Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients (NCT06639763) | Clinical Trial Compass
RecruitingNot Applicable
Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients
Belgium1,000 participantsStarted 2024-07-06
Plain-language summary
This study seeks to explore the various methods used by transgender men for sexual intercourse following phalloplasty or metoidioplasty, focusing on their satisfaction with different erectile aids, as well as the satisfaction of their partners. Phalloplasty and metoidioplasty are gender-affirming surgeries that often require additional aids to achieve the desired sexual function, particularly for penetration. While internal erectile prostheses are common after phalloplasty, they come with high complication rates, leading some patients to opt for non-surgical aids. However, the effectiveness and comfort of these aids are not well-documented. This study aims to fill this gap by examining the types of aids transgender men use, how well these aids meet their sexual needs, and how satisfied both they and their partners are with the outcomes, providing much-needed insight for healthcare providers and patients alike.
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 (and their partners).
* Patients have undergone phalloplasty or metoidioplasty as a form of genital gender affirming surgery.
* ≥6 months after phalloplasty or metoidioplasty (any type of flap or technique is allowed).
* Sexually active or has been sexually active since phalloplasty or metoidioplasty with a partner or main sexual partner.
* Voluntarily agreed that the data may be used for an anonymized scientific study.
Exclusion Criteria:
* Patient age \< 18 years.
* Cisgender patients treated with phalloplasty or metoidioplasty for various reasons.
* \<6 months after phalloplasty or metoidioplasty.
* Not sexually active since phalloplasty/metoidioplasty.
* Patient and/or partner have no interest in penetrative sexual intercourse.
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
Types of erectile aids used
Timeframe: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
2
Treatment satisfaction
Timeframe: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty