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.

The Outcomes of Pelvic Fracture Urethral Injuries Stratified by Urethral Injury Severity: A Prospective Multi-institutional Genitourinary Trauma Study (MiGUTS).

OBJECTIVE: To determine patient outcomes across a range of pelvic fracture urethral injury (PFUI) severity. PFUI is a devastating consequence of a pelvic fracture. No study has stratified PFUI outcomes based on severity of the urethral distraction injury. METHODS: Adult male patients with blunt-trauma-related PFUI were followed prospectively for a minimum of six months at 27 US medical centers from 2015-2020. Patients underwent retrograde cystourethroscopy and retrograde urethrography to determine injury severity and were categorized into three groups: (1) major urethral distraction, (2) minor urethral distraction, and (3) partial urethral injury. Major distraction vs minor distraction was determined by the ability to pass a cystoscope retrograde into the bladder. Simple statistics summarized differences between groups. Multi-variable analyses determined odds ratios for obstruction and urethroplasty controlling for urethral injury type, age, and Injury Severity Score. RESULTS: There were 99 patients included, 72(72%) patients had major, 13(13%) had minor, and 14(14%) had partial urethral injuries. The rate of urethral obstruction differed in patients with major (95.8%), minor (84.6%), and partial injuries (50%) (P < 0.001). Urethroplasty was performed in 90% of major, 66.7% of minor, and 35.7% of partial injuries (P < 0.001). CONCLUSION: In PFUI, a spectrum of severity exists that influences outcomes. While major and minor distraction injuries are associated with a higher risk of developing urethral obstruction and need for urethroplasty, up to 50% of partial PFUI will result in obstruction, and as such need to be closely followed.

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

OBJECTIVE: To evaluate potential associations between patient risk factors and incontinence related patient-reported outcome measures (PROMs) preandpost artificial urinary sphincter (AUS) implantation. We hypothesize patient risk factors, including prior radiation and diabetes will have a negative association with post AUS PROMs. METHODS: A review of prospectively collected preandpostoperative Incontinence Symptom Index [ISI] and Incontinence Impact Questionnaire-7 (IIQ-7)s from multiple institutions in the Trauma and Urologic Reconstruction Network of Surgeons was performed. Changes in preandpost AUS ISI and IIQ-7 scores were compared for the entire cohort then stratified by patients with prior AUS, obesity, diabetes, prior radiation, and mixed urinary incontinence. RESULTS: A total of 145 patients, 67.2 (SD 10.9) years had complete preandpost AUS questionnaires (median follow up 186 days, IQR 136-362). Post AUS ISI and IIQ-7 scores improved significantly for the group at large. Prior radiation was associated with less improvement in total IIQ-7 scores, -25.5 (31.9) vs -39 (33.0), P = .03. Obesity was associated with a greater reduction in incontinence severity -13.6 (SD 9.1) vs -9.2 (SD 8.9), P<0.01, urge -5.2(SD 4.2) vs -2.5(SD 4.5), P <.01, and total ISI score -29.7(SD19.7) vs -21.2 (SD 19.9), P = .02. Prior AUS, diabetes, and mixed incontinence were not associated with post AUS PROMs outcome. CONCLUSION: Overall, patients reported a significant reduction in incontinence severity, bother, impact, and distress following AUS placement. Prior radiation was associated with less improvement in total IIQ-7 scores. In contrast, obesity demonstrated a greater reduction in ISI severity and urge scores compared to non-obese patients.

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 urethroplasty outcomes for urethral stricture disease for patients with neurogenic bladder or bladder dysfunction requiring clean intermittent catheterization.

BACKGROUND: Our objective is to better comprehend treatment considerations for urethral stricture disease (USD) in patients requiring long-term clean intermittent catheterization (CIC). Patient characteristics, surgical outcomes and complications are unknown in this population. METHODS: Six members of the Trauma and Urologic Reconstruction Network of Surgeons (TURNS) participated in a prospective (2009 to present) and retrospective (prior to 2009) database recording patient demographics, surgical approach and outcomes. We included all patients undergoing urethroplasty who perform CIC. Descriptive statistics were used to analyze results. RESULTS: A total of 37 patients with 39 strictures were included. Bladder dysfunction was characterized as detrusor failure in 35% and neurogenic etiology in 65%. Median stricture length was 3 cm (IQR: 1.5-5.5) with 28% repaired with dorsal onlay buccal mucosal graft, 26% excision and primary anastomosis, 8% dorsal inlay, 8% ventral and dorsal, 8% flap based 8% non-transecting and 15% other. Functional success was 90%: 4 patients required DVIU or dilation due to recurrence, with 2 of those ultimately requiring repeat urethroplasty. 86% of patients returned to CIC; no patients reported new pad use for urinary leakage after urethroplasty. During a median follow-up period of 3.1 years (IQR: 1.0-5.3), no patients underwent urinary diversion. CONCLUSIONS: Urethroplasty is suitable, safe and effective for patients dependent on CIC suffering from USD. The effect of continual CIC on long-term outcomes remains uncertain.

