Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes

Background: Until recently, all available erectile devices were manufactured in accordance with the anatomy of a native penis and led to high explantation rates when implanted in the neophallus. Aim: The aim of this study was to investigate surgical outcomes after implantation of the ZSI 475 FTM in the neophallus; this is the first erectile device specifically manufactured for implantation after phalloplasty. Methods: This is a prospective observational study of patients undergoing implantation of the ZSI 475 FTM in the neophallus at a tertiary referral center since September 2017. Patients with a follow-up < 3 months were excluded from this analysis. Outcomes: Intraoperative and postoperative complications were analyzed with descriptive statistics and explantation-free survival was assessed using a Kaplan-Meier survival analysis. Results: In total, 57 patients were included with a median (IQR) follow-up of 16 (10-21) months. No intraoperative complications occurred. Postoperative complications were seen in 18 of 57 (32%) patients and included cylinder protrusion (1/57, 1.8%), infection (8/57, 14%), malpositioning (4/57, 7.0%), mechanical failure (4/57, 7.0%), and urinary retention (1/57, 1.8%). A total of 13 of 57 (23%) devices were explanted which corresponds with an estimated explantation-free survival rate (SD) of 84% (4.9), 80% (5.6), and 80% (5.6) after, respectively, 6, 12, and 18 months of follow-up. Clinical implications: By better addressing the specific needs after phalloplasty, this innovative erectile device might lead to improved cylinder protrusion, malpositioning, and mechanical failure rates, but device infection remains common. Strengths & limitations: This is the largest study on this topic to date and the first to report prospective data. Main limitations involve the relatively small sample size and the limited follow-up. Conclusion: Short-term cylinder protrusion, malpositioning, and mechanical failure rates are encouraging, although device infection remains a common problem. These complications resulted in a device explantation rate of 23%. Verla W, Goedertier W, Lumen N, et al. Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes. J Sex Med 2021;18:615e622. Copyright (C) 2020, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.