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Preliminary study of a specific penile prosthesis conceived for phalloplasty, the ZSI® 475 FtM

Neuville, P1; Terrier, JE1; Paparel, P1; Ruffion, A1; Morel-Journel, N1

1: Centre Hospitalier Lyon Sud, France

Objective: Assessing security, feasibility and patient satisfaction of a new type of penile prosthesis specifically designed for phalloplasty.

Material and Method: Patients were included from June 2016 to September 2017 at a single institution by a single surgeon. Medical data were collected from the patients’ hospital files. Patients were then proposed to answer a satisfaction questionnaire that included IIEF (International Index of Erectile Function) questionnaire, EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) questionnaire, SEAR (Self-Esteem and Relationship) questionnaire, and specific items.

Results: Twenty patients were included, mean age 37.9 years, and 21 prostheses were implanted. All had gender dysphoria and phalloplasty type were forearm flap (n=15, 75%), suprapubic (n=4, 20%) and pedicled inguinal (n=1, 5%). 17 patients (85%) had functional urethroplasty. Complications were 2 (10%) infections medically treated, 1 (5%) infection treated by explantation, 2 (10%) mechanical failures and 1 (5%) malposition. Mean operating time was 102.6 min (SD 13.2) and mean duration of hospitalization was 2.7 days (SD 0.5%). Fourteen patients (70%) answered the satisfaction questionnaire. Twelve (85.7%) patients had sexual relationship regularly. Mean IIEF was 20.2 over 25 (SD 7.9), mean SEAR was 84.5 over 100 (SD 9.9) and mean EDITS was 82 over 100 (SD 17.5). Thirteen patients (92.8%) were satisfied or very satisfied with the prosthesis.

Conclusions: This study shows that implantation of this new prosthesis is feasible. Security seems to be satisfactory even if longer follow-up is needed, and patient satisfaction is high. Preliminary results of the ZSI® 475 FtM are encouraging. Long-term studies are needed to pursue analyzing its results.


Work supported by industry: no.

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