Optilume Drug-Coated Balloon Dilation for Male Sphincteric (Membranous) Urethral Strictures: 53 Consecutive Cases.

Background/Objectives: Reconstruction of membranous urethral strictures poses significant surgical challenges, including risks of urinary incontinence and erectile dysfunction. Optilume drug-coated balloon dilation (DCBD) is a minimally invasive treatment for short, recurrent bulbar urethral strictures, but its application in strictures involving the sphincteric urethra remains controversial. This study aims to evaluate the safety, efficacy, and impact on continence of DCBD in membranous urethral strictures involving the male sphincter. Methods: A retrospective analysis was conducted on 53 consecutive patients with urethral strictures involving the sphincteric urethra, treated with Optilume DCBD between June 2021 and June 2025 at a tertiary center. After preoperative imaging, dilation to 20 Fr, then DCBD (30 Fr, 10 bar, 10 min) were performed. We assessed anatomical success (≥18 Fr as per cystoscopy/calibration), freedom from re-intervention, and continence status. Patients with neurological conditions or urinary infections were excluded. Results: The cohort included 35 membranous urethral strictures and 18 vesicourethral anastomosis stenoses that extended into the sphincter. The median follow-up was 13.3 months. At last follow-up, 66.6% and 65.6% of patients in both groups were free from recurrence and re-intervention with satisfactory voiding. No de novo incontinence was observed; two patients with prior post-prostatectomy incontinence remained incontinent. The median age was 68 years; median prior interventions were 2.5, and median stricture length was 3 cm. Conclusions: Optilume DCBD appears to be a safe and effective option for membranous urethral strictures involving the sphincter, without inducing de novo incontinence. Although not a replacement for reconstruction, it offers a minimally invasive alternative for selected patients.