Outcomes of a Noninferiority Randomised Controlled Trial of Surgery for Men with Urodynamic Stress Incontinence After Prostate Surgery (MASTER).

BACKGROUND: Stress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking. OBJECTIVE: To compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery. DESIGN, SETTING, AND PARTICIPANTS: A noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries. INTERVENTION: Participants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery. RESULTS AND LIMITATIONS: A total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} -11.6 to 4.6], pNI = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2-2.6], p =  0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS. CONCLUSIONS: Using a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS. PATIENT SUMMARY: Urinary incontinence after prostatectomy has considerable effect on men's quality of life. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling.

Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT.

BACKGROUND: Men who suffer recurrence of bulbar urethral stricture have to decide between endoscopic urethrotomy and open urethroplasty to manage their urinary symptoms. Evidence of relative clinical effectiveness and cost-effectiveness is lacking. OBJECTIVES: To assess benefit, harms and cost-effectiveness of open urethroplasty compared with endoscopic urethrotomy as treatment for recurrent urethral stricture in men. DESIGN: Parallel-group, open-label, patient-randomised trial of allocated intervention with 6-monthly follow-ups over 24 months. Target sample size was 210 participants providing outcome data. Participants, clinicians and local research staff could not be blinded to allocation. Central trial staff were blinded when needed. SETTING: UK NHS with recruitment from 38 hospital sites. PARTICIPANTS: A total of 222 men requiring operative treatment for recurrence of bulbar urethral stricture who had received at least one previous intervention for stricture. INTERVENTIONS: A centralised randomisation system using random blocks allocated participants 1 : 1 to open urethroplasty (experimental group) or endoscopic urethrotomy (control group). MAIN OUTCOME MEASURES: The primary clinical outcome was control of urinary symptoms. Cost-effectiveness was assessed by cost per quality-adjusted life-year (QALY) gained over 24 months. The main secondary outcome was the need for reintervention for stricture recurrence. RESULTS: The mean difference in the area under the curve of repeated measurement of voiding symptoms scored from 0 (no symptoms) to 24 (severe symptoms) between the two groups was -0.36 [95% confidence interval (CI) -1.78 to 1.02; p = 0.6]. Mean voiding symptom scores improved between baseline and 24 months after randomisation from 13.4 [standard deviation (SD) 4.5] to 6 (SD 5.5) for urethroplasty group and from 13.2 (SD 4.7) to 6.4 (SD 5.3) for urethrotomy. Reintervention was less frequent and occurred earlier in the urethroplasty group (hazard ratio 0.52, 95% CI 0.31 to 0.89; p = 0.02). There were two postoperative complications requiring reinterventions in the group that received urethroplasty and five, including one death from pulmonary embolism, in the group that received urethrotomy. Over 24 months, urethroplasty cost on average more than urethrotomy (cost difference £2148, 95% CI £689 to £3606) and resulted in a similar number of QALYs (QALY difference -0.01, 95% CI -0.17 to 0.14). Therefore, based on current evidence, urethrotomy is considered to be cost-effective. LIMITATIONS: We were able to include only 69 (63%) of the 109 men allocated to urethroplasty and 90 (80%) of the 113 men allocated to urethrotomy in the primary complete-case intention-to-treat analysis. CONCLUSIONS: The similar magnitude of symptom improvement seen for the two procedures over 24 months of follow-up shows that both provide effective symptom control. The lower likelihood of further intervention favours urethroplasty, but this had a higher cost over the 24 months of follow-up and was unlikely to be considered cost-effective. FUTURE WORK: Formulate methods to incorporate short-term disutility data into cost-effectiveness analysis. Survey pathways of care for men with urethral stricture, including the use of enhanced recovery after urethroplasty. Establish a pragmatic follow-up schedule to allow national audit of outcomes following urethral surgery with linkage to NHS Hospital Episode Statistics. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98009168. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 61. See the NIHR Journals Library website for further project information.

