Drug-Coated Balloon (Optilume®) for the Management of Bulbar Urethral Stricture, Our Experience.

Abstract

Objective: The drug (paclitaxel)-coated balloon (DCB) Optilume® is designed to dilate the urethral lumen via balloon dilation while also promoting long-term urethral patency through the targeted and circumferential delivery of paclitaxel. As an antimitotic agent, paclitaxel functions by inhibiting cellular proliferation and migration. The objective of this study is to assess the safety and efficacy of this DCB in managing bulbar urethral strictures. Methods: This study is a retrospective study, involving 19 patients who underwent treatment with DCB for bulbar strictures. Patients' characteristics, preoperative and postoperative maximum flow rates (Qmax), and the duration until recurrence were recorded. Postoperative complications were also noted. Results: Success was achieved in 15 out of 19 patients (78.9%) with a median follow up period of 352 days. The mean maximum urine flow rate preoperatively was 5 mL/s (with a range of 4.00-6.50 mL/s). Subsequent mean flow rates at 3 months, 6 months, 12 months, and 24 months post-treatment were 32 mL/s, 32 mL/s, 24 mL/s, and 20 mL/s, respectively. Notably, there was no recurrence among the 7 patients without previous surgical interventions (47%, P-value .01). The mean duration of stricture-free survival following surgery was 648 days (approximately 21.6 months) (95% CI 500.4-700.2). Importantly, no complications were reported throughout the study. Conclusion: The use of DCB for managing bulbar urethral stricture demonstrated a success rate of 78.9%. Patients without a history of urethral surgery exhibited significantly improved treatment outcomes. Furthermore, the study reported no significant complications associated with the use of DCB.