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

Abstract

The Optilume ® Drug Coated Balloon (DCB) is a urethral 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 study is a randomized, single blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. Materials and Methods: Eligibility criteria were: adult men with anterior strictures ≤12F in diameter and ≤3cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11, and maximum flow rate <15 mL/sec. 127 subjects were enrolled at 22 sites. The primary study endpoint was anatomic success (≥14F by cystoscopy or calibration) at 6 months. Key secondary endpoints included freedom from repeat treatment, International Prostatic Symptom Score (IPSS), and peak flow rate (Qmax). The primary safety endpoint included freedom from serious device or procedure related complications. Results: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7cm. Anatomic success for Optilume DCB was significantly higher than Control at 6 months (75% vs 27%, p<0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequently adverse events included urinary tract infection, postprocedural hematuria, and dysuria. Conclusions: The results of this randomized controlled trial support that Optilume is safe and superior to standard DVIU/dilation for the treatment of recurrent anterior urethral strictures <3cm in length. The Optilume DCB may serve as an important alternative for men that have had an unsuccessful DVIU/dilation but want to avoid or delay urethroplasty.

Economic evaluation of Optilume, a drug‐coated balloon for recurrent anterior male urethral stricture

“…The ROBUST III trial, used for treatment recurrence rates of Optilume and endoscopic management, was conducted in the United States and reported considerably higher recurrence rates than the United Kingdom based OPEN trial. The monthly recurrence probabilities reported in ROBUST III for endoscopic management and Optilume are 16.3% and 2.6%, respectively, in the OPEN RCT they are 1.9% and 0.5% 4,6 . The ROBUST III trial was determined to be a better data source than the OPEN RCT as the given rates are generally in line with those reported in other studies evaluating treatments for stricture recurrence 7,8,13 .…”

“…Costs were taken from the BNF and NHS reference costs, sources that are widely adopted for economic evaluations in England 9,10 . The effectiveness of Optilume was modelled based on data from the pivotal, phase III, single‐blind, randomised controlled study ROBUST III 4 . The ROBUST III consisted of 127 subjects.…”

“…The following input data were used to populate the model, and full details are in Table 1. Transition probabilities were derived for each health state based on data from the ROBUST III trial and OPEN RCT 4,6 . The monthly probability of recurrence after endoscopic management or Optilume was taken from the ROBUST III trial 4 .…”

“…Recurrence of male urethral stricture after receiving endoscopic treatment is common, reported to be as high as 16% after 1 month 4,5 . Recurrences of a urethral stricture often require further treatment, resulting in increased costs to the health system and impacting on patient's quality of life 6 .…”

“…Optilume was designed for the treatment of anterior male urethral strictures for people aged 18 years or older for stricture length equal to, or less than, 3 cm. Optilume is a surgical intervention that has a lower male urethral stricture recurrence rate than endoscopic management 4 . This is the first analysis that attempts to estimate the cost impact of implementing Optilume as an alternative treatment for male urethral stricture in the England.…”