Introduction: To evaluate efficacy and long-term outcomes of ZSI-375 artificial urinary sphincter for the treatment of male urinary incontinence in male patients at the Urological Clinic at the University Hospital of Foggia, Italy. Methods: 36 male patients with iatrogenic urinary incontinence, who underwent ZSI-375 artificial urinary sphincter (AUS) implantation in the Urological Clinic at the University Hospital of Foggia, Italy from 2013 to 2019, were eligible. Daily pads number, ICIQ-SF, IIEF-5 and complication rate were evaluated and assessed. Patients’ mean age was 70 years (62-75) and the follow-up lasted an average of 36.8 months (24.6-48). 32/36 (88%) had developed incontinence following radical prostatectomy, while 4/36 (12%) after TURP. Twenty-five patients (69.4%) reported severe preoperative incontinence, while moderate incontinence was observed in the remaining cohort. Median preoperative IIEF-5 was 22 (18-25). Results: Postoperative follow-up of patients was performed at 3, 6, 12, and 24 months after ZSI-375 activation. At 6 months after surgery, urinary incontinence rate dropped to 11.1% but then it raised again at two years to 33.3% and up to 44.1 % at 48 months. Complications after surgery affected 20 patients (55,5%): 33,3% (12/36) patients experienced malfunctioning of the device; 11,1% (4/36) infection, while 11,1% (4/36) erosion. Concerning potency rates, potency rate (IIEF) decreased to a median value of 10 points at six months after surgery and median postoperative IIEF-5 at 24 months was 15.7 (5-20). Conclusions: In our experience ZSI 375 artificial urinary sphincter did not improve urinary incontinence in long term observation and led to further surgical procedure due to several complications. Further literature is needed to a better and proper critical analysis. SOURCE OF Funding: None
