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Introduction <p>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.</p> Methods <p>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 <a href="https://osf.io/vf4dw">https://osf.io/vf4dw</a>.</p> Results <p>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.</p> Conclusion <p>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.</p>

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Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月9日

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  • 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

摘要

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.