The urethra carries urine from the bladder to the tip of the penis. Men can develop a condition called urethral stricture when part of the urethra narrows due to scarring. This can lead to difficulties in passing urine and can recur. There are two operations for urethral stricture. The standard approach is endoscopic urethrotomy. The alternative is open urethroplasty. This study wanted to find out which operation was preferable in terms of symptom control, time before further surgery and which operation was best value for the NHS. All aspects of the study were informed by patients. Two hundred and twenty-two men who had received at least one previous operation for stricture took part. The choice of operation was decided by chance (randomisation). Of these men, 113 were randomised to urethrotomy and 109 were randomised to urethroplasty. Following their operation, the men filled in questionnaires every 3­6 months for 2 years about their symptoms and if any further surgery was needed. The two groups were then compared. Of the 222 men who took part, 159 provided enough information for inclusion in the comparison (90 were in the urethrotomy group and 69 were in the urethroplasty group). The improvement over time in urinary symptoms was similar for the two groups. Men in the urethrotomy group were twice as likely to need a further operation over the 2-year study period. Very few men experienced serious complications. This study showed that both operations led to symptom improvement for men with recurrent urethral stricture. Urethroplasty, however, appears unlikely to offer good value for money for the NHS. Men needing treatment for recurrent urethral stricture can use this information to weigh up the pros and cons of each operation to decide with their clinical team which one to undergo.

Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial).

BACKGROUND: Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty. OBJECTIVE: To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture. DESIGN, SETTING, AND PARTICIPANTS: This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy. INTERVENTION: Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention. RESULTS AND LIMITATIONS: The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was -0.36 (95% confidence interval [CI] -1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31-0.89]). CONCLUSIONS: In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty. PATIENT SUMMARY: There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.

Innovations in indwelling urethral catheterisation.

The indwelling urethral catheter remains an integral part of contemporary medical care, despite its significant design shortcomings. Urethral catheterisation is responsible for well-recognised complications including catheter-associated urinary tract infection (CAUTI), catheter-associated urethral injury (CAUI), catheter blockage, and bladder mucosal irritation. In this narrative review, we provide an update on current innovations in urethral catheter design, aimed at safeguarding against these complications. There is an obvious need to improve catheter technology and urologists should support the translation of innovations into clinical practice.

Single-stage tubular urethral reconstruction using oral grafts is an alternative to classical staged approach for selected penile urethral strictures.

Penile urethral strictures have been managed by a staged surgical approach. In selected cases, spongiofibrosis can be excised, a neo-urethral plate created using buccal mucosa graft (BMG) and tubularized during the same procedure, performing a "two-in-one" stage approach. We aim to identify stricture factors which indicate suitability for this two-in-one stage approach. We assess surgical outcome and compare with staged reconstruction. We conducted an observational descriptive study. The data were prospectively collected from two-in-one stage and staged penile urethroplasties using BMG in a single center between 2007 and 2017. The minimum follow-up was 6 months. Outcomes were assessed clinically, radiologically, and by flow-rate analysis. Failure was defined as recurrent stricture or any subsequent surgical or endoscopic intervention. Descriptive analysis of stricture characteristics and statistical comparison was made between groups. Of 425 penile urethroplasties, 139 met the inclusion criteria: 59 two-in-one stage and 80 staged. The mean stricture length was 2.8 cm (single stage) and 4.5 cm (staged). Etiology was lichen sclerosus (LS) 52.5% (single stage) and 73.8% hypospadias related (staged). 40.7% of patients had previous failed urethroplasties in the single-stage group and 81.2% in the staged. The most common stricture locations were navicular fossa (39.0%) and distal penile urethra (59.3%) in the single-stage group and mid or proximal penile urethra (58.7%) in the staged group. Success rates were 89.8% (single stage) and 81.3% (staged). A trend toward a single-stage approach for select penile urethral strictures was noted. We conclude that a single-stage substitution penile urethroplasty using BMG as a "two-in-one" approach is associated with excellent functional outcomes. The most suitable strictures for this approach are distal, primary, and LS-related strictures.

Analysis of a 7-year national online audit of the management of open reconstructive urethral surgery in men.

