Urinary Diversion as Last Option After Failed Artificial Urinary Sphincter and Iatrogenic Devastated Bladder Outlet.

Objective: The aim of this study was to evaluate the impact of perioperative anticoagulation on artificial urinary sphincter (AUS) device outcomes.Methods: Following institutional review board approval, patients undergoing AUS surgery from 1983 to 2014 were evaluated to assess device survival in patients with warfarin use compared to individuals without warfarin use. Hazard regression analysis was used to determine the association between warfarin use and device outcomes.Results: From 1983 to 2014, there were 2125 AUS procedures at Mayo Clinic. Of these, information regarding anticoagulation use was available in 651, including 43 patients who were on warfarin and 608 who were not. On univariate analysis, the use of warfarin was associated with an increased rate of infection/erosion [hazard ratio (HR) 2.58, p = 0.02]. However, there was no increased risk of overall AUS failure (HR 1.66, p = 0.06), malfunction of AUS (HR 1.19, p = 0.74) or urethral atrophy (HR 1.09, p = 0.88). Kaplan–Meier assessment of device survival for individuals not on warfarin versus individuals on warfarin at 1 and 5 years was 91% versus 83% and 72% versus 57%, respectively (p = 0.058). On multivariate analysis, warfarin was not associated with an increased risk of infection/erosion (HR 1.37, p = 0.51).Conclusion: Perioperative management of AUS patients on warfarin requires expert care; however, long-term AUS device survival is not significantly affected by warfarin use. Recognition of these outcomes is important for improving preoperative patient counseling and surgical patient selection.

Causes of Artificial Urinary Sphincter Failure and Strategies for Surgical Revision: Implications of Device Component Survival

Long-Term Durability and Functional Outcomes Among Patients With Artificial Urinary Sphincters: A 10-Year Retrospective Review From the University of Michigan

REVISION RATE AFTER ARTIFICIAL URINARY SPHINCTER IMPLANTATION FOR INCONTINENCE AFTER RADICAL PROSTATECTOMY: ACTUARIAL ANALYSIS

THE LONG-TERM OUTCOME OF ARTIFICIAL URINARY SPHINCTERS

The Indiana Experience With Artificial Urinary Sphincters in Children and Young Adults

The aim of this study was to examine preoperative patients' characteristics associated with the urinary diversion (UD) type (continent vs. incontinent) after radical cystectomy (RC) and UD-associated postoperative complications. In 2011, 679 bladder cancer patients underwent RC at 18 European tertiary care centers. Data were prospectively collected within the 'PROspective MulticEnTer RadIcal Cystectomy Series 2011' (PROMETRICS 2011). Logistic regression models assessed the impact of preoperative characteristics on UD type and evaluated diversion-related complication rates. Of 570 eligible patients, 28.8, 2.6, 59.3, and 9.3% received orthotopic neobladders, continent cutaneous pouches, ileal conduits, and ureterocutaneostomies, respectively. In multivariable analyses, female sex (odds ratio [OR] 3.9; p = 0.002), American Society of Anesthesiologists score ≥3 (OR 2.3; p = 0.02), an age-adjusted Charlson Comorbidity Index ≥3 (OR 4.1; p < 0.001), and a positive biopsy of the prostatic urethra in the last transurethral resection of the bladder prior to RC (OR 4.9; p = 0.03) were independently associated with incontinent UD. There were no significant differences in 30- and/or 90-day complication rates between the UD types. Perioperative transfusion rates and 90-day mortality were significantly associated with incontinent UD (p < 0.001, respectively). Limitations included the small sample size and a certain level of heterogeneity in the application of clinical pathways between the different participating centers. Within this prospective contemporary cohort of European RC patients treated at tertiary care centers, the majority of patients received an incontinent UD. Female sex and pre-existing comorbidities were associated with receiving an incontinent UD. The risk of overall complications did not vary according to UD type.

Outcomes and Risk Factors of Revision and Replacement Artificial Urinary Sphincter Implantation in Radiated and Nonradiated Cases.

