Gender DysphoriaPROGASNCT04993469
Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
A study testing Semmes-Weinstein monofilament testing and questionnaires in people with Gender Dysphoria, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- Semmes-Weinstein monofilament testing and questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 27 May 2021to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, East-Flanders, 9000
Wietse Claeys, MD, 003293321702, wietse.claeys@uzgent.be
Nicolaas Lumen, MD, PhD, 003293322276, nicolaas.lumen@uzgent.be
About this study
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.
Read the 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.
- Conditions
- Gender Dysphoria
- Being tested
- Semmes-Weinstein monofilament testing and questionnaires
- Keywords
- Phalloplasty, Metoidioplasty, Vaginoplasty, Vulvoplasty
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semmes-Weinstein monofilament testing and questionnairesDiagnostic test
Semmes-Weinstein test for the assessment of genital sensation Battery of questionnaires assessing sexual function, voiding function, quality of life and patient satisfaction
| Study group | Role | What they receive |
|---|---|---|
| Genital sensation and sexual functioning assessment | Experimental | Genital sensation testing with clinical assessment and self-examination questionnaire.
Sexual functioning testing with questionnaires. Receives: Diagnostic Test: Semmes-Weinstein monofilament testing and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Assessed with Male Sexual Health Questionnaire/Female Sexual Function Index questionnaires (MSHQ/FSFI) with added questions specifically on penetrative sexual activity
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Change in maximum flow rate
Assessed by uroflowmetry (Qmax)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline questions, followed by reassessed at 12 and 24 months of follow-up
Postoperative complication rate
Categorized according to Clavien-Dindo classification system
Measured: Within 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start27 May 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment Single centre open label prospective
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993469
- Sponsor's protocol ID
- B6702021000410
- Acronym
- PROGAS
- Status last verified
- Dec 2023
- First submitted
- 4 Jun 2021
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
- ClinicalTrials.gov ID
- NCT04993469
- Acronym / sponsor ID
- PROGAS / B6702021000410
- Conditions
- Gender Dysphoria
- Keywords
- Phalloplasty, Metoidioplasty, Vaginoplasty, Vulvoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment Single centre open label prospective
| Arm | Type | Receives |
|---|---|---|
| Genital sensation and sexual functioning assessment | Experimental | Diagnostic Test: Semmes-Weinstein monofilament testing and questionnairesGenital sensation testing with clinical assessment and self-examination questionnaire. Sexual functioning testing with questionnaires. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semmes-Weinstein monofilament testing and questionnairesSemmes-Weinstein test for the assessment of genital sensation Battery of questionnaires assessing sexual function, voiding function, quality of life and patient satisfaction | Diagnostic test | Genital sensation and sexual functioning assessment |
Primary outcome
Change in genital sensitivity pattern at 24 months
Time frame: Baseline function test, followed by reassessment at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up
Mapping of pressure thresholds of Semmes-Weinstein monofilaments in pre-defined areas of the neo-genital area
12 secondary outcomes
Change in postoperative sexual function
Time frame: Baseline questionnaire, followed by reassessment at 12 and 24 months of follow-up
Change in self-assessment of genital anatomy and genital sensitivity
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up
Change in voiding function
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Change in urinary continence
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Change in maximum flow rate
Time frame: 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
Time frame: 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
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Change in quality of life assessed by Likert scales.
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Change in quality of life assessed by VAS scale.
Time frame: 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.
Time frame: 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
Time frame: Baseline questions, followed by reassessed at 12 and 24 months of follow-up
Postoperative complication rate
Time frame: Within 90 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semmes-Weinstein monofilament testing and questionnaires in people with Gender Dysphoria, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in genital sensitivity pattern at 24 months (time frame: Baseline function test, followed by reassessment at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.