Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

Objective: The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture. Materials and Methods: Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection). Conclusion: The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

Female Urethral Reconstruction: Urethral Diverticulectomy, Urethral Strictures, Vesicovaginal Fistula.

Urethral reconstruction in women encompasses a variety of different entities including female urethral stricture, female urethral diverticulum, and vesicovaginal fistula. Although very different in their causes, they all have in common a vague and nonspecific onset of symptoms and, usually, a delayed diagnosis. Once identified and evaluated, urologists must review the management options with the patient, which range from minimally invasive procedures to complex reconstructive surgeries. In complicated cases, we recommend referral to an experienced specialized center for definitive management.

A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study.

Introduction: Endoscopic management of male anterior urethral stricture disease is common; however, repeat treatment is associated with high recurrence rates. Here, we report the 3-year results of the ROBUST I trial, which evaluated the safety and efficacy of the Optilume® drug coated balloon (DCB) in men with recurrent urethral strictures. Methods: Adult men with recurrent bulbar urethral strictures ≤2 cm in length and 1-4 prior endoscopic interventions were treated with the Optilume DCB. Functional success was defined as ≥50% reduction in International Prostate Symptom Score (IPSS) without need for retreatment. Other outcomes included quality of life, maximum flow rate, post-void residual urine volume, erectile function, and freedom from repeat intervention. Results: Of the 53 enrolled and treated men, 33 completed the 3-year visit, with 10 patients experiencing clinical failures at previous visits, giving a total of 43 subjects evaluable for the functional success endpoint. Functional success was achieved in 67% (29/43) and freedom from retreatment in 77% (33/43). Average IPSS improved from 25.2 at baseline to 5.5 at 3 years (p<0.0001). Significant improvements were observed in quality of life, flow rate, and post-void residual urine volume. Erectile function was not affected by treatment. Device-related adverse events were mild or moderate in nature and resolved quickly after onset. There were no serious treatment-related adverse events. Conclusion: Symptomatic improvement after treatment with the Optilume DCB was maintained through 3 years in a population highly susceptible to recurrent urethral stricture disease. This minimally invasive therapy is safe with no negative impact on sexual function.

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral Strictures.

PURPOSE: The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. MATERIALS AND METHODS: Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications. RESULTS: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria. CONCLUSIONS: The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence.

OBJECTIVE: To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). METHODS: A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations. RESULTS: Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047). CONCLUSIONS: In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.

Changes in patient reported outcome measures after treatment for female urethral stricture.

INTRODUCTION: There is a paucity of patient reported outcome measure (PROM) data for women with urethral strictures. To address this gap, we aim to evaluate change in PROM among women who underwent surgery for a stricture. METHODS: American Urological Association Symptom Index (AUA-SI) and Urogenital Distress Inventory (UDI-6) data from a multi-institutional retrospective cohort study of women treated for urethral stricture was assessed. RESULTS: Fifty-seven women had either AUA-SS or UDI-6 and 26 had baseline and postoperative data for either. Most women underwent urethroplasty (77%) and the majority (73%) remained stricture free at median follow-up of 21 months (interquartile range [IQR] 7-37). The median baseline AUA-SI was 21 (IQR 12-28) and follow-up was 10 (IQR 5-24). After treatment, there was a median decrease of 12 (IQR -18 to -2) in AUA-SI (p = 0.003). The median AUA Quality of life (QOL) score at baseline and follow-up were 6 (IQR 4-6) and 3 (IQR 2-5), respectively. There was a median AUA-QOL improvement of 2 points (-5,0; p = 0.007) from a baseline 5 (unhappy) to 3 (mixed). Median UDI-6 scores were 50 (IQR 33-75) at baseline and 17 (IQR 0-39), at follow-up. After treatment, there was a median decrease of 19 (-31 to -11; p = 0.01). CONCLUSION: Women with urethral strictures have severe lower urinary tract symptoms which improved after surgery. This study substantiates the claims that recognizing and treating women with urethral stricture disease greatly improves lower urinary tract symptoms and QOL.

