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.

ObjectiveThe 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 MethodFrom 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.ResultsMedian 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.ConclusionsImplantation, 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.

No severe side effects were observed. The urodynamic parameters of the bladder were improved clearly in all patients, subjective satisfaction was reached in 72.7 %.

IntroductionThe 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 methodsThis 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.ResultsA 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.ConclusionsThe ZSI 375 is an effective surgical treatment option in men with severe stress urinary incontinence.

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