Optilume and Optilume BPH, a minimally invasive drug-coated balloon (DCB) combining mechanical dilation with paclitaxel delivery, offers a novel approach for treating urethral strictures and benign prostatic hyperplasia (BPH) respectively. This scoping review summarizes current evidence on their efficacy, safety, and long-term outcomes to evaluate their role in reducing recurrence and improving patient-reported and functional outcomes.
Following PRISMA guidelines, a systematic search (Embase, PubMed, Cochrane, Scopus) until March 2025 identified 287 studies. Eligibility followed PICOS criteria, excluding non-English articles, reviews, and case reports. Risk of bias was assessed using Cochrane RoB 2 and MINORS tools. Data extraction focused on anatomical success, symptom improvement, complications, and retreatment rates. This review was registered at https://osf.io/vf4dw .
After screening, 20 studies met inclusion criteria: 2 preclinical animal studies, 12 clinical studies on urethral strictures, and 6 on BPH. For urethral strictures, the ROBUST trials demonstrated 71.7% freedom from reintervention at 5 years, with sustained improvements in peak flow rate (Qmax: 5.0 to 19.9 mL/s) and IPSS (25.2 to 7.2). In BPH, the PINNACLE trial reported a 67.5% responder rate (≥ 30% IPSS improvement) at 2 years, with IPSS reduced from 23.4 to 11.0. Qmax improved from 8.9 to 19.0 mL/s, and sexual function (IIEF scores) remained stable. Safety profiles were favorable, with transient hematuria (15-39.8%) and no severe complications. Cost analyses indicated potential savings due to reduced retreatment.
Optilume provides significant symptom relief for BPH and urethral strictures, with low recurrence rates and preserved sexual function. Its minimally invasive nature, combined with targeted drug delivery, positions it as a promising alternative to traditional surgeries. Further research is needed to expand indications and validate long-term outcomes and cost-effectiveness across diverse populations.
BMC urology. 2025 Aug 09*** epublish ***
Vineet Gauhar, Steffi Kar Kei Yuen, Nariman Gadzhiev, Marcelo Wroclawski, Giacomo Maria Pirola, Ee Jean Lim, Angelo Cormio, Carlo Giulioni, Angelo Cafarelli, Dmitry Enikeev, Yunfu Liu, Jeremy Yuen Chun Teoh, Dean Elterman, Thomas Hermann, Daniele Castellani
Department of Urology, Ng Teng Fong Hospital, Singapore, Singapore., European Association of Urology Section of Endourology (ESEUT), Arnhem, The Netherlands. ., Department of Urology, Saint Petersburg State University Hospital, St. Petersburg, Russian Federation., Hospital Israelita Albert Einstein, São Paulo, Brazil., IRCCS Multimedica, Ospedale San Giuseppe, Milano, Italy., Department of Urology, Singapore General Hospital, Academia Level 5, 20 College Rd, Singapore, 169856, Singapore., Department of Urology, Azienda Ospedaliero-Universitaria delle Marche, Polytechnic University of Marche, Ancona, Italy., Department of Urology, Casa di Cura Villa Igea, Ancona, Italy., Rabin Medical Center (Belenson, Hasharon), Petah Tikva, Israel., The First Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China., S. H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China., Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada., European Association of Urology Section of Endourology (ESEUT), Arnhem, The Netherlands.