Benefit seen with Optilume Drug Coated Balloon at 4 years for recurrent anterior strictures

Treatment of recurrent anterior urethral strictures with the Optilume Drug Coated Balloon (DCB) shows significant benefits in patients at 4-year follow-up, according to data presented at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting in Scottsdale, Arizona.¹

The investigators estimated freedom from repeat intervention to be 71% in the Optilume DCB arm.

According to the investigators, led by urologist Allen F. Morey, MD, FACS, of Urology Clinics of North Texas in McKinney, the Optilume DCB “is a 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 (NCT03499964) randomized controlled trial evaluated the Optilume DCB vs direct visual internal urethrotomy (DVIU) or dilation.

A total of 127 patients were randomly assigned 2:1 at 23 centers to receive either the Optilume DCB (79) or DVIU or dilation (48). Follow-up beyond 1 year occurred only in patients treated with the Optilume DCB. Patients were eligible for the study if they were adult males with anterior strictures who had received at least 2 prior treatments and had a stricture length of 3 cm or less. The study’s end points “included freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax),” the authors wrote.

Patients in the Optilume DCB arm had received an average of 3.2 prior treatments and had an average stricture length of 1.6 cm; in 46% of patients, the average stricture length was 2 cm or higher. Eight (10.1%) patients had penile strictures and 9 (11.4%) patients had received prior pelvic radiation.

The investigators reported a significant improvement in IPSS, from 21.9 at baseline to 12.6 at 4 years. This was a slight deterioration from the 3- (11.3), 2- (10.1), and 1-year (9.0) results.

A significant improvement in Qmax was also observed, going from 7.7 mL/sec at baseline to 13.2 mL/sec at 4 years. According to the authors, this “was in line with the 3-year (12.0 mL/sec) and 2-year (13.9 mL/sec) data.

The investigators estimated freedom from repeat intervention to be 71% in the Optilume DCB arm.

Regarding adverse events (AEs), the investigators did not observe any late-onset treatment-related AEs.

“The Optilume DCB continues to achieve significant improvements in symptoms, flow, and reintervention rates through 4 years post treatment,” the investigators wrote in their conclusion.

During a presentation of interim results from this study at the 2024 American Urological Association Annual Meeting in San Antonio, Texas, study author Sean P. Elliott, MD, MS, commented on the freedom from reintervention rates.²

“At 1 year…the freedom from retreatment for the control group at was 22%, the freedom from retreatment in the Optilume group at 1 year was 83%. If you go out to 4 years, the Optilume freedom from retreatment is still 71%. And of course, that's much better than the control [at] 1 year,” said Elliott, professor, vice chairman, and director of reconstructive urology at the University of Minnesota in Minneapolis.

Commenting on the interim results in a video interview with Urology Times®, Dean S. Elterman, MD, MSc, FRCSC, said, “In summary, what we’re able to see here is, in the Optilume Drug Coated Balloon, even when compared to real-world DVIU or dilation, significant improvements in symptoms, in flow, and any need for reintervention, even through 4 years’ time.” Elterman is a urologist at the University of Toronto in Canada.

REFERENCES

1. The Optilume® Drug Coated Balloon for recurrent anterior urethral strictures: Robust III study 4-year interim results. Presented at: 2024 Sexual Medicine Society of North America Fall Scientific Meeting. October 17-20, 2024. Scottsdale, Arizona. Abstract 215

2. Elliott S, Virasoro R, DeLong J, et al. The Optilume® Drug Coated Balloon for recurrent anterior urethral strictures: ROBUST III study 4-year interim results. Presented at: 2024 American Urological Association Annual Meeting. May 3-6, San Antonio, Texas. MP06-15