Efficacy and Safety of Optilume Drug-Coated Balloon for Urethral Stricture Treatment: A Systematic Review and Meta-Analysis
Peter Estaphanous, Ahmed Khedr Khalifa, Youstina Makar
Abstract
The Optilume drug-coated balloon (DCB) (North Plymouth, USA) is a novel treatment option for urethral stricture disease that combines mechanical dilation with localized delivery of paclitaxel, an antiproliferative drug aimed at reducing recurrence rates by inhibiting scar tissue formation. This systematic review and meta-analysis, conducted using studies published in the last 10 years up to November 2024, assessed the efficacy and safety of Optilume DCB across seven studies involving 457 patients. Key outcomes included significant reductions in symptom scores, as measured by the International Prostate Symptom Score (IPSS), and improvements in urinary flow rates (QMax). The recurrence-free rate was approximately 80.83%, suggesting that Optilume offers durable symptom relief. The complication rate, calculated as a weighted average across studies, was low at 9.5%, with most adverse events being mild and temporary, including dysuria and urinary tract infections. These findings support Optilume DCB as a promising minimally invasive alternative to standard treatments, offering durable outcomes with a favorable safety profile. Further randomized trials with longer follow-ups are recommended to confirm these benefits in diverse patient populations.