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OpenTrials
Completed

NCT Number: NCT05292820

Sexual Function of Trans Women After Vaginoplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lille University Hospital, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure

Other

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.

Primary outcomes

  1. evaluation of FSFI : Female Sexual Function Index

    Time frame: At inclusion

    specific questionnaire scale

  2. evaluation of FGSIS : Female Genital Self Imaging Scale

    Time frame: At inclusion

    specific questionnaire scale

  3. evaluation of BIS : Body Image Scale

    Time frame: At inclusion

    specific questionnaire scale

  4. evaluation of Rosenberg Self-esteem scale

    Time frame: At inclusion

    specific questionnaire scale

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Exploring Sexual Function and Satisfaction of Trans Women After Vaginoplasty: Results of a Multicentric Survey

Acronym: GGAS-SEX

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2022
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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