NCT06639763 Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients
| NCT ID | NCT06639763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Transgenderism |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-07-06 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-07-06 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Anne-Françoise Spinoit, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06639763 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Transgenderism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06639763 currently recruiting?
Yes, NCT06639763 is actively recruiting participants. Contact the research team at wietse.claeys@ugent.be for enrollment information.
Where is the NCT06639763 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06639763 clinical trial?
NCT06639763 is sponsored by University Hospital, Ghent. The principal investigator is Anne-Françoise Spinoit, MD, PhD at University Hospital, Ghent. The trial plans to enroll 1,000 participants.