Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
158 participants
OBSERVATIONAL
2021-11-16
2022-01-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Peritoneum Vaginoplasty; Implementation According to IDEAL Framework
NCT05925361
Female Sexual Function After Cystectomy
NCT04592848
Urogynecological and Sexual Functions After Vecchietti Operation
NCT03809819
Gynaecological Care for Transgender People in France in 2024.
NCT06357130
Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
NCT02859272
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Transwomen vaginoplasty
Transgender women who underwent vaginoplasty
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lille University Hospital
Lille, , France
Limoges University Hospital
Limoges, , France
Lyon South Hospital
Lyon, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69HCL21_0746
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.