Mp06-15 the Optilume® Drug Coated Balloon for Recurrent Anterior Urethral Strictures: Robust Iii Study 4-Year Interim Results

You have accessJournal of UrologyReconstruction: Urethral Reconstruction (including stricture) I (MP06)1 May 2024MP06-15 THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: ROBUST III STUDY 4-YEAR INTERIM RESULTS Sean Elliott, Ramon Virasoro, Jessica DeLong, Karl Coutinho, Kasier Robertson, Richard D'Anna, Kent Chevli, Serge Carrier, Melanie Aube-Peterkin, Chris Cantrill, Michael Ehlert, Alexis Te, Jeffrey Dan, Steven Brandes, Judith Hagedorn, Richard Levin, Amy Schlaifer, Euclid DeSouza, David DiMarco, Brad Erickson, Richard Natale, Douglas Husmann, Allen Morey, and Carl Olsson Sean ElliottSean Elliott , Ramon VirasoroRamon Virasoro , Jessica DeLongJessica DeLong , Karl CoutinhoKarl Coutinho , Kasier RobertsonKasier Robertson , Richard D'AnnaRichard D'Anna , Kent ChevliKent Chevli , Serge CarrierSerge Carrier , Melanie Aube-PeterkinMelanie Aube-Peterkin , Chris CantrillChris Cantrill , Michael EhlertMichael Ehlert , Alexis TeAlexis Te , Jeffrey DanJeffrey Dan , Steven BrandesSteven Brandes , Judith HagedornJudith Hagedorn , Richard LevinRichard Levin , Amy SchlaiferAmy Schlaifer , Euclid DeSouzaEuclid DeSouza , David DiMarcoDavid DiMarco , Brad EricksonBrad Erickson , Richard NataleRichard Natale , Douglas HusmannDouglas Husmann , Allen MoreyAllen Morey , and Carl OlssonCarl Olsson View All Author Informationhttps://doi.org/10.1097/01.JU.0001009452.79331.fd.15AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND 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. The Optilume® 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. 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 an 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 21.9 at baseline to 12.6 at 4 years, which showed slight deterioration from the 3 year (11.3), 2 year (10.1) and 1 year (9.0) results. Qmax significantly improved from a baseline of 7.7 mL/sec to 13.2 mL/sec at 4 years, which was in line with the 3 year (12.0) and 2 year (13.9) data. 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. Download PPT Source of Funding: Laborie © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e57 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Sean Elliott More articles by this author Ramon Virasoro More articles by this author Jessica DeLong More articles by this author Karl Coutinho More articles by this author Kasier Robertson More articles by this author Richard D'Anna More articles by this author Kent Chevli More articles by this author Serge Carrier More articles by this author Melanie Aube-Peterkin More articles by this author Chris Cantrill More articles by this author Michael Ehlert More articles by this author Alexis Te More articles by this author Jeffrey Dan More articles by this author Steven Brandes More articles by this author Judith Hagedorn More articles by this author Richard Levin More articles by this author Amy Schlaifer More articles by this author Euclid DeSouza More articles by this author David DiMarco More articles by this author Brad Erickson More articles by this author Richard Natale More articles by this author Douglas Husmann More articles by this author Allen Morey More articles by this author Carl Olsson More articles by this author Expand All Advertisement PDF downloadLoading ...