Outcomes of drug-coated balloon dilation in patients with radiation-related urethral stenosis.

Background: The Optilume^® drug-coated balloon is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III trial concludes that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. However, there have been limited studies to show efficacy in the treatment of urethral stricture in the setting of post-radiation patients. This study aimed to clarify the safety and early efficacy of Optilume balloon dilation for urethral strictures in post-radiation patients.

Methods: All patients undergoing Optilume balloon dilation with at least 3 months of follow-up were evaluated over 27 months in a retrospective multi-institutional setting. Thirty patients who received pelvic radiation and subsequently developed symptomatic urethral strictures were selected from a total of 246 patients identified with symptomatic urethral strictures. Success was defined as the absence of recurrence of original presenting symptoms, no need for intermittent self-dilation, and no requirement for surgical intervention within the follow-up period for their urethral stricture.

Results: Successful Optilume balloon dilations without recurrence of symptoms were achieved in 24/30 (80%) patients. Failures with recurrence of strictures occurred in 20% (6/30) of cases. At a median follow-up of 353 (range: 91-818) days, 80% (24/30) of radiated patients had successful Optilume balloon dilation. Our data showed that 83% (5/6) of patients who experienced recurrence did so after 12 months. Among radiated patients without baseline incontinence, new stress incontinence developed postoperatively in 20% (3/15), while one patient had improved stress incontinence.

Conclusions: Optilume balloon dilation is a safe mechanism of treatment for urethral stricture disease in radiated patients. Early follow-up data of the treatment of urethral strictures in radiated patients suggests similar efficacy. However, long-term follow-up data is needed.