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 ...

We assessed patient perceptions of regular intermittent self-dilation in men with urethral stricture. We constructed and distributed a visual analog questionnaire to evaluate intermittent self-dilation via catheterization by men referred for urethral stricture management at a total of 4 institutions. Items assessed included patient duration, frequency, difficulty and pain associated with intermittent self-dilation as well as interference of intermittent self-dilation with daily activity. The primary outcome was patient perceived quality of life. Multivariate analysis was performed to assess factors that affected this outcome. Included in the study were 85 patients with a median age of 68 years, a median of 3.0 years on intermittent self-dilation and a median frequency of 1 dilation per day. On a 1 to 10 scale the median intermittent self-dilation difficulty was 5.0 ± 2.7, the median pain score was 3.0 ± 2.7 and median interference with daily life was 2.0 ± 1.3. Overall quality of life in patients with stricture was poor (median score 7.0 ± 2.6 with poor quality of life defined as 7 or greater). On univariate analysis younger age (p <0.01), interference (p = 0.03), pain (p <0.01) and difficulty performing intermittent self-dilation (p = 0.03) correlated with poor quality of life in a statistically significant manner. On multivariate analysis only difficulty catheterizing (p <0.01) and younger age (p = 0.05) were statistically significant predictors. Patients with stricture involving the posterior urethra had a statistically significant increase in difficulty and decrease in quality of life (each p = 0.04). Most patients with urethral stricture who are on intermittent self-dilation rate difficulty and pain as moderate, and inconvenience as low but report poor quality of life.

We analyzed our initial 100-case experience with the 3.5 cm artificial urinary sphincter cuff to identify risk factors for cuff erosion. We reviewed the records of a single surgeon, consecutive series of patients treated with 3.5 cm artificial urinary sphincter cuff placement from September 2009 to August 2013. Each patient underwent single perineal cuff placement via standardized technique. Preoperative characteristics, technical considerations and postoperative outcomes were analyzed and compared to those in a cohort of patients in whom a larger (4.0 cm or greater) artificial urinary sphincter cuff was placed during the same period. We identified clinical factors associated with an increased risk of 3.5 cm artificial urinary sphincter cuff erosion. Of the 176 men who met study inclusion criteria during the 4-year period 100 (57%) received the 3.5 cm artificial urinary sphincter cuff and 76 (43%) received a larger cuff (4.0 cm or greater). The continence rate (83% vs 80%, p = 0.65) and mean followup (32 vs 25 months, p = 0.14) were similar in the 2 groups. Erosion developed in 16 of the 176 patients (9%) during the study period, of whom 13 had the 3.5 cm cuff. Of the 100 patients with the 3.5 cm cuff 52 (52%) had a history of radiation, including 11 (21%) with erosion. Cuff erosion developed only rarely in nonirradiated men (2 of 48 or 4%, p = 0.01). A history of radiation was the only significant risk factor associated with 3.5 cm cuff erosion (OR 6.2, 95% CI 1.3-29.5). Men with a history of radiation who underwent placement of a 3.5 cm artificial urinary sphincter cuff experienced an increased (21%) risk of cuff erosion.

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.