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.

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.

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.

Liposomal Bupivacaine Local Infiltration for Buccal Mucosal Graft Harvest Site Pain Control: A Single-blinded Randomized Controlled Trial.

OBJECTIVE: To assess efficacy and safety of liposomal bupivacaine (LB) infiltration of the buccal mucosal graft (BMG) harvest site in alleviating pain by evaluating the postoperative narcotic usage, pain score, and morbidities. PATIENTS AND METHODS: Single-blinded randomized controlled trial of 43 adult patients for BMG substitution urethroplasty between January 2015 to June 2017 (Clinicaltrials.gov: NCT03720223). A computer-generated allocation scheme randomized patients to control group (n = 22) no further local anesthetic infiltration aside from that of used in the hydrodissection for BMG harvest, and to intervention group with additional infiltration of LB to BMG harvest site (n = 21). We assessed postoperative cumulative narcotic use on post-op day 1 and 2 (24- and 48-hour total intravenous [IV] morphine equivalents in milligrams). A self-reported 10-point numeric rating scale survey was administered to assess postprocedural oral pain, oral conditions, and morbidity on days 1-3, and at 1-month follow-up. Fisher's exact test and independent T test were performed to assess differences between treatment groups. Linear regression was used to determine adjusted effect estimates of intervention. RESULTS: Compared to controls, a significantly lower narcotic use was noticed among the LB treatment group on post-op day 1 (IV morphine equivalent mean difference 8.58 mg; 95% confidence interval 1.59, 15.56, P =.017), while no significant difference was noticed on post-op day 2. There was no significant difference between treatment groups with regards to postprocedural oral pain score or oral morbidities. CONCLUSION: Our study showed that LB infiltration of the BMG harvest site is safe and associated with lower 24-hour narcotic use only at post-op day 1.

Surgical management and outcomes of adult acquired buried penis with and without lichen sclerosus: a comparative analysis.

PURPOSE: Adult acquired buried penis (AABP) can present with concomitant Lichen Sclerosus (LS), a chronic dermatosis that may affect surgical outcomes. Our aim was to evaluate outcomes of patients undergoing AABP repair with and without LS. METHODS: A retrospective cohort study was performed for AABP repair patients at a single institution from 1/1991 to 12/2017. Patient characteristics and surgical and peri-operative outcomes, including success, erectile function, and complications, were collected. RESULTS: Sixty-seven AABP patients with mean follow-up of 16.1 ± 20.4 months were identified. Overall surgical success was 91%. Overall surgical complication rate was 50.7% (23.9% Clavien-Dindo ≥ 3). Forty-two (62.7%) patients had concomitant LS. A higher proportion of patients with LS required a STSG (90% vs 60%, p = 0.005). There was no difference in surgical success (90.5% vs 92.0%, p = 0.999), overall complication rate (57.1% vs 40.0%, p = 0.212), Clavien-Dindo ≥ 3 complications (23.8% vs 24.0%, p = 0.999) or early complications (35.7% vs 32.0%, p = 0.797) between patients with and without LS, respectively. However, a higher proportion of patients with LS experienced late complications (33.3% vs 8.0%, p = 0.020), which were mainly related to wound healing. Satisfaction with erectile function was higher among patients with LS (59.5% vs 320%, p = 0.043). CONCLUSION: AABP patients with LS behave somewhat differently than their non LS counterparts. They are more likely to require skin graft during surgical treatment. Though surgical success and complications are similar, they do experience a higher rate of late complications from impaired wound healing. Work on improving wound healing in this population should be considered.

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.

Long-term Success Durability of Transobturator Male Sling.

