NCT06639776 Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
| NCT ID | NCT06639776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Transgenderism |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2024-12-31 |
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 150 participants in total. It began in 2024-07-15 with a primary completion date of 2024-12-31.
⚠ 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 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
Eligibility Criteria
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.
Contact & Investigator
Anne-Françoise Spinoit, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06639776 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 NCT06639776 currently recruiting?
Yes, NCT06639776 is actively recruiting participants. Contact the research team at wietse.claeys@ugent.be for enrollment information.
Where is the NCT06639776 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06639776 clinical trial?
NCT06639776 is sponsored by University Hospital, Ghent. The principal investigator is Anne-Françoise Spinoit, MD, PhD at University Hospital, Ghent. The trial plans to enroll 150 participants.