Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: To assess the effectiveness, safety and risk factors of failure and complications associated with Adjustable Continence Therapy (ACT®) balloons as a treatment for female stress urinary incontinence (SUI). METHODS: In the present multicentric retrospective study, all women implanted with ACT® balloons between 2000 and 2018 were considered eligible. Effectiveness and safety were assessed at 1 year, and risk factors for failure and complications were sought. The effectiveness was categorized into three distinct groups Success = maximum 1 pad/day and patient's impression of improvement using a numerical rating scale (NRS) ≥ 8/10; Improvement = decrease of daily pad use and NRS ≥ 5/10; Failure = increase or stability of daily pad use or NRS < 5/10. The intra- and postoperative surgical complications were collected. RESULTS: Over the study period, 281 women were included. Among them, 104 (37.0%), 94 (33.5%) and 83 (29.5%) were categorized as success, improvement, and failure, respectively. Intra-, early and late postoperative complications occurred in 13 (4.6%), 35 (12.5%) and 75 (26.7%) women, respectively. Most early surgical complications were minor according to the Dindo-Clavien classification. Of women that presented a late postoperative surgical complication, 64 (22.8%) underwent an explantation performed under local or general anesthesia without associated sequalae. CONCLUSIONS: The short-term effectiveness associated with ACT® balloons, their minimally invasive implantation and the frequent but easily manageable and sequelae-free complications suggest that they should be part of the therapeutic arsenal for female SUI.