First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty. Issue 2 (9th January 2019)

• Record Type: Journal Article
• Authors: Neuville, Paul; Morel-Journel, Nicolas; Cabelguenne, Delphine; Ruffion, Alain; Paparel, Philippe; Terrier, Jean-Etienne
• Is Part Of: Journal of sexual medicine. Volume 16:Issue 2(2019)
• Page Start: 316
• Page End: 322
• Publication Date: 2019-01-09
• Subjects: Erectile Device -- Phalloplasty -- Female-to-Male Transsexualism -- Gender Dysphoria -- Neophallus -- Penile Prosthesis; Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1016/j.jsxm.2018.11.013
• Languages: English
• ISSNs: 1743-6095

Abstract

Abstract: 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.