Still ROBUST: A Retrospective Study of Optilume Drug-Coated Balloon Dilation for Complex Urethral Stricture Disease

Area of Science:

• Urology
• Minimally Invasive Surgery
• Medical Devices

Background:

• Complex urethral strictures often have limited treatment options.
• Existing drug-coated balloon (DCB) trials largely excluded patients with complex strictures.
• Optilume™ DCB efficacy was established for short-segment bulbar strictures.

Purpose of the Study:

• To evaluate the outcomes of Optilume™ paclitaxel drug-coated balloon (DCB) dilation in patients with complex urethral strictures.
• To assess the safety and efficacy of DCB dilation in a patient population previously excluded from clinical trials.
• To compare outcomes in complex strictures against established benchmarks.

Main Methods:

• Retrospective review of male patients undergoing DCB dilation (2022-2025).
• Complex strictures defined by prior urethroplasty, radiation, penile involvement, or length >3 cm.
• Primary endpoint: anatomic success at 6 months (cystoscopic recurrence grade 0-1). Secondary outcomes: AUA Symptom Score, Qmax, 1-year freedom from intervention.

Main Results:

• 68% of 88 patients had complex strictures; 43% completed 6-month follow-up.
• Anatomic success was 73.1% in complex strictures, not significantly different from favorable strictures (69.2%) or the 75% benchmark.
• Significant improvement in Qmax (7.1 to 12.1 mL/s) and AUA Symptom Score; 81.7% 1-year freedom from intervention.

Conclusions:

• DCB dilation demonstrates promising short-term anatomic and functional outcomes in complex urethral stricture disease.
• Small sample size and incomplete follow-up limit definitive conclusions on equivalence.
• Further research is needed to establish the long-term efficacy of DCB dilation for complex strictures.