First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty

Introduction: The ZSI 475FtM is a new prosthesis that has recently been specifically designed for phalloplasty. It has several functions that have been conceived to answer the challenges of implantation after phalloplasty: a large base for pubic bone fixation, realistically shaped hard glans, and a pump shaped like a testicle.

Aim: To assess the safety, feasibility, and patient satisfaction of the ZSI 475 FtM.

Methods: Surgical outcomes were analyzed after implantation of the prosthesis between June 2016 and September 2017 (single institution, single surgeon). Patients were then asked to answer a satisfaction questionnaire that included the International Index of Erectile Function-5, Erectile Dysfunction Inventory of Treatment Satisfaction, and Self-Esteem and Relationship, as well as other non-validated questions.

Main outcome measure: Complication rates and the scores of the different questionnaires were reviewed.

Results: 20 patients who had gender dysphoria and underwent operation for a female-to-male procedure were included. The mean age was 37.9 years. Complications after 21 implantations included 2 (9.5%) infections that were medically treated (Clavien II), 1 (4.7%) infection treated by explantation (Clavien IIIb), 2 (9.5%) mechanical failures (Clavien IIIb), and 1 (4.7%) malpositioning (Clavien IIIb). The mean follow-up was 8.9 months (SD 4.0), with 50% of the implanted patients having >12 months of follow-up. 14 patients (70%) answered the satisfaction questionnaire. 12 patients (85.7%) had regular penetrative sexual intercourse. The mean International Index of Erectile Function-5 score was 20.2 of 25 (standard deviation [SD] 7.9), the mean Self-Esteem and Relationship score was 84.5 of 100 (SD 9.9), and the mean Erectile Dysfunction Inventory of Treatment Satisfaction score was 82 of 100 (SD 17.5). 13 patients (92.8%) were satisfied or very satisfied with the prosthesis.

Clinical implications: This new innovative prosthesis could better answer the challenges faced by the implantation of an erectile device by phalloplasty.

Strength & limitations: Our study is the first to report data on this new prosthesis. The main limitation is the small number of patients and the short follow-up.

Conclusion: Preliminary results for the ZSI 475 FtM are encouraging. Safety seems to be satisfactory, and patient satisfaction is high. Long-term studies are needed for further analysis. Neuville P, Morel-Journel N, Cabelguenne D, et al. First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty. J Sex Med 2019;16:316-322.