A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study

  • Rachel A. Mann University of Minnesota
  • Ramon Virasoro
  • Jessica M. DeLong
  • Rafael E. Estrella
  • Merycarla Pichardo
  • Ramon Rodríguez Lay
  • Gustavo Espino
  • Joshua D. Roth
  • Sean P. Elliott University of Minnesota
Keywords: Urethral Stricture, Paclitaxel, Dilation, Lower Urinary Tract Symptoms, Medical Device, Clinical Trial

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Author Biographies

Rachel A. Mann, University of Minnesota

Department of Urology, University of Minnesota, Minneapolis, MN, USA

Ramon Virasoro

Department of Urology, Eastern Virginia Medical School, Norfolk, VA, USA

Jessica M. DeLong

Department of Urology, Eastern Virginia Medical School, Norfolk, VA, USA

Rafael E. Estrella

Clinica Union Medica, Santiago de los Caballeros, Dominican Republic

Merycarla Pichardo

URUS, Santo Domingo, Dominican Republic

Ramon Rodríguez Lay

Urology Royal Center Panamá City, Panamá

Gustavo Espino

Centro Especializado San Fernando, Panamá City, Panamá

Sean P. Elliott, University of Minnesota

Department of Urology, University of Minnesota, Minneapolis, MN, USA

Published
2020-07-27
How to Cite
Mann, R. A., Virasoro, R., DeLong, J. M., Estrella, R. E., Pichardo, M., Rodríguez Lay, R., Espino, G., Roth, J. D., & Elliott, S. P. (2020). A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study. Canadian Urological Association Journal, 15(2), 20-5. https://doi.org/10.5489/cuaj.6661
Section
Original Research