Safety and Efficacy Outcomes of ZSI 475 Penile Prosthesis

Abstract

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.