Efficacy and safety of onabotulinumtoxinA for the treatment of overactive bladder in men and women: A pooled analysis.

BACKGROUND: This pooled analysis of randomized controlled studies investigated the safety and efficacy of onabotulinumtoxinA in male and female patients with overactive bladder (OAB). METHODS: Data were pooled from four similarly designed trials in North America and Europe. Adults with idiopathic OAB for ≥6 months inadequately managed by at least one anticholinergic were randomized 1:1 or 2:1 to receive onabotulinumtoxinA 100 U or matched placebo in Cycle 1 and could request open-label retreatment with onabotulinumtoxinA 100 U at ≥12 weeks. Efficacy outcomes at Week 12 included the primary endpoint of mean urinary incontinence (UI) episodes per day and other variables, such as the proportion of patients with ≥50% reduction in daily UI episodes. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Analyses by sex were descriptive. Males were further analyzed by benign prostatic hyperplasia (BPH) diagnosis status. RESULTS: In the pooled population (N = 1564), there were 194 males (12.4%) and 1370 females (87.6%). Mean number of baseline UI episodes per day was 4.9 in males and 5.5 in females. At Week 12, numerically greater mean reductions from baseline in number of daily UI episodes were observed with the onabotulinumtoxinA 100 U group (females: -3.0; males: -2.2) versus placebo (females: -1.1; males: -1.3). Achievement of ≥50% reduction in daily UI episodes was numerically greater with onabotulinumtoxinA 100 U (females: 64.8%; males: 61.2%) versus placebo (females: 30.6%; males: 44.8%), and numerically higher in males without BPH (onabotulinumtoxinA: 65.1%; placebo: 50.9%) versus with BPH (onabotulinumtoxinA: 54.3%; placebo: 36.6%). A total of 34.7% of males and 39.4% of females experienced at least one TEAE in the first 12 weeks during treatment Cycle 1. Urinary tract infection rate was 13.1% in females and 4.2% in males; incidence of hematuria was 6.8% in males and 1.1% in females. Incidence of urinary retention (defined as incomplete emptying, requiring catheterization) was 2.7% in females and 4.7% in males. CONCLUSION: OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH. No new safety findings were identified when data were analyzed by sex.

Efficacy and safety of an alternative onabotulinumtoxinA injection paradigm for refractory overactive bladder.

AIMS: In studies utilizing a 20-injection-site paradigm of onabotulinumtoxinA treatment for overactive bladder (OAB), some patients performed clean intermittent catheterization (CIC). An alternative injection paradigm of fewer injections targeting the lower bladder may reduce the need for CIC by maintaining upper bladder function. This study evaluated the efficacy and safety of an unapproved alternative 10-injection-site paradigm targeting the lower bladder. METHODS: In this phase 4, double-blind, parallel-group study, patients with OAB and urinary incontinence (UI) for ≥6 months with ≥3 episodes of urinary urgency incontinence (no more than 1 UI-free day) and ≥8 micturitions per day over 3 days during screening were randomized 2:1 to onabotulinumtoxinA 100 U or placebo injected at 10 sites in the lower bladder. RESULTS: Of 120 patients, 78 in the onabotulinumtoxinA group and 39 in the placebo group had efficacy assessments. In the double-blind phase, mean change from baseline at week 12 in daily frequency of UI episodes was greater with onabotulinumtoxinA (-2.9) versus placebo (-0.3) (least squares mean difference [LSMD]: -2.99, p < 0.0001). Achievement of 100% (odds ratio [OR]: 6.15 [95% confidence interval, CI: 0.75-50.37]), ≥75% (OR: 7.25 [2.00-26.29]), and ≥50% improvement (OR: 4.79 [1.87-12.28]) from baseline in UI episodes was greater with onabotulinumtoxinA versus placebo. Reductions from baseline in the daily average number of micturitions (LSMD: -2.24, p < 0.0001), nocturia (LSMD: -0.71, p = 0.0004), and urgency (LSMD: -2.56, p < 0.0001) were greater with onabotulinumtoxinA than with placebo. Treatment benefit was improved or greatly improved in the onabotulinumtoxinA group (74.0% of patients) versus placebo (17.6%) (OR: 13.03 [95% CI: 3.23-52.57]). Mean change from baseline in Incontinence Quality of Life score was greater with onabotulinumtoxinA versus placebo (LSMD: 24.2, p = 0.0012). Two of 78 (2.6%) patients in the onabotulinumtoxinA group used CIC during the double-blind period; no females used CIC during the double-blind period. Commonly reported adverse events (≥5%) were urinary tract infection (UTI), dysuria, and productive cough for both groups; rate of UTI was higher with onabotulinumtoxinA versus placebo. CONCLUSION: In patients treated with onabotulinumtoxinA for OAB with UI, an unapproved alternative injection paradigm targeting the lower bladder demonstrated efficacy over placebo, with a low incidence of CIC.

