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

NCT04064671 | Recruiting

• 1 other identifier: 2019/0025 (BC-4486)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction; Gender Dysphoria

Keywords

female-to-male; transgender; transsexual; Zephyr; erectile device; erectile implant; neophallus; phalloplasty; gender reassignment surgery; sex reassignment surgery

Outcome Measures

Primary Outcomes (1)

• Explantation-free survival

  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 Outcomes (2)

• Complication rate after implantation of this device

  90 days after implantation

• 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)

Interventions

Implantation of the Zephyr ZSI 475 FTM erectile implant OTHER

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: female-to-male transgenders after phalloplasty
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Urology, Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Gender Dysphoria

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Wesley Verla

  Dept. of Urology, Ghent University Hospital

  STUDY DIRECTOR

• Piet Hoebeke

  Dept. of Urology, Ghent University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley Verla

CONTACT

+32 9 332 22 76; wesley.verla@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 22, 2019
• Study Start: September 19, 2017
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)