented RUF. Lane et al. [540] treated 21 Flap urethroplasty 1 men with RUF following primary external beam Colo-anal anastomosis 1 radiotherapy and one after adjuvant external beam radiation therapy for prostate cancer. Time from the Abdominoperineal resection of rectum 1 last radiation treatment to fistula presentation was 6 Radiation therapy 2 months to 20 years. Four patients underwent proctectomy with permanent fecal and urinary diversion. Successful fistula closure was achieved in the 9 patients who underwent urethral reconstruction. Nyam et al. [532] reviewed records of all patients who Chrouser et al. [541] identified a total of 51 patients were diagnosed with RUF between January 1981 with a history of external beam radiation for prostate and December 1995 and 16 males were identified. All cancer that subsequently had a urinary fistula. Of 20 patients were interviewed by telephone for follow-up. patients meeting inclusion criteria, 30% received The mean age was 68 years and the mean follow-up external beam RT alone, 30% received brachytherapy was 80 months. Adenocarcinoma of the prostate in 15 and 40% had received combined external beam patients and recurrent transitional cell carcinoma of RT/brachytherapy. Most fistulas (80%) were from the the bladder in one patient were the underlying rectum to the urinary tract with an average diameter malignant diseases. Nine patients had had a RRP of 3.2 cm. Of patients with rectal fistulas 81% had a with 2 fistulas after radiation, 2 after brachytherapy, history of rectal stricture, urethral stricture, rectal and 3 after a combination of radiation and biopsy, rectal argon beam therapy or transurethral brachytherapy. One patient formed a fistula after prostate resection after radiation. All patients with cystectomy and dilation of a stricture. This rectourethral fistulas who achieved symptomatic heterogenous group of patients received multiple resolution required urinary and fecal diversion. therapies including initial colostomy (7 patients), Shakespeare et al. [517] reviewed the potential factors transanal repair (2 patients), parasacral repair (2 in fistula development and identified three cases patients), transperineal repair (2 patients), coloanal (0.2%) of RUF among 1455 patients treated with anastomosis (3 patients), and muscle transposition (3 prostate brachytherapy (BT), occurring at 19-27 patients). Four of the patients required a permanent months following BT. All these patients had BT stoma. monotherapy and had been investigated with Badalament et al. [533] managed one patient (0.4%) endoscopy and low rectal biopsy. They concluded with a urethrorectal fistula after cryoablation therapy that gastrointestinal specialists should not perform for prostate cancer. Zippe [534] reviewed preliminary biopsy of the anterior rectum in patients who have results of prostate cryosurgery and reported a 2 to 5% had BT unless there is a very high clinical incidence of RUF. Porter [519] found a 2.5% rate of suspicion of malignancy. Marguet et al.[542] RUF in 210 patients after TRUS-guided prostate described 6 cases of RUF in patients treated with cryosurgery and no urethroperineal fistulae. Ismail et brachytherapy plus external beam radiotherapy for al.[535] reported the experience of using salvage localized prostate cancer and subsequent rectal targeted cryoablation of the prostate (TCAP) in 100 biopsies or rectal surgery. Four patients underwent patients for the recurrence after radiotherapy. The hyperbaric oxygen therapy, which failed. Three patients underwent fecal diversion with gracilis interposition mean follow-up was 33.5 months and RUF occurred flaps, and two underwent pelvic exenteration. They in 1%. also concluded that biopsy of rectal ulcers in the Montorsi et al. [536] reported a RUF after transrectal clinical setting of combined radiotherapy should prostatic hyperthermia (43 degree C) in patients with not be performed.

1154 Badalament et al. [533] managed one patient (0.4%) with a urethrorectal fistula after cryoablation therapy for prostate cancer. Zippe [534] reviewed preliminary results of prostate cryosurgery and reported a 2 to 5% incidence of RUF. Porter [519] found a 2.5% rate of RUF in 210 patients after TRUS-guided prostate cryosurgery and no urethroperineal fistulae. Ismail et al.[535] reported the experience of using salvage targeted cryoablation of the prostate (TCAP) in 100 patients for the recurrence after radiotherapy. The mean follow-up was 33.5 months and RUF occurred in 1%. Montorsi et al. [536] reported a RUF after transrectal prostatic hyperthermia (43 degree C) in patients with advanced prostatic cancer after multiple treatment sessions. The fistula was cured after a urethral catheter was left in place for one month. Chang et al. [543] published a case of prostatic malakoplakia masquerading as a rectal tumor due to formation of a fistulous tract to the rectal muscular layers. Cools et al. [544] reported a very uncommon type of fistula between the large bowel and the prostatic Figure 4 : Cystogram demonstrates a rectourethral urethra due to Crohn’s disease. Felipetto et al. [545] fistula that occurred after a laparoscopic radical described a prostatocutaneous fistula as a prostatectomy complication of pseudomonas prostatitis. double diversion or selectively by others. Gibbons Transrectal high-intensity focused ultrasound (HIFU) [547] stressed the need for a diverting colostomy for destroys prostate cells by coagulative necrosis of the 3-4 months. tissue. Recent reports of efficacy also include morbidity. Rebillard et al. [297] reported RUF in 0-3% in a review However, as surgeons obtained more experience, involving 37 articles/abstracts. bowel preparations became standardized, and effective antibiotics were developed, and the c) Diagnosis of RUF enthusiasm for colostomy diminished. Currently, RUF may be strongly suspected from the patient’s colostomy is recommended in circumstances where history (fecaluria, abnormal urethral discharge, antibiotics alone cannot control the inflammation and pneumaturia, leakage of urine from the rectum during infection associated with the fistula or when the fistula micturition). Rectal examination, proctoscopy, careful involves radiated tissue. Low residue diet is also useful urethroscopy, intraurethral injection of methylene blue for healing. Suitable drainage (perineal and urethral dye, radiopaque contrast agent placed into the bladder splinting) is stressed. and then voided usually appears in the rectum on X- e) Surgical Approaches ray, are the most important diagnostic steps [522, 546] (Figure 4). Surgical management for rectourinary fistulas remains a reconstructive challenge. Two-layer closure of the d) Therapy of RUF urethra and rectum with suture lines at right angles Small fistulae may resolve spontaneously with urinary and with interposition of soft tissue (eg. omentum and/or fecal diversion. Therefore, an initial trial of [548], gracilis muscle [549], or scrotal flap [550]) has conservative therapy is reasonable. Selected patients been described. Surgical approaches include with chronic fistulas who are poor surgical candidates transabdominal, transvesical, or direct exposure of may also be managed conservatively with antiobiotics, the RUF. pads and symptomatic care. Timing of repair is often There are only a few guidelines to direct the surgeon individualized, mainly according to the etiology, delay to the most successful and least morbid technique. in diagnosis, size of fistula, whether it is the first or Rivera et al. [551] staged RUF as stage I—low (less subsequent repairs, and the general condition of than 4 cm from anal verge and nonirradiated), stage patient. II—high (more than 4 cm from anal verge and Diversion of urine (suprapubic cystostomy) is generally nonirradiated), stage III—small (less than 2 cm recommended as well as correction of any urethral irradiated fistula), stage IV—large (more than 2 cm stricture distal to the fistula. Fecal diversion, with irradiated fistula) and stage V—large (ischial decubitus colostomy is used by some as a mandatory part of fistula). Diverting colostomy was performed for stages