OBJECTIVE: To determine the long-term outcome of transobturator sling for male stress urinary incontinence (SUI) clustered according to preoperative SUI severity, and to identify predictors of treatment success durability and failure occurrence in long-term follow-up. METHOD: A nonconcurrent study was conducted on all transobturator male sling cases performed from August 2006 to June 2012 by a single surgeon. Preoperative SUI severity was clustered into mild (≤2 ppd), moderate (3-4 ppd) or severe (≥5 ppd). Success was defined as complete dryness with 0 pads used (cured), and a patient with ≥50% improvement, satisfied without further procedures needed. Otherwise it was considered a treatment failure. Clinical variables significantly associated with long-term treatment success were determined. Time-to-event (Kaplan-Meier) and Multiple-Cox regression analysis were performed to determine predictors of long-term treatment outcome. RESULTS: A total of 215 patients (mild-59, moderate-94, and severe-62) with a mean follow-up of 56.4 ± 41.6 months were included. On long-term follow-up, 150 (69.8%) patients-maintained treatment success and 96 (44.7%) were dry. The long-term outcome success clustered according to SUI severity as mild, moderate, and severe was 84.7%, 72.3%, and 51.6%, respectively. Kaplan-Meier with Log-rank test and Multiple Cox-regression determined that both concomitant urge incontinence and preoperative SUI severity were independent predictors of long-term durability of treatment success and failure occurrence. Preoperative SUI severity was the only predictor of long-term cure sustainability. CONCLUSION: The time to event analysis with an average of ∼5 years postoperative follow-up has determined that the preoperative severity and presence of concomitant urge incontinence were independent predictors for long-term outcome.

Training Genitourinary Reconstructive Surgeons: A Survey of Graduated Fellows and Fellowship Directors.

OBJECTIVE: To review the Society of Genitourinary Reconstructive Surgeons fellowship and matching process. There are currently 20 fellowships offered. A centralized match began in 2013-2014. Fellowship directors and graduated fellows were surveyed regarding their experience in their matching process, fellowship, employment opportunities, and their current practice. METHODS: A web-based survey was distributed to fellowship graduates and directors. A total of 20 and 14 open ended and multiple-choice questions were asked, respectively. Multiple choice questions were rated using a Likert scale. RESULTS: A total of 24/41 (59%) graduated fellows and 14/17 (82%) fellowship directors completed the survey. Overall satisfaction for the application and match process was 4/5 for both groups. Fellow respondents reported a 96%, 92%, 92%, and 88% feeling of competency in urethral reconstruction, male incontinence, urinary diversion/ureteral reconstruction, and male sexual health, respectively. A total of 92% of graduates practice in a location that they consider in their top 3 destinations. The majority, 58%, practice in academia. CONCLUSION: The Society of Genitourinary Reconstructive Surgeons has offered a recognized fellowship since 2014. Recent graduates express positive support of their fellowship training with excellent competency and employment opportunities. Fellowship directors continue to discuss broadening training to further advance this dynamic field.

Attributes of Society of Genitourinary Reconstructive Surgeons Fellows and Early Career Trajectory of the Recent Graduates.

INTRODUCTION: We identified the attributes that the Society of Genitourinary Reconstructive Surgeons (GURS) fellowship directors prioritize in applicants. The secondary objective was to study the early career trajectory of recent GURS fellowship graduates. METHODS: GURS fellowship directors and fellows from 2014 to 2018 were surveyed electronically using Qualtrics® software. We asked fellowship directors to rate 12 items for their importance in match selection on a Likert scale. Fellows were prompted for details of practice size, case mix and research time. We assessed research productivity based on published articles on PubMed® and Google Scholar™. Findings were summarized with descriptive statistics and continuous variables were reported as median with interquartile range. RESULTS: Fellowship directors (90% response rate) rated subjective personal qualities as more important compared to more objective measures and achievements. Personality (5, 5-5), overall interview performance (5, 4-5) and letters of recommendation (5, 4-5) were most important. About 4 papers were published during fellowship per fellow. However, research productivity did not persist during early career. Upon graduation the majority of graduates were the only reconstructionist at their practice, with approximately 40% of their operative time dedicated to such cases. While we identified a variety of practice settings, an academic career focusing on urethroplasty and male incontinence was the most common. CONCLUSIONS: Our data provide potential applicants with a better understanding of how to optimize their candidacy and what to expect in their early careers.

Nonclosure Versus Closure of Buccal Mucosal Graft Harvest Site: A Systematic Review and Meta-Analysis of Patient-Reported Outcomes.

