Three-Year Data from ROBUST III Confirms Long-Term Durability of Optilume® Drug-Coated Balloon for Recurrent Urethral Strictures

Findings Published in Journal of Endourology Support Minimally Invasive Alternative to Repeat Endoscopic Procedures

PORTSMOUTH, N.H., May 8, 2025 /PRNewswire/ -- Laborie Medical Technologies Corp. (Laborie), a global leader in diagnostic and therapeutic urology, announced the publication of three-year outcomes from the ROBUST III randomized controlled trial in the Journal of Endourology. The results underscore the long-term durability and safety of the Optilume^® Drug-Coated Balloon (DCB) as a minimally invasive treatment for recurrent anterior urethral strictures in men.

The study showed that 71.9% of patients treated with Optilume remained free from repeat intervention at three years, consistent with prior two-year data and three times higher than the one-year control group (23.6%). Patients also experienced a sustained average improvement in symptom scores, with the International Prostate Symptom Score (IPSS) improving from 22.0 at baseline to 11.6 at three years.

Objective voiding parameters also demonstrated durable benefit. The average peak urinary flow rate (Qmax) improved from 7.6 mL/s at baseline to 15.5 mL/s at one year and remained at 10.6 mL/s at three years. Meanwhile, postvoid residual (PVR) volumes declined from 101.6 mL at baseline to 42.2 mL at three years, reinforcing the clinical efficacy of the Optilume DCB over time. Importantly, no late-onset serious treatment-related adverse events were observed during the study's follow-up period.

"Minimally invasive, yet durable treatments for stricture disease have been something we have been waiting for in the stricture space," said Dr. Karl Coutinho, M.D. "Optilume gives us an endoscopic option that provides real staying power, especially for patients unable to have urethroplasty or looking to avoid more invasive procedures."

Optilume combines mechanical dilation with localized delivery of paclitaxel, an antiproliferative drug that limits scar tissue regrowth. The dual mechanism provides both immediate symptom relief and long-term protection against recurrence.

Importantly, the study demonstrated consistent efficacy across high-risk subgroups, including patients with longer strictures and those with five or more prior dilations—populations traditionally prone to early recurrence. Even in these challenging cases, patients experienced durable outcomes comparable to the broader treatment cohort.

Additionally, patients in the control group who crossed over to receive Optilume after treatment failure with standard endoscopic management also saw marked improvement, with more than 75% remaining free from reintervention one year post-crossover.

This milestone publication builds on growing clinical evidence from the ROBUST trial program, including ROBUST I five-year data, further establishing Optilume as a disruptive innovation in stricture care.

To read the complete study, visit the Journal of Endourology. For more information on Optilume, visit www.optilume.com.

About Laborie Medical Technologies

Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on Urology, Urogynecology, Gastroenterology, Obstetrics, Gynecology & Neonatal Health. We manufacture and deliver high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals look to us as the market-leading experts in our business segments, and we support our products with a world-class clinical education & information program. Laborie is a portfolio company of Patricia Industries. For more information visit www.laborie.com.

SOURCE Laborie Medical Technologies