Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: 5-year Results From the ROBUST I Study.

Abstract

To report the 5-year study close-out results for the ROBUST I trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) for men with short, recurrent bulbar urethral strictures. Adult men with recurrent bulbar urethral strictures ≤ 2 cm long and lumen < 12 Fr were included in the study and treated with the Optilume DCB. Outcome measures included symptom questionnaires, maximum urinary flow rate (Qmax), post void residual (PVR), and freedom from repeat intervention. Functional success was defined as improvement in International Prostate Symptom Score (IPSS) of ≥ 50% without retreatment. Fifty-three men were enrolled and treated, and 31 subjects completed all follow-up. Functional success was achieved in 58% (25/43) patients at 5 years. Average IPSS improved from a mean of 25.2 at baseline to 7.2 at 5 years (P < .001). Freedom from repeat intervention was maintained through 5 years at 71.7% estimated by Kaplan-Meier. Qmax improved from 5.0 mL/s at baseline to 19.9 (P < .01) and average PVR was reduced from 141.4 mL to 59.5 mL (P < .01) at 5 years follow up. Erectile function remained unaffected. There were no serious treatment-related adverse events. In this challenging cohort of men with failed prior endoscopic treatment, the Optilume DCB shows sustained improvement in subjective and objective voiding parameters at 5 years. Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty. Results are in line with the ROBUST III randomized controlled trial that will continue follow-up through 5 years.