Evaluating outcomes of a new penile implant for transgender men after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the surgical outcomes following the implantation of the Zephyr ZSI 475 FTM inflatable penile implant in the neophallus of female-to-male transgender individuals. The study aims to address the challenges of achieving erectile function post-phalloplasty, which has been historically difficult due to anatomical differences. The Zephyr implant is specifically designed for this population, featuring a single cylinder and unique anchorage to improve stability and reduce complications. The study will collect data on the effectiveness and safety of this device in enhancing erectile function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
* Age ≥ 18 years.
* Female-to-male transsexual patient.
* Implantation of Zephyr ZSI 475 FTM erectile device.

Exclusion Criteria:

* Absence of signed written informed consent.
* Age \< 18 years.
* Biological males.
* Patients opting for penile implants other than the Zephyr ZSI 475 FTM.

Where it's running

• Department of Urology, Ghent University Hospital
  Ghent, Oost-Vlaanderen, Belgium Recruiting

Study contacts

• Principal investigator: Piet Hoebeke — Dept. of Urology, Ghent University Hospital
• Study coordinator: Wesley Verla
• Email: wesley.verla@uzgent.be
• Phone: +32 9 332 22 76

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.