The Optilume® Drug Coated Balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures.
Eligibility criteria were: adult men with anterior strictures ≤12F in diameter and ≤3cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11, and maximum flow rate<15 mL/sec. 127 subjects were enrolled at 22 sites. The primary study endpoint was anatomic success (≥14F by cystoscopy or calibration) at 6 months. Key secondary endpoints included freedom from repeat treatment, International Prostatic Symptom Score (IPSS), and peak flow rate (Qmax). The primary safety endpoint included freedom from serious device or procedure related complications.
Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomic success for Optilume DCB was significantly higher than Control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequently adverse events included urinary tract infection, post-procedural hematuria, and dysuria.
The results of this randomized controlled trial support that Optilume is safe and superior to standard DVIU/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men that have had an unsuccessful DVIU/dilation but want to avoid or delay urethroplasty.
The Journal of urology. 2021 Dec 02 [Epub ahead of print]
Sean P Elliott, Karl Coutinho, Kaiser J Robertson, Richard D'Anna, Kent Chevli, Serge Carrier, Melanie Aube-Peterkin, Christopher H Cantrill, Michael J Ehlert, Alexis E Te, Jeffrey Dann, Jessica M DeLong, Steven B Brandes, Judith C Hagedorn, Richard Levin, Amy Schlaifer, Euclid DeSouza, David DiMarco, Brad A Erickson, Richard Natale, Douglas A Husmann, Allen Morey, Carl Olsson, Ramón Virasoro
University of Minnesota, Minneapolis, Minnesota., New Jersey Urology LLC, Millburn, New Jersey., Chesapeake Urology, Hanover, Maryland., Arkansas Urology, Little Rock, Arkansas., Western New York Urology Associates, Cheektowaga, New York., McGill University Health Center, Montreal, Quebec, Canada., Urology San Antonio, San Antonio, Texas., Metro Urology, a division of Minnesota Urology, Woodbury, Minnesota., Weill Cornell Medicine, New York, New York., Advanced Urology Institute, Daytona Beach, Florida., Urology of Virginia PLLC, Virginia Beach, Virginia., Columbia University, New York, New York., University of Washington, Seattle, Washington., Chesapeake Urology Research Associates, Annapolis, Maryland., Academic Urology & Urogynecology of Arizona, Phoenix, Arizona., Adult and Pediatric Urology PC, Omaha, Nebraska., Oregon Urology Institute, Springfield, Oregon., University of Iowa Hospitals and Clinics, Iowa City, Iowa., Carolina Urology Partners PLLC, Concord, North Carolina., Mayo Clinic, Rochester, Minnesota., UT Southwestern Medical Center, Dallas, Texas., Integrated Medical Professionals, New York, New York.