1155 III to V 6 weeks before definitive therapy. Some of is simpler than some complicated transabdominal or the patients in addition to the RUF will also have transperineal approaches to RUF. It is still used urethral strictures that have to managed. because it allows direct visualization of the fistula via Reconstruction of both aspects to restore functional parasacrococcygeal (transsphincteric) incision anatomy is possible with complex reconstructions especially to fistulae in the mid to lower rectum [538]. [552]. After the skin incision the mucocutaneous junction is marked with sutures and the internal sphincter is The surgical approaches including the numbers of exposed. Division of the sphincter mechanism and reported patients are listed in Table 18 [524, 527- posterior rectal wall allows exposure of the fistula. 530, 538, 546, 550, 553-569]. Each sphincter muscle is tagged with color-coded 1. PERINEAL APPROACH sutures. The next step of this procedure is the incision around fistula, followed by excision of the fistulous In 1926, Young [553] dissected the rectum away from tract exposing the catheter in the prostatic urethra. The sphincters, divided the fistula, closed the urethra, and undermining of rectal wall allows sufficient mobilization. mobilized the rectum further cephalad in such a fashion After closure of the prostatic urethra it is recommended as to pull the affected rectum caudally out of the anus that the full-thickness rectal wall flaps are close in a where it was then transected and discarded, suturing “vest over pants” technique (Figure 6). It is important the proximal rectum to the anal skin. Subsequently to make sure that the suture lines do not overlie each Lewis, in 1947 [554], described suturing the levator other. The procedure is completed by suture of the muscle fibers together in the anterior midline when rectal wall and approximation of the sphincter muscles possible. (Figure 7). Fengler and Abcarian [538] reported Goodwin et al.[555] reported a series of 22 RUF healing of RUF in all of 8 patients with the York-Mason approached perineally. They extensively mobilized approach. Bukowski et al. [562] managed 7 acquired the rectum posteriorly and the bladder anteriorly recurrent RUF (3 after prostatectomy, 3 after trauma and 1 after perineal abscess) using York-Mason through wide perineal exposure allowing interposition technique and a similar experience was described by of the levator ani muscles between the urinary tract 561 and rectum. Singh et al. [570] described the Fournier et al. in the management of a case of the management of a delayed post-traumatic RUF urethro-prostato-rectal fistula after a gunshot wound. repaired via transperineal access without rectal or Stephenson and Middleton [559] modified the York- sphincteric transgression. An example of a Mason repair and reported their experience with preoperative and postoperative urethrogram is in posterior sagittal, transanal, transrectal repair of RUF Figure 5. Pratap et al. [571] described a simultaneous in 15 patients. The transsphincteric, transanal surgical perineal and abdominal approach in a series of 8 approach provides many advantages, including easy patients with traumatic perineal injuries who had both access and identification of the fistula tract, good complex urethral disruptions and RUF. surgical exposure, adequate resection back to well 2. POSTERIOR SAGITTAL APPROACH vascularized tissue, and access to several vascularized flaps for interposition between the repaired urinary Kraske in 1885 [572] described a posterior midline and gastrointestinal tracts. incision extending to the left paramedian aspect of the coccyx and sacrum that involved partial removal of the Culkin [565] reported preliminary experience with the sacrum in addition to coccygectomy. His method did transsphincteric, transanal surgical approach to correct not involve division of the sphincters, but rather acquired urethrorectal fistula in five men. Mean patient sweeping the rectum laterally to ultimately facilitate age was 56.6 years (range 37 to 72). The etiology was resection and reanastomosis of a tumour-bearing surgical (radical prostatectomy) in 3 cases, traumatic rectal segment, thereby preserving fecal continence. in 1 and idiopathic in 1.The time from the diagnosis In 1962, Kilpatrick and Thompson [558] used this of urethrorectal fistula to surgery was 4 weeks to 4 approach when the rectum was completely mobilized years. Five men underwent excision and closure of circumferentially proximal and distal to the fistula. The a urethrorectal fistula with diverting colostomy. In 4 men RUF was then divided, sparing as much as possible (80%) urinary continence subsequently returned with on the urethral aspect. The rectal part of the fistula was adequate sphincter tone, while in 1 (20%) with perineal excised and closed in two layers, and the urethra was trauma and active proctitis the fistula recurred 6 weeks repaired and stented with a catheter. after surgery. Dal Moro et al. [573] reviewed a 15-year experience 3. POSTERIOR (PARASACROCOCCYGEAL) TRANSSPHINCTERIC using the York-Mason posterior sagittal transrectal APPROACH approach to iatrogenic RUF in 7 patients. In one In 1969 Kilpatrick and Mason [560] updated this patient with Crohn’s disease the fistula recurred 11 method and advocated a more radical method of years after the first surgery. The colostomy remained dividing the rectal sphincters to give direct access to in place only in one patient with Crohn’s disease and the RUF. The procedure (the York-Mason approach) in another with ulcerative rectocolitis. 1156 Table 18. Surgical approaches to rectourethral fistulas Approach Author, Year No. Pts PERINEAL Young, 1926 553 11 Lewis, 1947 554 13 Goodwin, 1958 555 22 Culp and Calhoon, 1964 524 20 Smith and Veenema,1972 528 4 Youssef,1999 556 (perineal dartos flap) 12 Benchekroun,1999 527 11 Ng, 2004 557(buccal graft) 27 POSTERIOR - SAGITTAL Kilpatrick and Thompson, 1962 558 6 POSTERIOR – TRANSSPHINCTERIC Stephenson,1996 559 15 Kilpatrick and Mason, 1969 560 7 Culp, 1964 524 20 Fengler,1997 538 8 Fournier, 1996 561 1 Bukowski,1995 562 7 TRANSANAL Vose,1949 563 4 Parks and Motson, 1983 564 1 Tiptaft,1983 529 3 Noldus,1997 530 5 Culkin, 2003 565 5 COMBINED (posterior transsphincteric Al-Ali,1997 546 16 anterior rectal wall advancement) ANTERIOR TRANSANORECTAL Geceleter,1973 566 19 Venable,1989 550 1 Zinman, 2003 567 22 ENDOSCOPIC Wilbert, 1996 568 2 Bardari, 2001569 1

Figure 5 : A. Cystogram demonstrates RUF caused by a TURP. Negative shadow from Foley catheter is seen in the bladder. B. Retrograde urethrogram after transperineal closure of RUF

1157 Figure 6 : Rectourethral fistula repair. Full thick- Figure 7 : York-Mason approach to a rectourethral ness rectal wall is mobilized to close in a “vest over fistula via a parasacrococcygeal (transsphincteric) pants” technique to close the fistula. incision. Sutures are used to mark the sphincters. The speculum has been placed at the bottom of the incision and the anterior rectal wall is visible.

