Paclitaxel Drug-Coated Balloon (Optilume®) for Bladder Neck Stenosis and Vesicourethral Anastomotic Stenosis: A Narrative Review.

Background and

Objectives

Bladder neck stenosis (BNS) and vesicourethral anastomotic stenosis (VUAS) are challenging complications following prostate surgery and radiation therapy, with recurrence rates reaching 30-60% after conventional endoscopic management. The Optilume® paclitaxel drug-coated balloon (DCB) has emerged as a novel minimally invasive treatment combining mechanical dilation with local anti-fibrotic drug delivery. This narrative review synthesizes current evidence on Optilume DCB specifically for BNS and VUAS. Materials and

Methods

A comprehensive literature search identified eight relevant publications (2024-2026), including randomized controlled trials, prospective and retrospective cohort studies, and case series addressing Optilume DCB for posterior urethral stenoses.

Results

Across the reviewed studies, freedom from reintervention for BNS ranged from 77.5% to 100% at 12 months, while VUAS outcomes were more variable (40-81%). A comparative study of 141 patients demonstrated significantly improved recurrence-free survival with DCB versus standard endoscopic treatment (HR 0.40, p = 0.021). Radiation-induced posterior urethral stenosis showed 81.1% freedom from repeat intervention. Complications were predominantly minor (Clavien-Dindo grade I), with no de novo incontinence attributable to the device.

Conclusions

Optilume DCB represents a promising minimally invasive option for BNS and VUAS, particularly in patients with recurrent disease or those unsuitable for reconstructive surgery. BNS appears to respond more favorably than VUAS, likely reflecting distinct pathophysiological mechanisms. Prior radiation therapy remains a negative prognostic factor. Prospective randomized trials with longer follow-up are needed to define the role of DCB in posterior urethral stenosis management.