Abstract
BACKGROUND: Artificial urinary sphincter (AUS) is the gold standard for severe male stress urinary incontinence (SUI). This study aims to evaluate the interest of a new cutaneous preparation regarding the risk of early device infection. METHODS: A retrospective review of medical records has been built with all patients who underwent an AUS, implanted by experienced surgeons, between January 2010 and January 2023. Before January 2015, all AUS received a standard protocol (SP) of cutaneous cleansing with soap povidone iodine and disinfection with alcoholic povidone iodine. After January 2015, all AUS received the new protocol (NP) with two cleansings with soap povidone iodine and two disinfections with alcoholic povidone iodine. The primary focus was to compare the risk of early device infection between the two protocols. Multivariate analyses were done with several risk factors such as age, diabetes, underlying pathology (prostate cancer surgery, surgical treatment of benign prostatic hyperplasia or others), past history of pelvic radiation therapy and past AUS implantation. RESULTS: One hundred and fifty-six cases were enrolled, with 34 following the SP and 122 following the NP. In the univariate analysis, there were 15 explantations in the SP arm versus 8 for the NP arm due to infection (45.5% vs. 25%, P=0.09). The was no difference between the NP and the SP in multiparametric analysis [odds ratio (OR): 0.97; P=0.96]. No other risk factors were associated with increased risk of AUS removal. CONCLUSIONS: Our study showed no correlation between the two types of skin preparation and the risk of AUS removal or revision. Future studies are needed to highlight the legitimate risk factors.