Sexual Function of Trans Women After Vaginoplasty (GGAS-SEX)

February 9, 2023 updated by: Hospices Civils de Lyon

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Lille University Hospital
      • Limoges, France, 87000
        • Limoges university hospital
      • Lyon, France, 69000
        • Lyon South Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Transwomen who underwent vaginoplasty or revision in Lyon, Lille, Limoges between January 2007 and December 2019

Description

Inclusion Criteria:

  • > 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

Exclusion Criteria:

  • < 18 years old
  • Vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transwomen vaginoplasty
Transgender women who underwent vaginoplasty
Other: Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of FSFI : Female Sexual Function Index
Time Frame: At inclusion
specific questionnaire scale
At inclusion
evaluation of FGSIS : Female Genital Self Imaging Scale
Time Frame: At inclusion
specific questionnaire scale
At inclusion
evaluation of BIS : Body Image Scale
Time Frame: At inclusion
specific questionnaire scale
At inclusion
evaluation of Rosenberg Self-esteem scale
Time Frame: At inclusion
specific questionnaire scale
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2021

Primary Completion (ACTUAL)

January 5, 2022

Study Completion (ACTUAL)

January 5, 2022

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (ACTUAL)

March 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0746

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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