Urologic Education in the Era of COVID-19: Results From a Webinar-Based Reconstructive Urology Lecture Series.

OBJECTIVE: To determine the response to a virtual educational curriculum in reconstructive urology presented during the COVID-19 pandemic. To assess learner satisfaction with the format and content of the curriculum, including relevance to learners' education and practice. MATERIALS AND METHODS: A webinar curriculum of fundamental reconstructive urology topics was developed through the Society of Genitourinary Reconstructive Surgeons and partnering institutions. Expert-led sessions were broadcasted. Registered participants were asked to complete a survey regarding the curriculum. Responses were used to assess the quality of the curriculum format and content, as well as participants' practice demographics. RESULTS: Our survey yielded a response rate of 34%. Survey responses showed >50% of practices offer reconstructive urologic services, with 37% offered by providers without formal fellowship training. A difference in self-reported baseline knowledge was seen amongst junior residents and attendings (P < .05). Regardless of level of training, all participants rated the topics presented as relevant to their education/practice (median response = 5/5). Responders also indicated that the curriculum supplemented their knowledge in reconstructive urology (median response = 5/5). The webinar format and overall satisfaction with the curriculum was highly rated (median response = 5/5). Participants also stated they were likely to recommend the series to others. CONCLUSION: We demonstrate success of an online curriculum in reconstructive urology. Given >50% of practices surveyed offer reconstruction, we believe the curriculum's educational benefits (increasing access and collaboration while minimizing the risk of in-person contact) will continue beyond the COVID-19 pandemic and that this will remain a relevant educational platform for urologists moving forward.

Lingual versus buccal mucosal graft for augmentation urethroplasty: a meta-analysis of surgical outcomes and patient-reported donor site morbidity.

PURPOSE: This study aimed at comparing surgical outcomes and patient-reported donor site morbidity between lingual mucosal graft (LMG) and buccal mucosal graft (BMG) through a meta-analysis of comparative studies. METHODS: A systematic literature search was performed in January 2019 including non-randomized comparative studies and randomized controlled trials (RCT). The assessed data included urethroplasty outcomes, complications, and donor site morbidities such as pain, bleeding, swelling, numbness, difficulty speaking, difficulty eating, mouth opening, and difficulty with tongue protrusion. RESULTS: A total of 632 patients (LMG 323, BMG 309) from 12 comparative studies (four RCTs and eight non-randomized) were included in the meta-analysis. Overall pooled effect estimates revealed no significant difference on reported surgical outcomes and operative stricture-related complications. The LMG group reported a higher proportion of patients with difficulty speaking (RR 6.96, 95% CI 2.04-23.70) and difficulty with tongue protrusion (RR 12.93, 95% CI 3.07-54.51) within 30 days post-op. In comparison, the BMG group had significantly more incidence of early post-procedural donor site swelling (RR 0.39, 95% CI 0.25-0.61) and numbness within 30 days post-op (RR 0.48, 95% CI 0.23-0.97) and 3-6 months (RR 0.52, 95% CI 0.30-0.90) post-op. CONCLUSION: The evidence suggests no overall significant difference between LMG and BMG with regard to urethroplasty outcomes at 1-year follow-up. While patients undergoing LMG urethroplasty have a higher chance of experiencing difficulty with speech and difficulty with tongue protrusion within 1 month of surgery, the BMG group is more likely to experience early donor site swelling and mouth opening difficulty within 30 days post-op, as well as oral numbness for up to 6 months.

A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study.

INTRODUCTION: Mechanical balloon dilation and direct visualization internal urethrotomy (DVIU) are the most widely used treatments for urethral stricture disease in the U.S., but recurrence rates are high, especially after re-treatment. This study investigates the safety and efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent strictures. METHODS: Men with recurrent bulbar strictures ≤2 cm with 1-4 prior endoscopic treatments were treated with the Optilume™ drug-coated balloon. Patients were evaluated within 14 days, three, six, 12, and 24 months post-treatment. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was ≥50% improvement in International Prostate Symptom Score (IPSS) at 24 months. Secondary outcomes included quality of life, erectile function, flow rate, and post-void residual urine volume. RESULTS: A total of 53 subjects were enrolled and treated; 46 completed the 24-month followup. Forty-three percent of men had undergone >1 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at two years. Success was achieved in 32/46 (70%), and baseline IPSS improved from a mean of 25.2 to 6.9 at 24 months (p<0.0001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function. CONCLUSIONS: Two-year data indicates the Optilume™ paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.

