A single-institution experience with the Optilume Urethral Drug Coated Balloon for management of urethral stricture disease

Abstract

Background: Urethral stricture disease is detrimental to quality of life. The Optilume Urethral Drug Coated Balloon (DCB) offers a solution utilizing a paclitaxel-coated balloon to expand strictures and prevent recurrence. Following the ROBUST trials, it has been proposed that DCB is more effective than conventional endoscopic management for recurrent, small anterior urethral strictures. Our study provides insights into practical applications and outcomes using DCB for urethral stricture disease.

Methods: A retrospective review was performed of patients who underwent DCB for urethral strictures at our institution from November 2022 to August 2023 with follow-up evaluated through January 2024. Demographics, stricture characteristics, operative details, and postoperative outcomes were collected. Primary endpoint was need for repeat intervention as determined by symptomatic burden and subsequently postoperative post-void residual if obtained. Secondary endpoint was complication rate. Statistical analysis was conducted using STATA/BE17.0 software to create Kaplan-Meier curves for time to repeat intervention after treatment with DCB.

Results: Of 43 patients, 16 had no prior treatment. The other 27 had endoscopic treatment and of this group, 11 also had additional urethroplasty. Stricture etiologies included 20 iatrogenic, 14 idiopathic, 5 radiation-related, 2 inflammatory, and 2 traumatic. Stricture locations were 2 fossa navicularis, 7 pendulous, 17 bulbar, 7 membranous, 3 prostatic, and 7 bladder neck contractures. Mean balloon dilation lasted 8.4±2.7 minutes. All patients had a minimum follow-up of 150 days postoperatively and the mean duration of follow-up for the cohort was 290.3±87.0 days. The average postoperative post-void residual was 33.4±90.6 milliliters. Two patients had immediate complications: 1 with urinary retention after catheter removal requiring suprapubic tube placement and 1 with urinary tract infection requiring antibiotics. Four patients required repeat interventions: 1 endoscopic dilation, 1 graft urethroplasty, and 2 repeat DCB procedures. Mean time to repeat intervention was 203.5±82.6 days, and no patient required repeat intervention within 145 days of initial surgery.

Conclusions: DCB offers a safe and less invasive treatment for both treatment-naïve and recurrent urethral strictures with paclitaxel coating to prevent recurrence. Repeat intervention was not required for 90.7% of our cohort within an average follow-up duration of 9 months postoperatively. As DCB grows in clinical use, investigation into its long-term efficacy is justified.