MedTrace Logo

Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons

NCT06639776 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-10-15

No results posted yet for this study

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

Conditions

Interventions

DIAGNOSTIC_TEST

Questionnaire

All erection prosthesis placements in post-phalloplasty transgender and gender non-conforming individuals at Ghent University Hospital from start of the gender clinic until June 2023 will be evaluated. All patients that are at least 6 months after erection prosthesis placement and currently have a functioning prosthesis in place are eligible and will be contacted. Upon inclusion and informed consent, the patient's medical files will be used to gather all necessary underlying medical information that is relevant to this study. will receive an email asking them to complete a questionnaire for themselves. At the end of this questionnaire the patient will be asked if they have a sexual partner and if this partner is willing to participate as well. After affirmation, the partner will be contacted in the same way. Patients will receive a series of questionnaires reviewing recent sexual activity, sexual preference, satisfaction with the erectile prosthesis and quality partner relationship.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Anne-Françoise Spinoit, MD, PhD · University Hospital, Ghent

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2024-12-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06639776 on ClinicalTrials.gov