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

Abstract

Introduction: We aimed to investigate the safety and preliminary efficacy of the OptilumeTM paclitaxel-coated balloon for the treatment of recurrent urethral stricture.
 Methods: Men with bulbar urethral strictures ≤2 cm with 1–4 prior endoscopic treatments were enrolled at four study sites after Ethics Committee approvals. All subjects were treated with mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment. Patients were evaluated at 2–5 days, 14 days, three, six, and 12-months post-treatment. The primary safety endpoint was serious complications through 90 days post-procedure. The preliminary efficacy endpoint was anatomic success, defined as urethral lumen ≥14 Fr at 12 months.
 Results: A total of 53 subjects were enrolled and treated; 46 completed the 12-month followup. Forty-three percent of men had undergone >1 previous dilation; the mean for the overall study population was 1.7 prior dilations. There were no serious adverse events related to the treatment within 90 days. Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54–82%) at 12 months. The 14 failures included seven cystoscopic recurrences, five retreatments, and two patients who exited the study early due to symptom recurrence.
 Conclusions: One-year data indicates the OptilumeTM 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.

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

“…A sample size of 126 provided 90% power to show superiority of DCB to DVIU/dilation assuming a 32% between-group difference. 9,10,17 A Kaplan-Meier curve was generated for freedom from repeat intervention, utilizing a log-rank test for comparison between arms. Subject characteristics were evaluated with the Fisher's exact test for categorical measures and unpaired t-test for continuous measures.…”

Ectopic Germinal Centres with B and T Cells and Follicular Dendritic Cell Networks in Urethral Stricture Tissue: Possible Avenue for Immunological Treatments

“…Other treatments include oral steroids and injection of antifibrotic mitomycin C along the incision during internal urethrotomy as a safe option for patients with bulbar strictures unfit for open reconstruction [22] , [23] . The coated balloon technique, which combines balloon dilatation and concomitant drug delivery, was used in a nonrandomised clinical trial ( n = 53) to deliver paclitaxel, which inhibits cell replication and limits fibrotic scar formation; the success rate at 1 yr was 70% [24] .…”

Female urethral stricture: techniques for reconstruction

“…Both tissue engineering and drugcoated balloons may be options that will increase our armamentarium. Although more robust data in tissue engineering is found for male patients, there are some ongoing preclinical and clinical studies open on FUS, which hopefully will show good preliminary results in this innovative field [47] . Drug-coated balloons for the treatment of urethral stricture also showed promising results in male patients with 70% success at 12-month follow-up and is yet to be determined with future studies if it could demonstrate similar efficacy in female patients [48] .…”