Efficacy and safety of Optilume® paclitaxel-coated urethral dilatation balloon in real-life: experience in a Spanish multicenter study.

INTRODUCTION

The Optilume® Paclitaxel-coated urethral dilatation balloon is an alternative to conventional endoscopic treatments that combines mechanical dilatation with local delivery of paclitaxel.

OBJECTIVE

To describe the success rate and analyze the safety of the device in real clinical practice. To evaluate possible predictors of treatment failure.

MATERIALS AND METHODS

Retrospective multicenter study in patients diagnosed with urethral stricture and treated with an Optilume® balloon in routine clinical practice. Data were collected from flowmetry, questionnaires (PROM and IPSS) and cystoscopy before surgery, and 3, 6 and 12 months after the procedure, according to standard practice. Surgical success was defined as the absence of subsequent urethral manipulation and a Qmax >10 ml/s.

RESULTS

238 patients treated with Optilume® in 12 Spanish hospitals between May 2021 and April 2024 were included in the study. Of these, 156 who had a minimum follow-up of 3 months, were analyzed. Median stricture length: 1.5 cm (0.5-5.3), mainly in bulbar urethra (87.7%). Of the total, 12.8% of patients had a history of pelvic radiotherapy, and 81.4% had undergone prior urethral manipulation. Postoperative complications were reported in 14.2% of the total. The treatment success rate was 73.8%, with a median follow-up of 8 months (5-12). No predictors of stricture recurrence were identified. Recurrence rates were higher in strictures located in the posterior versus anterior urethra (42.9% vs. 24.6%, p = 0.126). No significant differences were observed between patients with and without prior urethral manipulation.

CONCLUSION

Treatment with Optilume® has been shown to be safe and effective in short-term routine clinical practice.