First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty.
J Sex Med
; 16(2): 316-322, 2019 Feb.
Article
in En
| MEDLINE
| ID: mdl-30638882
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 OUTCOMEMEASURE:
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;16316-322.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Penis
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Prosthesis Design
/
Penile Prosthesis
/
Patient Satisfaction
/
Gender Dysphoria
Type of study:
Observational_studies
Limits:
Adult
/
Humans
/
Male
Language:
En
Journal:
J Sex Med
Journal subject:
GINECOLOGIA
/
MEDICINA REPRODUTIVA
/
UROLOGIA
Year:
2019
Document type:
Article
Affiliation country:
France