Status Plus




Surgical outcome and patient’ satisfaction after ZSI 475 penile prosthesis implantation

Vagnoni, V1; Franceschelli, A1; Fiorillo, A1; Gentile, G1; Schiavina, R2; Brunocilla, E2; Colombo, F1

1: Andrology Unit, Department of Urology and Gynecology, University Hospital S.Orsola, Bologna, Italy; 2: Policlinico di S. Orsola, Urology, Bologna, Italy

Introduction and objectives: The aim of this study was to demonstrate safety and quality of life of patients after ZSI 475 hydraulic penile prosthesis three components implantation.

Materials and method: From December 2014 to October 2016, 10 ZSI 475 hydraulic penile three components prostheses were implanted by one surgeon. Standard peno-scrotal incision procedure was performed for all the patients. Erectile function was assessed by IIEF-15 (International Index of Erectile Function) self-administered questionnaire and quality of life after implantation was investigated with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire at 12 months after the implantation. The study was conducted in accordance with the principles of the Declaration of Helsinki of World Medical Association.

Results: Median follow-up was 20 months (range, 12-34), mean age of patients was 59 years old (range, 40-78). No intraoperative complications were observed in 9 patients. In the remaining one, an armed tube leakage, due to manufacturing defect, needed immediate prosthesis substitution. No major complications as glans ischemia, necrosis or persistent anesthesiae were recorded postoperatively. One patient experienced hyperpyrexia that has been controlled by antibiotic therapy; no patients recorded any infection. During the follow-up, 2 patients experienced mechanical failure of the prosthesis due to a rupture of the pump-cylinders connection-tube: a revision was needed and a prosthesis exchange was made. At the end of follow-up,no prosthesis migration or long-term pain were recorded; all of the patients had a functional prosthesis. The mean preoperative IIEF-score was 14.3±4.3; the mean postoperative IIEF-scores resulted 52.9±2.9. Table 1 shows mean and median values of the 16 items of QoLSPP questionnaire at 12 months. Results were skewed toward the positive end of the scale in all domains: Forty per cent of responses to several items were maximum values and 86% of responses falling on the positive side of the scale. Interestingly, only 20% of the patients reported a harder rigidity of the prosthesis in comparison with that obtained before the implantation; moreover, none of the patients reached daily or almost daily sexual intercourses while 60% reported a frequency of 4-6 times per month.

Conclusion: Optimal functional outcome and very good patient satisfaction were obtained with implantation of ZSI 475 hydraulic penile prosthesis; no major intra- or post-operative complication were reported.


Work supported by industry: no.

Go Back