MP56-06 THE OPTILUME DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: 3-YEAR RESULTS FROM THE ROBUST I STUDY

Abstract

You have accessJournal of UrologyTrauma/Reconstruction/Diversion: Urethral Reconstruction (including Stricture, Diverticulum) III (MP56)1 Sep 2021MP56-06 THE OPTILUME DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: 3-YEAR RESULTS FROM THE ROBUST I STUDY Sean Elliott, Ramon Virasoro, Rafael Estrella, Merycarla Pichardo, Ramón Rodríguez Lay, Gustavo Espino, and Jessica DeLong Sean ElliottSean Elliott More articles by this author , Ramon VirasoroRamon Virasoro More articles by this author , Rafael EstrellaRafael Estrella More articles by this author , Merycarla PichardoMerycarla Pichardo More articles by this author , Ramón Rodríguez LayRamón Rodríguez Lay More articles by this author , Gustavo EspinoGustavo Espino More articles by this author , and Jessica DeLongJessica DeLong More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002086.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Mechanical dilation and direct visualization internal urethrotomy (DVIU) are the most widely utilized treatments for urethral stricture disease, but recurrence rates are high after re-treatment. This single arm study investigates the safety and efficacy of the Optilume® paclitaxel drug-coated balloon (DCB) for the treatment of recurrent anterior strictures. METHODS: Ethics committee approval was gained prior to enrollment commencing. Men with recurrent bulbar strictures ≤ 2cm with 1-4 prior endoscopic treatments were treated with the DCB. Patients have been followed at 3 months, 6 months, and annually through 3 years. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was the proportion of subjects with ≥ 50% improvement in International Prostate Symptom Score (IPSS) at 3 years. Subjects receiving secondary treatment were treated as failures for this endpoint. Secondary outcomes included quality of life, freedom from repeat intervention, erectile function, flow rate, and post-void residual urine volume. RESULTS: A total of 53 subjects were enrolled and treated; 43 were evaluable at the 3-year follow-up for the primary endpoint. 43% of men had undergone ≥2 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at 3 years. Success was achieved in 29/43 (67%), which is consistent with 2-year results. IPSS improved from a mean of 25.2 at baseline to 5.5 at 3 years (p < 0.001). Freedom from repeat intervention of the study stricture was 33/43 (77%). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function. CONCLUSIONS: Subjects with recurrent bulbar strictures treated with Optilume® DCB exhibited significant improvement in symptomatic and functional outcomes through 3 years post treatment. The rate of success is consistent with reported 2-year outcomes. Long-term follow-up will continue through 5 years in the ROBUST I study and a randomized study is ongoing. Source of Funding: Urotronic; the maker of the device © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e971-e971 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sean Elliott More articles by this author Ramon Virasoro More articles by this author Rafael Estrella More articles by this author Merycarla Pichardo More articles by this author Ramón Rodríguez Lay More articles by this author Gustavo Espino More articles by this author Jessica DeLong More articles by this author Expand All Advertisement Loading ...