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

PURPOSE: Risk factors for complications after artificial urinary sphincter surgery include a history of pelvic radiation and prior artificial urinary sphincter complication. The survival of a second artificial urinary sphincter in the setting of prior device complication and radiation is not well described. We report the survival of redo artificial urinary sphincter surgery and identify risk factors for repeat complications. MATERIALS AND METHODS: A multi-institutional database was queried for redo artificial urinary sphincter surgeries. The primary outcome was median survival of a second and third artificial urinary sphincter in radiated and nonradiated cases. A Cox proportional hazards survival analysis was performed to identify additional patient and surgery risk factors. RESULTS: Median time to explantation of the initial artificial urinary sphincter in radiated (150) and nonradiated (174) cases was 26.4 and 35.6 months, respectively (p=0.043). For a second device median time to explantation was 30.1 and 38.7 months (p=0.034) and for a third device it was 28.5 and 30.6 months (p=0.020), respectively. The 5-year revision-free survival for patients undergoing a second artificial urinary sphincter surgery with no risk factors, history of radiation, history of urethroplasty, and history of radiation and urethroplasty were 83.1%, 72.6%, 63.9% and 46%, respectively. CONCLUSIONS: Patients without additional risk factors undergoing second and third artificial urinary sphincter surgeries experience revision-free rates similar to those of their initial artificial urinary sphincter devices. Patients who have been treated with pelvic radiation have earlier artificial urinary sphincter complications. When multiple risk factors exist, revision-free rates decrease significantly.

Prevalence and Characteristics of Urinary Incontinence in a Treatment Seeking Male Prospective Cohort: Results from the LURN Study.

PURPOSE: Male urinary incontinence is thought to be infrequent. We sought to describe the prevalence of urinary incontinence in a male treatment seeking cohort enrolled in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network). MATERIALS AND METHODS: Study inclusion and exclusion criteria, including men with prostate cancer or neurogenic bladder, were previously reported. LURN participants prospectively completed questionnaires regarding lower urinary tract symptoms and other clinical variables. Men were grouped based on incontinence type, including 1) no urinary incontinence, 2) post-void dribbling only and 3) urinary incontinence. Comparisons were made using ANOVA and multivariable regression. RESULTS: Of the 477 men 24% reported no urinary incontinence, 44% reported post-void dribbling only and 32% reported urinary incontinence. African American men and those with sleep apnea were more likely to be in the urinary incontinence group than in the no urinary incontinence group (OR 3.2, p = 0.02 and OR 2.73, p = 0.003, respectively). Urinary incontinence was associated with significantly higher bother compared to men without leakage (p <0.001). Compared to men without urinary incontinence and men with only post-void dribbling those with urinary incontinence were significantly more likely to report higher scores (more severe symptoms) on the PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires regarding bowel issues, depression and anxiety than men without urinary incontinence (p <0.01). CONCLUSIONS: Urinary incontinence is common among treatment seeking men. This is concerning because the guideline recommended questionnaires to assess male lower urinary tract symptoms do not query for urinary incontinence. Thus, clinicians may be missing an opportunity to intervene and improve patient care. This provides a substantial rationale for a new or updated symptom questionnaire which provides a more comprehensive symptom assessment.

Polyethylene glycol 3350 for constipation in children with dysfunctional elimination.

PURPOSE: Children with daytime wetting often have constipation, and treatment of constipation helps children become dry. Polyethylene glycol 3350 (Miralax, Braintree Laboratories, Braintree, Massachusetts) is a nonaddictive, tasteless powder that can be mixed with any liquid for treatment of constipation. MATERIALS AND METHODS: We review our use of polyethylene glycol 3350 in 35 girls and 11 boys with dysfunctional elimination. Noninvasive urodynamic studies and post-void residual measurement were performed before and during treatment. RESULTS: A significant increase in frequency of bowel movements occurred while taking polyethylene glycol 3350 (p = 0.0001). Average final dose was 0.63 gm/kg. The only reported adverse effect was diarrhea (9 patients). Of the children 18 became dry, 26 had decreased wetting and 2 had no improvement. Voided volume increased (146 vs 210 ml, p <0.0001) and post-void residual decreased significantly (92 vs 48 ml, p <0.0001) while on polyethylene glycol 3350. Ten children were still considered constipated including both patients who experienced no change in wetting. Average final dose in this group (0.69 gm/kg) did not differ significantly from those in whom constipation resolved (0.61 gm/kg). Patients in whom constipation resolved had a significantly lower post-void residual than those who remained constipated (11.8% vs 30.6%, p <0.01) and were significantly more likely to become dry or improved (p = 0.045). CONCLUSIONS: The efficacy, compliance and lack of significant side effects make polyethylene glycol 3350 an ideal substance for treatment of constipation in children with dysfunctional elimination. Persistent constipation was associated with decreased resolution of voiding symptoms and significantly increased post-void residuals.