Treatment of urethral stricture disease in women: A multi-institutional collaborative project from the SUFU research network.

AIM: Female urethral stricture disease is rare and has several surgical approaches including endoscopic dilations (ENDO), urethroplasty with local vaginal tissue flap (ULT) or urethroplasty with free graft (UFG). This study aims to describe the contemporary management of female urethral stricture disease and to evaluate the outcomes of these three surgical approaches. METHODS: This is a multi-institutional, retrospective cohort study evaluating operative treatment for female urethral stricture. Surgeries were grouped into three categories: ENDO, ULT, and UFG. Time from surgery to stricture recurrence by surgery type was analyzed using a Kaplan-Meier time to event analysis. To adjust for confounders, a Cox proportional hazard model was fit for time to stricture recurrence. RESULTS: Two-hundred and ten patients met the inclusion criteria across 23 sites. Overall, 64% (n = 115/180) of women remained recurrence free at median follow-up of 14.6 months (IQR, 3-37). In unadjusted analysis, recurrence-free rates differed between surgery categories with 68% ENDO, 77% UFG and 83% ULT patients being recurrence free at 12 months. In the Cox model, recurrence rates also differed between surgery categories; women undergoing ULT and UFG having had 66% and 49% less risk of recurrence, respectively, compared to those undergoing ENDO. When comparing ULT to UFG directly, there was no significant difference of recurrence. CONCLUSION: This retrospective multi-institutional study of female urethral stricture demonstrates that patients undergoing endoscopic management have a higher risk of recurrence compared to those undergoing either urethroplasty with local flap or free graft.

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.

A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study.

INTRODUCTION: We aimed to investigate the safety and preliminary efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent urethral stricture. METHODS: Men with bulbar urethral strictures ≤2 cm with 1-4 prior endoscopic treatments were enrolled at four study sites after ethics committee approvals. All subjects were treated with mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment. Patients were evaluated at 2-5 days, 14 days, three, six, and 12-months post-treatment. The primary safety endpoint was serious complications through 90 days post-procedure. The preliminary efficacy endpoint was anatomic success, defined as urethral lumen ≥14 Fr at 12 months. RESULTS: A total of 53 subjects were enrolled and treated; 46 completed the 12-month followup. Forty-three percent of men had undergone >1 previous dilation; the mean for the overall study population was 1.7 prior dilations. There were no serious adverse events related to the treatment within 90 days. Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54-82%) at 12 months. The 14 failures included seven cystoscopic recurrences, five retreatments, and two patients who exited the study early due to symptom recurrence. CONCLUSIONS: One-year data indicates the Optilume paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.

Non-transecting bulbar urethroplasty is favored over transecting techniques.

PURPOSE: To present current evidence supporting the vessel sparing technique to reconstruct bulbar urethral strictures via primary anastomosis. METHODS: English literature review of presented series of transecting and non-transecting bulbar urethroplasty from 2000 to 2018. RESULTS: Since its introduction in 2007, vessel-sparing excision and primary anastomosis (VS-EPA) has been utilized in multiple centers across the world. Success rates range from 90 to 98%, comparable to traditional transecting EPA. Complication rates and erectile function outcomes are similar or better in VS-EPA, according to recent publications. CONCLUSIONS: Non-transection excision and primary anastomosis is a well-tolerated, highly successful reconstructive option for short bulbar urethral strictures in appropriately selected patients. Results are comparable with traditional transecting anastomosis and mid-term multinational follow-up has proven efficacy and safety of the technique. Further well-designed multi-institutional studies are necessary to determine superiority to traditional EPA in terms of surgical outcomes and erectile function preservation.

