Long-term data point to durable efficacy of Optilume for urethral strictures

Three-year data from the ROBUST III trial (NCT03499964) show that the Optilume drug-coated balloon (DCB) continues to achieve significant improvements in symptoms and reintervention rates, while maintaining a favorable safety profile in male patients with recurrent urethral stricture disease.¹

The data were published in the Journal of Endourology.

Karl J. Coutinho, MD

"Minimally invasive yet durable treatments for stricture disease have been something we have been waiting for in the stricture space," said Karl J. Coutinho, MD, in a news release on the findings.² "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."

In total, the ROBUST III study enrolled 127 patients with urethral strictures who were randomly assigned to receive the Optilume DCB (n = 79) or to the control arm (n = 48). Forty-five patients remained on the study at the 3-year mark.

Data showed that at 3 years, the freedom from re-intervention rate was 71%, which is “nearly equal to the 2-year results and 3 times higher than that observed in the control group at the 1-year mark,” according to the authors.

The 1-year freedom from re-intervention rate in the control group was 23.6%.

Additionally, the average International Prostate Symptom Score (IPSS) in the treatment arm was 22.0 at baseline, which decreased to 9.0 at year 1 before steadily increasing to 10.1 and 11.6 at years 2 and 3, respectively. At the 3-year time point, 48% of patients in the Optilume arm experienced an IPSS improvement of at least 30% without repeat intervention.

The average Qmax at baseline was 7.6 mL/s at baseline, which increased to 15.5 mL/s at year 1 before steadily declining to 12.6 mL/s at 2 years and 10.6 mL/s at 3 years.

Overall, 32 of 48 participants in the control arm experienced stricture recurrence and opted to cross-over into the treatment arm.

Treatment with Optilume was also associated with a manageable safety profile. The most common treatment-related adverse events (AEs) included post-procedural hematuria (11.4%), dysuria (7.6%), and urinary tract infection (6.3%). According to the authors, “[Serious] AEs attributed to treatment were rare, with 1 case of aspiration/aspiration pneumonia and 1 case of urinary tract infection occurring in each treatment arm.”

There were no instances of late-onset treatment-related AEs or serious AEs reported.

Additional data on Optilume DCB

The ROBUST III findings are consistent with 5-year data from the ROBUST I trial (NCT03014726), which were reported earlier this year.³ In total, the prospective, multicenter, single-arm, open-label trial enrolled 53 men with urethral stricture disease across 4 clinical trial sites in Latin America.

Data showed that functional success, defined as at least a 50% improvement in IPSS, was achieved in 58% of patients (25 of 43) at 5-year follow-up. Average IPSS increased from 25.2 at baseline to 7.2 at 5 years (P < .0001).

The results also showed an improvement in average Qmax values following treatment with Optilume, with an increase from 5.0 mL/s at baseline to 19.9 mL/s at 5 years (P < .01). The investigators also found an improvement in average post-void residual, which decreased from 141.4 mL at baseline to 59.5 mL at 5 years (P < .01).

The estimated freedom from repeat intervention was 71.7% at the 5-year timepoint, with most failures occurring within the first 12 months of treatment, per Kaplan-Meier analysis.

Optilume was approved by the FDA in December 2021 for the treatment of men with urethral strictures based on data from the ROBUST I and ROBUST III clinical trials.⁴

REFERENCES

1. Srikanth P, DeLong J, Virasoro R, Elliott SP. A drug-coated balloon treatment for urethral stricture disease: Three-year results from the ROBUST III study. J Endourol. 2025. doi:10.1089/end.2024.0718

2. Three-year data from ROBUST III confirms long-term durability of Optilume drug-coated balloon for recurrent urethral strictures. News release. Laborie Medical Technologies. May 8, 2025. Accessed May 13, 2025. https://www.laborie.com/blog/2025/05/08/optilume-stricture-3-year-data-from-robustiii/

3. DeLong J, Virasoro R, Pichardo M, et al. Long-term outcomes of recurrent bulbar urethral stricture treatment with the Optilume drug-coated balloon: Five-year results from the ROBUST I Study. J Urol. 2025 Jan;213(1):90-98. doi:10.1097/JU.0000000000004229

4. FDA approves Optilume Urethral Drug Coated Balloon, a breakthrough treatment for urethral strictures. Published online December 13, 2021. Accessed May 13, 2025. https://www.biospace.com/fda-approves-optilume-urethral-drug-coated-balloon-a-breakthrough-treatment-for-urethral-strictures?s=74