ArticleBMC urology2025
Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review.
Article in BMC urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- The safety and efficacy of drug-coated balloon dilation system (Keeway) for benign prostate hyperplasia: a preclinical study.World journal of urology · 2026Article
- Internal urethrotomy versus Optilume™ drug-coated balloon dilatation for the management of anterior urethral strictures: morbidity comparison of the techniques.World journal of urology · 2026Article
- Outcomes of patients undergoing OptilumeWorld journal of urology · 2026Article
- Paclitaxel Drug-Coated Balloon (OptilumeMedicina (Kaunas, Lithuania) · 2026Review
- Efficacy and Mid-Term Outcomes of Paclitaxel-Coated Balloon (OptilumeJournal of clinical medicine · 2025Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOptilume 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.
methodsFollowing 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 .
resultsAfter 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.
conclusionOptilume 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.
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