2024 · FRENCH JOURNAL OF UROLOGY

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

Francois, Catherine, Chabannes, Eric, Kleinclauss, Francois, Frontczak, Alexandre

Journal
FRENCH JOURNAL OF UROLOGY
Année
2024
Volume
34
Numéro
7-8
Article
102662
Mois
JUL
DOI
10.1016/j.fjurol.2024.102662

Abstract

Background: 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 (R) balloons. This technique was chosen in our center to achieve continence. Our study aims to evaluate safety and efficacy of proACT (R) balloons implanted in our center by measuring the rate of efficacy. Methods: 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. Results: 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. Conclusions: 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. Level of evidence: 4. (c) 2024 Elsevier Masson SAS. All rights are reserved, including those for text and data mining, AI training, and similar technologies.

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