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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.

Eligibility

Primary outcome measure(s)

• Explantation-free survival — From date of surgery until the date of explantation or date of death from any cause, whichever came first, assessed up to 120 months postoperatively (assessment at 3 months postoperatively, 1 year postoperatively and then yearly)
  Interval between implantation date and explantation date (if explanted)

Trial sites (1)

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