Health TrialsbyHealthPanel

Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery

ConditionGender Dysphoria
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorUniversity Hospital, Ghent

About this trial

For genital gender affirming surgery, it remains unclear to what extent genital sensitivity might be expected and what the impact of this might be on sexual functioning.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Absence of signed written informed consent and thus a patient unwilling to participate.

Patient age < 18 years

Cisgender patients

Patients unfit for operation

Trial design

Design model

Single group

Treatments tested in this trial

  • Semmes-Weinstein monofilament testing and questionnaires

    Diagnostic test

    Semmes-Weinstein test for the assessment of genital sensation Battery of questionnaires assessing sexual function, voiding function, quality of life and patient satisfaction

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Genital sensation and sexual functioning assessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in genital sensitivity pattern at 24 months

Mapping of pressure thresholds of Semmes-Weinstein monofilaments in pre-defined areas of the neo-genital area

Time frame
Baseline function test, followed by reassessment at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up

Secondary outcomes

1

Change in postoperative sexual function

Assessed with Male Sexual Health Questionnaire/Female Sexual Function Index questionnaires (MSHQ/FSFI) with added questions specifically on penetrative sexual activity

Time frame
Baseline questionnaire, followed by reassessment at 12 and 24 months of follow-up
2

Change in self-assessment of genital anatomy and genital sensitivity

Assessed with Self-Assessment of Genital Anatomy and Sexual Function (Male and Female) questionnaires (SAGASF-M/SAGASF-F)

Time frame
Baseline questionnaire, followed by reassessment at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up
3

Change in voiding function

Assessed with International Consultation on Incontinence Questionnaire on Male and Female Lower Urinary Tract Symptoms (ICIQ-MLUTS/ICIQ-FLUTS)

Time frame
Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
4

Change in urinary continence

Assessed with International Consultation on Incontinence Questionnaire on Urge Incontinence short form questionnaire (ICIQ-UI SF)

Time frame
Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Source ClinicalTrials.gov
Apply now