Erickson et al. [574] reported a novel surgical technique with prolonged catheter drainage. The remaining 5 used to repair a rectourethral fistula associated with fistulas were all successfully closed with the transanal two short-segment urethral strictures located in the Latzko procedure. anterior and posterior segments of the urethra in a Al-Ali et al. [546] treated 30 men with RUF caused by patient with prior unsuccessful repairs. The anterior war wounds. He used the method of posterior urethral stricture was reconstructed with a ventral transsphincteric anterior rectal wall advancement as onlay of buccal mucosa in the exaggerated lithotomy the treatment of choice. Double diversion (end sigmoid position. In a modified prone position, the rectourethral colostomy and suprapubic cystostomy) for one month fistula was repaired using the transrectal was performed in all patients. Double diversion alone transsphincteric (York-Mason) technique and the resulted in ‘spontaneous’ RUF healing in 47% of posterior urethral stricture with a radial forearm patients but 53% required reconstruction. Early repair fasciocutaneous free flap which was anastomosed was recommended for large fibrous fistulas. to the inferior gluteal artery and vein. The coexistence Undiversion was done after two months when the of a rectourethral fistula and distal urethral stricture urethra and anorectal canals were normal. requires simultaneous repair, because the urethral pressure from the distal obstruction may compromise 5. ANTERIOR TRANSPHINCTERIC, TRANSANAL SURGICAL fistula closure. APPROACH (ASTRA)

4. TRANSANAL APPROACH In 1973 Gecelter [566] performed a midline perineal incision to gain access to the urinary tract after placing Parks and Motson [564] popularized the addition of the patient in exaggerated lithotomy position. The a full thickness local flap of anterior rectal wall as an sphincter was incised anteriorly, tag sutures carefully adjunct to fistula repair through the intact anal canal placed, and the rectal incision was carried to the (Figures 8 [575] and 9). They modified the transanal fistulous tract, which was excised and repaired in technique by denuding the rectal mucosa lateral and multiple layers with transposition of tissue as available. distal to the fistula, and mobilized the rectal wall away Castillo et al. [576] reviewed their first 110 consecutive from Denonvilliers´ fascia proximal to the fistula for four laparoscopic extraperitoneal radical prostatectomies centimeters. Tiptaft et al. [529] also used a special anal and reported 3 RUF. Only one was cured with retractor for this surgery. conservative management. The other 2 patients were With the Latzko procedure the RUF is closed in three repaired by anterior transphincteric, transanal surgical layers with absorbable suture. A transurethral catheter approach (ASTRA) is placed for 3 weeks. Noldus et al. [530] reported 23 6. ENDOSCOPIC APPROACH patients (3.9%) with rectal injury during 589 RP and cystoprostatectomies. Of these 23 patients, 12 Wilbert et al. [568] reported two patients with RUF developed a RUF. Seven fistulas closed spontaneously who were repaired endoscopically transanally. The

1158 Figure 8 : Transanal repair of rectourethral fistula [575]. A. Elliptical incision of the rectal mucosa around the fistula. B. Denudation of the rectal mucosa. C. Fistula closed with absorbable suture. D. Rectal mucosal flap sutured with absorbable suture.

A B

C D

Figure 9. A. Retrograde urethrogram of a 55 year-old man who underwent a radical prostatectomy. He com- plained of fecaluria and urine per rectum. This shows urethral contrast in the rectum through a rec- tourethral fistula (Black arrow). B. Intraoperative photograph of transanal rectourethral fistula repair. The anus is held open by the ring retractor to permit direct access to the fistula. C. Intraoperative view of the rectal mucosal sutures in the rectourethral fistula repair. D. Retrograde urethrogram 3 months after transanal rectourethral fistula repair. There is no contrast entering the rectum from the urethra. The patient’s suprapubic tube was removed and his colostomy was reversed.