Inter-rater reliability of retrograde urethrograms.

PURPOSE: Reliability of pre-operative testing is important for adequate surgical planning. For urethral stricture disease, preoperative planning frequently includes retrograde urethrogram (RUG). The radiographic interpretation of RUGs is often done by urologists themselves. We aimed to evaluate the reliability of RUG interpretation by urologists at our institution. METHODS: We examined the RUGs of 193 patients. These were deidentified and interpreted by three urologists, two general urologists and one reconstructive urologist. These interpretations were compared in 2 ways. Each of the general urologists was compared to the "gold standard" reconstructive urologist interpretation, and the general urologists were additionally compared to each other. We used intraclass correlation coefficient (ICC) for numerical variables and Fleiss' Kappa or Cohen's Kappa statistic (κ) for categorical variables to rate inter-interpreter reliability and agreement among interpretations with regards to the quantitative variables of stricture length and caliber. RESULTS: Level of agreement ranged from poor to moderate across all variables interpreted. Comparing general urologists to the gold standard yielded no better than moderate agreement, with the majority being poor to fair. Similarly, agreement amongst the general urologists did not reach above moderate, with the majority being poor to slight. CONCLUSION: To our knowledge, this is the first analysis of inter-rater reliability of RUGs among practicing urologists. Our analysis showed clinically unacceptable reliability with regards to stricture length, location, caliber, and indicated procedures. This study suggests a need for standardized interpretation of RUGs and poses an opportunity for actionable improvement in management of strictures.

Identifying urethral strictures using machine learning: a proof-of-concept evaluation of convolutional neural network model.

INTRODUCTION: To evaluate urethral strictures and to determine appropriate surgical reconstructive options, retrograde urethrograms (RUG) are used. Herein, we develop a convolutional neural network (CNN)-based machine learning algorithm to characterize RUG images between those with urethral strictures and those without urethral strictures. METHODS: Following approval from institutional REB from participating institutions (The Hospital for Sick Children [Toronto, Canada], St. Luke's Medical Centre [Quezon City, Philippines], East Virginia Medical School [Norfolk, United States of America]), retrograde urethrogram images were collected and anonymized. Additional RUG images were downloaded online using web scraping method through Selenium and Python 3.8.2. A CNN with three convolutional layers and three pooling layers were built (Fig. 1). Data augmentation was applied with zoom, contrast, horizontal flip, and translation. The data were split into 90% training and 10% testing set. The model was trained with one hundred epochs. RESULTS: A total of 242 RUG images were identified. 196 were identified as strictures and 46 as normal. Following training, our model achieved accuracy of up to 92.2% with its training data set in characterizing RUG images to stricture and normal images. The validation accuracy using our testing set images showed that it was able to characterize 88.5% of the images correctly. CONCLUSION: It is feasible to use a machine learning algorithm to accurately differentiate between a stricture and normal RUG. Further development of the model with additional RUGs may allow characterization of stricture location and length to suggest optimal operative approach for repair.

Review of clinical experience on biomaterials and tissue engineering of urinary bladder.

