Evaluating outcomes of a new penile implant for transgender men after surgery
ZEPHYR: A Prospective 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
This study is testing a new penile implant designed for transgender men to see if it can help improve erectile function after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT04064671 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are female-to-male transgender individuals aged 18 and older who are seeking implantation of the Zephyr ZSI 475 FTM erectile device.
Not a fit: Patients who may not benefit from this study include biological males and those opting for penile implants other than the Zephyr ZSI 475 FTM.
Why it matters
Potential benefit: If successful, this study could significantly improve erectile function and quality of life for transgender men undergoing phalloplasty.
How similar studies have performed: Previous studies have shown mixed results with penile implants in transgender men, but the Zephyr device represents a novel approach specifically tailored for this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ghent, Oost-Vlaanderen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.