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- Title
(064) The Optilume® Drug Coated Balloon for Recurrent Anterior Urethral Strictures: Robust III Study 3-year Interim Results.
- Authors
Krug, A; Morey, A; Coutinho, K; Robertson, K; D'anna, R; Chevli, K; Carrier, SC; Cantrill, C; Ehlert, MJ; Te, AE; Dann, J; Delong, JM; Brandes, SB; Hagedorn, J; Levin, R; Schlaifer, A; Desouza, E; Dimarco, D; Erickson, B; Elliott, S
- 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.
- Subjects
DRUG coatings; URETHRA stricture; PENIS; RANDOMIZED controlled trials; PHRENIC nerve
- Publication
Journal of Sexual Medicine, 2024, p1
- ISSN
1743-6095
- Publication type
Article
- DOI
10.1093/jsxmed/qdae001.060