Optilume® drug-coated balloon for urethral stricture management: a real-world single-institution experience

Objectives To evaluate the safety and effectiveness of the Optilume® drug-coated balloon (DCB) in a diverse, real-world cohort treated at a tertiary referral center, with particular attention to outcomes across clinically meaningful subgroups, including treatment-naïve individuals and those with more complex disease presentations. Methods We conducted a retrospective cohort study of all patients who underwent Optilume treatment at a single institution between September 2022 and December 2025. Clinical, demographic, and operative data were collected without exclusion. The primary outcome was freedom from repeat intervention at 1 and 2 years. Secondary outcomes included 30-day safety events and patient-reported outcomes. Results A total of 80 patients underwent Optilume treatment, including 83% with anterior urethral strictures and 41% who were treatment naïve. Kaplan–Meier estimates of freedom from reintervention were 85% at 1 year and 68% at 2 years. Anatomical recurrence was observed more frequently than reintervention. Five patients (6.3%) experienced a safety event within 30 days. No statistically significant associations with reintervention were identified in subgroup analyses. Conclusion Treatment with the Optilume drug-coated balloon demonstrated promising freedom from reintervention and relatively few early safety events in a heterogeneous, real-world cohort of patients with urethral stricture disease. Although anatomical recurrence was more frequent than reintervention, these findings suggest potential clinical benefit. Longer-term prospective studies with standardized surveillance and patient-reported outcome assessments are needed to better establish treatment durability and identify patients most likely to benefit.