Gender Dysphoria Vaginoplasty SexualityGGAS-SEXNCT05292820
Sexual Function of Trans Women After Vaginoplasty
An observational study of Gender Dysphoria Vaginoplasty Sexuality, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Genital feminine affirming surgery may be an important step for transgender women. Vaginoplasty consists in the creation of external female genitalia and an operational vaginal cavity, and thus responds to major functional and aesthetic issues. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gender Dysphoria Vaginoplasty Sexuality
- What is being tested?
- Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure
- How many people
- 158 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Nov 2021to 5 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Transwomen who underwent vaginoplasty or revision in Lyon, Lille, Limoges between January 2007 and December 2019
Who may be able to join
- > 18 years old
- Underwent vaginoplasty or revision in Lyon South Hospital, Lille University Hospital, Limoges University Hospital, between January 2007 and December 2019
- Penile inversion vaginoplasty with scrotal skin graft
Who cannot join
- < 18 years old
- Vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap
Trial locations and contacts
3 sites in 1 country.
France3 sites
Lille University Hospital
Lille, 59000
Limoges University Hospital
Limoges, 87000
Lyon South Hospital
Lyon, 69000
About this study
Official title: Exploring Sexual Function and Satisfaction of Trans Women After Vaginoplasty: Results of a Multicentric Survey
Genital feminine affirming surgery may be an important step for transgender women. Vaginoplasty consists in the creation of external female genitalia and an operational vaginal cavity, and thus responds to major functional and aesthetic issues.
Different techniques are available: inversion of penile skin flap for creation of the vulva. The vaginal cavity may come from scrotal skin graft, sigmoid segment, small intestine, or peritoneal flap.
Read more
Vaginoplasty has a major place in the the transgender woman pathway, but the specific evaluation of long-term sexuality has not been explored so far.
Multicentric (Lyon, FR - Lille, FR - Limoges, FR), prospective, observational study Patients who underwent vaginoplasty or revision vaginoplasty.
Main objective:
To assess sexuality after sex reassignment surgery in transgender women.
- Conditions
- Gender Dysphoria Vaginoplasty Sexuality
- Being tested
- Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure
- Keywords
- Genital gender affirming surgery, Gender dysphoria, Transwomen, Vaginoplasty, Sexuality, Satisfaction
- Medical subject headings
- Gender Dysphoria, Sexuality, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedureOther
Validated questionnaire : Female Sexual Function Index (FSFI), Female Genital Self-Imaging Scale (FGSIS), Body Image Scale (BIS), Non-validated questionnaire exploring post-surgery satisfaction, self-esteem scale, sexology.
| Study group | Role | What they receive |
|---|---|---|
| Transwomen vaginoplasty | Transgender women who underwent vaginoplasty Receives: Other: Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of FSFI : Female Sexual Function Index
specific questionnaire scale
Measured: At inclusion
evaluation of FGSIS : Female Genital Self Imaging Scale
specific questionnaire scale
Measured: At inclusion
evaluation of BIS : Body Image Scale
specific questionnaire scale
Measured: At inclusion
evaluation of Rosenberg Self-esteem scale
specific questionnaire scale
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start16 Nov 2021
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Dysphoria Vaginoplasty SexualityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292820
- Sponsor's protocol ID
- 69HCL21_0746
- Acronym
- GGAS-SEX
- Status last verified
- Feb 2023
- First submitted
- 14 Mar 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Sexual Function and Satisfaction of Trans Women After Vaginoplasty: Results of a Multicentric Survey
- ClinicalTrials.gov ID
- NCT05292820
- Acronym / sponsor ID
- GGAS-SEX / 69HCL21_0746
- Conditions
- Gender Dysphoria Vaginoplasty Sexuality
- Keywords
- Genital gender affirming surgery, Gender dysphoria, Transwomen, Vaginoplasty, Sexuality, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 23 Mar 2022 (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.
Genital feminine affirming surgery may be an important step for transgender women. Vaginoplasty consists in the creation of external female genitalia and an operational vaginal cavity, and thus responds to major functional and aesthetic issues.
Different techniques are available: inversion of penile skin flap for creation of the vulva. The vaginal cavity may come from scrotal skin graft, sigmoid segment, small intestine, or peritoneal flap.
Vaginoplasty has a major place in the the transgender woman pathway, but the specific evaluation of long-term sexuality has not been explored so far.
Multicentric (Lyon, FR - Lille, FR - Limoges, FR), prospective, observational study Patients who underwent vaginoplasty or revision vaginoplasty.
Main objective:
To assess sexuality after sex reassignment surgery in transgender women.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transwomen vaginoplasty | – | Other: Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedureTransgender women who underwent vaginoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transwomen who underwent vaginoplasty or revision in Lyon, Lille, Limoges between January 2007 and December 2019
Key inclusion criteria (3 listed)
- > 18 years old
- Underwent vaginoplasty or revision in Lyon South Hospital, Lille University Hospital, Limoges University Hospital, between January 2007 and December 2019
- Penile inversion vaginoplasty with scrotal skin graft
Key exclusion criteria (2 listed)
- < 18 years old
- Vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap
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 |
|---|---|---|
| Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedureValidated questionnaire : Female Sexual Function Index (FSFI), Female Genital Self-Imaging Scale (FGSIS), Body Image Scale (BIS), Non-validated questionnaire exploring post-surgery satisfaction, self-esteem scale, sexology. | Other | Transwomen vaginoplasty |
Primary outcome
evaluation of FSFI : Female Sexual Function Index
Time frame: At inclusion
specific questionnaire scale
evaluation of FGSIS : Female Genital Self Imaging Scale
Time frame: At inclusion
specific questionnaire scale
evaluation of BIS : Body Image Scale
Time frame: At inclusion
specific questionnaire scale
evaluation of Rosenberg Self-esteem scale
Time frame: At inclusion
specific questionnaire scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria Vaginoplasty Sexuality, run by Hospices Civils de Lyon at 3 sites in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of FSFI : Female Sexual Function Index (time frame: At inclusion). The study lists 4 primary outcomes in all. 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 10 Feb 2023.