{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T16:40:09Z","timestamp":1793032809485,"version":"4.5.0"},"reference-count":29,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,12,18]],"date-time":"2023-12-18T00:00:00Z","timestamp":1702857600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJUI Compass"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The aim of this study is to report the updated 2\u2010year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug\u2010coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>Eligible patients included men with recurrent anterior urethral stricture \u22643\u00a0cm in length and \u226412Fr in diameter, International Prostate Symptom Score (IPSS) \u226511 and peak flow rate (Qmax) &lt;15\u2009mL\/s. Patients were randomized to treatment with the Optilume DCB or standard\u2010of\u2010care endoscopic management. Primary efficacy endpoints measured at 2\u00a0years included freedom from re\u2010intervention and changes in IPSS, Qmax and post\u2010void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure\u2010 or device\u2010related adverse events (AEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard\u2010of\u2010care dilation and 79 to DCB dilation). Seventy\u2010five patients in the DCB arm entered the open\u2010label phase after 6\u2009months. Participants averaged 3.2 prior endoscopic interventions (range 2\u201310); most (89.9%) had bulbar strictures with an average stricture length of 1.63\u2009cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2\u00a0years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2\u00a0years versus the Control arm at 1\u00a0year (77.8% vs. 23.6%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). During the follow\u2010up period, there were 15 treatment failures and two non\u2010study\u2010related deaths. Treatment\u2010related AEs were rare and generally self\u2010limited (haematuria, dysuria and urinary tract infection).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2\u2010year follow\u2010up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bco2.312","type":"journal-article","created":{"date-parts":[[2023,12,19]],"date-time":"2023-12-19T05:14:59Z","timestamp":1702962899000},"page":"366-373","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":46,"title":["Optilume drug\u2010coated balloon for anterior urethral stricture: 2\u2010year results of the ROBUST III trial"],"prefix":"10.1002","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1778-7359","authenticated-orcid":false,"given":"Maia E.","family":"VanDyke","sequence":"first","affiliation":[{"name":"UT Southwestern Medical Center  Dallas Texas 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 Cheektowaga New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher H.","family":"Cantrill","sequence":"additional","affiliation":[{"name":"Urology San Antonio  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Ehlert","sequence":"additional","affiliation":[{"name":"Metro Urology, a division of Minnesota Urology  Woodbury Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis E.","family":"Te","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Dann","sequence":"additional","affiliation":[{"name":"Advanced Urology Institute  Daytona Beach Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica M.","family":"DeLong","sequence":"additional","affiliation":[{"name":"MultiCare Urology  Puyallup Washington 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