Preliminary outcomes of the European multicentre experience with the ZSI 375 artificial urinary sphincter for treatment of stress urinary incontinence in men.

INTRODUCTION: The ZSI 375 is a new artificial urinary sphincter utilised in men suffering from stress urinary incontinence (SUI). We present the first European multicentre study on the effectiveness of ZSI 375. MATERIAL AND METHODS: This study was conducted in a retrospective, non-randomized format in centres across Europe. Between May 2009 and December 2014, ZSI 375 was fitted in 109 SUI patients following radical prostatectomy, transurethral resection of prostate (TURP), rectal surgery and high intensity focused ultrasound (HIFU). Patients with history of pelvic radiotherapy or previous surgical treatment for incontinence or stricture were excluded from the series. Follow-up was completed by December 2016. The key outcome measures included overall improvement and complication rates. RESULTS: A total of 109 patients in 10 European centres were recruited and had the ZSI 375 device implanted. The average patient age was 72 years old. The indication for the majority of patients was incontinence following radical prostatectomy (100/109 patients, 91.74%). On average, patients were incontinent for 48.6 months prior to treatment. All patients used ≥4 pads daily at baseline and thus were classified as suffering from 'severe incontinence'. The average follow-up until the final visit was 43 months. The pad usage decreased to 0.84 on average by the last visit. There were no reported cases of device infection. A total of 9 patients had urethral cuff erosion (8.25%),which was the most common complication in this series. A further 3 men (2.75%) experienced mechanical failure requiring subsequent device reimplantation. The implantation of the ZSI 375 device was considered successful in 92.66% of patients. CONCLUSIONS: The ZSI 375 is an effective surgical treatment option in men with severe stress urinary incontinence.

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

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.

Safety and Efficacy Outcomes of ZSI 475 Penile Prosthesis.

OBJECTIVE: The aim of this study was to demonstrate safety and efficacy of ZSI 475 hydraulic penile prosthesis three components. Preparation, procedure and functional results are similar to AMS 700 and Coloplast Titan. This study was conducted from September 2012 to December 2016. PATIENTS AND METHOD: From September 2012 to December 2016, 29 ZSI 475 hydraulic penile prostheses three components were implanted by six surgeons in 28 patients in five European centres. Mean age of patients was 60 years old (44-75). Standard peno-scrotal incision procedure was performed for the 28 patients. Erectile function was assessed by IIEF-5 self-administered questionnaire. RESULTS: Median follow-up was 35.11 months (8-47). Postoperative complications were limited to scrotal pump torsion that required a revision, an armed tubing breakage and a scrotal haematoma. At the end of follow-up, 100% of patients had a functional prosthesis and 92.86% were satisfied. CONCLUSIONS: Implantation, risks of complications, functional outcome and patient satisfaction with penile implant ZSI 475 are similar to standard hydraulic penile implants three components as AMS 700 and Coloplast Titan.

ZSI 375 artificial urinary sphincter for male urinary incontinence: a preliminary study.

OBJECTIVE: To assess retrospectively the safety and efficacy of an artificial urinary sphincter, the ZSI 375 device (Zephyr Surgical Implants, Geneva, Switzerland), in male patients with moderate-to-severe stress urinary incontinence after a prostate or bladder intervention. PATIENTS AND METHODS: The ZSI 375 device is a one-piece device consisting of an adjustable cuff, moulded to fit around the urethra, which is connected by a tube to a pump and a pressure-regulating tank. It has no abdominal reservoir. Patients underwent a perineal incision for cuff placement and an inguinal incision for pump and tank scrotal placement. Complications and pads used to manage incontinence were recorded. RESULTS: Between May 2009 and April 2011, 36 patients underwent ZSI 375 device placement. The median (range) follow-up was 15.4 (6-28) months. No patient experienced bladder overactivity, chronic urinary retention, or any other adverse effect after device activation. Complications leading to device removal arose in four patients (one case of erosion, three cases of infection). Social continence (0 or 1 pad/day) was achieved in 28/36 patients (78%) at 3 months and 26/36 patients (73%) at 6 months after device activation. In 12/14 patients for a sphincter closure pressure range of 60-70 cm H2O, in 3/3 patients for a range of 70-80 cm H2O and in 2/11 for a range of 90-100 cm, H2O social continence was achieved only after increasing the pressure of the cuff by trans-scrotal injection of saline. CONCLUSIONS: The ZSI 375 device is safe and effective but our follow-up may not have been long enough to identify all potential complications. Further research is needed to confirm these results and extend our investigation, for instance, to the peno-scrotal approach.