Abstract
Abstract Introduction The ROBUST III study is a randomized controlled trial comparing the Optilume® Drug Coated Balloon (DCB) against direct visual internal urethrotomy (DVIU) or dilation. 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 4-year follow-up are presented here. Objective To determine long-term endpoints after Optilume® DCB including freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax). 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 ≤ 3 cm. Results Subjects randomized to receive the DCB had an average of 3.2 prior treatments and average stricture length of 1.6 cm (46% ≥ 2 cm), with 8/79 (10.1%) having penile strictures and 9/79 (11.4%) having prior pelvic radiation. IPSS significantly improved from 21.9 at baseline to 12.6 at 4 years. Qmax significantly improved from a baseline of 7.7 mL/sec to 13.2 mL/sec at 4 years. Freedom from repeat intervention for DCB subjects was estimated to be 71%. 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 4 years post treatment. Disclosure Yes, this is sponsored by industry/sponsor: Laborie. Clarification: Industry funding only - investigator initiated and executed study.
Published Version
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