Long-term device survival after a first implantation of AMS800 TM for stress urinary incontinence: Comparison between men and women

Purpose: Artificial urinary sphincter is the reference treatment for stress urinary incontinence in men, but it remains rarely used in women. This study aimed to compare long-term device survival between women and men, after the first implantation of an AMS 800TM artificial urinary sphincter (Boston Scientific, USA) for the treatment of a non-neurogenic stress urinary incontinence.Materials and methods: This retrospective cohort study included all patients with non-neurogenic stress urinary incontinence who underwent surgery in a large-volume university hospital between 2000 and 2013. The primary outcome was the overall survival of the device, defined as the absence of any repeated surgery (revision or explantation) during follow-up. Men and women were matched 3:1 according to age and year of implantation. Differences were analyzed using a Cox model accounting for matching and applying time intervals because hazards were not proportional over time. Sensitivity analyzes were performed, excluding firstly population with history of radiotherapy and secondly population with more than one previous surgery for urinary incontinence.Results: A total of 107 women were matched to 316 men. Median follow-up was 6.0 years (Q1-Q3 1.8 – 9.4): 7.0 years (Q1-Q3 3.1 – 10.3) for women and 5.1 years (Q1-Q3 1.3 – 9.1) for men. During the follow-up, 56 patients had an explantation of the device: 44 men (13.9%) and 12 women (11.2%) and 113 had a revision: 85 men (26.9%) and 28 women (26.1%). Men have a significantly higher risk of explantation or revision than women between 6 months and 8 years after implantation (HR 2.12 (1.29-3.48)). Before 6 months and after 8 years, there were not significant differences. Both sensitivity analyses found consistent results.Conclusions: This study suggests that device survival seems better in women after the first 6 months.