Research and Reports in Urology (May 2022)
A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study
Abstract
Ramón Virasoro,1 Jessica M DeLong,1 Rafael E Estrella,2 Merycarla Pichardo,3 Ramón Rodriguez Lay,4 Gustavo Espino,5 Sean P Elliott6 1Urology of Virginia PLLC, Virginia Beach, VA, USA; 2Clinica Unión Medica, Santiago de los Caballeros, Dominican Republic; 3URUS, Santo Domingo, Dominican Republic; 4Cirujano Urologo Royal Center Panama City, Panama City, Panama; 5Centro Especializado San Fernando, Panama City, Panama; 6Department of Urology, University of Minnesota, Minneapolis, MN, USACorrespondence: Ramón Virasoro, Urology of Virginia PLLC, 225 Clearfield Ave, Virginia Beach, VA, 23462, USA, Tel +1 757-457-5100, Email [email protected]: Endoscopic management of male anterior urethral stricture disease is common; however, repeat treatment is associated with high recurrence rates. Here, we report the 3-year results of the ROBUST I trial, which evaluated the safety and efficacy of the Optilume® drug coated balloon (DCB) in men with recurrent urethral strictures.Methods: Adult men with recurrent bulbar urethral strictures ≤ 2 cm in length and 1– 4 prior endoscopic interventions were treated with the Optilume DCB. Functional success was defined as ≥ 50% reduction in International Prostate Symptom Score (IPSS) without need for retreatment. Other outcomes included quality of life, maximum flow rate, post-void residual urine volume, erectile function, and freedom from repeat intervention.Results: Of the 53 enrolled and treated men, 33 completed the 3-year visit, with 10 patients experiencing clinical failures at previous visits, giving a total of 43 subjects evaluable for the functional success endpoint. Functional success was achieved in 67% (29/43) and freedom from retreatment in 77% (33/43). Average IPSS improved from 25.2 at baseline to 5.5 at 3 years (p< 0.0001). Significant improvements were observed in quality of life, flow rate, and post-void residual urine volume. Erectile function was not affected by treatment. Device-related adverse events were mild or moderate in nature and resolved quickly after onset. There were no serious treatment-related adverse events.Conclusion: Symptomatic improvement after treatment with the Optilume DCB was maintained through 3 years in a population highly susceptible to recurrent urethral stricture disease. This minimally invasive therapy is safe with no negative impact on sexual function.Keywords: lower urinary tract symptoms, paclitaxel, urethral dilation, medical device, clinical trial
