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JU Insight: One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume Drug-Coated Balloon for Anterior Urethral Strictures
By: Sean P. Elliott, MD, MS; Karl Coutinho, MD; Kaiser J. Robertson, MD; Richard D’Anna, MD; Kent Chevli, MD; Serge Carrier, MD; Melanie Aube-Peterkin, MD; Christopher H. Cantrill, MD; Michael J. Ehlert, MD; Alexis E. Te, MD; Jeffrey Dann, MD; Jessica M. DeLong, MD; Steven B. Brandes, MD; Judith C. Hagedorn,MD; Richard Levin, MD; Amy Schlaifer, MD; Euclid DeSouza, MD; David DiMarco, MD; Brad A. Erickson, MD; Richard Natale, MD; Douglas A. Husmann, MD; Allen Morey, MD; Carl Olsson, MD; Ramon Virasoro, MD | Posted on: 01 Apr 2022
Elliott SP, Coutinho K, Robertson KJ et al: One-year results for the ROBUST III randomized controlled trial evaluating the Optilume® drug-coated balloon for anterior urethral strictures. J Urol 2021; https://doi.org/10.1097/JU.0000000000002346.
Study Need and Importance
The gold standard treatment of urethral stricture is urethroplasty with 90% success, but the most common treatments by far are urethral dilation and/or direct vision internal urethrotomy (DVIU). Dilation/DVIU is successful in <50%, especially in recurrent disease. This creates a need for a therapy that is less invasive than urethroplasty but more successful than dilation/DVIU. The Optilume® paclitaxel-coated balloon combines urethral dilation with circumferential delivery of an antiproliferative agent that inhibits fibroblast growth and stricture recurrence.
What We Found
We randomized 127 men to Optilume vs dilation/DVIU. At 6 months, the rate of anatomical success (defined by the ability to pass a flexible cystoscope) was 75% for Optilume and 27% for dilation/DVIU. Several different 1-year outcomes were also superior for Optilume vs dilation/DVIU: freedom from repeat intervention was 83% vs 22% (see figure), urinary symptoms as measured by the International Prostate Symptom Score were 9 vs 20 and maximum urinary flow rate was 16 vs 8 ml per second, respectively. Most side effects were similar across treatments except hematuria and dysuria, which were more common after Optilume (11% vs 2% for both events).
Limitations
As this trial only compared Optilume with dilation/DVIU, we don’t know how Optilume would compare with urethroplasty. It is possible that the early positive results are impacted by surgeons opening the urethra to a larger size with Optilume; however, immediately post-treatment the luminal diameter, measured by urethrogram, was the same (8 mm) in both groups.
Interpretation for Patient Care
Early findings indicate that Optilume offers superior outcomes to dilation/DVIU for men with recurrent bulbar urethral stricture. Men who have suffered stricture recurrence after dilation/DVIU may consider Optilume as an alternative to repeat dilation/DVIU.