Clinical trial NCT04064671: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Erectile Dysfunction
Gender Dysphoria
Keywords: female-to-male
transgender
transsexual
Zephyr
erectile device
erectile implant
neophallus
phalloplasty
gender reassignment surgery
sex reassignment surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All female-to-male transsexual patients asking for the implantation of an erectile device are carefully counseled and during their visit, all available devices are discussed with their inherent benefits and drawbacks. If the patient independently chooses for the Zephyr ZSI 475 FTM erectile device, and if this patient meets the aforementioned inclusion criteria, he will be included in this study after voluntarily signing the written informed consent form.

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

Detailed description: Obtaining erectile function after phalloplasty in female-to-male transsexuals remains a challenging issue and requires the implantation of a device. For biological males, several erectile implants exist and widespread research has demonstrated the successful outcome of these devices. However, substantial differences exist between a native penis and a neophallus and explain the poorer outcome of these devices in female-to-male transsexuals.

In 2018, Falcone et al. published the largest retrospective series on this subject so far and reported that after a mean follow-up of 20 months, only 58% of their patients still had their original implant in place. The main obstacle in these female-to-male transsexuals is represented by the lack of corpora cavernosa in the neophallus which leads to difficult anchorage of the prosthesis, little stability of the prosthesis and a higher risk of cylinder erosion.

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.

So far, no literature regarding surgical or functional outcome of the Zephyr ZSI 475 FTM exists. The aim of this study is to prospectively collect data of all female-to-male transsexuals that are treated with the implantation of this device at Ghent University Hospital.

Eligibility 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.

Primary outcomes:
measure: Explantation-free survival
timeFrame: 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)
Secondary outcomes:
measure: Complication rate after implantation of this device
timeFrame: 90 days after implantation
measure: Type of complications
timeFrame: 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)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Urology, Ghent University Hospital
state: Oost-Vlaanderen
Study officials:
affiliation: Dept. of Urology, Ghent University Hospital
name: Wesley Verla
role: STUDY_DIRECTOR
affiliation: Dept. of Urology, Ghent University Hospital
name: Piet Hoebeke
role: PRINCIPAL_INVESTIGATOR
References: