Optilume® Balloon Dilatation for Urethral Stricture Disease: An Institutional Review of Outcomes for Multiple Stricture Aetiologies and Characteristics

Introduction Optilume^® balloon dilatation has shown encouraging results for men with urethral stricture disease. The Re-establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) trials demonstrated superior treatment efficacy compared to conventional endoscopic management, although they had very strict inclusion criteria. We present our patient case series, with their outcomes, to demonstrate its efficacy across all patient and stricture demographics. Methods Between February 2022 and December 2024, patients who underwent Optilume^® balloon dilatation for urethral strictures and bladder neck stenoses were analysed. Demographics, stricture characteristics, prior treatments and post-operative outcomes were gathered. The primary outcome was the need for reintervention and/or restarting self-dilatation. Cox regression analysis was performed to generate hazard ratios (HRs), 95% confidence intervals (95%CI) and identify associations with failure. Results Thirty-eight patients were identified with a median follow-up of 22.9 months (range 6.1-40.5). Median patient age was 64 years (range 21-86 years), stricture diameter 6Fr (range 3-16Fr), stricture length 3 cm (range 1-5) and prior number of treatments two (range 0-12). Seventeen (44%) were idiopathic strictures, 12 (32%) iatrogenic, seven (19%) radiotherapy/brachytherapy induced and two (5%) bladder neck contractures. At the time of reporting, 31/38 (82%) patients were reintervention free. There was no association with time to failure for age (HR 0.98, 95% confidence interval (CI) 0.91-1.04, <i>p</i>=0.46), stricture length (HR 0.94, 95%CI 0.38-2.31, <i>p</i>=0.89), lumen size (HR 0.89, 95%CI 0.61-1.29, <i>p=</i>0.53), number of prior treatments (HR 1.13, 95%CI 0.86-1.49, <i>p</i>=0.39) or any stricture aetiology. Conclusions Optilume^® balloon dilatation produced excellent outcomes for the treatment of urethral strictures across multiple stricture aetiologies, characteristics, and patient demographics. It may have curative potential for patients who are unfit or wish to avoid the morbidity of urethroplasty.