OBJECTIVE: To conduct an audit of the management of urethral pathology in men presenting for reconstructive urethral surgery in the UK. METHODS: Between 1 June 2010 and 31 May 2017, data on men presenting with urethral pathologies requiring reconstruction were entered onto a secure online data platform. Surgeon-entered information was collected in 95 fields regarding the stricture aetiology, prior management, mode of presentation, type of surgery and outcomes, with a potential 283 variable responses in the 95 fields. Data were analysed to compare UK practice with that reported in the contemporary literature and with guidelines. RESULTS: Data on 4809 men were entered by 39 centres and 50 surgeons. Field completeness was 70.7%, 74.3% and 53.7% for preoperative, operative and follow-up data, respectively. Referral for stricture reconstruction frequently followed two prior endoscopic procedures and the stricture was not always assessed anatomically before surgery. Urinary retention was a common symptom in men awaiting reconstruction. Short unifocal strictures of the anterior urethra were the commonest reason for referral, whilst lichen sclerosus and hypospadias generated a significant volume of revisional stricture surgery. Lower numbers of very complex interventions are required for the management of posterior urethral pathology. Although precise criteria for determining success are not clear, management of urethral reconstruction in the UK was found to have a low risk of Clavien-Dindo grade 3 or higher complications, and was associated with outcomes similar to those reported in contemporary series except in the management of posterior urethral fistulae. CONCLUSIONS: Online databases can provide volume data on the management of reconstructive urethral surgery across a multiplicity of centres in one country. They can also indicate compliance with accepted standards of, and expected outcomes from, this tertiary practice.

Syringoceles of Cowper's ducts and glands in adult men.

Cowper's syringoceles are uncommon, usually described in children and most commonly limited to the ducts. We describe more complex variants in an adult population affecting with varying degrees of severity, the glands themselves, and the complications they may lead to. One hundred consecutive urethrograms of patients with unreconstructed strictures were reviewed. Twenty-six patients (mean age: 41.1 years) with Cowper's syringoceles who were managed between 2009 and 2016 were subsequently evaluated. Presentation, radiological appearance, treatment (when indicated), and outcomes were assessed. Of 100 urethrograms in patients with strictures, 33.0% demonstrated filling of Cowper's ducts or glands, occurring predominantly in patients with bulbar strictures. Only 1 of 26 patients with non-bulbar strictures had a visible duct/gland. Of 26 symptomatic patients, 15 presented with poor flow. In four patients, a grossly dilated Cowper's duct obstructed the urethra. In the remaining 11 patients, a bulbar stricture caused the symptoms and the syringocele was identified incidentally. Eight patients presented with perineal pain. In six of them, fluoroscopy and magnetic resonance imaging (MRI) revealed complex multicystic lesions within the bulbourethral glands. Four patients developed perineoscrotal abscesses. In the 11 patients with strictures, the syringocele was no longer visible after urethroplasty. In three of four patients with urethral obstruction secondary to a dilated Cowper's duct, this resolved after transperineal excision (n = 2) and endoscopic deroofing (n = 1). Five of six patients with complex syringoceles involving Cowper's glands were excised surgically with symptomatic relief in all. In conclusion, Cowper's syringocele in adults is more common than previously thought and may cause lower urinary tract symptoms or be associated with serious complications which usually require surgical treatment.

Involving medical students in service improvement: evaluation of a student-led, extracurricular, multidisciplinary quality improvement initiative.

BACKGROUND: Quality improvement (QI) is considered a duty of every doctor and, as such, it is fundamental that medical schools nurture QI skills of medical students. At a London medical school, a novel initiative was designed to involve medical students in QI. Such novel aspects include its student leadership, multidisciplinary approach and extra-curricular nature. The aim of this study is to evaluate the effectiveness of the initiative, and thus add to the experiences of existing medical student QI programs, as well as provide guidance to other institutions wishing to involve medical students in QI. METHODS: The key features of the initiative's design is described. Its effectiveness was evaluated by the collection of retrospective data on the quality of the initiative's QI projects (QIPs), including the proportion which: 1) reached completion; 2) resulted in a significant improvement in their primary outcome; 3) had sustained results at follow-up; 4) achieved publication; and 5) contributed towards a prize or conference presentation. RESULTS: There were 109 students involved throughout 10 projects from 14 different undergraduate and postgraduate courses from 2015-2019. 50% of the initiative's projects achieved a significant improvement in their primary outcome, and the proportion of projects which sustained these improvements at follow-up was 100%. Furthermore, 20% of projects were published, and 60% contributed towards a prize or conference presentation. CONCLUSION: The results of this study show that the initiative was effective at involving medical students in QI. As such, other groups establishing medical student QI programs may benefit from replicating positive elements of its design and operation.