PURPOSE: In recent pre-clinical studies, biomaterials and bladder tissue engineering have shown promising outcomes when addressing the need for bladder tissue replacement. To date, multiple clinical experiences have been reported. Herein, we aim to review and summarize the reported clinical experience of biomaterial usage and tissue engineering of the urinary bladder. METHODS: A systematic literature search was performed on Feb 2019 to identify clinical reports on biomaterials for urinary bladder replacement or augmentation and clinical experiences with bladder tissue engineering. We identified and reviewed human studies using biomaterials and tissue-engineered bladder as bladder substitutes or augmentation implants. The studies were then summarized for each respective procedure indication, technique, follow-up period, outcome, and important findings of the studies. RESULTS: An extensive literature search identified 25 studies of case reports and case series with a cumulative clinical experience of 222 patients. Various biomaterials and tissue-engineered bladder were used, including plastic/polyethylene mold, preserved dog bladder, gelatine sponge, Japanese paper with Nobecutane, lypholized human dura, bovine pericardium, amniotic membrane, small intestinal mucosa, and bladder tissue engineering with autologous cell-seeded biodegradable scaffolds. However, overall clinical experiences including the outcomes and safety reports were not satisfactory enough to replace enterocystoplasty. CONCLUSION: To date, several clinical experiences of biomaterials and tissue-engineered bladder have been reported; however, various studies have reported non-satisfactory outcomes. Further technological advancements and a better understanding is needed to advance bladder tissue engineering as a future promising management option for patients requiring bladder drainage.

The role of international partnerships in improving urethral reconstruction in low- and middle-income countries.

PURPOSE: To explore the impact of education and training in international surgical partnerships on outcomes of urethral stricture disease in low- and middle-income countries. To encourage data collection and outcomes assessments to promote evidence-based and safe surgical care. METHODS: Qualitative data were collected through observation of a reconstructive surgical workshop held by IVUmed at a host site in Dakar, Senegal. Quantitative data were collected through a retrospective review of 11 years of hospital data to assess surgical outcomes of urethral stricture disease before and after IVUmed started reconstructive workshops at the site. RESULTS: In the 11-year study period, 569 patients underwent 774 surgical procedures for urethral strictures. The numbers and types of urethroplasty techniques increased after IVUmed started its workshops. The average number of urethroplasties increased from 10 to 18.75/year. There was a statistically significant improvement in the mean success rate of urethroplasties from 12.7% before to 29% after the workshops. Anastomotic urethroplasty success rates doubled from 16.7 to 35.1%, but this was not statistically significant (p = 0.07). The improved success rate was sustained in cases performed without an IVUmed provider. CONCLUSIONS: Urethral stricture disease treatment in low- and middle-income countries is fraught with challenges due to complex presentations and limited subspecialty training. Improper preoperative management, lack of specialty instruments, and suboptimal wound care all contribute to poor outcomes. International surgical groups like IVUmed who employ the "teach-the-teacher" model enhance local practitioner expertise and independence leading to long-term improvements in patient outcomes. Tailoring practice guidelines to the local resource framework and encouraging data collection and outcomes assessment are vital components of providing responsible care and should be encouraged.

Placental membrane grafts for urethral replacement in a rabbit model: a pilot study.

PURPOSE: Several graft materials are available for use in the treatment of urethral stricture disease. Placental membrane is being used in a variety of settings as a graft in wound healing and tissue repair. We aim to evaluate the effect of implanting decellularized human placental membrane into rabbit urethras. METHODS: Dorsal onlay graft urethroplasty using prepared human placental membrane was performed in 10 New Zealand White rabbits (Oryctolagus cuniculus). After 3 months, the rabbits underwent cystourethroscopy to evaluate urethral patency. The rabbits were then euthanized and the urethras examined for pathological findings. RESULTS: All urethroplasties were performed without complication. There were no observed episodes of urinary retention, infection, or renal failure. Urethral patency was achieved in all rabbits 3 months postoperatively. Urothelial replacement of the placental membrane graft was observed in all rabbits without malignant transformation. CONCLUSION: Dorsal onlay urethroplasty using decellularized human placental membrane can safely be performed in a rabbit model. This pilot study demonstrated urothelial replacement of human placental membrane in the rabbit urethra without stricture formation. Placental membrane is a promising biomaterial for urethral reconstruction.

Time for a mandatory urology rotation? Adequacy of urological exposure during medical school - a survey of graduates of the University of the West Indies, Trinidad and Tobago.

