Does Optilume drug-coated balloon dilation compromise female sphincter function?

Abstract

Purpose: Female urethral strictures (FUS) are rare, yet when present very bothersome. Repeated dilation often results in recurrence, requiring surgical urethral reconstruction in the long term. We assessed the outcomes of female patients with urethral stricture disease undergoing Optilume drug-coated-balloon (DCB) dilation.

Methods: Between August 2021 and May 2024, 14 female patients with FUS underwent DCB dilation. Two transgender male-to-female patients were excluded. The diagnosis was confirmed by inability to pass a 14Fr catheter, translabial ultrasound or voiding cystourethrogram (VCUG). Exclusion criteria were urinary tract infection, neurological disease and previous urethroplasty. Written consent was obtained prior to intervention and included the option of urethroplasty. After hydrophilic urethral dilation, urethrocystoscopy was performed. DCB (5 cm) dilation was done to 30Fr at 10 bar for 10 min. General or local anaesthesia was used depending on patient's preference. Transurethral catheter was placed for 2-5 days. Endpoints were urinary continence, anatomical success (≥ 14Fr by cystoscopy/calibration) and freedom from repeat intervention at 6 months.

Results: The mean age was 52.3 years (range: 31-81), the mean number of prior interventions was 4.3 (range: 0-40). The mean follow-up was 12 months (range: 6-41). At the time of analysis, 11 out of 12 subjects (91.7%) were free from recurrence and repeat intervention. All patients remained continent after the intervention, with two reporting complete resolution of preexisting incontinence. Limitations of the study include the small sample size, short follow-up and single centre nature.

Conclusions: Optilume DCB dilation demonstrates short-term efficacy, is well tolerated, safe, and notably preserves sphincter function.