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

Abstract

Introduction Endoscopic management of male anterior urethral stricture disease is common; however, repeat treatment is associated with high recurrence rates. Here, we report the 3-year results of the ROBUST I trial, which evaluated the safety and efficacy of the Optilume ® drug coated balloon (DCB) in men with recurrent urethral strictures. Methods Adult men with recurrent bulbar urethral strictures ≤2 cm in length and 1–4 prior endoscopic interventions were treated with the Optilume DCB. Functional success was defined as ≥50% reduction in International Prostate Symptom Score (IPSS) without need for retreatment. Other outcomes included quality of life, maximum flow rate, post-void residual urine volume, erectile function, and freedom from repeat intervention. Results Of the 53 enrolled and treated men, 33 completed the 3-year visit, with 10 patients experiencing clinical failures at previous visits, giving a total of 43 subjects evaluable for the functional success endpoint. Functional success was achieved in 67% (29/43) and freedom from retreatment in 77% (33/43). Average IPSS improved from 25.2 at baseline to 5.5 at 3 years (p<0.0001). Significant improvements were observed in quality of life, flow rate, and post-void residual urine volume. Erectile function was not affected by treatment. Device-related adverse events were mild or moderate in nature and resolved quickly after onset. There were no serious treatment-related adverse events. Conclusion Symptomatic improvement after treatment with the Optilume DCB was maintained through 3 years in a population highly susceptible to recurrent urethral stricture disease. This minimally invasive therapy is safe with no negative impact on sexual function.

Balloon dilation for the treatment of male urethral strictures: a systematic review and meta-analysis

“…Balloons coated with drugs such as paclitaxel have achieved promising clinical results in recent years. Two studies on paclitaxel-coated balloons for recurrent urethral strictures revealed the considerable effect of these devices on recurrent urethral strictures, with a relatively objective functional success rate (67%) and an anatomical success rate (74.6%) 27 28. The functional success rate was defined as the percentage of subjects with ≥50% improvement in IPSS scores who did not require retreatment.…”

“…Patients’ subjective perception of improvement in voiding symptoms is a crucial indicator of the true efficacy of urethral stricture treatment, and the results are summarised in table 4 . The ROBUST III study 28 revealed that patients’ International Prostate Symptom Score-Quality of Life scores increased significantly by 30 days after balloon dilation, indicating outstanding short-term efficacy. Moreover, 3-year follow-up results from the ROBUST I trial study 27 indicated significant improvements in both QoL scores and Patient-Reported Outcome Measure for Urethral Stricture Surgery scores for patients who underwent balloon dilation compared with baseline status (p<0.0001).…”

“… 55 The drug can penetrate the epithelium and act on deep urethral tissue, effectively reducing inflammation and inhibiting urethral fibrosis. In the recent ROBUST I study, 28 an optilume DCB was shown to maintain symptom relief for 3 years after treatment in a highly susceptible population with recurrent urethral strictures. Foorty-three patients in this trial had a functional success rate of 67%, a retreatment-free rate of 77% and an improvement in the mean IPSS from 25.2 at baseline to 5.5 at 3 years (p<0.0001).…”

Urethral Stricture Disease Guideline Amendment (2023)

“…19 The 3-year outcomes for the same drug-coated balloon from the Robust I trial demonstrated a 67% functional success. 20 Although drug-coated balloons are approved by the FDA for anterior urethral strictures, the trial was not powered to assess results patients with penile urethra strictures; therefore, the Panel recommends that drug-coated balloons are restricted to treat patients with recurrent bulbar urethral strictures. Furthermore, the efficacy of repeated use of the drug-coated balloon has not been ascertained and is not recommended.12.…”

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

“…9 Treatment with paclitaxel-coated balloons has also been shown to significantly reduce the rate of stricture recurrence in men with urethral strictures. 10,11 This study compares the safety and efficacy of Optilume BPH to a sham surgical procedure for the treatment of LUTS secondary to BPH with outcomes reported through 12 months of follow-up.…”