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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT04064671

Collaborator

(none)

100

Enrollment

Location

146.4

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Gender Dysphoria	Other: Implantation of the Zephyr ZSI 475 FTM erectile implant

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 19, 2017

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Dec 1, 2029

Outcome Measures

Primary Outcome Measures

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)

Secondary Outcome Measures

Complication rate after implantation of this device [90 days after implantation]
The Clavien-Dindo system (<90d) to report surgical complications will be used
Type of complications [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)]
Complications that will be assessed, involve: Urinary tract infection (yes or no) Hematuria (yes or no) Wound infection (yes or no) Wound dehiscence (yes or no) Abscess formation (yes or no) Fistula formation (yes or no) Protrusion of the device (yes or no) Malfunction of the device (yes or no) migration of the device (yes or no) Infection of the device (yes or no)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, Ghent University Hospital	Ghent	Oost-Vlaanderen	Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Study Director: Wesley Verla, Dept. of Urology, Ghent University Hospital
Principal Investigator: Piet Hoebeke, Dept. of Urology, Ghent University Hospital