1159 patients were positioned prone and the rectoscope All eight patients had a temporary ileostomy, which was mounted to the operating table was inserted into the successfully reversed in 7. rectum .The fistula was visualized and the opening excised to the level of the perirectal tissues with f) Summary cautery. The rectal wall was mobilized full thickness A review of recent literature shows an increasing with scissors and closed primarily in two layers with number of papers describing treatment. All available a microscope. The patient was then placed in lithotomy studies are retrospective cases and case series position and the urethral side of the fistula was (level 3 evidence). There are many causes of these coagulated and injected with fibrin. fistulas described in the literature but there is a lack Bardari et al. [569] used cyanoacrilic biological glue of valid epidemiologic data about the incidence of to close one prostato-perineal fistula complicating an UCF and RUF. The diagnostic algorithm has not abdominoperineal resection of rectum and one changed in many years. persistent neobladder-ileal fistula. The biologic sealant The aim of the surgical approach is the closure of was administrated endoscopically through an open- all types of fistulas. While spontaneous closure and end 6F ureteral catheter. Quinlan et al. [577] presented success with a one-stage procedure has been the case of an iatrogenic fistula in a 71-year-old man reported, most cases to date involve 3 stages (double treated by a transanal endoscopic microsurgical (TEM) diversion, closure technique, and undiversion). An approach, without recourse to a stoma. Bochove- endoscopic approach using biological sealants is Overgaauw et al. [578] reported successful repair of promising. Only a few urologists and general 1 of 2 RUF with transanal endoscopic microsurgery surgeons have gained wide experience in the (TEM). The RUF occurred after laparoscopic radical management of UCF or RUF. No single procedure prostatectomy. has yet proved to be best or universally applicable. Conservative treatment is generally ineffective in 7. OTHER MODIFICATIONS the management of large RUF. Surgical intervention Youssef et al. [556] successfully treated 12 male offers symptomatic relief and improved quality of patients who presented with RUF from 1990 to 1997 life in most patients. All reports are still only using the perineal subcutaneous dartos flap retrospective case series (Level of evidence 3; procedure. The RUF resulted from crush pelvic injury grade of recommendation C). in 6 cases, gunshot wounds in 2, and post prostatectomy in 4. The fistula was associated with a urethral stricture in 4 cases. A perineal approach was XII. THE ARTIFICIAL URINARY used and combined with a transsymphyseal approach SPHINCTER (AUS) in the 4 patients with posterior urethral stricture. They interposed a subcutaneous dartos flap as a tissue Different devices designed to control urinary flap between the repaired rectum and urethra. No incontinence in the male go back to the middle of the leakage or perineal collection developed and there was 18th century [582]. Since then research eventually no fistula recurrence. Follow-up ranged from 9 to 42 produced external and implantable devices. The gold months. This technique of a perineal subcutaneous standard today is considered to be the artificial urinary dartos flap may fulfill the principles for successful sphincter (AUS) designed by F.B. Scott, W.E. Bradley, repair of RUF. Varma et al. [579] also concluded that and G.W. Timm in 1973 [583]. The original model dartos muscle interposition is a straightforward underwent a number of modifications, but the basic technique that can result in successful fistula repair. principle remained the same. It consists of a fluid filled but should not be used in immunocompromised hydraulic system with a cuff around the urethra, a patients or after radiation therapy. pressure regulating balloon and an activating device, Felipetto et al. [545] used human fibrin sealant the pump, placed in the scrotum. (Tissucol) to close a prostato-cutaneous fistula (as a 1. AVAILABILITY AND COST complication of pseudomonas prostatitis). Venkatesh The results of an e-mail survey among urologists and and Ramanujam [580] prospectively studied the gynecologists were previously published in the 3rd efficacy of autologous fibrin glue for closure of recurrent ICI, whereby members of the International Continence anorectal fistulas. Overall success rate was 60% Society asking them if the AUS was available in their however patients with acquired immunodeficiency country; and if so, what was the price of the device syndrome who had fistulas associated with the urinary (in US dollars). About 10% of the members responded tract failed to respond. by email from 31 countries. The price varied from Finally Chirica et al. [581] reported their experience $4000 to $10,000 USD. The high price in some with coloanal sleeve anastomosis (Soave procedure) countries at the time (Georgia, Hong-Kong, Romania as a salvage procedure for complex rectourinary and Saudi Arabia) precluded its use. Very few fistulas after radical prostatectomy or followed anterior gynecologists implant the sphincter, probably since the resection for rectal cancer after radiochemotherapy. majority of patients receiving the device are male. 1160 2. INDICATIONS can also be successfully implanted in patients after bladder substitution [311], and in those with locally The indication for AUS placement is for the treatment recurrent prostate cancer with a relatively good of SUI due to ISD that is persistently bothersome prognosis [593], or those with severe post-radical despite 6-12 months of active conservative prostatectomy anastomotic stricture in whom a stent management. As the most common cause of SUI in has been placed previously [320]. men is iatrogenic injury during prostate cancer surgery, it follows that the most common indication for AUS is Finally, advanced age is not a contra-indication to post-prostatectomy incontinence (PPI). The use of AUS placement. A retrospective analysis by O’Connor the AUS for the treatment of PPI varies regionally. and colleagues of a cohort of men over age 75, For example, within the United States, state-by-state revealed excellent success rates, with 21 of 29 men use of the AUS ranges from 1% to 10% of all RRP (72%) achieving successful continence. Revision rate patients, with an average of 6% of RRP patients was 14% at an average of 5 years follow-up, with ultimately undergoing AUS implantation. In 2005, 14% requiring explantation, and 21% requiring device 4,426 AUS units were sold in the United States, which deactivation due to deterioration in overall health represents approximately 1 unit per every 3 U.S. precluding proper use of the AUS at an average of 47 urologists [584]. Nearly half of all AUS implantations months after placement [235]. in the U.S. were indicated for SUI following prostate 3. SURGICAL TECHNIQUES cancer surgery [184, 193, 263, 585, 586]. The remaining 50% of units are used for patients with The original technique of implantation is illustrated in neurogenic disorders (such as spina bifida or Figure 10. The cuff of the sphincter around the bulbous neurogenic ISD), for those with incontinence after urethra is placed via a midline perineal incision, while transurethral resection of the prostate, and for females the pressure regulating balloon and the scrotal pump with ISD following failed sling surgery. are inserted via a separate inguinal incision. A relatively new surgical approach has been described using a Previous radiotherapy to the pelvis is not a single, upper transverse scrotal incision which allows contraindication for AUS placement in males, [587] as the placement of all 3 components of the system, the the ultimate outcome seems to be similar in men cuff, the pump in a scrotal pouch, and the reservoir whether or not they have received radiation therapy behind the fascia transversalis [223]. Alternatively, [236], although a higher incidence of urethral atrophy, the pressure-regulating balloon may be placed through erosion and infection requiring surgical revision has a separate inguinal incision, with the cuff and control been reported in irradiated patients compared to those pump placed via a single trans-scrotal incision, with not irradiated (41% vs 11%). Despite this observation, the connections among scrotal pump, balloon reservoir, long term continence and patient satisfaction appear and urethral cuff tubing made in the usual inguinal not to be adversely affected in the irradiated male incision. While the trans-scrotal approach potentially patient [236]. Unlike in men, previous external beam minimizes the invasiveness of the AUS surgery, by radiation is a relative contra-indication for implantation limiting the surgical approach to a single incision [223], in females due to a considerably higher erosion rate a few reports have revealed that surgical success [263]. might be diminished compared with perineal cuff The compressive effect of the AUS is temporarily placement and abdominal balloon reservoir placement relieved when the patient squeezes the scrotal/labial [594, 595]. Henry and colleagues [595] noted in their pump, transferring fluid from the urethral cuff to the retrospective analysis of patients treated with a perineal pressure-regulating balloon. Subsequently, the bladder versus trans-scrotal AUS over a 17-year period (mean can then empty either by bladder contraction and/or follow-up not given), the former group had a completely by abdominal straining. Accordingly, patients voiding dry rate of only 28%, versus 57% in the perineal group with the Valsalva manoeuvre because of an (p<0.03). Beyond the difference in “completely dry” underactive or neurologically acontractile bladder, do rate, social continence was also better in the perineal not seem to be at an increased risk of complications versus scrotal surgery (73% versus 60%). Thus the [588]. It should also be noted that patients with previous perineal approach for initial artificial urinary sphincter anti-incontinence procedures show a significantly implantation appears to control male stress higher explantation rate [589]. incontinence better than the trans-scrotal approach. Clinical experience suggests that enterocystoplasty The trans-scrotal approach appears particularly useful or gastrocystoplasty can be done simultaneously with for simultaneous placement of an AUS and inflatable the implantation of the AUS [590, 591]. However, penile prosthesis through a single incision, with AUS placement at the time of cystoplasty is associated Kendirci and colleagues [596] reporting a urethral with earlier infections, especially during the first 3 erosion rate of 9%, an overall revision rate of 14%, years post-operatively [592]. In the long-term (> 3 and a social continence rate of 100% in 22 patients years) the infection rate is the same whether the AUS at 17 months average follow-up. Sellers, et al. [597] is implanted after or at the time of cystoplasty. AUS recommend the simultaneous surgery for cost-efficacy.

