Abstract
Urethral stricture disease treatment presents significant challenges due to high recurrence rates and limited minimally invasive options. This review evaluates the efficacy, safety, and clinical applicability of the Optilume® drug-coated balloon, which combines mechanical urethral dilation with paclitaxel delivery, as an innovative alternative to traditional treatments. A narrative review was conducted using PubMed, focusing on studies published in the last decade addressing the use of Optilume® for urethral strictures. Keywords included "urethral stricture", "Optilume", and "drug-coated balloon". Data from clinical trials (ROBUST I and III) and real-world studies were synthesized to assess functional and anatomical success, patient outcomes, and safety profiles. Optilume® demonstrated high efficacy in recurrent anterior urethral strictures. ROBUST I showed a 58% functional success rate at five years, with significant improvements in Qmax (5 to 19.9 mL/s) and International Prostate Symptom Score (IPSS) (25.2 to 7.2). The randomized ROBUST III trial reported superior freedom from reintervention compared to standard treatments (77.8% vs. 23.6% at two years). Real-world studies confirmed these findings across diverse patient populations, including those with complex strictures. Immediate- and short-term postoperative complications were mild and infrequent, with no significant impact on erectile function. Optilume® offers a safe, effective, and minimally invasive solution for urethral stricture management, bridging the gap between endoscopic treatments and urethroplasty. Its advantages include reduced recurrence, shorter recovery times, and preserved sexual function. Future studies should explore its role in treatment-naïve and complex cases to expand its clinical applicability.