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

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria
• Intervention / Treatment: Diagnostic test: Semmes-Weinstein monofilament testing and questionnaires

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • Recruiting
      • University Hospital Ghent
      • Principal Investigator: Anne-Françoise Spinoit, MD, PhD
      • Sub-Investigator: Wietse Claeys, MD
      • Contact: Wietse Claeys, MD; Phone Number: 003293321702; Email: wietse.claeys@uzgent.be
      • Contact: Nicolaas Lumen, MD, PhD; Phone Number: 003293322276; Email: nicolaas.lumen@uzgent.be
      • Principal Investigator: Nicolaas Lumen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 108 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genital sensation and sexual functioning assessment; Genital sensation testing with clinical assessment and self-examination questionnaire. Sexual functioning testing with questionnaires.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
Postoperative complication rate	Categorized according to Clavien-Dindo classification system	Within 90 days postoperatively

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Vaginoplasty; Phalloplasty; Metoidioplasty; Vulvoplasty
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: B6702021000410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No