ProACT™ (Uromedica, Plymouth, USA) balloons for male urinary incontinence: A fourteen-year-old cohort

Male urinary incontinence is attributed to SUI consecutive to benign prostate hypertrophy surgery, trauma, neurological diseases, or injury. Medical devices are developed to treat male urinary incontinence among them proACT® balloons. This technique was chosen in our center to achieve continence. Our study aims to evaluate safety and efficacy of proACT® balloons implanted in our center by measuring the rate of efficacy. We performed a retrospective and single centre study. A single expert surgeon performed all surgeries. Seventy-one balloons were implanted in 57 male patients between 2007 and 2020. Primary endpoint was the efficacy time lapse of the balloons after surgery. The analysis was performed using Kaplan-Meier method. Factors, which could affect the efficacy of the balloons, were analysed using a Cox regression analysis. In all, 45 balloons successfully cured stress urinary incontinence among the 57 men implanted resulting in a 63.38% success rate. Twenty-six balloons failed to treat stress urinary incontinence and were retrieved out of the 71 implanted. Ten balloons failed to treat urinary stress incontinence without organic cause, 6 balloons deflated, 5 balloons migrated out of the initial implantation site, 2 eroded, and 3 ended up infected. Fifty percent of the balloons were successful for a median time of 95 months. Univariate analysis did not reveal any predictive factor of failure. Our study showed 50% success rate at 95 months follow-up, therefore allowing a life expectancy of 7.9 years for the balloons. This safe mini-invasive technique ensured stress urinary incontinence in men. 4. L’incontinence urinaire d’effort chez l’homme est une pathologie souvent due à un traitement pour cancer ou hypertrophie de la prostate ou lésion médullaire, par insuffisance sphinctérienne. Plusieurs dispositifs ont été développés afin de la traiter dont les ballonnets péri-urétraux proACT® implantés sous le col vésical par voie mini-invasive. Notre critère de jugement principal est d’évaluer la sûreté et l’efficacité de ces ballonnets. Cette étude est rétrospective et monocentrique. Un seul chirurgien, expert dans le domaine, a réalisé l’ensemble des procédures. Soixante et onze ballonnets ont été implantés chez 57 hommes entre 2007 et 2020. Le critère de jugement principal est la durée d’efficacité des ballonnets. L’analyse a été réalisée en utilisant la méthode de Kaplan-Meier. Les facteurs pouvant influencer l’efficacité des ballonnets ont été déterminés s