1161 A B

C D

E F

Figure 10 : A. With the patient in lithotomy position, a perineal incision is made behind the scrotum to expose the bulbar urethra. B. The urethra is mobilized circumferentially within the bulbospongiosus mus- cle and the measuring tape is used to obtain the cuff size. C. The belt-like cuff is positioned around the ure- thra. D. A right lower quadrant (RLQ) abdominal incision is made and the extraperitoneal space is entered lateral to the rectus muscle for insertion of the reservoir.E. After reservoir insertion the cuff is pressurized with fluid. F. A scrotal space is created under the dartos and the pump is inserted (held with a Babcock clamp).

1162 G H

Figure 10 : G. The cuff tubing is brought from the perineal incision to the RLQ incision with a tubing pass- er. H. Connectors are placed to join the tubes from the cuff and reservoir to the corresponding tubes from the pump in the RLQ incision.

They demonstrated a $7,000 cost savings when both may be more closely related to the physiologic state devices were implanted simultaneously through a of the host rather than the experience of the surgical scrotal approach, compared to staged implantation with team, provided standard precautions are strictly 2 separate surgeries. applied. The trans-scrotal approach is also useful for revision a) Incontinence surgery. Van der Horst and colleagues [598] described AUS revision through a trans-scrotal approach, with Incontinence following implantation of an AUS can addition of a second cuff distal to the primary cuff. In result from (1) alteration in bladder function, (2) atrophy addition, Comiter [166] described the trans-scrotal of the urethra, or (3) mechanical failure of the device. approach for placement of an AUS following previous These causes may co-exist. perineal sling surgery. In the case of suboptimal 1. ALTERATION IN BLADDER FUNCTION continence following sling surgery, placing the AUS cuff distal to the sling through a scrotal incision allows the This situation has been reported principally in patients surgeon to avoid the previous operative field, with neurogenic bladder dysfunction, especially in minimizing dissection through potentially scarred children [599-604]. These changes include de novo tissue; secondly, it leaves the proximally placed sling involuntary detrusor contractions, decrease in bladder as a partially effective compressive device proximal compliance, and the development of a high pressure to the AUS cuff. system, causing incontinence, hydronephrosis and ultimately renal failure. Modifications in detrusor 4. COMPLICATIONS behavior (including its consequences on the upper Complications following implantation of the AUS can urinary tract) occur in up to 57% of cases [599-610]. be divided into the broad categories of incontinence, It should be pointed out, however, that there has never erosion and/or infection, and unusual complications. been a published report of hydronephrosis following While the number of AUS procedures performed varies implantation of an AUS for incontinence after geographically throughout the world, especially within prostatectomy [611]. The best candidates for sphincter the United States. Certain “centers of excellence” implantation are those with a low pressure, relaxed, perform substantially more procedures than do and compliant bladder but an incompetent urethral community hospitals [584]. However, the total number sphincter [608]. of procedures done in a given center does not seem 2. ATROPHY OF THE URETHRA to be a determining risk factor for complications. Comparable erosion/infection rates have been reported This may occur at the cuff site secondary to long- from centers with fewer than 50 or more than 100 term mechanical compression of the periurethral and cases [206]. This suggests that erosion and infection urethral tissues. It is not often reported and some

1163 authors do not even mention it as a possible cause A likely etiology of early erosion is intra-operative of AUS failure [237, 263, 611]. About 4 months following laceration of the urethra when dissecting it from the implantation, cuff efficiency diminishes, presumably corpora cavernosa, where a difficult anatomical plane because pressure atrophy occurs in every patient to exists. Intraoperative recognition of urethral injury can some extent [612]. The incidence of urethral atrophy be facilitated by retrograde perfusion sphincterometry leading to revision varies from 3% to 9.3% [178, 184, using a flexible cystoscope [32]. While recognition of 187, 586, 609, 613-615]. This atrophy can be lessened a urethral injury may alert the surgeon to the necessary with nocturnal deactivation of the cuff [616]. termination of the procedure, urethral erosion may still occur without a known urethral laceration [626]. 3. MECHANICAL FAILURE As mentioned above, while the majority of authors This includes perforation of one of the components with consider previous radiotherapy a risk factor for loss of fluid from the system, air bubbles or organic increased infection and erosion, it is not a debris within the system causing inadequate function contraindication to implantation of an AUS in the male of the pump, disconnection of the tubes, or kinking of patient with PPI [177, 179, 200, 236, 237, 260, 627]. the tubes. Introduction of “kink-free” tubing has virtually Overall patient satisfaction is similar in those who eliminated this last complication. have been irradiated, compared to those who have The incidence of these complications varies widely with not been [177, 188, 236]. Furthermore, the degree of ranges from 0% [613] to 52.5% [193] with the longest satisfaction does not diminish with an increased follow-up. In this latter study, the cuff seemed to be number of surgical revisions [192, 628]. the most vulnerable part of the system (22 cuff failures 5. RARE COMPLICATIONS in 18 patients, most of them occurring during the first 2 to 3 years following implantation), followed by pump Several unusual, although rare complications have failure (6 times in 4 patients). Blockage is an been recently reported in the literature, such as the exceptional event, occurring only once in 61 patients intravesical migration of the reservoir with secondary followed from 10 to 15 years [193]. In a recent stone formation in the bladder [629], or a giant urethral publication from Baylor [187], chronicling a 13-year diverticulum at the site of a previously removed cuff experience with the AUS, mechanical failure occurred because of erosion and urinary extravasation [630]. at an average of 68.1 months postoperatively. An 5. DURABILITY OF AUS COMPONENTS unusual mechanical complication has been reported recently. The locking tab became displaced distally into When defining durability of one of the components or the cycling portion of the cuff preventing the fluid from the AUS as a whole, one should distinguish between flowing into the cuff surrounding the urethra [617]. explantation of the device due to device malfunction (e.g. leak in one of the components) or complications 4. EROSION AND/OR INFECTION caused by an otherwise properly functioning sphincter Erosion and infection are two major complications unit (e.g. erosion by the cuff, infection at the site of that almost invariably necessitate removal of the implantation, etc.). This distinction is rarely made in prosthesis. Their incidence may be reported separately, the literature. Durability of a device is defined as time or more commonly as a single complication. The elapsed during which no mechanical problem alters incidence of these complications varies from 0% to the normal function of the device. This should exclude 24.6% [178, 263, 586, 602, 608, 609, 613-615, 618, the second group from further analysis. 619]. Most recent large series report an incidence of There are very few references in the literature infection and erosion generally less than 8% [51, 186, pertaining to the length of time a device functioned 187, 198, 237, 611, 620, 621]. As would be expected, normally before its removal due to mechanical failure. the highest incidence has been reported with the In a multicenter trial, for neurogenic bladders, longest follow-up (10-15 years) [178]. Lai and conducted in France [609], the authors mention that colleagues [187] from Baylor recently reported that the “mean operational life” of the sphincter was 56 erosion occurred at an average of 19.8 months post- months (range 3-118 months). Haab et al [184] operatively rather than in the peri-operative period. analyzed 68 patients and noted that the mechanical Previous surgery [622] at the site of cuff placement failure rate dropped from 44.4% to 12.4% since increases the risk of erosion. This, however, may be modifications were made to the device, mainly the decreased by delayed cuff activation [623]. Some cuff component. Survival time of these components authors, however, did not find an increased incidence was not provided. Similar conclusions can be drawn of complications when a new cuff was implanted at the from a series from the Mayo Clinic [190] where the site where several months before a cuff has been modification of the cuff design (narrower back) resulted removed for infection or erosion [624]. Other risk in a significant drop of the reoperation rate at 5 years. factors include urethral catheterization and urethral In the “narrow back” group 17% (31/184) required endoscopic manipulations with an activated sphincter reoperation. In that cohort, non-mechanical failure in place [625]. decreased from 17% to 9% and mechanical failure

