(064) The Optilume® Drug Coated Balloon for Recurrent Anterior Urethral Strictures: Robust III Study 3-year Interim Results

Abstract

Abstract Introduction The Optilume® Drug Coated Balloon (DCB) is a dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. Outcomes after 3-year follow-up are presented here. Objective The ROBUST III study is a randomized controlled trial comparing the Optilume® Drug Coated Balloon (DCB) against direct visual internal urethrotomy (DVIU) or dilation. Methods 127 subjects were randomized in a 2:1 fashion at 23 sites. Seventy-nine were treated with the DCB and 48 were treated with DVIU or dilation. Follow-up past 1 year was limited to those treated with the DCB. Eligibility criteria included adult males with anterior strictures with ≥2 prior treatments and stricture length ≤3cm. Long-term endpoints included freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax). Results Subjects randomized to receive the DCB had an average of 3.2 prior treatments and average stricture length of 1.6cm (46% ≥2cm), with 8/79 (10.1%) having penile strictures and 9/79 (11.4%) having prior pelvic radiation. IPSS significantly improved from 22.0 at baseline to 11.3 at 3 years. Qmax significantly improved from a baseline of 7.7 mL/sec to 12.2 mL/sec at 3 years. Freedom from repeat intervention for DCB subjects was estimated to be 74%. No late-onset treatment related adverse events were observed. Conclusions The Optilume® DCB continues to achieve significant improvements in symptoms, flow, and reintervention rates through 3 years post treatment. Disclosure No.