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

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

Abstract

Introduction: We aimed to investigate the safety and preliminary efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent urethral stricture.

Methods: Men with bulbar urethral strictures ≤2 cm with 1–4 prior endoscopic treatments were enrolled at four study sites after ethics committee approvals. All subjects were treated with mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment. Patients were evaluated at 2–5 days, 14 days, three, six, and 12-months post-treatment. The primary safety endpoint was serious complications through 90 days post-procedure. The preliminary efficacy endpoint was anatomic success, defined as urethral lumen ≥14 Fr at 12 months.

Results: A total of 53 subjects were enrolled and treated; 46 completed the 12-month followup. Forty-three percent of men had undergone >1 previous dilation; the mean for the overall study population was 1.7 prior dilations. There were no serious adverse events related to the treatment within 90 days. Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54–82%) at 12 months. The 14 failures included seven cystoscopic recurrences, five retreatments, and two patients who exited the study early due to symptom recurrence.

Conclusions: One-year data indicates the Optilume paclitaxelcoated 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

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

Rachel A. Mann, University of Minnesota

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

Rafael E. Estrella

Clinica Union Medica, Santiago de los Caballeros, Dominican Republic

Merycarla Pichardo

URUS, Santo Domingo, Dominican Republic

Ramon Rodriguez Lay

Cirujano Urology Royal Center Panama City, Panama

Gustavo Espino

Centro Especializado San Fernando, Panama City, Panama

Joshua D. Roth

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

Sean P. Elliott

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

Published
2020-01-20
How to Cite
Virasoro, R., DeLong, J., Mann, R., Estrella, R., Pichardo, M., Rodriguez Lay, R., Espino, G., Roth, J., & Elliott, S. (2020). A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. Canadian Urological Association Journal, 14(6), 187-91. https://doi.org/10.5489/cuaj.6323
Section
Original Research