{"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":1793032809473,"version":"4.5.0"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T00:00:00Z","timestamp":1764374400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T00:00:00Z","timestamp":1764374400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100005743","name":"Universit\u00e0 Cattolica del Sacro Cuore","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005743","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int Urol Nephrol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Urethral stricture disease remains a challenging condition in urology, particularly in cases with recurrent anterior urethral narrowing following prior endoscopic treatments. Traditional options such as dilation and direct vision internal urethrotomy (DVIU) are limited by high failure rates. The Optilume\n                      <jats:sup>\u00ae<\/jats:sup>\n                      drug-coated balloon (DCB) delivers mechanical dilation combined with localized paclitaxel delivery, aiming to reduce restenosis and improve durability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To evaluate the short-term functional outcomes and safety of Optilume\n                      <jats:sup>\u00ae<\/jats:sup>\n                      DCB in patients with recurrent urethral strictures.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design, setting, and participants<\/jats:title>\n                    <jats:p>This was a prospective single-center study including 35 male patients with anterior urethral strictures\u2009\u2264\u20093\u00a0cm and at least one prior endoscopic treatment. Outcomes were assessed at 1, 3, and 6\u00a0months post-procedure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome measurements and statistical analysis<\/jats:title>\n                    <jats:p>Primary outcomes included changes in Qmax (uroflowmetry), post-void residual (PVR), IPSS, and erectile function (IIEF-5). Recurrence was defined as symptomatic deterioration, Qmax\u2009&lt;\u200910\u00a0mL\/s, or need for retreatment. Paired t-tests were used for pre- and post-treatment comparisons, with p\u2009&lt;\u20090.05 considered statistically significant. As this was an exploratory pilot study, no formal sample size calculation was performed; analyses were descriptive and hypothesis-generating.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results and limitations<\/jats:title>\n                    <jats:p>Mean Qmax improved from 10.2\u2009\u00b1\u20094.9 to 21.6\u2009\u00b1\u20093.1\u00a0mL\/s (p\u2009&lt;\u20090.001), and PVR decreased from 74.6\u2009\u00b1\u200936.3 to 24.8\u2009\u00b1\u200916.0\u00a0mL (p\u2009&lt;\u20090.001). IPSS improved from 21.8\u2009\u00b1\u20094.8 to 8.7\u2009\u00b1\u20092.0 (p\u2009&lt;\u20090.0001), and IIEF-5 scores increased from 13.7\u2009\u00b1\u20097.7 to 18.5\u2009\u00b1\u20097.6 (p\u2009=\u20090.012). The recurrence rate at 6\u00a0months was 8.6% (3\/35). Minor adverse events included transient hematuria and dysuria. No Clavien-Dindo grade\u2009\u2265\u20092 complications were recorded. Study limitations include its single-arm, non-randomized design and relatively short follow-up, limiting direct comparison with DVIU, urethroplasty, or emerging minimally invasive surgical therapies (MISTs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Optilume\n                      <jats:sup>\u00ae<\/jats:sup>\n                      DCB treatment demonstrated significant improvements in urinary flow and symptoms with a low recurrence and complication rate at 6\u00a0months. It may serve as a minimally invasive alternative for patients unsuitable or unwilling to undergo urethroplasty. Further prospective evaluation is warranted, including its potential role in bladder neck sclerosis and benign prostatic obstruction.