Pelvic fracture urethral injury in males-mechanisms of injury, management options and outcomes.

Pelvic fracture urethral injury (PFUI) management in male adults and children is controversial. The jury is still out on the best way to manage these injuries in the short and long-term to minimise complications and optimise outcomes. There is also little in the urological literature about pelvic fractures themselves, their causes, grading systems, associated injuries and the mechanism of PFUI. A review of pelvic fracture and male PFUI literature since 1757 was performed to determine pelvic fracture classification, associated injuries and, PFUI classification and management. The outcomes of; suprapubic catheter (SPC) insertion alone, primary open surgical repair (POSR), delayed primary open surgical repair (DPOSR), primary open realignment (POR), primary endoscopic realignment (PER), delayed endoscopic treatment (DET) and delayed urethroplasty (DU) in male adults and children in all major series have been reviewed and collated for rates of restricture (RS), erectile dysfunction (ED) and urinary incontinence (UI). For SPC, POSR, DPOSR, POR, PER, DET and DU; (I) mean RS rate was 97.9%, 53.9%, 18%, 58.3%, 62.0%, 80.2%, 14.4%; (II) mean ED rate was 25.6%, 22.5%, 71%, 37.2%, 23.6%, 31.9%, 12.7%; (III) mean UI rate was 6.7%, 13.6%, 0%, 14.5%, 4.1%, 4.1%, 6.8%; (IV) mean FU in months was 46.3, 29.4, 12, 61, 31.4, 31.8, 54.9. For males with PFUI restricture and new onset ED is lowest following DU whilst UI is lowest following DPOSR. On balance DU offers the best overall outcomes and should be the treatment of choice for PFUI.

Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

BACKGROUND: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. METHODS/DESIGN: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. DISCUSSION: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.

The Nontransecting Approach to Bulbar Urethroplasty.

The standard treatment of bulbar urethral strictures of appropriate length is excision and primary anastomosis (EPA), irrespective of the cause of the stricture. This involves transection of the corpus spongiosum (CS) and disruption of the blood flow within the CS as a consequence. The success rate of EPA in curing these strictures is very high, but there is a considerable body of evidence and of opinion to suggest that there is a significant risk of sexual dysfunction and, potentially, of other adverse consequences that occur because of transection of the CS.

Rectourethral Fistulas Secondary to Prostate Cancer Treatment: Management and Outcomes from a Multi-Institutional Combined Experience.

PURPOSE: Rectourethral fistula is a known complication of prostate cancer treatment. Reports in the literature on rectourethral fistula repair technique and outcomes are limited to single institution series. We examined the variations in technique and outcomes of rectourethral fistula repair in a multi-institutional setting. MATERIALS AND METHODS: We retrospectively identified patients who underwent rectourethral fistula repair after prostate cancer treatment at 1 of 4 large volume reconstructive urology centers, including University of California-San Francisco, University College London Hospitals, Lahey Clinic and Devine-Jordan Center for Reconstructive Surgery, in a 15-year period. We examined the types of prostate cancer treatment, technical aspects of rectourethral fistula repair and outcomes. RESULTS: After prostate cancer treatment 201 patients underwent rectourethral fistula repair. The fistula developed in 97 men (48.2%) after radical prostatectomy alone and in 104 (51.8%) who received a form of energy ablation. In the ablation group 84% of patients underwent bowel diversion before rectourethral fistula repair compared to 65% in the prostatectomy group. An interposition flap or graft was placed in 91% and 92% of the 2 groups, respectively. Concomitant bladder neck contracture or urethral stricture developed in 26% of patients in the ablation group and in 14% in the prostatectomy group. Postoperatively the rates of urinary incontinence and complications were higher in the energy ablation group at 35% and 25% vs 16% and 11%, respectively. The ultimate success rate of fistula repair in the energy ablation and radical prostatectomy groups was 87% and 99% with 92% overall success. CONCLUSIONS: Rectourethral fistulas due to prostate cancer therapy can be reconstructed successfully in a high percent of patients. This avoids permanent urinary diversion in these complex cases.

