Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons (NCT06639776) | Clinical Trial Compass
RecruitingNot Applicable
Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
Belgium150 participantsStarted 2024-07-15
Plain-language summary
This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty. While phalloplasty can create a neophallus, the lack of natural erectile tissue often necessitates the use of erectile aids, including internal prostheses. However, these prostheses, originally designed for cisgender men, face challenges when used in transgender patients, such as higher risks of complications, infections, and mechanical failures. Despite these issues, some studies report high patient satisfaction, though partner satisfaction rates are significantly lower. The study will use validated and non-validated questionnaires to assess satisfaction with various types of erectile prostheses, addressing the gap in understanding how these devices impact the sexual and relational functioning of both transgender men and their partners. These questionnaires will be provided to all included patients that are minimum 6 months after placement of an internal erection prosthesis and have a functional erection prosthesis in place
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient and partner age ≥ 18 years.
* Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria.
* Patients have undergone phalloplasty as a form of genital gender affirming surgery (any type of flap combination or technique is allowed).
* Erection prosthesis placement ≥ 6 months after phalloplasty, performed at the Ghent University Hospital. Any type of prosthesis is allowed.
* Patient has a functional erectile prosthesis at the time of the study. Number of erectile prosthesis is not relevant for inclusion.
* Patient is Dutch, English or French speaking.
* Voluntary signed and written consent by patient and their optional partner.
Exclusion Criteria:
* Patient age \< 18 years.
* Cisgender patients treated with phalloplasty and/or erection prosthesis for various reasons.
* The erection prosthesis has been explanted or the current prosthesis is nonfunctional at time of data assessment.
* Erection prosthesis placement \< 6 months before study start will be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment satisfaction
Timeframe: One-time questionnaire at least 6 months after erection prosthesis placement
2
Capability of vaginal and/or anal penetration of the participant and sexual functioning
Timeframe: One-time questionnaire at least 6 months after erection prosthesis placement