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

NCT04993469 | Recruiting

• 1 other identifier: B6702021000410
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gender Dysphoria

Keywords

Phalloplasty; Metoidioplasty; Vaginoplasty; Vulvoplasty

Outcome Measures

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

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

Secondary Outcomes (12)

• Change in postoperative sexual function

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

• Change in self-assessment of genital anatomy and genital sensitivity

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

• Change in voiding function

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

• Change in urinary continence

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

• Change in maximum flow rate

  Uroflowmetry at baseline, followed by uroflowmetry at 3, 6, 12 and 24 months of follow-up

Study Arms (1)

Genital sensation and sexual functioning assessment

EXPERIMENTAL

Genital sensation testing with clinical assessment and self-examination questionnaire. Sexual functioning testing with questionnaires.

Diagnostic Test: Semmes-Weinstein monofilament testing and questionnaires

Interventions

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

Genital sensation and sexual functioning assessment

Eligibility Criteria

• Age: 18 Years - 110 Years
• Gender Eligibility Details: The study is specific to patients with gender dysphoria who wish to undergo genital gender affirming surgery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment Single centre open label prospective

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: August 6, 2021
• Study Start: May 27, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)