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

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.

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

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.

Complication rates and the scores of the different questionnaires were reviewed.

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.

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

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.

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.