Gender Dysphoria Clinical Trial
— PROGASOfficial title:
Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
Verified date | December 2023 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Ghent | East-Flanders |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Baseline questionnaire, followed by reassessment at 12 and 24 months of follow-up | |
Secondary | 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) | Baseline questionnaire, followed by reassessment at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up | |
Secondary | Change in voiding function | Assessed with International Consultation on Incontinence Questionnaire on Male and Female Lower Urinary Tract Symptoms (ICIQ-MLUTS/ICIQ-FLUTS) | Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up | |
Secondary | Change in urinary continence | Assessed with International Consultation on Incontinence Questionnaire on Urge Incontinence short form questionnaire (ICIQ-UI SF) | Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up | |
Secondary | Change in maximum flow rate | Assessed by uroflowmetry (Qmax) | Uroflowmetry at baseline, followed by uroflowmetry at 3, 6, 12 and 24 months of follow-up | |
Secondary | Change in satisfaction with life by Likert and VAS scales | Assessed with Satisfaction with life scale (SWLS) questionnaire | Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up | |
Secondary | Change in satisfaction with life by Likert and VAS scales | Assessed with Subjective happiness scale (SHS) questionnaire | Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up | |
Secondary | Change in quality of life assessed by Likert scales. | Assessed by the EuroQol questionnaire EQ-5D-3L. | Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up | |
Secondary | Change in quality of life assessed by VAS scale. | Assessed by the EuroQol questionnaire EQ-VAS (0-100) | Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up | |
Secondary | Subjective patient satisfaction with surgical and functional outcome assessed by Likert scales. | Assessed with seven subjective patient satisfaction questions on different surgical and functional outcomes aspects using Likert scales | Assessed at 12 and 24 months of follow-up | |
Secondary | Patient motivations for surgery and extent to which these expectations were met as a result of the operation assessed by VAS scales | Assessed with fourteen motivational questions using VAS scales (0-100) | Baseline questions, followed by reassessed at 12 and 24 months of follow-up | |
Secondary | Postoperative complication rate | Categorized according to Clavien-Dindo classification system | Within 90 days postoperatively |
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