OBJECTIVE: To compare the postprocedural oral pain scale and other patient reported oral morbidities for nonclosure vs closure of buccal mucosal graft (BMG) harvest sites through systematic review and meta-analysis of comparative studies. METHODS: A systematic literature search was performed in September 2018. Nonrandomized comparative studies were summarized and randomized controlled trials were evaluated according to the Cochrane Collaboration recommendations. The outcomes assessed were: pain, perioral numbness, mouth opening tightness, and impairment of oral intake. Standardized mean difference, and relative risk with corresponding 95% confidence intervals were extrapolated. Effect estimates were pooled using the inverse variance method with a random-effects model. Subgroup analysis was performed according to the shape of the BMG harvested. PROSPERO registry (CRD42016043502). RESULTS: A total of 269 patients from 4 randomized controlled trials were included for meta-analysis. Overall pooled effect estimates on the reported pain score assessed on postprocedural day 1, day 3-7 and 6 months, have shown no significant difference between the closure and nonclosure treatment groups. Subgroup analysis showed that rectangular shaped BMG harvest sites that were not closed had lower pain scores (standardized mean difference-0.90, 95% confidence interval -1.70, -0.10) on postoperative day 1. No reported short or long-term oral morbidities required further surgical intervention in either treatment group. CONCLUSION: The evidence suggests that at 6-month follow-up, there is no overall significant difference between nonclosure and closure of BMG harvest sites. However, among rectangular shaped BMG, not closing the harvest site may lead to less immediate postoperative pain when compared to closure of the harvest site.

AdVance male sling.

The AdVance sling (American Medical Systems, Minnetonka, MN, United States of America) is a synthetic transobturator sling, which is a safe and effective minimally invasive treatment for mild to moderate stress urinary incontinence (SUI) in male patients. This article provides a step-by-step description of our technique for placement of the AdVance male sling, including details and nuances gained from surgical experience, advice for avoidance of complications and discussion on management of complications and sling failures. Patient selection is very important, including exclusion and preoperative treatment of urethral stenosis and bladder dysfunction. Previous pelvic radiation is a poor prognostic factor. In brief, the steps of sling placement are: (I) mobilization of the corpus spongiosum (CS); (II) marking and mobilization of the central tendon; (III) passage of the helical trocar needles exiting at the apex of the angle between the CS and inferior pubic ramus; (IV) fixation of the broad part of the sling body to the CS at the previous mark; (V) cystoscopy during sling tensioning; (VI) placement of a Foley urethral catheter; (VII) Subcutaneous tunnelling of the sling arms back toward the midline; (VIII) wound closure. The most common early postoperative complication is urinary retention but long-term retention is extremely rare. Management of sling failures include placement of an artificial urinary sphincter, repeat AdVance sling, urethral bulking agent or ProACT device.

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.

Perspectives on International Urological Volunteerism: A Survey of IVUmed Resident Scholar Alumni.

INTRODUCTION: The primary intentions of international surgical programs are to directly benefit those receiving medical care, educate local physicians and staff, and improve care delivery models. IVUmed, a nonprofit organization dedicated to providing urological care to resource poor areas of the world, provides scholarship opportunities for urology trainees. We assessed the motivations and barriers of IVUmed traveling resident scholars regarding continuing international surgical work after completion of the program. METHODS: An Internet based survey was sent to all previous IVUmed resident scholars assessing potential factors associated with repeat international service. Logistic regression was used to examine the association between survey responses and the likelihood of repeating an international service trip after completion of training. RESULTS: Of 196 IVUmed resident scholar participants 100 (51%) responded to the survey. Of the 69 attending surgeons 17 (25%) had repeated an international service trip. Altruism (100%), personal fulfillment (99%) and practicing in a resource limited setting (94%) were the most frequently cited motivating factors for repeat participation, while lack of time (96%) was the most commonly reported barrier. Respondents in private practice were less likely to participate in a subsequent trip compared to those in an academic setting (OR 0.16, CI 0.03-0.80, p = 0.03). No other factors were associated with the likelihood of repeating an international service trip. CONCLUSIONS: Among urologists who participated in a funded international scholarship program during residency repeat participation during the subsequent 7 years was modest. Private practitioners were less likely to repeat international service compared to academic urologists.

The Artificial Urinary Sphincter in the Management of Incontinence.

Despite the emergence of different devices in the treatment of postprostatectomy urinary incontinence, the AMS 800 (American Medical Systems, Minnetonka, MN) remains the gold standard for the treatment of stress urinary incontinence in men. We reviewed the current literature regarding the indications, surgical principles, outcomes, and complications of artificial urinary sphincter placement for stress urinary incontinence after prostatectomy. Despite all the available information, heterogeneous data, different success definitions, and the lack of high-quality prospective studies with long-term follow-up, it is difficult to compare outcomes between studies. In spite of these, the perineal implantation of a single cuff artificial urinary sphincter has withstood the test of time.