1164 decreased from 21% to 8% following introduction of In other recent series, the global long term (2 to 7.7 the narrow back cuff [190]. Mean time to reoperation years) revision rate, for any of the above mentioned was 26.2 months (mean 2-68 months). Using Kaplan- reasons varies between 16% and 50% [186, 187, Meier statistical analysis for this group of patients, 191, 192, 628, 632-635.] In Webster’s recent report the overall 5 year expected product survival was 75%. [628] of 554 implantations over a 10 year period, (i.e. In Lai’s report regarding Baylor’s recent 13-year performed since the 1987 device modification), he experience with the AUS, only 6% of devices failed noted a mechanical failure rate of only 31/554 (5.5%). mechanically, at an average of 68.1 months, with 75% Non-mechanical failure was 88/554 (15.9%), with of patients requiring no revisions at 5 years [187]. In 63/554 (11.3%) due to urethral atrophy and 21/554 a review, Venn et al [263] analysed the outcome of 100 (3.8%) due to cuff erosion. Of the total cohort, 21.4% patients in whom an artificial urinary sphincter was required at least one revision surgery, while 78.6% did implanted for more than 10 years. Thirty-six percent not. Of those 119 patients who required re-operation, of them still had the original sphincter and were 76.5% required no further treatment (similar to the continent at a median follow-up of 11 years. The bulbar non-reoperation rate of the initial cohort), while 23.5% cuff, as compared to the bladder neck cuff provided required re-operation for either mechanical or non- a slightly better continence rate at 10 years, 92% and mechanical failure. Five-year durability of the AUS 84%, respectively. The lowest erosion rate occurred following primary or secondary implantation was with the bulbar cuff. Device survival rate at 10 years comparable, with 80% for the initial placement, and was 66% in this series. 88% following revision surgery. Similarly, continence In a series of 30 boys with spina bifida Spiess et al status was comparable, with 90% of primary and 82% [631] found that the mean lifetime of all AUS was 4.7 of revision patients achieving 0-1 pad per day urinary years, with no statistically significant difference in control. Patients with neurological deficit seem to sphincter survival of those inserted at the bladder have a higher risk of non-mechanical failure and the neck or the bulbous urethra (4.6 and 4.9 years, overall continence rate may be poorer compared to respectively). A sharp drop was observed at 100 non-neurologic patients [29]. months with only 8.3% of the original sphincters still 6. DIAGNOSTIC PROCEDURES RELATED TO functioning beyond this point. In a series of 35 ARTIFICIAL SPHINCTER FAILURE adolescents with neurogenic voiding dysfunction implanted with a bladder neck cuff over an 11-year The diagnostic evaluation of urinary incontinence after period, with an average follow-up of 5.5 years, Lopez the placement of the AUS is critical for the Pereira and colleagues [632] reported a 20% management of these patients and represents a mechanical failure rate, with an additional 8.6% erosion challenging problem for the urologist. Several rate. Adverse bladder storage changes developed in diagnostic and management algorithms have been 31.8% of patients, who thereby required augmentation proposed, some relatively simple, others more complex cystoplasty. However, continence was achieved in [29, 30, 200, 206, 610, 636-638]. Figure 11 shows an 91.4% of individuals. Ruiz and colleagues [633] algorithm to investigate and treat the male patient followed 19 adolescents for an average of 80 months with a previously functioning AUS who becomes who were implanted with bladder neck cuffs over a 14 incontinent. year period for reasons other than spina bifida. They reported a mechanical failure rate of 26.3%, an Physical examination should exclude infection at the infection/erosion rate of 15.8%, and a revision rate of site of the cuff or the scrotal/labial pump. Difficulty 26.3%. However, even in this very high risk group, a compressing the pump suggests tube kinking, fluid loss continence rate of 87% was achieved despite this or an obstructed system. high complication rate. It might be useful to consider Plain X-rays of the abdomen or pelvis may show fluid patients with ‘primary adequate function’ when no loss, if the system is filled with radio-opaque solution revision is necessary to achieve continence separately [639, 640] (Figure 1). Alternatively, sonography of from those with ‘additional procedure-assisted the pressure regulating balloon may show volume adequate function’, where one or more revisions are loss. It is necessary to obtain a baseline film at the necessary to obtain favourable outcome. Klijn et al. discharge of the patient from the hospital for [183] showed in their series of 27 men who became subsequent comparison because radiographic imaging incontinent after a radical prostatectomy that at a of the balloon does not detect changes until at least mean follow-up of 35 months, 81 % of the patients 50% of its volume has been lost [12]. achieved satisfactory continence. The 5-year ‘primary adequate function’ and ‘additional procedure-assisted Cystometrogram or complete urodynamic study will adequate function’ rates, based on the Kaplan-Meier demonstrate changes in bladder behavior following curves, were 49% and 71%, respectively. The median insertion of the AUS as described above. time to failure for the ‘primary adequate function’ group Cystourethrography could eventually demonstrate a was 48 months, the median time to definitive failure urethral diverticulum at the site of previous cuff erosion of ‘additional procedure-assisted adequate function’ (Figure 2). Endoscopy will disclose any urethral erosion was more than 72 months. by the cuff (Figure 12). 1165 Figure 11 : Algorithm for managing incontinence after AUS placement

