PROACT™ (UROMEDICA, PLYMOUTH, USA) BALLOONS FOR MALE URINARY INCONTINENCE: A FOURTEEN-YEAR-OLD COHORT.

BACKGROUNDː 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. 71 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. 45 balloons successfully cured stress urinary incontinence among the 57 men implanted resulting in a 63,38% success rate. 26 balloons failed to treat stress urinary incontinence and were retrieved out of the 71 implanted. 10 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. 50% 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.

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