Actively Recruiting

Age: 18Years +
FEMALE
ID06639776

Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons: a Retrospective Cohort

Led by University Hospital, Ghent · Updated on 2024-10-15

150

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying sexual satisfaction in transgender men and their partners after receiving erectile prostheses following phalloplasty surgery. Phalloplasty creates a neophallus but lacks natural erectile tissue, so internal erectile aids are often used. The study addresses challenges with prostheses originally designed for cisgender men, including higher risks of complications and mechanical failures. It also explores the gap in knowledge about patient and partner satisfaction using validated and non-validated questionnaires in individuals at least 6 months post-prosthesis placement with a functioning device. Participants include transgender or gender non-conforming individuals who have had phalloplasty and received an internal erectile prosthesis at least six months prior, with any type of prosthesis allowed. The study collects data through questionnaires sent by email, covering sexual activity, preference, satisfaction with the prosthesis, and quality of partner relationships. Partners may also participate if willing. The study focuses on understanding satisfaction and complications related to different prostheses, including newer devices designed specifically for transgender men. During the study, participants complete one-time questionnaires assessing treatment satisfaction, sexual function including capability of vaginal or anal penetration, relationship and sexual satisfaction, quality of life, willingness to undergo redo surgery, prior use of external devices, urinary symptoms, and prosthesis complications. Medical records are reviewed for relevant information. The study is observational and involves no experimental treatments. Participants and their partners provide voluntary consent, and the research aims to improve understanding of sexual and relational outcomes in this population.

CONDITIONS

Brief Title

Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient and partner age 18 years or older
  • Transgender or gender non-conforming individuals diagnosed with gender dysphoria according to DSM-5
  • Patients who have undergone phalloplasty of any type
  • Erectile prosthesis placement at least 6 months after phalloplasty at Ghent University Hospital
  • Functional erectile prosthesis at the time of study
  • Ability to speak Dutch, English, or French
  • Voluntary written consent by patient and optional partner
Not Eligible

You will not qualify if you...

  • Patient younger than 18 years
  • Cisgender patients treated with phalloplasty or erection prosthesis
  • Prosthesis removed or nonfunctional at time of assessment
  • Prosthesis placement less than 6 months before study start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility and obtain consent

Diagnostic Evaluation

Duration - One-time assessment at least 6 months after erection prosthesis placement

Participants complete questionnaires regarding sexual activity, satisfaction with the erectile prosthesis, and partner relationship quality.

1 questionnaire completion session (remote or in-person)

Trial Site Locations

Total: 1 location

1

Department of Urology, University Hospital Ghent

Ghent, East-Flanders, Belgium, 9000

Actively Recruiting

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Research Team

W

Wietse Claeys, MD

A

Anne-Françoise Spinoit, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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