Urethral atrophy after implantation of an artificial urinary sphincter: fact or fiction?

OBJECTIVES: To investigate the concept of 'urethral atrophy', which is often cited as a cause of recurrent incontinence after initially successful implantation of an artificial urinary sphincter (AUS); and to investigate the specific cause of the malfunction of the AUS in these patients and address their management. PATIENTS AND METHODS: Between January 2006 and May 2013, 50 consecutive patients (mean age 54.3 years) with recurrent incontinence had their AUS explored for malfunction and replaced with a new device with components of exactly the same size, unless there was a particular reason to use something different. Average time to replacement of the device was 10.1 years. The mean follow-up after replacement of the device was 24.7 months. All patients without an obvious cause for their recurrent incontinence had preoperative urodynamic evaluation, including measurement of the Valsalva leak point pressure (VLPP) and the retrograde cuff occlusion pressure (RCOP). After explantation of the AUS in patients without any apparent abnormality of the device at the time of replacement, the pressure generated by the explanted pressure-regulating balloon (PRB) was measured manometrically, when this was possible. In a select group of six consecutive patients of this type, the fibrous capsule surrounding the old cuff was incised then excised to expose and evaluate the underlying corpus spongiosum. RESULTS: In 31 of the 50 patients (62%) undergoing exploration, a specific cause for the malfunction of their AUS was defined. In the other 19 patients (38%) no cause was found, either preoperatively or at the time of exploration, other than a low VLPP and RCOP. A typical 'waisted' or 'hour-glass' appearance of the underlying corpus spongiosum was demonstrable, to some degree, on explanting the cuff in all cases. In the six patients in whom the restrictive sheath surrounding the cuff was excised, the urethral circumference immediately returned to normal after the compressive effect of the sheath was released. Manometry of the explanted PRBs, when this was possible, showed a loss of pressure in all instances. Replacement of the explanted AUS with a new device with the same size cuff and PRB in 14 of these 19 patients was successful in 12 (85.7%). CONCLUSIONS: These results, and other theoretical considerations, suggest that recurrent incontinence, years after initially successful implantation of an AUS, is because of material failure of the PRB, probably attributable to its age and consequent loss of its ability to generate the pressure it was designed to produce, and that urethral atrophy does not occur. Simply replacing the old device with a new one with the same characteristics, unless there is a particular reason to do otherwise, is usually successful and avoids the complications of alternatives such as as cuff downsizing, implanting a PRB with a higher pressure range, implantation of a second cuff or transcorporeal cuff placement, all of which have been advocated in these patients.

Fistulation into the Pubic Symphysis after Treatment of Prostate Cancer: An Important and Surgically Correctable Complication.

PURPOSE: Chronic pubic pain after the treatment of prostate cancer is often attributed to osteitis pubis. We have become aware of another complication, namely fistulation into the pubic symphysis, which is more serious and more common than previously thought. MATERIALS AND METHODS: A total of 16 patients were treated for urosymphyseal fistulas after the treatment of prostate cancer between January 2011 and April 2014. Clinical presentation was characterized by chronic, debilitating pubic/pelvic/groin pain in all patients. Diagnosis was confirmed by magnetic resonance imaging. Conservative management was successful in only 1 patient. The remaining patients were treated surgically with excision of the fistulous track and involved symphyseal bone and omentoplasty, followed by reconstruction when feasible. RESULTS: All 16 patients had had radiotherapy as primary treatment (8) or after prostatectomy (8). There were 5 patients (31.3%) who underwent various combinations of brachytherapy, external beam radiotherapy and cryotherapy. Bladder neck contractures developed in 13 patients (81.3%), whose treatment (endoscopic or open reconstruction) resulted in urinary leak leading to urosymphyseal fistulas. Reconstruction was possible in 7 of 15 patients (46.7%) with salvage radical prostatectomy and substitution/augmentation cystoplasty. The other 8 patients (53.3%) underwent cystectomy and ileal conduit diversion. All patients experienced resolution of symptoms, most significantly the almost immediate resolution of pain. CONCLUSIONS: A high index of suspicion must be maintained in irradiated patients presenting with symptoms suggestive of urosymphyseal fistulas, especially after having undergone treatment of bladder neck contractures or prostatic urethral stenoses. Although extensive, surgery for urosymphyseal fistulas, with a high risk of morbidity and mortality and a protracted recovery, leads to immediate and dramatic improvement in symptoms.

