A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study

Abstract

Introduction: Mechanical balloon dilation and direct visualization internal urethrotomy (DVIU) are the most widely used treatments for urethral stricture disease in the U.S., but recurrence rates are high, especially after re-treatment. This study investigates the safety and efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent strictures.
 Methods: Men with recurrent bulbar strictures ≤2 cm with 1–4 prior endoscopic treatments were treated with the Optilume™ drug-coated balloon. Patients were evaluated within 14 days, three, six, 12, and 24 months post-treatment. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was ≥50% improvement in International Prostate Symptom Score (IPSS) at 24 months. Secondary outcomes included quality of life, erectile function, flow rate, and post-void residual urine volume.
 Results: A total of 53 subjects were enrolled and treated; 46 completed the 24-month followup. Forty-three percent of men had undergone >1 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at two years. Success was achieved in 32/46 (70%), and baseline IPSS improved from a mean of 25.2 to 6.9 at 24 months (p<0.0001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.
 Conclusions: Two-year data indicates the Optilume™ paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.

Long-Term Experience with Balloon Dilation for Short Bulbar and Membranous Urethral Strictures: Establishing a Baseline in the Active Drug Treatment Era

“…The recent and ongoing ROBUST trials have introduced a paclitaxel-coated balloon system, now FDA-approved in the USA, and have demonstrated their safety and efficacy for the treatment of urethral stricture disease [ 7 , 8 ]. In light of the introduction of this novel balloon system, we sought to establish a fundamental clinical baseline by evaluating our experience with “traditional” BD.…”

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume ® Drug-Coated Balloon for Anterior Urethral Strictures

“…Previous publications of phase I/II studies have shown that men treated with Optilume have a functional success rate of 70% at 2 years. 15 Results of a phase III, single-blind, randomized, controlled trial of Optilume vs standard endoscopic therapy are reported here.…”

A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study

“…Functional success in this study was based on improvement in IPSS and had similar rates at 2 and 3 years (68% and 67%, respectively). 8 The reduction in IPSS by an average of 72% (19.7 points) was considered clinically meaningful through 3 years post-treatment for a population with moderate-to-severe symptoms at baseline. 9 Significant improvements were also observed in voiding function, with average Qmax remaining >15 mL/sec at all follow-up visits through 3 years.…”

“… 7 Based on the study design, cystoscopy was not performed after 1 year, however functional success occurred in 70% (32/46) at 2 years, defined as International Prostate Symptom Score (IPSS) improvement ≥50% in the absence of retreatment need. 8 We now report the 3-year safety and efficacy outcomes of the ROBUST I trial.…”

“…We previously reported the 1- and 2-year ROBUST I trial results, which evaluated the Optilume ® DCB in men with recurrent urethral strictures up to 2 cm in length. 7 , 8 Anatomic success in ROBUST I was achieved in 70% at 1 year based on the ability to pass a 16F flexible cystoscope or 14F Foley catheter. 7 Based on the study design, cystoscopy was not performed after 1 year, however functional success occurred in 70% (32/46) at 2 years, defined as International Prostate Symptom Score (IPSS) improvement ≥50% in the absence of retreatment need.…”