INTRODUCTION: 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.

METHODS: 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 .

RESULTS: 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.

CONCLUSION: 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.