1166 medical contraindications, or the drug may be ineffective. Other options such as bladder augmen- tation or enterocystoplasty may be considered. To date no report can be found where implantation of an artificial sphincter resulted in the deterioration of the upper urinary tract in a neurologically normal post- prostatectomy patient 188, 611. It has been reported that enterocystoplasty performed together with the placement of an AUS in the same operative session does not increase the morbidity of the procedure and does not affect the success rate [590]. However, in a recent review of 286 patients Furness et al. [641] demonstrated an infection rate of 14.5% and 6.8% with simultaneous and staged procedures, respectively. Catto, et al. [592] however, showed that while infections may occur earlier with simultaneous procedures, the ultimate infection rate is no different when augmentation cystoplasty and AUS placement separately or simultaneously. No clear urodynamic guidelines exist to select patients who need bladder augmentation in combination with an AUS [612], although small voided volumes with reduced cystometric capacity, poor compliance, or severe detrusor overactivity after failed medical treatment Figure 12 : Endoscopic view of AUS cuff erosion would suggest the need. into the bulbar urethra. The patient had undergone radiation after radical prostatectomy. b) Atrophy of the urethra Several therapeutic options exist to increase cuff Retrograde perfusion sphincterometry has been pressure around the atrophied urethral wall: changing reported to diagnose the loss of compressive pressure the balloon reservoir for one generating a higher in the urethral cuff [29]. It is done by infusing fluid pressure, downsizing the cuff diameter [12, 179, 642], from the meatus in a retrograde fashion. If the AUS or increasing the amount of fluid in the system. Another cuff is functional and the urethral is intact there should approach consists of placing the cuff inside the corporal be no flow when the pressure equals the AUS balloon tunica albuginea on the dorsal aspect of the urethra pressure. This technique can also be used (transcorporal). This allows a safer mobilization of intraoperatively to detect urethral perforation or to the urethra and adds some supplementary bulk of adjust the pressure in the cuff [32]. This seems to be tissue to the circumference of the urethra, possibly more useful than urethral pressure profile (UPP) [606]. decreasing the risk of erosion [196]. It should be Intraoperative electrical testing, using an ohmmeter mentioned, however, that there is a risk of reduced [619, 637] has been described to determine the site erectile function with this technique. The vast majority of fluid leakage from the system. This test can be of such patients, however, already suffer from erectile helpful to avoid the need to change the whole system, dysfunction secondary to the prostate cancer surgery. and allow replacement of the leaking part only. Guralnick reported a retrospective chart review of 31 7. TREATMENT OF COMPLICATIONS patients with an average of 17 months follow-up after trans-corporal cuff placement for varied indications As outlined above, complications directly related to the (previous erosion, urethral atrophy, radiation). The presence of an artificial sphincter can be divided into vast majority of patients (84%) realized 0-1 pad per categories: incontinence from alteration in bladder day leakage post-operatively, with no device erosions function, urethral atrophy, and/or mechanical failure, or infections, while 3 patients (9.7%) required revision and infection/erosion. The treatment of each of these surgery for malfunction. Overall, 29 of 31 had erectile complications deserves comment, as no detailed dysfunction prior to the procedure, and only 1 of 2 reference can be found in the literature dealing with had deterioration of his erectile function post- the treatment of these complications. operatively. Magera and Elliott [643] reported their a) Alterations in bladder function results of 18 patients who underwent tandem cuff transcorporal salvage surgery. Ten patients had only De novo (or pre-existing) detrusor overactivity can the distal cuff placed transcorporally, while 18 had be treated with parasympatholytics. In a small both cuffs placed transcorporally. Infection occurred proportion of patients systemic side effects will prevent in 1 patient (5.5%), and erosion occurred in 1 patient the use of these drugs; there might also be some (5.5%), while 69% reported that they were very 1167 improved or extremely improved with respect to convert a double-cuff system into a single cuff system continence at an average of 26 months follow-up. [647]. It is logical that intra-operative urethral injury may The implantation of a double-cuff AMS 800 has precipitate cuff erosion if unrecognized. However, become more popular, as a primary procedure in the Petrou and colleagues [626] showed that early totally or severely incontinent patient [197, 644], or as postoperative cuff erosion can occur even when no a salvage procedure, by adding a second cuff, following laceration is demonstrated by intraoperative a failed previous single cuff [194, 195, 644]. Dimarco’s intraurethral instillation of indigo carmine. group [195] and others have shown excellent results 8. CONSENSUS PROTOCOL FOR with the addition of a second urethral cuff, placed FOLLOW-UP OF PATIENTS WITH AUS 1.5–2.0 cm distal to the primary cuff. Alternatively, a circumurethral wrap of an organic bulking agent can As complications continue to be seen for years after be fitted, with subsequent placement of the AUS cuff implantation [648], it is helpful to have a structured over the biologic external urethral bulking agent [645]. follow-up plan. However, no standardized recom- Early reports of primary double cuff placement did mendations are available in the literature. not demonstrate any significant increase in morbidity The consensus upon which the members of this with the double-cuff as compared with the single cuff subcommittee agreed and which is based on expert system [197], and patient satisfaction also seems to opinion are as follows: be higher [198] at an average of 21-41 months follow- up. However, with longer follow-up (58-74 months), 1. Perioperative antibiotics are recommended. the same group [199] reported that the complication Gram-negative enteric bacteria and rate was higher in men with primary double-cuff Staphylococcus epidermidis are the most placement (55% versus 28%), and there were no frequently encountered microorganisms in significant differences in overall continence and QOL infected prostheses [625]. measures. 2. Hospital stay should be kept to a minimum. c) Mechanical failure 3. Urethral catheters, if inserted, should be As with any device, mechanical failure can be expected withdrawn within 24-48 hours of surgery and with the AMS 800 AUS. The treatment involves surgical the preoperative continence management replacement of the failed component and reconnecting continued. the system. d) Infection 4. In general the sphincter device should not be activated immediately postoperatively. In the With overt infection the accepted treatment option is initial period scrotal oedema and pain prevent removal of the entire device and appropriate antibiotics. patients from manipulating the pump adequately. A second system can be subsequently implanted with When this subsides after 6 to 8 weeks the device equally good results [623]. It has been demonstrated, can be activated. Earlier activation may also be however, that immediate reimplantation of a new AUS acceptable. Irradiated patients may benefit from after the removal of an infected, but not eroded, a longer initial period of deactivation, up to 12 prosthesis can be a valid option with an overall success weeks [179]. Nocturnal deactivation should be rate of 87% [646]. In 2007, AMS introduced the considered in high-risk patients 178]. InhibiZone-coated artificial urinary sphincter (rifampin and minocycline hydrochloride coating) [643]. 5. Patients are reviewed at 3 months after e) Erosion activation to ensure the device is working adequately, and to assess the continence status. In case of urethral erosion by the cuff, the “offending” cuff must be removed. No clear guidelines exist 6. Long-term follow-up is different in the neurogenic whether removal of the whole system is superior to and non-neurogenic patient. With time, alteration removal of the cuff alone but it must be assessed for in bladder function may jeopardize renal function infection. If infection is present the whole device should in the neurogenic patients. Periodic ultrasound be removed. Reservoir erosion into the bladder has evaluation of the upper urinary tract and been described following the removal of an eroded cuff monitoring of renal function is essential. If [629]. Furthermore, it is not known whether it is changes occur, urodynamic studies should be necessary to allow the urethra to heal over a catheter done to rule out detrusor overactivity. In non- versus surgical repair. The former risks diverticulum neurogenic patients, periodic ultrasound may formation (Figure 2), and the latter may increase the not be necessary. amount of the periurethral fibrosis. This might 7. When changes in the continence status occur compromise success of a new cuff. However, the new diagnostic procedures depicted in Figure 11 cuff should be positioned away from the erosion site. should be considered. (Level of evidence 3; In case of the erosion of one of the cuffs of a double Grade of recommendation B-C) system removal of the eroded cuff can successfully

