Assessing genital sensitivity and sexual function after gender-affirming surgery
Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
This study is trying to see how gender-affirming surgery affects genital sensitivity and sexual function in transgender individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, East-Flanders) |
| Trial ID | NCT04993469 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of genital gender-affirming surgery on genital sensitivity and sexual functioning in individuals with gender dysphoria. It involves transgender males and females who wish to undergo surgeries such as phalloplasty, metoidioplasty, vaginoplasty, or vulvoplasty. Participants will undergo Semmes-Weinstein monofilament testing and complete questionnaires to assess their outcomes post-surgery. The goal is to better understand the relationship between surgical techniques and sexual function outcomes.
Who should consider this trial
Good fit: Ideal candidates include transgender individuals aged 18 and older with diagnosed gender dysphoria who are seeking genital gender-affirming surgery.
Not a fit: Patients who are cisgender or those who are unfit for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving sexual function and satisfaction for transgender individuals post-surgery.
How similar studies have performed: While there have been studies on urological outcomes, this specific focus on genital sensitivity and sexual function post-surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations * Patient age ≥ 18 years * Transgender male, female of gender non-conforming patient with diagnosed gender dysphoria and the specific wish to undergo genital gender affirming surgery * Fit for operation, based on the surgeon's expert opinion * Patient is able and willing to attend the follow-up consultations Exclusion Criteria: * Absence of signed written informed consent and thus a patient unwilling to participate. * Patient age \< 18 years * Cisgender patients * Patients unfit for operation * Patient declares that it will be impossible for him to attend the follow-up consultations
Where this trial is running
Ghent, East-Flanders
- University Hospital Ghent — Ghent, East-Flanders, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.