[Survival analysis of adjustable continence therapy device (ACT®/proACT®): a new message for patients].

INTRODUCTION The main purpose was to assess the failure free survival of adjustable continence therapy ACT®/proACT® after continence was obtained and to seek factors influencing it. MATERIAL AND METHODS Retrospective, single-center survival study of peri-urethral balloons implanted between 2007 and 2014. Efficacy was defined by the wearing of 0 or 1 safety pad per day. The primary end point was time to failure estimated from a survival curve (Kaplan-Meier). Factors that could influence failure free survival were: sex, age, radiotherapy, diabetes, number of pad before surgery, number of balloon inflation, early complications, mixed urinary incontinence and previous ACT®/proACT® placement. They were analyzed in a COX regression. RESULTS Of the 82 peri-urethral balloons placed, 41 were effective in 36 patients. The failure free survival was 50 % at 60 months. Radiotherapy, diabetes and previous peri-urethral balloon placement appeared to significantly decrease survival (P=0.031;P=0.025;P=0.029, respectively). Fifteen peri-urethral balloons were still effective at the last follow-up, one was lost to follow-up and 25 required re-intervention for loss of efficacy. The main cause of efficacy loss was system leakage. Fifty-two percent of peri-urethral balloons that became ineffective were replaced by new peri-urethral balloons and 28% by an artificial urinary sphincter. CONCLUSION Patients who became continent with adjustable continence therapy (ACT®/proACT®) had a 50 % new surgery probability at 5 years for a loss of efficacy. Radiotherapy seems to be the main risk factor of the efficacy loss. LEVEL OF EVIDENCE IV.