The outcomes of inflatable penile prosthesis implantation in the context of Genital Gender Affirming Surgery in Assigned Female At Birth patients: A comparative study between cis-male Dacron modified and Zephyr Surgical Implants 475 Female To Male Penile Prosthesis.

Abstract

The ideal device to be implanted into a neophallus has yet to be identified. Since 2016 Zephyr Surgical Implant 475 Female To Male (ZSI 475 FtM, Switzerland) series penile prosthesis (PP) have been proposed as "ad hoc" device. The aim of the study is to compare the outcomes of cis-male Dacron modified PP with ZSI 475 FTM PP. A single-center prospective study was performed between March 2011 and April 2024. Patients received either the implantation of a cis-male Dacron modified PP or ZSI 475 FTM PP. The primary endpoint was the comparison of the surgical outcomes. The secondary endpoint was the evaluation of device survival. 47 assigned female at birth (AFAB) patients were included in: 29 underwent a cis-male Dacron modified PP, 18 received ZSI 475 FTM PP. The median follow-up was 36 months (IQR 13-70). A significantly shorter operative time was observed in ZSI FTM PP group when compared to cis-male Dacron modified PP group (mean value of 85 (IQR 78-97) VS. 105 (IQR 89-150) minutes, p 0.001). No statistically significant differences were found regarding the rate of postoperative complications, although the cis-male Dacron-modified PP appeared to have a higher tendency for infection (24.1% vs. 5.6%) and mechanical failure (31% vs. 22.2%, p = 0.09 and p = 0.51, respectively) compared with the ZSI 475 FTM PP. Explantation free survival (EFS) at 12 months was higher in the ZSI 475 FTM PP group (100 VS. 79.3%, p-value 0.039). However, at 24 months, this advantage was lost (94.4% VS. 72.4%, p value 0.062). Both cis-male Dacron modified and ZSI 475 FTM PP may guarantee satisfactory surgical outcomes. High powered prospective trials are warranted to confirm the data.