One-Year Outcomes of the ROBUST II Study Evaluating the Use of a Drug-Coated Balloon for Treatment of Urethral Stricture

Objective To report 1-year results of the ROBUST II study investigating the safety and efficacy of a paclitaxel-coated balloon for the treatment of recurrent urethral strictures. Methods Subjects were adult men with a single anterior urethral stricture ≤ 3 cm in length and at least 2 prior stricture treatments. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed through 1 year. The primary safety endpoint was the rate of treatment-related serious complications at 90 days post-procedure. Efficacy outcomes included symptomatic assessments, erectile function measured using the International Index of Erectile Function (IIEF), Qmax, and anatomic success. Results Sixteen men with an average of 4.1 prior dilations were treated with the DCB. Anatomic success was achieved at 6 months in 73%. Average IPSS improved from 18.4 to 6.0 at 1 year (P < 0.001). Qmax improved from 6.9 mL/sec to 20.8 mL/sec (P < 0.001). There was no change in IIEF. Four subjects received additional treatment within 1 year. There were no treatment-related serious complications. Conclusions Short-term follow-up of men with urethral stricture treated with the Optilume DCB showed durable anatomic results at 6 months and sustained symptomatic improvement through 1 year. Treatment with the device was safe.