Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-04 @ 2:32 AM
Study NCT ID:
NCT05292820
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Function of Trans Women After Vaginoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000068116', 'term': 'Gender Dysphoria'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of FSFI : Female Sexual Function Index', 'timeFrame': 'At inclusion', 'description': 'specific questionnaire scale'}, {'measure': 'evaluation of FGSIS : Female Genital Self Imaging Scale', 'timeFrame': 'At inclusion', 'description': 'specific questionnaire scale'}, {'measure': 'evaluation of BIS : Body Image Scale', 'timeFrame': 'At inclusion', 'description': 'specific questionnaire scale'}, {'measure': 'evaluation of Rosenberg Self-esteem scale', 'timeFrame': 'At inclusion', 'description': 'specific questionnaire scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genital gender affirming surgery', 'Gender dysphoria', 'Transwomen', 'Vaginoplasty', 'Sexuality', 'Satisfaction'], 'conditions': ['Gender Dysphoria Vaginoplasty Sexuality']}, 'descriptionModule': {'briefSummary': '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.\n\nDifferent 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.\n\nVaginoplasty has a major place in the the transgender woman pathway, but the specific evaluation of long-term sexuality has not been explored so far.\n\nMulticentric (Lyon, FR - Lille, FR - Limoges, FR), prospective, observational study Patients who underwent vaginoplasty or revision vaginoplasty.\n\nMain objective:\n\nTo assess sexuality after sex reassignment surgery in transgender women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transwomen who underwent vaginoplasty or revision in Lyon, Lille, Limoges between January 2007 and December 2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old\n* Underwent vaginoplasty or revision in Lyon South Hospital, Lille University Hospital, Limoges University Hospital, between January 2007 and December 2019\n* Penile inversion vaginoplasty with scrotal skin graft\n\nExclusion Criteria:\n\n* \\< 18 years old\n* Vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap'}, 'identificationModule': {'nctId': 'NCT05292820', 'acronym': 'GGAS-SEX', 'briefTitle': 'Sexual Function of Trans Women After Vaginoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Exploring Sexual Function and Satisfaction of Trans Women After Vaginoplasty: Results of a Multicentric Survey', 'orgStudyIdInfo': {'id': '69HCL21_0746'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transwomen vaginoplasty', 'description': 'Transgender women who underwent vaginoplasty', 'interventionNames': ['Other: Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure']}], 'interventions': [{'name': 'Validated and non-validated questionnaire for exploration of sexuality and satisfaction after surgical procedure', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Transwomen vaginoplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Lille University Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'Limoges University Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Lyon South Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}