A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST III Study.

Abstract

Introduction: The goal of this study is to report the updated 3-year safety and efficacy outcomes of the intervention arm of the ROBUST III randomized controlled trial, comparing the Optilume® drug-coated balloon (DCB) with standard endoscopic management of recurrent male anterior urethral stricture. Methods: Eligible patients included adult men with recurrent anterior urethral stricture ≤3 cm in length and ≤12 Fr in diameter, International Prostate Symptom Score (IPSS) ≥11, and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary endpoints evaluated over the 3-year follow-up period included freedom from reintervention and alterations in IPSS, Qmax, and postvoid residual (PVR). The primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: Descriptive statistics of the intervention cohort have been published previously. The treatment arm maintained a high percentage of patients free from repeat intervention (71%), nearly equal to the 2-year results and three times higher than that observed in the control group at the 1-year mark. Clinically significant subgroups, including those with history of repeat endoscopic dilations (≥5 prior dilations) and longer stricture lengths (≥2 cm), did not demonstrate any significant differences in observed metrics, including IPSS score, Qmax, or PVR. In the crossover cohort of patients who experienced treatment failure with standard endoscopic management and opted for DCB treatment, the Kaplan-Meier curve for freedom from reintervention closely resembles that of the original DCB cohort. Treatment-related AEs were rare and generally self-limited (hematuria, dysuria, and urinary tract infection). Conclusion: The Optilume DCB continues to achieve significant improvements in symptoms and reintervention rates through 3 years posttreatment and represents a viable endoscopic alternative with durable results and a low-risk safety profile for the management of recurrent anterior urethral strictures ≤3 cm in length.