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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%.

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