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11255-025-04922-3","type":"journal-article","created":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T19:39:22Z","timestamp":1764445162000},"page":"1951-1956","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Single-center prospective experience with Optilume\u00ae drug-coated balloon for recurrent urethral strictures: preliminary functional and safety outcomes"],"prefix":"10.1007","volume":"58","author":[{"given":"Antonio","family":"Cret\u00ec","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauro","family":"Ragonese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierluigi","family":"Russo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nazario","family":"Foschi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni Battista","family":"Filomena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Silvestri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Fantasia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Cavarra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eros","family":"Scarciglia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco Pio","family":"Bizzarri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariachiara","family":"Sighinolfi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernardo Maria Cesare","family":"Rocco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Pinto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,29]]},"reference":[{"issue":"1","key":"4922_CR1","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1016\/j.urology.2012.08.062","volume":"81","author":"E Palminteri","year":"2013","unstructured":"Palminteri E, Berdondini E, Verze P, De Nunzio C, Vitarelli A, Carmignani L (2013) Contemporary urethral stricture characteristics in the developed world. Urology 81(1):191\u2013196. https:\/\/doi.org\/10.1016\/j.urology.2012.08.062. (Epub 2012 Nov 13 PMID: 23153951)","journal-title":"Urology"},{"issue":"1","key":"4922_CR2","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1111\/j.1464-410X.2010.09800.x","volume":"107","author":"AR Mundy","year":"2011","unstructured":"Mundy AR, Andrich DE (2011) Urethral strictures. BJU Int 107(1):6\u201326. https:\/\/doi.org\/10.1111\/j.1464-410X.2010.09800.x. (PMID: 21176068)","journal-title":"BJU Int"},{"issue":"5","key":"4922_CR3","doi-asserted-by":"publisher","first-page":"2051","DOI":"10.1016\/S0022-5347(05)64293-0","volume":"168","author":"CF Heyns","year":"2002","unstructured":"Heyns CF, Marais DC (2002) Prospective evaluation of the American Urological Association symptom index and peak urinary flow rate for the followup of men with known urethral stricture disease. J Urol 168(5):2051\u20132054. https:\/\/doi.org\/10.1016\/S0022-5347(05)64293-0. (PMID: 12394706)","journal-title":"J Urol"},{"issue":"1","key":"4922_CR4","doi-asserted-by":"publisher","first-page":"182","DOI":"10.1016\/j.juro.2016.07.087","volume":"197","author":"H Wessells","year":"2017","unstructured":"Wessells H, Angermeier KW, Elliott S, Gonzalez CM, Kodama R, Peterson AC, Reston J, Rourke K, Stoffel JT, Vanni AJ, Voelzke BB, Zhao L, Santucci RA (2017) Male urethral stricture: American Urological Association guideline. J Urol 197(1):182\u2013190. https:\/\/doi.org\/10.1016\/j.juro.2016.07.087. (Epub 2016 Aug 3 PMID: 27497791)","journal-title":"J Urol"},{"key":"4922_CR5","doi-asserted-by":"publisher","first-page":"68","DOI":"10.1016\/j.ejphar.2016.02.038","volume":"776","author":"F Li","year":"2016","unstructured":"Li F, Liu Y, Song J et al (2016) Paclitaxel attenuates fibroblast proliferation and collagen deposition in vitro and in vivo. Eur J Pharmacol 776:68\u201375. https:\/\/doi.org\/10.1016\/j.ejphar.2016.02.038","journal-title":"Eur J Pharmacol"},{"issue":"1","key":"4922_CR6","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1016\/S0735-1097(97)00461-5","volume":"31","author":"R Kornowski","year":"1998","unstructured":"Kornowski R, Hong MK, Tio FO et al (1998) In-stent restenosis: contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol 31(1):224\u2013230. https:\/\/doi.org\/10.1016\/S0735-1097(97)00461-5","journal-title":"J Am Coll Cardiol"},{"issue":"2","key":"4922_CR7","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1089\/end.2020.0633","volume":"35","author":"CD McClung","year":"2021","unstructured":"McClung CD, Brandes SB, Andriole GL et al (2021) Robotic optical urethrotomy system with paclitaxel-coated balloon for recurrent urethral strictures: ROBUST I trial. J Endourol 35(2):169\u2013175. https:\/\/doi.org\/10.1089\/end.2020.0633","journal-title":"J Endourol"},{"issue":"1","key":"4922_CR8","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1097\/JU.0000000000004229","volume":"213","author":"J DeLong","year":"2025","unstructured":"DeLong J, Virasoro R, Pichardo M, Estrella R, Rodr\u00edguez Lay R, Espino G, Elliott S (2025) Long-term outcomes of recurrent bulbar urethral stricture treatment with the Optilume drug-coated balloon: five-year results from the ROBUST I study. J Urol 213(1):90\u201398. https:\/\/doi.org\/10.1097\/JU.0000000000004229","journal-title":"J Urol"},{"issue":"1","key":"4922_CR9","doi-asserted-by":"publisher","first-page":"80","DOI":"10.1016\/j.acuroe.2024.10.003","volume":"49","author":"C Ballesteros Ruiz","year":"2025","unstructured":"Ballesteros Ruiz C, Campos-Juanatey F, Mart\u00edn Povo et al (2025) Efficacy and safety of Optilume\u00ae paclitaxel-coated urethral dilatation balloon in real-life: experience in a Spanish multicenter study. Actas Urol Esp (Engl Ed) 49(1):80\u201385. https:\/\/doi.org\/10.1016\/j.acuroe.2024.10.003. (English, Spanish Epub 2024 Oct 30 PMID: 39486795)","journal-title":"Actas Urol Esp (Engl Ed)"},{"issue":"4","key":"4922_CR10","first-page":"10322","volume":"27","author":"DS Elterman","year":"2020","unstructured":"Elterman DS, Coutinho K, Hagedorn JC (2020) How I do it: The Optilume drug-coated balloon for urethral strictures. Can J Urol 27(4):10322\u201310328 (PMID: 32861260)","journal-title":"Can J Urol"},{"key":"4922_CR11","doi-asserted-by":"publisher","first-page":"175628722413125","DOI":"10.1177\/17562872241312522","volume":"16","author":"M VanDyke","year":"2024","unstructured":"VanDyke M, Ceballos B, Graham KS et al (2024) Efficacy of the Optilume paclitaxel drug-coated balloon after prior urethroplasty: a multi-institutional analysis. Ther Adv Urol 16:17562872241312522. https:\/\/doi.org\/10.1177\/17562872241312522","journal-title":"Ther Adv Urol"},{"issue":"11","key":"4922_CR12","doi-asserted-by":"publisher","first-page":"1192","DOI":"10.1089\/end.2024.0318","volume":"38","author":"Z Alhamdani","year":"2024","unstructured":"Alhamdani Z, Ong S, Zhong W, Chin P (2024) Optilume\u00ae\u00a0Drug-Coated Balloon may lower the re-treatment rate postintervention for challenging urethral stricture disease in long-term follow-up: a prospective cohort study. J Endourol 38(11):1192\u20131200. https:\/\/doi.org\/10.1089\/end.2024.0318","journal-title":"J Endourol"},{"issue":"11","key":"4922_CR13","doi-asserted-by":"publisher","first-page":"E319","DOI":"10.5489\/cuaj.8737.PMID:38976898;PMCID:PMC11534392","volume":"18","author":"SA Kaplan","year":"2024","unstructured":"Kaplan SA, Pichardo M, Rijo E, Espino G, Lay RR, Estrella R (2024) Long-term outcomes after treatment with Optilume BPH Four-year results from the EVEREST study. Can Urol Assoc J 18(11):E319\u2013E325. https:\/\/doi.org\/10.5489\/cuaj.8737.PMID:38976898;PMCID:PMC11534392","journal-title":"Can Urol Assoc J"}],"container-title":["International Urology and Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11255-025-04922-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11255-025-04922-3","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11255-025-04922-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T13:41:39Z","timestamp":1779370899000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11255-025-04922-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,29]]},"references-count":13,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2026,6]]}},"alternative-id":["4922"],"URL":"https:\/\/doi.org\/10.1007\/s11255-025-04922-3","relation":{},"ISSN":["1573-2584"],"issn-type":[{"value":"1573-2584","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,29]]},"assertion":[{"value":"5 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 November 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 November 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}