{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:51:01Z","timestamp":1787028661683,"version":"build-2736575974"},"reference-count":28,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T00:00:00Z","timestamp":1756166400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Penile urethral stricture is a therapeutically challenging condition that significantly impacts quality of life and is often managed initially with urethral dilation or internal urethrotomy. However, both techniques are associated with high recurrence rates, limited long-term efficacy, and potential adverse effects, particularly in the penile urethra. Urethroplasty remains the gold standard but is invasive and not suitable for all patients. Optilume, a paclitaxel-coated balloon, combines mechanical dilation with localized drug delivery to reduce recurrence rates and the need for re-intervention. This study evaluated its effectiveness in patients with penile urethral strictures. Methods: A retrospective, multicenter study was conducted at two German clinics. Eight male patients (mean age 59) with symptomatic penile urethral strictures underwent Optilume treatment. Symptom severity was assessed using the International Prostate Symptom Score (IPSS) and quality of life (QoL) scores before and after treatment. The primary endpoint was symptom improvement, while the secondary endpoint was the need for reintervention. Patients were followed for a median of 16.5 months. Statistical analyses included Wilcoxon signed-rank and Mann\u2013Whitney U tests. Results: The median IPSS improved from 25.5 to 5.0 and QoL scores from 4.5 to 1.0 after treatment (p &lt; 0.01 for both). No patients required reintervention during follow-up. The subgroup analysis showed slightly better outcomes in patients without prior interventions, although differences were not statistically significant. The stricture length did not correlate with treatment response. Conclusions: Optilume significantly reduces urinary symptoms and improves QoL in penile urethral strictures, and the absence of re-interventions during follow-up underscores its durable mid-term success. It offers a minimally invasive alternative to urethroplasty, particularly for patients seeking symptom relief with a shorter recovery time and no hospital stay or general anesthesia. These preliminary findings suggest that Optilume may be a promising minimally invasive option for selected patients. Larger, controlled studies are warranted to validate these results and refine patient selection criteria.<\/jats:p>","DOI":"10.3390\/jcm14176022","type":"journal-article","created":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T10:35:17Z","timestamp":1756204517000},"page":"6022","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy and Mid-Term Outcomes of Paclitaxel-Coated Balloon (Optilume\u00ae) for Penile Strictures"],"prefix":"10.3390","volume":"14","author":[{"given":"Johannes","family":"Salem","sequence":"first","affiliation":[{"name":"Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontan, 14770 Brandenburg, Germany"},{"name":"CUROS Urology Center, 50996 Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9571-8171","authenticated-orcid":false,"given":"Juan Jose","family":"Menendez-Suarez","sequence":"additional","affiliation":[{"name":"Department of Urology, St Elisabeth Hospital Cologne Hohenlind, 50935 Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgi","family":"Tosev","sequence":"additional","affiliation":[{"name":"Praxis Urologie Mannheim, 68239 Mannheim, Germany"},{"name":"Department of Urology, University Hospital Heidelberg, Im Neuenheimer Feld 420, 69120 Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrik","family":"Borgmann","sequence":"additional","affiliation":[{"name":"Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontan, 14770 Brandenburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5570-2745","authenticated-orcid":false,"given":"Timur","family":"Kuru","sequence":"additional","affiliation":[{"name":"Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontan, 14770 Brandenburg, Germany"},{"name":"CUROS Urology Center, 50996 Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"310","DOI":"10.1111\/j.1464-410X.2011.10339.x","article-title":"Urethral trauma. Part I: Introduction, history, anatomy, pathology, assessment and emergency management","volume":"108","author":"Mundy","year":"2011","journal-title":"BJU Int."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1667","DOI":"10.1016\/j.juro.2007.01.041","article-title":"Male urethral stricture disease","volume":"177","author":"Santucci","year":"2007","journal-title":"J. Urol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1016\/j.urology.2013.09.009","article-title":"SIU\/ICUD Consultation On Urethral Strictures: Epidemiology, etiology, anatomy, and nomenclature of urethral stenoses, strictures, and pelvic fracture urethral disruption injuries","volume":"83","author":"Latini","year":"2014","journal-title":"Urology"},{"key":"ref_4","first-page":"209","article-title":"Epidemiology of urethral strictures","volume":"3","author":"Alwaal","year":"2014","journal-title":"Transl. Androl. Urol."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Shen, J., Vale, L., Goulao, B., Whybrow, P., Payne, S., and Watkin, N. (2021). Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: The OPEN randomised trial cost-effectiveness analysis. BMC Urol., 21.","DOI":"10.21203\/rs.3.rs-126788\/v1"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1097\/JU.0000000000003826","article-title":"Affirming Long-Term Outcomes After Contemporary Urethroplasty: The Adverse Impact of Increasing Stricture Length, Lichen Sclerosus, Radiation, and Infectious Strictures","volume":"211","author":"Calvo","year":"2024","journal-title":"J. Urol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1111\/bju.16566","article-title":"Decision regret and long-term success rates after ventral buccal mucosa graft urethroplasty","volume":"135","author":"Santiago","year":"2025","journal-title":"BJU Int."