Pd46-12 implantation of the Zephyr Zsi 475 FTM Erectile Device in Cis- And Transmen After Phalloplasty

INTRODUCTION AND OBJECTIVE: Until recently, all available erectile devices were designed according to the anatomy of a native penis and implantation of these devices in a neophallus required creativity and led to poor surgical outcome. However, in 2016, the Zephyr ZSI 475 FTM was designed and represented the first 3-piece inflatable erectile device specifically manufactured for implantation in a neophallus. The aim of this study is to report the initial experience with this new prosthesis and to assess surgical outcome. METHODS: Data of all cis- and transmen who underwent implantation of the Zephyr ZSI 475 FTM since 2017 were prospectively collected in a database. This analysis excluded patients with <3m of follow-up. Descriptive statistics were used and explantation-free survival (EFS) was analyzed using Kaplan-Meier statistics. This study was approved by the local Ethics Committee (UZG2019/0025). RESULTS: In total, 46 patients with a median (IQR) age of 35 (27-43) years were included for analysis, comprising 7 cismen and 39 transmen. Median (IQR) follow-up was 12 (8-18) months. A total of 27/46 patients (59%) had a history of ≥1 prior implanted erectile device. Median (IQR) operation time and hospital stay were respectively 54 (42-60) minutes and 1 (1-2) night. No intra-operative complications occurred. Postoperative complications comprised infection of the prosthesis in 5 patients (11%), prosthesis malpositioning in 2 patients (4.3%), mechanical failure in 2 patients (4.3%) and distal cilinder protrusion in 1 patient (2.2%). All complications required revisional surgery. In total, 9/46 devices (20%) were explanted and the estimated EFS rate (SD) at 6, 12 and 18 months was respectively 83% (5.6), 83% (5.6) and 83% (5.6). All but one explantations (89%) were required within 3 months after initial implantation. CONCLUSIONS: Implantation of the Zephyr ZSI 475 FTM erectile device in patients after phalloplasty is feasible and safe. Early surgical outcome is promising, though future analyses with longer follow-up are required to confirm these findings. Source of Funding: None.