To retrospectively evaluate the outcome of artificial urinary sphincter (AUS) placement in 79 children, with a mean follow-up of 12.5 years. A total of 89 children had an AUS placed between 1977 and 1994; complete data were obtained for 79 (63 boys and 16 girls). The indication for AUS placement was urinary incontinence caused by sphincteric deficiency with a stable bladder. Before and after surgery, all patients underwent ultrasonography, voiding cysto-urethrography and urodynamics. Logistic regression was used to assess the factors influencing the outcome. The mean (range) age at surgery was 11.7 (3-18) years. The cause of incontinence was a neuropathic bladder in 74 patients and bladder exstrophy in five. At a mean (range) follow-up of 12.5 (5-22) years, 63 of 79 patients (80%) had an intact AUS. The AUS was removed in 16 patients (20%) because of erosion at a mean (range) of 5.6 (1-11) years after insertion; there were 0.035 revisions per patient-year. Of 63 patients with an AUS in place, 57 (90%) are completely dry and 36 (57%) are using clean intermittent catheterization. Thirteen patients (20%) developed bladder instability during the follow-up, which was managed by anticholinergics in eight, spinal cord de-tethering in three and enterocystoplasty in two. Hydronephrosis occurred in 12 of 126 renal units (10%) that improved after enterocystoplasty or anticholinergics. The overall 10-year survival of the AUS was 79% (78% for early models and 80% for the AMS800); the survival was not affected by age, sex, model, previous bladder neck surgery, augmentation cystoplasty or intermittent catheterization. Bladder exstrophy was associated with lower AUS survival, as four of the five patients affected had the AUS removed secondary to erosion (P = 0.014). In children the AUS has a 79% 10-year survival and gives a 90% continence rate. Bladder instability after AUS placement can be managed with anticholinergics or enterocystoplasty. The AUS is not a justifiable treatment option for patients with bladder exstrophy.

Patient Risk Factors Associated with Reported Urinary Quality of Life Following Artificial Urinary Sphincter Placement: A Paired Pre and Postoperative Analysis

Long-term follow-up of continent urinary diversion after pelvic exenteration for gynecologic malignancies

The most common cause of urinary incontinence in men after radical prostatectomy is intrinsic sphincter deficiency, which can affect long-term quality of life. The prevalence of stress urinary incontinence (SUI) after radical prostatectomy has been reported to be 2.5% to 90%. For patients with moderate to severe male SUI, the artificial urinary sphincter (AUS) is considered the gold standard in surgical treatment. To review the available literature on the development, patient selection, surgical technique, complications, and management of AUS for male SUI. A literature review was performed through PubMed from 1947 to 2015 regarding AUS for male SUI. To assess various surgical techniques related to AUS insertion, outcomes, and complications and to offer recommendations regarding management of complications. The AUS can be placed through a perineal or trans-scrotal incision, particularly in the setting of dual insertion of an AUS and an inflatable penile prosthesis. The most commonly used cuff is 4.0 cm. The efficacy of InhibiZone is debatable. Pressure-regulating balloons can be filled with saline or contrast material and can be placed in an orthotopic or an ectopic location. In a systematic review of the literature, dry or improved continence rates are achieved in 79% of patients, with 90% reporting satisfaction and improved quality-of-life index scores after surgery. The most common AUS complications include a nonfunctioning device, sub-cuff atrophy, erosion, and infection. These complications are managed by strategies such as cuff downsizing, tandem cuff placement, and explantation. Dual AUS and inflatable penile prosthesis insertion is feasible for patients with SUI and erectile dysfunction. The AUS is a durable and effective device for the management of SUI. Surgeons should be versed in the different device components, their potential complications, and their management.

Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. The trial was set in 28 UK urological centres in the NHS. Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. We compared male synthetic sling with artificial urinary sphincter. The clinical primary outcome measure was men's reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation). In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference -0.034, 95% confidence interval -0.117 to 0.048; non-inferiority p = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of -15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months' follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49; p = 0.032). The number of serious adverse events was small (male sling group, n = 8; artificial urinary sphincter group, n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%. Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included. Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling. Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries. This trial is registered as ISRCTN49212975. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

Editorial Comment

To assess how trends in urinary diversion (UD) type following radical cystectomy (RC) have changed in recent years and investigate pre-operative predictors of UD type. Data were abstracted from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) from 2011 to 2015. We quantified the percentages of continent diversions (CD) versus incontinent diversions (ID) completed over this time frame. Using univariate and multivariable logistic regression analyses, we compared UD type across year of operation as well as predictors of type of diversion. We identified 4790 patients in the cohort, of which 81% underwent an incontinent diversion. Patients undergoing incontinent diversions were older (p<0.001), more likely to be female (p<0.001), had higher American Society of Anesthesiologists (ASA) classification (p<0.001) and had more comorbidities with worse preoperative lab values. On multivariable analysis, the odds of incontinent diversion increased per year (OR 1.16, 95% CI 1.06-1.26; p=0.001). Neoadjuvant chemotherapy (NAC) was associated with lower odds of receiving an ID (OR 0.33, 95% CI 0.17-0.64; p=0.001). Being male, healthy and young were associated with higher odds of CD. We demonstrate that there has been a decrease in continent diversion use in recent years. Neoadjuvant chemotherapy, proxies of life expectancy and gender are significant predictors of continent diversion. Further investigation to determine the underlying cause of decreased utilization of CD is warranted.