Urinary artificial sphincter ZSI 375 for treatment of stress urinary incontinence in men: 5 and 7 years follow-up report

Abstract

STUDY DESIGN: This is a retrospective, non-randomised study. OBJECTIVES: The aim of this study was to evaluate safety and efficacy of artificial urinary sphincter ZSI 375 inserted in male patients with stress urinary incontinence (SUI). METHODS: Between May 2009 and January 2017, 45 men with SUI underwent ZSI 375 device insertion. Operations were performed in two French centres by one surgeon. Complications and pad used to manage continence were recorded. RESULTS: From May 2009 to January 2012, 45 patients with a mean age of 70.42 years underwent placement of the ZSI 375 device in France. The most common cause for incontinence was radical prostatectomy (RP, 33/45 -patients, 73.33%). The minimal period of incontinence was 6 months. Twenty-seven out of 45 patients (60.00%) had a severe incontinence (at least four pads per day), 13 patients (28.89%) had moderate incontinence (three pads per day) and five patients (11.11%) had two pads per day. With a long follow-up, the ZSI 375 device was considered to be successful in 73.33% patients after 5 years (60 months) and 72% of patients after 7 years (84 months). The infection rate was 2.2 % affecting one in 45 patients. Six out of 45 patients presented a urethral erosion (13.33%). Mechanical failure with a revision occurred in three patients (6.67%). CONCLUSIONS: The ZSI 375 device is a safe and effective device to treat severe SUI in men.