Optilume shows strong freedom from reintervention rates in patients with strictures

Data from 4 years post treatment indicate that the Optilume Drug Coated Balloon (DCB) is associated with excellent long-term freedom from reintervention rates in patients with recurrent anterior urethral strictures.¹

Sean Elliott, MD, MS

Findings from the ROBUST III study (NCT03499964) were presented at the 2024 American Urological Association Annual Meeting by Sean Elliott, MD, MS, professor, vice chairman, and director of reconstructive urology at the University of Minnesota in Minneapolis.

Optilume, a drug-coated (paclitaxel) balloon system, was compared with direct visual internal urethrotomy (DVIU) or dilation. Adult males with anterior strictures who had been treated at least 2 times previously with a stricture length of 3 cm or less were eligible for inclusion in the study.

“Long-term end points included freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax),” the authors wrote in the abstract.

For the study, the investigators randomly assigned 127 patients 2:1 at 23 centers. A total of 79 patients were treated with Optilume, whereas 48 received treatment with DVIU or dilation.

Regarding stricture etiology, strictures were iatrogenic in 16 of 47 patients in the control arm (34%) compared with 21 of 78 (27%) in the Optilume arm; idiopathic in 22 of 47 (47%) vs 42 of 78, respectively; inflammatory in 2 of 47 vs 1 of 78, respectively; traumatic in 7 of 47 vs 14 of 78, respectively; P = .57. Six patients in the control arm (13%) received prior pelvic radiation vs 21 (78%) in the Optilume arm. Anatomic location was bulbar in 45 of 47 patients in the control arm vs 71 of 79 patients (90%) in the Optilume arm, and penile in 2 of 47 patients (4%) in the control arm vs 8 of 79 in the Optilume arm. The investigators reported a significant improvement in IPSS—21.9 at baseline compared with 12.6 at 4 years, “which showed slight deterioration from the 3-year (11.3), 2-year (10.1), and 1-year (9.0) results, wrote the authors. Qmax was also significantly improved, with a baseline of 7.7 mL/sec compared with 13.2 mL/sec at 4 years.

“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,” Elliott said during his presentation.

Patients in the Optilume arm received an average of 3.2 prior treatments, with an average stricture length of 1.6 cm. Forty-six percent of patients had a stricture length of at least 2 cm.

Commenting on the study in a recent 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.

REFERENCE

1. 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