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

OBJECTIVES: To evaluate outcomes of Optilume™ paclitaxel drug-coated balloon (DCB) dilation in patients with "complex" urethral strictures, who were largely excluded from trials establishing its efficacy for short-segment bulbar strictures. METHODS: We retrospectively reviewed male patients undergoing DCB dilation at a single academic center between 2022 and 2025. "Complex" strictures were defined by prior urethroplasty, pelvic radiation, penile urethral involvement, or length >3 cm. The primary endpoint was anatomic success at 6 months, defined as grade 0-1 recurrence on cystoscopy (grade 2-4 = failure). Anatomic success was compared between cohorts (Fisher's exact test) and benchmarked against the 75% ROBUST III rate (one-sample chi-square and one-sided exact binomial tests). Secondary outcomes included AUA Symptom Score, maximum urinary flow rate (Qmax), and 1-year freedom from intervention. RESULTS: Of 88 patients, 60 (68%) had complex disease; 26 (43%) completed 6-month cystoscopy. Anatomic success was 73.1% (19/26; 95% CI 54-86%) in the complex cohort versus 69.2% (9/13) in the favorable cohort (p = 1.00). The complex rate did not differ from the 75% benchmark (χ2 = 0.05, p = 0.82) and was not significantly lower (exact binomial p = 0.48). Qmax improved significantly in the complex cohort (7.1 to 12.1 mL/s at 6 weeks; p = 0.007), AUA-SS declined, and 1-year freedom from intervention was 81.7%. CONCLUSIONS: DCB dilation showed promising short-term anatomic and functional outcomes in complex stricture disease, though small sample size and incomplete follow-up preclude equivalence claims. Further evaluation is warranted to determine DCB efficacy.