Early Real-World Experience With Optilume Drug-coated Balloon for Anterior Urethral Strictures and Posterior Urethral Stenoses

Objective To determine the early experience with paclitaxel-drug coated balloon (DCB) for both anterior urethral stricture disease (aUSD) and posterior urethral stenoses (PUS). Methods A retrospective review of patients undergoing Optilume DCB in the Trauma and Urologic Reconstructive Network of Surgeons (TURNS) database was performed. Both functional (improved subjective voiding without a secondary procedure) and anatomic (open lumen on cystoscopy) success rates were determined. Kaplan Meier estimates were used to determine the risk of failure by LSE classification and LSE Stage. Results A total of 319 patients were treated with the DCB, of which 260 were for aUSD and 59 were for PUS. Median age was 64 years (Interquartile range [IQR] 48-73). Recurrence was noted in 119 patients (37.3%) at a median follow-up of 5.7 months (IQR 3-12). For aUSD, the 1-year functional recurrence-free survival was 78.4% (95% CI 71.8-85.4) and anatomical recurrence-free survival was 66.4% (95% CI 59.5-74.2). For PUS, the 1-year functional recurrence-free survival was 75.8% (95% CI 61.4-93.7) and anatomical recurrence-free survival was 59.4% (95% CI 44.1-80). Recurrences of any kind were significantly more likely in patients with strictures after hypospadias repair (HR 5.21, 95% CI 1.06-25.6, P = .042), and use of 24 Fr, 3 cm DCB (HR 3.64, 95% 1.10-12.09, P = .035). These were also significant predictors of anatomical recurrences. Conclusion Multi-institutional utilization of the DCB for aUSD and PUS demonstrates a low effectiveness among high-risk strictures . Recurrence after DCB varies based on stricture characteristics and subtype, which are important for preoperative counseling and postoperative surveillance.