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.

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.

Intralesional Collagenase Clostridium histolyticum Causes Meaningful Improvement in Men with Peyronie's Disease: Results of a Multi-Institutional Analysis.

PURPOSE: In a multi-institutional setting we studied the efficacy and safety outcomes at multiple high volume centers where collagenase Clostridium histolyticum is used to treat Peyronie's disease. MATERIALS AND METHODS: We collected retrospective data on consecutive patients with Peyronie's disease who underwent treatment with collagenase C. histolyticum between April 2014 and March 2018 at a total of 5 institutions. Included in the study were 918 patients. Main outcomes of interest included the change in curvature after receiving collagenase C. histolyticum therapy and the frequency of serious treatment related adverse events. The 2-tailed paired Student t-test was used to compare continuous variables. Univariate and multivariate regression analyses were performed to assess predictors of the success of collagenase C. histolyticum therapy to improve curvature. RESULTS: In the cohort of 918 patients curvature improved from a mean of 48.2 degrees before treatment to 32.9 degrees after treatment, a 30.1% improvement from baseline (p <0.0001). Of the men 68.7% had a 20% or greater improvement in curvature. In the 502 patients who completed 4 or more cycles curvature improved from a mean of 49.7 degrees before to 32.7 degrees after treatment, a 33% improvement from baseline (p <0.0001). Of these men 74.4% experienced a 20% or greater improvement in curvature. A complication of treatment developed in 9% of patients. The number of cycles of collagenase C. histolyticum received was predictive of curvature improvement (p <0.0001). CONCLUSIONS: This large multi-institutional analysis confirms the safety and efficacy of collagenase C. histolyticum therapy in men with Peyronie's disease. Intralesional collagenase C. histolyticum for Peyronie's disease according to the IMPRESS (Investigation of Maximal Peyronie's Reduction Efficacy and Safety Studies) trial protocol produced an improvement in penile curvature in men with Peyronie's disease with a low rate of complications.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute Phase Peyronie's Disease: A Multi-institutional Analysis.

OBJECTIVE: To study, in a multi-institutional setting, the efficacy/safety outcomes in acute phase Peyronie's disease (PD) of multiple high-volume centers employing CCH to treat PD, which is defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis. It is a chronic condition that afflicts 3%-13% of the US male population. There is no current multi-institutional research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD. METHODS: Retrospective data were collected for consecutive patients with PD who underwent treatment with CCH between April 2014 and March 2018 at 5 institutions. 918 patients were included. Patients with duration of PD no longer than 6 months at presentation qualified as being in the acute phase of PD. Main outcomes of interest include the change in curvature after receiving CCH therapy, and frequency of serious treatment-related adverse events. Successful improvement in curvature is defined as an at least 20% decrease in penile curvature from baseline after CCH therapy. RESULTS: A total of 918 patients were included in the analysis, of which 134 (14.6%) qualified as acute phase PD (group 1) and the remaining 784 (85.4%) qualified as stable phase (group 2). Mean duration of PD was 4.44 ± 1.68 months for group 1, and 40.8 ± 61.2 months for group 2. There was no significant difference in final change in curvature between acute and stable phase of PD (13.5° vs 15.6°, P = .09). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (16 patients, 11.9%) and the stable phase (77 patients, 9.8%; P = .44). In our multivariate analysis, only number of CCH cycles received was predictive of improvement of curvature. CONCLUSION: This large multi-institutional analysis confirms that CCH therapy is as safe and efficacious in acute phase PD as it is in stable phase PD.

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.

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.

Dorsal buccal graft urethroplasty in female urethral stricture disease: a multi-center experience.

BACKGROUND: Female urethral stricture disease is under-recognized and is often treated with dilation despite poor definitive outcomes. Our objective was to describe a multi-institutional experience treating female urethral stricture disease with female dorsal onlay buccal mucosa graft (FD-BMG) urethroplasty outcomes. METHODS: We retrospectively identified 39 consecutive FD-BMG urethroplasty operations performed by 6 reconstructive surgeons from 12/2007 to 1/2016. Surgical technique included dorsally-placed buccal mucosal grafts in all cases. Stricture recurrence was defined by cystoscopy. RESULTS: Mean age was 50 (range, 29-81) years. Stricture etiology was unknown (49%), iatrogenic (36%), or trauma/straddle injury (15%). A majority of women (87%) women had undergone a prior stricture-related urethral procedure(s) before the surgeons' index urethroplasty. Mean stricture length was 2.1 cm and mean caliber was 11 Fr. Mean postoperative follow-up was 33 (range, 7-106) months. Postoperative complications within 30 days were seen in 7 individuals (18%) and were all Clavien-Dindo grade II. Stricture recurrence was seen in 9 (23%) patients, with mean time to recurrence 14 months. No patients experienced de novo incontinence. CONCLUSIONS: FD-BMG urethroplasty is a safe and effective management option for female urethral strictures. Referral to a reconstructive center is encouraged to avoid repeated unnecessary endoscopic procedures that have poor definitive success.