Predictors of surgical complications and evaluation of outcomes after surgical correction of adult-acquired buried penis.

OBJECTIVE: To determine predictors for surgical complications and assess patient satisfaction after surgical treatment of Adult-Acquired Buried Penis (AABP). METHODS: A retrospective review was performed on all patients diagnosed with AABP who underwent surgical treatment at a single institution from January 2013-December 2017. Patient demographics and peri-operative data were extracted. Univariate and multivariate regression analyses were performed to identify predictors for surgical complications. Patients' post-operative satisfaction was likewise assessed for factors such as successful outcome, post-operative erection quality, and complications related to the surgery. RESULT: Twenty-four patients of median age 61.5 years (IQR 54-67) with median follow-up of 12 months (IQR 3.25-29) were included. Overall success was 87.5% (21/24). Complications occurred in 15 (62.5%) patients with 7 (29%) Clavien-Dindo category ≥ 3. Based on regression analyses, body mass index (BMI) ≥ 40 (HR 25; 95% CI 1.45-431.81) and tobacco smoking (HR 14.6; 95% CI 1.15-199.98) were identified as independent predictors of overall complications. Concomitant performance of abdominal panniculectomy was associated with Clavien-Dindo category ≥ 3 (HR 28; 95% CI 2.4-326.74) complications. Patient satisfaction was associated with surgical success (p < 0.0001), post-operative erection (p < 0.027), and absence of surgical morbidity that needed further surgical intervention (p = 0.032). CONCLUSION: Surgical management of AABP following an individualized algorithm results in a high success rate but also in relatively high procedure-related morbidity. Peri-operative BMI ≥ 40 and tobacco smoking have higher odds for overall complication occurrence, while concomitant abdominal panniculectomy results in more occurrence of Clavien-Dindo category ≥ 3 morbidities. Patient's eventual satisfaction correlates well with surgical success, post-procedural erection condition, and lack of Clavien-Dindo ≥ 3 morbidity.

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.

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.

Urethroplasty After Urethral Urolume Stent: An International Multicenter Experience.

OBJECTIVE: To evaluate the outcomes and factors affecting success of urethroplasty in patients with stricture recurrence after Urolume urethral stent. MATERIAL AND METHODS: This is a retrospective international multicenter study on patients treated with urethral reconstruction after Urolume stent. Stricture and stent length, time between urethral stent insertion and urethroplasty, age, mode of stent retrieval, type of urethroplasty, complications and baseline, and posturethroplasty voiding parameters were analyzed. Successful outcome was defined as standard voiding, without need of any postoperative adjunctive procedure. RESULTS: Sixty-three patients were included. Stent was removed at urethroplasty in 61 patients. Reconstruction technique was excision and primary anastomosis in 14 (22.2%), dorsal onlay buccal mucosa graft (BMG) in 9 (14.3%), ventral onlay BMG in 6 (9.5%), dorsolateral onlay BMG in 9 (14.3%), ventral onlay plus dorsal inlay BMG in 3 (4.8%), augmented anastomosis in 5 (7.9%), pedicled flap urethroplasty in 6 (9.5%), 2-stage procedure in 4 (6.4%), and perineal urethrostomy in 7(11.1%). Success rate was 81% at a mean 59.7 ± 63.4 months. Dilatation or internal urethrotomy was performed in 10 (15.9%) and redo-urethroplasty in 5 (7.9%). Total International Prostate Symptom Score, quality of life, urine maximum flow, and postvoid residual significantly improved (P <.0001). Complications occurred in 8 (12.7%), all Clavien-Dindo ≤2. Disease-free survival rate after reconstruction was 88.1%, 79.5%, and 76.7% at 1, 3, and 5 years, respectively. Explant of individual strands followed by onlay BMG is the most common approach and was significantly advantageous over the other techniques (P = .018). CONCLUSION: Urethroplasty in patients with Urolume urethral stents is a viable option of reconstruction with a high success rate and very acceptable complication rate. Numerous techniques are viable; however, urethral preservation, tine-by-tine stent extraction, and use of BMG augmentation produced significantly better outcomes.

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.