Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
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
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
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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