1168 neck reconstruction has also been reported on a XIII. SUMMARY AND limited basis. (Level of evidence 3; grade of RECOMMENDATIONS recommendation C)

1. EVALUATION 6. INCONTINENCE IN ADULT EPISPADIAS- EXSTROPHY COMPLEX Prior to surgery a basic patient evaluation should consist of history and physical examination, urinalysis Patients should be treated in centres of excellence. and postvoid residual urine (Level of evidence 1-2: A patient-directed approach should be taken. The grade of recommendation A). A voiding diary is helpful choices include further bladder neck reconstructive to assess functional capacity and total urine output surgery, bladder neck closure, bladder reconstruction (Level of evidence 1-2: grade of recommendation B). or diversion with bowel. The data are insufficient for Pad tests may be useful in certain circumstances a specific recommendation. Transition is important (Level of evidence 1-2: grade of recommendation B). between the pediatric and adult urologist. Life-long Blood testing (BUN, creatinine, glucose) is follow-up is mandatory in terms of continence, voiding recommended if compromised renal function is efficiency, upper tract status and other urological suspected or if polyuria (in the absence of diuretics) complications. (Level of evidence 3; Grade of is documented. Additional testing with cystoscopy recommendation C) and appropriate imaging of the urinary tract are also 7. REFRACTORY URGENCY INCONTINENCE helpful in guiding therapy (Level of evidence 2-3: AND DETRUSOR OVERACTIVITY grade of recommendation B). The committee felt that multichannel urodynamics are useful prior to Botulinum toxin-A bladder injections is a minimally invasive treatment for incontinence. (Level of invasive treatment with some efficacy. Neuromo- evidence 3: grade of recommendation C) dulation is a treatment option with success reported in a limited number of male patients. Detrusor 2. INCONTINENCE POST-PROSTATECTOMY myectomy has also been reported to be successful FOR BPO AND POST-RADICAL PROSTATE- in a small number of male patients. Augmentation CTOMY FOR PROSTATE CANCER cystoplasty is potentially successful in controlling symptoms but may be associated with unacceptable After a period of conservative management, which may also be from 6 to 12 months, the artificial sphincter side effects. Urinary diversion is a final option. (Level is the preferred treatment for properly selected men of evidence 3; grade of recommendation C) who have stress incontinence after radical 8. REDUCED CAPACITY BLADDER prostatectomy with the longest record of safety and Augmentation cystoplasty has been successful in efficacy. Male slings are an alternative with most etiologies apart from radiation. (Level of intermediate data support their safety and efficacy in evidence 3; grade of recommendation C) men with more moderate degrees of PPI, although long-term data are beginning to accumulate. However, 9. URETHROCUTANEOUS FISTULA AND the literature contains results on many different kinds RECTOURETHRAL FISTULA of slings. Injectable agents are a less effective option Etiologic factors causing acquired urethrocutaneous for some men with mild to moderate incontinence. (Level of evidence 3; grade of recommendation C) fistulae are demonstrated by clinical, endoscopic and imaging studies. Surgical reconstruction is applied 3. AGE as required. Similar diagnostic maneuvers are applied to rectourethral fistulae. Age is not a restriction for surgical treatment of urinary incontinence. Cognitive impairment and lack of In those that do not close with or without temporary dexterity may be restrictions for the artificial sphincter urinary and fecal diversion, surgical reconstruction and must be determined preoperatively. (Level of may be carried out. Most repairs are now carried out evidence 3-4; grade of recommendation C) after prior fecal diversion. Various techniques are available for closure and can be done in collaboration 4. INCONTINENCE FOLLOWING OTHER with colorectal surgeons. (Level of evidence 3; grade TREATMENTS FOR PROSTATE CANCER of recommendation C) The artificial sphincter is most widely used but radiation 10. MANAGEMENT OF AUS COMPLICATIONS may be a risk factor for an increase in complications. Slings have variable results after radiation. Injectable Incontinence may result from alteration in bladder agents have not been successful in this setting. (Level function, urethral atrophy, or mechanical malfunction. of evidence 3; grade of recommendation C) Infection and/or erosion of components demand 5. INCONTINENCE FOLLOWING PELVIC surgical removal of all or part of the prosthesis. A treatment algorithm is presented to aid in management TRAUMA and in follow-up of patients. (Level of evidence 3; The artificial sphincter is most widely reported. Bladder grade of recommendation C) 1169 11. NEW TECHNOLOGIES of days required to obtain reliable results. Neurourol Urodyn. 2003;22(2):92-96. Evidence for the adjustable balloons is accruing and 7. Mouritsen L, Berild G, Hertz J. Comparison of different the early high complication rate appears to have been methods for quantification of urinary leakage in incontinent resolved. However, more evidence is required before women. Neurourol Urodyn. 1989;8:579-587. specific recommendations can be made. (Level of 8. Starer P, Libow LS. 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