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1016\/S0022-5347(01)65296-0","article-title":"Internal urethrotomy versus dilation as treatment for male urethral strictures: A prospective, randomized comparison","volume":"157","author":"Steenkamp","year":"1997","journal-title":"J. Urol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"184","DOI":"10.5152\/tud.2016.90490","article-title":"Catheter dwell time and diameter affect the recurrence rates after internal urethrotomy","volume":"42","author":"Yentur","year":"2016","journal-title":"Turk. J. Urol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1016\/j.urology.2017.04.037","article-title":"Direct Vision Internal Urethrotomy for Short Anterior Urethral Strictures and Beyond: Success Rates, Predictors of Treatment Failure, and Recurrence Management","volume":"106","author":"Kluth","year":"2017","journal-title":"Urology"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"18","DOI":"10.4103\/0974-7796.198835","article-title":"Direct visual internal urethrotomy: Is it a durable treatment option?","volume":"9","author":"Pal","year":"2017","journal-title":"Urol. Ann."},{"key":"ref_12","first-page":"656459","article-title":"Visual Internal Urethrotomy for Adult Male Urethral Stricture Has Poor Long-Term Results","volume":"2015","author":"Seyam","year":"2015","journal-title":"Adv. Urol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"175","DOI":"10.3109\/00365599109107943","article-title":"Erectile dysfunction following direct vision internal urethrotomy","volume":"25","author":"Graversen","year":"1991","journal-title":"Scand. J. Urol. Nephrol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"190","DOI":"10.1016\/j.eururo.2021.05.022","article-title":"European Association of Urology Guidelines on Urethral Stricture Disease (Part 1): Management of Male Urethral Stricture Disease","volume":"80","author":"Lumen","year":"2021","journal-title":"Eur. Urol."},{"key":"ref_15","first-page":"90","article-title":"Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: Five-Year Results From the ROBUST I Study","volume":"213","author":"DeLong","year":"2025","journal-title":"J. Urol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.ucl.2016.08.001","article-title":"Definition of Successful Treatment and Optimal Follow-up after Urethral Reconstruction for Urethral Stricture Disease","volume":"44","author":"Erickson","year":"2017","journal-title":"Urol. Clin. North Am."},{"key":"ref_17","first-page":"132","article-title":"Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model","volume":"83","author":"Yazdani","year":"2014","journal-title":"Catheter. Cardiovasc. Interv."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1007\/s11886-025-02249-0","article-title":"In-Stent Restenosis: Incidence, Mechanisms, and Treatment Options","volume":"27","author":"Sola","year":"2025","journal-title":"Curr. Cardiol. Rep."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"180","DOI":"10.1016\/j.urology.2017.05.025","article-title":"Natural History of Low-stage Urethral Strictures","volume":"108","author":"Purohit","year":"2017","journal-title":"Urology"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1016\/j.urology.2014.01.054","article-title":"Multi-institutional 1-year bulbar urethroplasty outcomes using a standardized prospective cystoscopic follow-up protocol","volume":"84","author":"Erickson","year":"2014","journal-title":"Urology"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1016\/j.euros.2025.03.002","article-title":"Off-label Use of the Optilume Drug-coated Balloon in the Treatment of Bladder Neck Stenosis and Vesicourethral Anastomosis Stenosis","volume":"75","author":"Tosev","year":"2025","journal-title":"Eur. Urol. Open Sci."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Srikanth, P., DeLong, J., Virasoro, R., and Elliott, S.P. (2025). A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST III Study. J. Endourol., ahead of print.","DOI":"10.1089\/end.2024.0718"},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Oszczud\u0142owski, M., Bia\u0142ek, \u0141., and Vetterlein, M.W. (2025). Trauma and Reconstructive Urology Working Party of the European Association of Urology Young Academic Urologists. Paclitaxel-coated Balloon Dilation for Urethral Stricture Disease: 5 Years of Clinical Insights and Future Directions for Optilume. Eur. Urol. Focus, in press.","DOI":"10.1016\/j.euf.2025.03.013"},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Gauhar, V., Yuen, S.K.K., Gadzhiev, N., Wroclawski, M., Pirola, G.M., Lim, E.J., Cormio, A., Giulioni, C., Cafarelli, A., and Enikeev, D. (2025). Optilume, a minimally invasive solution for BPH and urethral stricture: What we know, what we need? An EAU endourology scoping review. BMC Urol., 25.","DOI":"10.1186\/s12894-025-01896-3"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"2011","DOI":"10.1016\/j.juro.2007.07.034","article-title":"Buccal mucosa graft urethroplasty for anterior urethral stricture repair: Evaluation of the impact of stricture location and lichen sclerosus on surgical outcome","volume":"178","author":"Levine","year":"2007","journal-title":"J. Urol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1038\/nrurol.2013.275","article-title":"Male urethral strictures and their management","volume":"11","author":"Hampson","year":"2014","journal-title":"Nat. Rev. Urol."},{"key":"ref_27","first-page":"e74069","article-title":"Efficacy and Safety of Optilume Drug-Coated Balloon for Urethral Stricture Treatment: A Systematic Review and Meta-Analysis","volume":"16","author":"Estaphanous","year":"2024","journal-title":"Cureus"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1002\/bco2.312","article-title":"Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial","volume":"5","author":"VanDyke","year":"2024","journal-title":"BJUI Compass"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/17\/6022\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:33:02Z","timestamp":1760034782000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/17\/6022"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,26]]},"references-count":28,"journal-issue":{"issue":"17","published-online":{"date-parts":[[2025,9]]}},"alternative-id":["jcm14176022"],"URL":"https:\/\/doi.org\/10.3390\/jcm14176022","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,26]]}}}