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

Ramón Virasoro, Jessica M. Delong, Rafael E. Estrella, Merycarla Pichardo, Ramón Rodriguez Lay, Gustavo Espino, Sean P. Elliott

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


Introduction: 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.

Original languageEnglish (US)
Pages (from-to)177-183
Number of pages7
JournalResearch and Reports in Urology
StatePublished - 2022

Bibliographical note

Funding Information:
The study was sponsored and funded by Urotronic, Inc.

Publisher Copyright:
© 2022 Virasoro et al.


  • clinical trial
  • lower urinary tract symptoms
  • medical device
  • paclitaxel
  • urethral dilation

PubMed: MeSH publication types

  • Case Reports
  • Clinical Trial


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