Intermittent self-dilatation for urethral stricture disease in males: A systematic review and meta-analysis.

BACKGROUND: Intermittent self-dilatation (ISD) may be recommended to reduce the risk of recurrent urethral stricture. Level one evidence to support the use of this intervention is lacking. OBJECTIVES: Determine the clinical and cost-effectiveness of ISD for the management of urethral stricture disease in males. SEARCH METHODS: The strategy developed for the Cochrane Incontinence Review Group as a whole (last searched May 7, 2014). SELECTION CRITERIA: Randomised trials where one arm was a programme of ISD for urethral stricture. DATA COLLECTION AND ANALYSIS: At least two independent review authors carried out trial assessment, selection, and data abstraction. RESULTS: Data from six trials that were pooled and collectively rated very low quality per the GRADE approach, indicated that recurrent urethral stricture was less likely in men who performed ISD than those who did not (RR 0.70, 95% CI 0.48-1.00). Two trials compared programmes of ISD but the data were not combined and neither were sufficiently robust to draw firm conclusions. Three trials compared devices for performing ISD, results from one of which were too uncertain to determine the effects of a low friction hydrophilic catheter versus a polyvinyl chloride catheter on risk of recurrent urethral stricture (RR 0.32, 95% CI 0.07 to 1.40); another did not find evidence of a difference between 1% triamcinolone gel for lubricating the ISD catheter versus water-based gel on risk of recurrent urethral stricture (RR 0.68, 95% CI 0.35 to 1.32). No trials gave cost-effectiveness or validated PRO data. CONCLUSIONS: ISD may decrease the risk of recurrent urethral stricture. A well-designed RCT is required to determine whether that benefit alone is sufficient to make this intervention worthwhile and in whom. Neurourol. Urodynam. 35:759-763, 2016. © 2015 Wiley Periodicals, Inc.

Open urethroplasty versus endoscopic urethrotomy--clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial.

BACKGROUND: Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms such as reduced urine flow. Initial treatment is typically by endoscopic urethrotomy but recurrence occurs in about 60% of men within 2 years. The best treatment for men with recurrent bulbar stricture is uncertain. Repeat endoscopic urethrotomy opens the narrowing but it usually scars up again within 2 years requiring repeated procedures. The alternative of open urethroplasty involves surgically reconstructing the urethra, which may need an oral mucosal graft. It is a specialist procedure with a longer recovery period but may give lower risk of recurrence. In the absence of firm evidence as to which is best, individual men have to trade off the invasiveness and possible benefit of each option. Their preference will be influenced by individual social circumstances, availability of local expertise and clinician guidance. The open urethroplasty versus endoscopic urethrotomy (OPEN) trial aims to better guide the choice of treatment for men with recurrent urethral strictures by comparing benefit over 2 years in terms of symptom control and need for further treatment. METHODS/DESIGN: OPEN is a pragmatic, UK multicentre, randomised trial. Men with recurrent bulbar urethral strictures (at least one previous treatment) will be randomised to undergo endoscopic urethrotomy or open urethroplasty. Participants will be followed for 24 months after randomisation, measuring symptoms, flow rate, the need for re-intervention, health-related quality of life, and costs. The primary clinical outcome is the difference in symptom control over 24 months measured by the area under the curve (AUC) of a validated score. The trial has been powered at 90% with a type I error rate of 5% to detect a 0.1 difference in AUC measured on a 0-1 scale. The analysis will be based on all participants as randomised (intention-to-treat). The primary economic outcome is the incremental cost per quality-adjusted life year. A qualitative study will assess willingness to be randomised and hence ability to recruit to the trial. DISCUSSION: The OPEN Trial seeks to clarify relative benefit of the current options for surgical treatment of recurrent bulbar urethral stricture which differ in their invasiveness and resources required. Our feasibility study identified that participation would be limited by patient preference and differing recruitment styles of general and specialist urologists. We formulated and implemented effective strategies to address these issues in particular by inviting participation as close as possible to diagnosis. In addition re-calculation of sample size as recruitment progressed allowed more efficient design given the limited target population and funding constraints. Recruitment is now to target. TRIAL REGISTRATION: ISRCTN98009168 Date of registration: 29 November 2012.

