ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

September 19, 2017

Primary Completion Date

September 30, 2027

Study Completion Date

December 31, 2029

Conditions
Erectile DysfunctionGender Dysphoria
Interventions
OTHER

Implantation of the Zephyr ZSI 475 FTM erectile implant

Until recently, all penile implants were manufactured for erectile dysfunction in biological males and thus presumed the presence of two corpora cavernosa. In 2016 however, the Swiss company, Zephyr Surgical Implants (ZSI), created a 3-piece inflatable erectile device specifically for female-to-male transsexuals: the Zephyr ZSI 475 FTM. This prosthesis has a realistic gland shape, only one cylinder, and a specific anchorage device made of titanium and silicone to anchor the system to the pubic bone of the patient. These specific features could potentially address the aforementioned issues with implanting erectile devices in the neophallus and hopefully lead to better surgical outcomes in these particular patients.

Trial Locations (1)

9000

RECRUITING

Department of Urology, Ghent University Hospital, Ghent

All Listed Sponsors
lead

University Hospital, Ghent

OTHER