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

Gender Dysphoria Clinical Trial

— PROGAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993469
• Other study ID #: B6702021000410
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Gender dysphoria refers to an inner mental unrest resulting from an incongruity between the assigned biological sex and the mentally experienced sex. The generally accepted treatment for gender dysphoria aims to bring a person's physical characteristics in line with his or her perceived gender identity. This gender-affirming treatment consists of a combination of psychological counselling, hormonal therapy and, if desired, genital gender-affirming surgery. This involves the removal of the biological reproductive organs and in some cases (part of) the biological sex organs. These can be replaced by surrogate sex organs of the desired sex while maintaining urological and sexual function. In transgender women, this is achieved with vulvoplasty or vaginoplasty, while in transgender men, metoidioplasty or phalloplasty is performed.

While urological functioning is an extensively studied topic in transgender patients after genital gender confirmation surgery, sexual functioning is often considered of secondary importance, even though it is one of the goals of gender confirmation surgery. In the transgender man, a phalloplasty is performed using microsurgical techniques that allow the nerves of the donor flap (usually from the forearm or upper leg) to be connected to the genital and inguinal nerves. In metoidioplasty, the clitoris is preserved and forms the base of a micro-penis. In the transgender woman, the glans penis is partially preserved to create a clitoris. The purpose of this is to achieve maximum sensitivity of the genital area.

There are few reports in the literature demonstrating sensory recovery in these extensively operated body parts, let alone what the added value on sexual functioning might be as a result of this recovery of genital sensitivity. At Ghent University Hospital, we now have more than 30 years' experience with such operations and have shared this experience in an almost entirely retrospective manner in various publications to date. However, in order to address the bias associated with retrospective research, this study aims to prospectively and observationally collect data on these patients who are counseled in a pathway for gender dysphoria. This study will include all patients - after informed consent - and will collect specific data on surgical outcome (complications after surgery, duration of surgery, type of surgery) and functional outcome (tailored questionnaires for patients undergoing such a treatment with questions on urination, erections, sexual experience, quality of life, patient satisfaction and genital sensitivity) for each of these various surgical options. These outcomes will be verified at follow-up moments (after 3 months, 6 months, 12 months and 24 months). Specifically for the component on genital sensitivity, we plan to follow up patients 3-monthly by means of a Semmes-Weinstein monofilament test of the genital region up to 24 months postoperatively. The aim of this study is therefore to use this prospectively collected data to truthfully map our experience, to be critical, to reflect and optimize our daily clinical practice in the interest of the patient.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Gender Dysphoria

Intervention

Diagnostic Test:
• Semmes-Weinstein monofilament testing and questionnaires
Semmes-Weinstein test for the assessment of genital sensation Battery of questionnaires assessing sexual function, voiding function, quality of life and patient satisfaction

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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