Initial experience of a single center with the use of ZSI 475 penile prosthesis

Objective: To evaluate surgical outcomes after implantation of the Zephyr ZSI 475 inflatable penile prosthesis (IPP) and patients' quality of life. Methods: From December 2014 to September 2018, 15 patients underwent prosthesis implantation with ZSI 475. A retrospective review of clinical data was performed. Patients' quality of life after implantation was investigated with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. Results: The median age of patients was 57 years and the average follow-up time was 22 months. Twelve patients received a standard implantation due to severe erectile dysfunction (ED); three patients also presented penile curvature and additional corporoplasty with grafting was necessary. Three procedures had to be interrupted due to defects of the insertion tools. In one case a manufacturing defect resulted in a pump leak. In one case, a severe postoperative complication occurred, which requested explanation of the device. During the follow-up, four patients experienced mechanical failure of the prosthesis. Results of QoLSPP questionnaire at 12 months were skewed toward the positive end of the scale in all domains. Conclusion: In our initial experience, ZSI 475 suffered a high rate of mechanical failures; on the other hand, the company showed great commitment in order to improve the quality and reliability of the device. The lower cost of ZSI 475 may add to the chances of the product to become a cost-effective alternative to treat those patient who need a IPP.