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

January 29, 2024 updated by: University Hospital, Ghent

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • Department of Urology, Ghent University Hospital
        • Contact:
        • Sub-Investigator:
          • Wesley Verla, MD
        • Principal Investigator:
          • Piet Hoebeke, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explantation-free survival
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate after implantation of this device
Time Frame: 90 days after implantation
The Clavien-Dindo system (<90d) to report surgical complications will be used
90 days after implantation
Type of complications
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2017

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/0025 (BC-4486)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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