INTRODUCTION: To objectively assess the self-reported adequacy and utility of exposure of our students to urology during their training. MATERIALS AND METHODS: A questionnaire was sent to the University of the West Indies graduating class of 2018, now functioning as medical interns. A questionnaire was designed to collect information regarding respondent demographics, perceptions of their urology exposure during their medical school training as well as their attitudes towards the specialty. The survey was also designed to capture respondents' comfort levels with commonly encountered urological scenarios and investigations. The survey was distributed in February 2019 using the online survey tool, Survey Monkey. RESULTS: A total of 196 surveys were distributed, of which 107 responses were returned. Clinic exposure was the most common form of interaction with the specialty during training. Their exposure to common urological procedures was low with only 9.3% and 4.7% having seen a circumcision or prostate biopsy respectively by graduation; 21.7% and 47.7% indicated that they were uncomfortable to review a KUB X-ray and CT respectively to identify a stone; 96.2% considered urology to be an important clinical sub-specialty but 42.4% indicated that their exposure to urology did not prepare them to manage urological conditions that they have encountered since graduation; 87.8% of respondents supported the idea of a urology rotation. CONCLUSION: The exposure of medical students to urology during their medical training is poor. There remains much room for improvement in exposing our medical students to urology during their training. A dedicated urology rotation should be strongly considered. This study has applications not just within the Caribbean, but further afield.

Incontinence after Prostate Treatment: AUA/SUFU Guideline.

PURPOSE: Urinary incontinence after prostate treatment (IPT) is one of the few urologic diseases that is iatrogenic, and, therefore, predictable and perhaps preventable. Evaluation of the incontinent patient, risk factors for IPT, the assessment of the patient prior to intervention, and a stepwise approach to management are covered in this guideline. Algorithms for patient evaluation, surgical management, and device failure are also provided. MATERIALS AND METHODS: This guideline was developed using a systematic review from the Mayo Clinic Evidence Based Practice Center with additional supplementation by the authors. A research librarian conducted searches from 2000 to December 21st, 2017 using Ovid, MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Databases of Systematic Reviews. Additional references through 12/31/2018 were identified. RESULTS: This guideline was developed by a multi-disciplinary panel to inform clinicians on the proper assessment of patients with IPT and the safe and effective management of the condition in both surgical and non-surgical contexts. Statements guiding the clinician on proper management of device failure are also included. CONCLUSION: Most patients who undergo radical prostatectomy (RP), and some patients who undergo radiation therapy (RT) or surgery for benign prostatic hyperplasia (BPH), will experience IPT. Although non-surgical options, such as pelvic floor muscle exercises (PFME), can hasten continence recovery, patients who remain incontinent at one-year post-procedure, or have severe incontinence at six months, may elect to undergo surgical treatment (e.g. artificial urinary sphincter). Prior to IPT surgery, the risks, benefits, alternatives, and additional likely procedures should be discussed with the patient.

Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon.

AIMS: The SUCCESS trial is a phase III study of the Vesair® balloon in the United States for female stress urinary incontinence (SUI). The purpose of this manuscript is to present the 3 month primary efficacy and tolerability outcome data. METHODS: The SUCCESS trial is a multi-center, prospective, single blind, randomized, sham-controlled study. Subjects were randomized on a 2.33:1 basis to either Vesair balloon placement or placebo. The primary efficacy endpoint was a composite of both a >50% reduction from baseline on 1 h provocative pad weight test and a ≥10-point improvement in symptoms on the Incontinence Quality of Life Survey (I-QOL) questionnaire assessed at the 3 month study visit. RESULTS: A total of 221 subjects were randomized, including 157 treatment arm subjects and 64 controls. The 3 month composite primary efficacy endpoint was achieved in 42.1% of treatment group subjects compared with 28.1% of controls on intention-to-treat analysis (p = 0.046). Treatment arm subjects were significantly more likely to report at least a 50% reduction in incontinence frequency on 7-day voiding diary (55.2% vs 32.3%, P = 0.002, ITT) and more commonly reported their incontinence was improved on Patient Global Impression of Improvement in Incontinence (PGI-I) at 3 months compared with controls (58.0% vs 37.7%, P = 0.007, ITT). No device- or procedure-related serious adverse events nor unanticipated adverse events were reported and no cases of urinary retention were observed. All adverse events fully resolved following balloon removal. CONCLUSIONS: In this phase three trial, the Vesair intravesical balloon achieved 3 month primary and secondary endpoints both objectively and subjectively.

The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial.

PURPOSE: In this double-blind, randomized study we compared the efficacy and safety of onabotulinumtoxinA or solifenacin vs placebo in patients with overactive bladder who had urinary incontinence and an inadequate response to or were intolerant of an anticholinergic. Post hoc analysis was done to compare the effects of onabotulinumtoxinA vs solifenacin. MATERIALS AND METHODS: Solifenacin naïve patients were randomized to onabotulinumtoxinA 100 U, solifenacin 5 mg, (which could escalate to 10 mg at week 6 according to predefined criteria) or placebo. Patients could request treatment 2 (open label onabotulinumtoxinA) after fulfilling prespecified criteria. End points included a change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a 100% reduction (dry) in the number of incontinence episodes per day as co-primaries, other urinary symptoms and quality of life, all at week 12, and adverse events. RESULTS: The change from baseline in incontinence episodes per day was significantly greater with onabotulinumtoxinA or solifenacin vs placebo (-3.19 or -2.56, respectively, vs -1.33, both p <0.001). The incontinence reduction was significantly greater for onabotulinumtoxinA vs solifenacin (p = 0.022). At week 12, 33.8% (vs placebo p <0.001), 24.5% (vs placebo p = 0.028) and 11.7% of patients receiving onabotulinumtoxinA, solifenacin and placebo, respectively, were dry. After treatment 2, which was open label onabotulinumtoxinA, 43.2%, 37.6% and 41.9% of patients in the onabotulinumtoxinA, solifenacin and placebo groups, respectively, were dry. Significant improvements in other urinary symptoms and quality of life were observed for both active treatments. Urinary tract infection in 25.5% of cases and urinary retention in 6.9% were more common with onabotulinumtoxinA. CONCLUSIONS: The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.

Augmented perineal urethrostomy using a dorsal buccal mucosal graft, bi-institutional study.

PURPOSE: To present our technique and outcomes for perineal urethrostomy augmented with a dorsal onlay buccal mucosa graft (BMG). Results from initial series and collaboration from an international center are included. METHODS: A retrospective chart review of all adult patients who underwent urethral reconstruction with perineal urethrostomy utilizing a buccal mucosal graft between January 1, 2002 and January 1, 2013 was performed. All surgeries were performed by three surgeons using the same technique (GHJ, KAM, and RV). Success was defined as no need for additional treatment following definitive surgery. RESULTS: A total of 44 patients met inclusion criteria. Mean patient age was 60 (range 44-81) years. All strictures were pananterior. Etiologies included unknown in 16 (36%), failed hypospadias repair in six (14%), lichen sclerosus in ten (23%), iatrogenic in seven (16%), Fournier's in three (7%), urethral cancer in one (2%) and penile cancer in one (2%). Mean follow-up was 45 (range 6-136) months. Overall success was 80%. Nine patients recurred, of which four had a successful revision, two are awaiting potential revision, and three are being managed with periodic dilations. CONCLUSIONS: BMG perineal urethrostomy is a valid alternative for complex urethral strictures due to lichen sclerosus, previous failed reconstructions or hypospadias cripples. Midterm results are encouraging for this novel technique.

Incidence and Management of Lower Urinary Tract Symptoms After Urethral Stricture Repair.

Lower urinary tract symptoms (LUTS) after urethral stricture repair are not uncommon. Urgency has been reported in 40% of men and urge incontinence in 12% of men after anterior urethroplasty. De novo urgency and urge incontinence is seen in 9 and 5% of men, respectively, after urethroplasty. Once a complication of urethroplasty (such as recurrent urethral stricture or diverticulum) has been excluded as a cause, evaluation of LUTS in such patients should focus on differentiating bladder dysfunction (overactive bladder, underactive bladder), from other outlet obstruction (such as benign prostatic obstruction), dysfunctional voiding, or medical causes (such as nocturnal polyuria). Management of overactive bladder may include behavioural modification, physical therapy, anticholinergic and/or beta-3 agonist medications, intravesical onabolulinum toxin, sacral neuromodulation or peripheral tibial nerve stimulation. Definitive treatment for underactive bladder is limited. Treatment of benign prostatic obstruction may include alpha-blocker and/or 5-alpha reductase inhibitor medication, or surgery to cavitate the prostate. Minimally invasive prostatic procedures are also an option. Although management of LUTS for patients after urethral stricture repair can usually proceed similarly as for patients without prior history of urethral reconstruction, special consideration and alterations in management need to be made when instrumenting the urethra, as the urethral lumen may be narrower in these patients.

