Outcomes of drug-coated balloon urethral dilation in patients with stricture recurrence after urethroplasty.

Background: Stricture recurrence after urethroplasty can be challenging to manage. Endoscopic intervention has been used with low success within this population. Optilume is a paclitaxel coated balloon dilator that has demonstrated high urethral patency rates and low risk of adverse events in patients with recurrent anterior urethral strictures when compared to endoscopic intervention. The objective of this study was to evaluate the utility of Optilume for treatment of stricture recurrence after urethroplasty.

Methods: We performed a retrospective cohort study of patients who underwent paclitaxel drug-coated balloon (DCB) dilation for urethral stricture recurrences after urethroplasty at two institutions between June 2022 and September 2024. Baseline patient characteristics were recorded including age, stricture etiology, and prior repair. The primary outcome was freedom from any repeat intervention.

Results: Of the 146 men who underwent DCB dilation at our institutions, 19 had stricture recurrence after urethroplasty and were included in our analysis. The mean age was 55 years (standard deviation, 18 years; range, 34-82 years). Idiopathic strictures were most predominant (42%), followed by iatrogenic (21%), lichen sclerosis associated (16%), radiation induced (11%), and trauma induced (11%). Stricture locations were bulbar (47%), penile (32%), membranous (16%), and prostatic (5%). Prior urethroplasties were: 9 buccal mucosal graft (BMG) augmentation, 7 excision and primary anastomosis (EPA), 1 scrotal skin graft, 1 prior hypospadias repair and 1 rectourethral fistula repair with EPA and gracilis flap interposition. Sixty-three percent of patients underwent endoscopic intervention prior to DCB dilation. Average time from urethroplasty to DCB dilation was 43±42 months. The median follow-up was 228 days with interquartile range of 182 to 369 days. Two patients with idiopathic and iatrogenic bulbar strictures, previously treated with BMG and EPA respectively, had recurrence after Optilume and opted for repeat DCB dilation. Average time between DCB treatments was 464 days in these two patients. DCB dilation resulted in a freedom from reintervention rate of 89% in our cohort.

Conclusions: DCB dilation was effective for treatment of urethral stricture recurrence after urethroplasty at a median follow-up of 228 days in our cohort. This minimally invasive intervention may be an option for patients who are not ideal surgical candidates or refuse repeat urethroplasty. Data on longer-term outcomes in this cohort is needed and is forthcoming.