Non-transecting bulbar urethroplasty.

Excision and end-to-end anastomosis (EPA) has been the preferred urethroplasty technique for short bulbar strictures and is associated with an excellent functional outcome. Driven by concerns over the potential morbidity associated with dividing the urethra, therefore compromising spongiosal blood flow, as well as spongiofibrosis being superficial in the majority of non-traumatic bulbar strictures, the non-transecting technique for bulbar urethroplasty has been developed with the aim of achieving the same success as EPA without the morbidity associated with transection. This manuscript highlights the fundamental principles underlying the ongoing debate-transection or non-transection of the strictured bulbar urethra? The potential advantages of avoiding dividing the corpus spongiosum of the urethra are discussed. The non-transecting anastomotic procedure together with its various modifications are decribed in detail. Our experience with this technique is presented. Non-transecting excision of spongiofibrosis with preservation of well vascularised underlying spongiosum provides an excellent alternative to dividing the urethra during urethroplasty for short non-traumatic proximal bulbar strictures.

Surgical correction of bladder neck contracture following prostate cancer treatment.

The surgical and non-surgical treatment of localised prostate cancer may be complicated by bladder neck contractures, prostatic urethral stenoses and bulbomembranous urethral strictures. In general, such complications following radical prostatectomy are less extensive, easier to treat and associated with a better outcome and more rapid recovery than the same complications following radiotherapy, high-intensity focussed ultrasound and cryotherapy. Treatment options range from minimally invasive endoscopic procedures to more complex and specialised open surgical reconstruction.In this chapter the surgical management of bladder neck contractures following the treatment of prostate cancer is described together with the management of prostatic urethral stenoses and bulbomembranous urethral strictures, given the difficulty in distinguishing them from one another clinically.

Reparación quirúrgica de la esclerosis de cuello vesical despues del tratamiento del cáncer de prostata / Surgical correction of bladder neck contracture following prostate cancer treatment

Los tratamientos del cáncer de próstata, quirúrgicos y no quirúrgicos, se pueden complicar con esclerosis del cuello vesical, estenosis de la uretra prostática y estenosis de la uretra bulbomembranosa. En general, dichas complicaciones son menos extensas después de la prostatectomía radical, más fáciles de tratar y asociadas con mejores resultados y recuperaciones más rápidas que las mismas complicaciones cuando aparecen después de radioterapia, HIFU y crioterapia. Las opciones de tratamiento van desde procedimientos endoscópicos mínimamente invasivos hasta reconstrucciones quirúrgicas abiertas mas complejas y especializadas. En este capítulo se describe el manejo quirúrgico de las esclerosis de cuello vesical después del tratamiento del cáncer de próstata junto con el manejo de las estenosis uretroprostáticas y de uretra bulbomembranosa, dada la dificultad en distinguir una de otra clínicamente

The surgical and non-surgical treatment of localised prostate cancer may be complicated by bladder neck contractures, prostatic urethral stenoses and bulbomembranous urethral strictures. In general, such complications following radical prostatectomy are less extensive, easier to treat and associated with a better outcome and more rapid recovery than the same complications following radiotherapy, high-intensity focussed ultrasound and cryotherapy. Treatment options range from minimally invasive endoscopic procedures to more complex and specialised open surgical reconstruction. In this chapter the surgical management of bladder neck contractures following the treatment of prostate cancer is described together with the management of prostatic urethral stenoses and bulbomembranous urethral strictures, given the difficulty in distinguishing them from one another clinically