Mechanical balloon dilation and direct visualization internal urethrotomy (DVIU) are the most widely used treatments for urethral stricture disease in the U.S., but recurrence rates are high, especially after re-treatment. This study investigates the safety and efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent strictures.
Men with recurrent bulbar strictures ≤2 cm with 1-4 prior endoscopic treatments were treated with the Optilume™ drug-coated balloon. Patients were evaluated within 14 days, three, six, 12, and 24 months post-treatment. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was ≥50% improvement in International Prostate Symptom Score (IPSS) at 24 months. Secondary outcomes included quality of life, erectile function, flow rate, and post-void residual urine volume.
A total of 53 subjects were enrolled and treated; 46 completed the 24-month followup. Forty-three percent of men had undergone >1 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at two years. Success was achieved in 32/46 (70%), and baseline IPSS improved from a mean of 25.2 to 6.9 at 24 months (p<0.0001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.
Two-year data indicates the Optilume™ paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.
Canadian Urological Association journal = Journal de l'Association des urologues du Canada. 2020 Jul 27 [Epub ahead of print]
Rachel A Mann, Ramón Virasoro, Jessica M DeLong, Rafael E Estrella, Merycarla Pichardo, Ramón Rodríguez Lay, Gustavo Espino, Joshua D Roth, Sean P Elliott
Department of Urology, University of Minnesota, Minneapolis, MN, United States., Department of Urology, Eastern Virginia Medical School, Norfolk, VA, United States., Clinica Union Medica, Santiago de los Caballeros, Dominican Republic., URUS, Santo Domingo, Dominican Republic., Urology Royal Center Panamá City, Panamá., Centro Especializado San Fernando, Panamá City, Panamá.