Multicentre Experience with ZSI 375 Artificial Urinary Sphincter for the Treatment of Stress Urinary Incontinence in Men

Abstract

Objectives The aim of this study was to evaluate the safety and efficacy of the artificial urinary sphincter ZSI 375 device in male patients with stress urinary incontinence (SUI) at 10 centres. Methods This was a retrospective, nonrandomised, multicentre study. From January 2012 to December 2014, and follow-up to February 2016, men with SUI were treated with the ZSI 375 device. The primary outcome was continence. The secondary outcome was complications rate. Results A total of 147 patients with moderate-to-severe stress incontinence and mean age of 70.67 (26-85) years underwent implantation of the ZSI 375 device at 10 centres. The most common indication for placement was incontinence after radical prostatectomy (121 patients: 82.31%). The ZSI 375 device was considered successful in 86.40% of cases after 12 months follow-up, 83.52% after 24 months follow-up and 78.26% after 36 months follow-up. The infection rate was 6.12%, urethral erosion was 12.92% and mechanical failure was limited to 3.40% leading to ZSI 375 improvement. Conclusions This study confirmed safety and efficacy of ZSI 375 device to treat moderate-to-severe SUI in men.

High/low‐volume center experience predicts outcome of AMS 800 in male stress incontinence: Results of a large middle European multicenter case series

“…Farag et al 15 found a shorter time to revision in their salvage cohort after implantation of a male sling. It is not clear whether prefilled sphincter models like the ZSI 375 (Zephyr Surgical Implants, Switzerland) may be an alternative for low‐volume centers; only data from a few centers with high levels of expertise have been published thus far 16 . An emerging innovation in artificial sphincter systems is adjustability.…”

Artificial sphincter “BR - SL - AS 904” in the treatment of urinary incontinence after radical prostatectomy: efficacy, practicality and safety in a prospective and multicenter study

“…All surgeons reported the implantation of BR - SL - AR 908 being straightforward, fast, feasible and reproducible, with also a short learning curve to achieve mastery (personal findings). Unlike the facility offered by our device, the gold standard sphincter (AM800) is still provided in several boxes and separated components to assemble during the procedure with a constraining preparation (12). In addition, none of patients submitted to our implant presented trans - operative or postoperative complications related to the surgical procedure, using Clavien - Dindo score (13).…”

Patients' quality of life after implantation of ZSI 375 artificial urinary sphincter due to stress urinary incontinence

“…Eight weeks later the AUS was activated in an outpatient setting. A detailed description of the ZSI 375 artificial sphincter implantation procedure was presented in earlier publications [ 5 , 7 , 8 ].…”