Penile Prosthesis Implantation in Patients with a History of Total Phallic Construction.

INTRODUCTION: Outcomes following penile prosthesis implantation in patients with a history of total phallic construction are not well described. AIM: The aim of this study was to evaluate outcomes following neophallus penile prosthesis placement. METHODS: Retrospective review penile prosthesis placement in patients with prior total phallic construction. GORE-TEX® (Gore Medical, Flagstaff, AZ) sleeve neotunica construction was utilized in all patients. MAIN OUTCOME MEASURE: Success defined as patient sexual activity with a functioning prosthesis. RESULTS: Thirty-one patients underwent neophallic prosthesis implantation at a mean 35.6 years of age. Prosthesis placement occurred at an average 56.3 months following phallic construction and follow-up was a mean of 59.7 months. Malleable prostheses were placed in 21 patients and inflatable in 10; implants were bilateral in 94%. Six percent experienced operative complications including a bladder injury (1) and phallic flap arterial injury (1). Postoperative complications occurred in 23% at a median 5.5 months following placement. Five prostheses were explanted secondary to infection or erosion and two additional required revisions. Of the explanted prosthesis two were later replaced without further complication. Eighty-one percent of patients were sexually active following prosthesis placement. CONCLUSIONS: Penile prosthesis placement is possible in patients with prior penile reconstruction/phallic construction. Although complications rates appear to be elevated in this population compared with historic controls of normal anatomic men, the majority of patients in this series were sexually active following prosthesis placement. This demonstrates the utility of prosthesis implantation in these difficult patients.

International multi-institutional experience with the vessel-sparing technique to reconstruct the proximal bulbar urethra: mid-term results.

OBJECTIVE: To present mid-term outcomes from an international, multi-institutional cohort of patients undergoing vessel-sparing excision and primary anastomosis urethroplasty for the reconstruction of the anterior urethra. MATERIALS AND METHODS: From June 2003 to December 2011, 68 patients underwent vessel-sparing anterior urethral reconstruction at five different international institutions using the vessel-sparing technique described by Jordan et al. (J Urol 177(5):1799-1802, 2007). RESULTS: Patients' age range was from 3 to 82 years (mean 51.2). Stricture length ranged from 1 to 3 cm (mean 1.78). After a mean follow-up of 17.6 months, 95.6 % of patients had a widely patent urethral lumen. Three patients failed the procedure, requiring either direct vision internal urethrotomy or urethral dilation, after which all were free of symptoms and did not require further instrumentation. Complications were minimal and as expected following open urethroplasty. CONCLUSION: Preservation of blood supply is a noble pursuit in surgery; however, it can be technically difficult and often requires more time and effort. This vessel-sparing technique for anterior urethral reconstruction is reproducible and appears to be reliable in this international cohort. Larger studies and longer follow-up are needed to support these encouraging results.

Artificial urinary sphincter for post-prostatectomy incontinence: a review.

The artificial urinary sphincter remains the gold standard for treatment of post-prostatectomy urinary incontinence. The AMS 800 (American Medical Systems, Minnetonka, MN, USA) is the most commonly implanted artificial urinary sphincter. Having been on the market for almost 40 years, there is an abundance of literature regarding its use, but no recent review has been published. We reviewed the current literature regarding the indications, surgical principles, outcomes and complications of artificial urinary sphincter implantation for stress urinary incontinence after prostatectomy. A PubMed search was carried out for articles on the artificial urinary sphincter from 1995 to present. The review was centered on articles related to the use of the AMS 800 for stress urinary incontinence in males after prostatectomy. Relevant articles were reviewed. The majority of patients will achieve social continence (1 pad per day) after artificial urinary sphincter implantation; however, rates of total continence (no pad usage) are significantly lower. Patient satisfaction outcomes average greater than 80% in most series. Potential complications requiring reoperation include infection (0.5-10.6%) and urethral erosion (2.9-12%). Revision surgeries are most commonly as a result of urethral atrophy, which ranges from 1.6 to 11.4%. The 5-year Kaplan-Meier freedom from reoperation ranges from 50 to 79%, while the 10-year Kaplan-Meier freedom from mechanical failure is 64%. The artificial urinary sphincter is a reliable device with good outcomes. As expected with any prosthetic device, complications including mechanical failure, infection, erosion and recurrent incontinence remain significant concerns. Despite known complications, the patient satisfaction rates after artificial urinary sphincter implantation remain high. Appropriate patient counseling and adherence to surgical principles are imperative.

Safety and tolerability of solifenacin add-on therapy to α-blocker treated men with residual urgency and frequency.

PURPOSE: VICTOR was a 12-week, double-blind, placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy. Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated. MATERIALS AND METHODS: A total of 398 men 45 years old or older were randomized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily. The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks, a total International Prostate Symptom Score of 13 or greater, a Patient Perception of Bladder Condition score of 3 or greater, a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater. Adverse events were monitored throughout the study. The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours. Secondary measures included mean change in urgency episodes per 24 hours, and changes in Patient Perception of Bladder Condition, Urgency Perception Scale and total International Prostate Symptom Scores. RESULTS: The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth (7% and 3%, respectively) and dizziness (3% and 2%, respectively). Of the patients on solifenacin plus tamsulosin 7 (3%) reported retention and 3 required catheterization. No patients on placebo plus tamsulosin reported retention. Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance (-1.05 vs -0.67, p = 0.135). However, patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency (-2.18 vs -1.10, p <0.001). Patient reported outcome measures showed no significant between group differences. CONCLUSIONS: Solifenacin plus tamsulosin was well tolerated. There was a low incidence of urinary retention requiring catheterization. At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes. Only urgency reached statistical significance vs placebo plus tamsulosin.

Transobturator male sling: is there a learning curve?

INTRODUCTION: A potential learning curve associated with AdVance (American Medical Systems, Minnetonka, MN, USA) sling placement has not been adequately reported. MATERIALS AND METHODS: Retrospective analysis of our AdVance single surgeon database. Patients with a history of a radical prostatectomy, no past radiation or prior incontinence interventions and at least 12 months of follow up were included. A learning curve was evaluated by predicting patient outcomes using their order within the surgical log. Univariate and multivariate logistic regressions were performed. RESULTS: Sixty patients with mean age of 65 years and an average 28.2 months of follow up were included in the analysis. Surgical order was not significant on either univariate or multivariate analysis for predicting outcomes following sling placement. Patients with a history of a retropubic radical prostatectomy did enjoy improved incontinence results at all time points tested. Other variables were mixed. CONCLUSION: Our data failed to demonstrate a significant surgical learning curve that would predict outcomes following AdVance sling placement.

Development and use of machine learning models for prediction of male sling success A proof-of-concept institutional evaluation.

INTRODUCTION: For mild to moderate male stress urinary incontinence (SUI), transobturator male slings remain an effective option for management. We aimed to use a machine learning (ML )-based model to predict those who will have a long-term success in managing SUI with male sling. METHODS: All transobturator male sling cases from August 2006 to June 2012 by a single surgeon were reviewed. Outcome of interest was defined as 'cure': complete dryness with 0 pads used, without the need for additional procedures. Clinical variables included in ML models were: number of pads used daily, age, height, weight, race, incontinence type, etiology of incontinence, history of radiation, smoking, bladder neck contracture, and prostatectomy. Model performance was assessed using area under receiver operating characteristic curve (AUROC), area under precision-recall curve (AUPRC), and F1-score. RESULTS: A total of 181 patients were included in the model. The mean followup was 56.4 months (standard deviation [SD ] 41.6). Slightly more than half (53.6%, 97/181) of patients had procedural success. Logistic regression, K-nearest neighbor (KNN ), naive Bayes, decision tree, and random forest models were developed using ML. KNN model had the best performance, with AUROC of 0.759, AUPRC of 0.916, and F1-score of 0.833. Following ensemble learning with bagging and calibration, KNN model was further improved, with AUROC of 0.821, AUPRC of 0.921, and F-1 score of 0.848. CONCLUSIONS: ML-based prediction of long-term transobturator male sling is feasible. The low numbers of patients used to develop the model prompt further validation and development of the model but may serve as a decision-making aid for practitioners in the future.