Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-29 @ 2:44 PM
Study NCT ID:
NCT05900869
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C012210', 'term': 'BES'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': 'Change from Baseline 3 yers after surgery', 'description': 'Questionnaire on the evolution of sexuality. FSFI consists of 19 questions assessing 6 domains: sexual desire, arousal, lubrication, orgasm, sexual satisfaction and pain. It is based on the sexuality of the last 4 weeks. The questions report a score ranging from 0 or 1 to 5 and a different coefficient is assigned to each domain. The sum of these results constitutes the final score, between 2 and 32 with the threshold value defining an alteration of sexuality below 26.5/32.'}], 'secondaryOutcomes': [{'measure': 'Body Esteem Scale (BES)', 'timeFrame': 'Change from Baseline 3 yers after surgery', 'description': 'Self-esteem questionnaire BES is composed of 23 questions, rated on a 5-point Likert scale (never, rarely, sometimes, often and always) and divided into 3 items corresponding to different dimensions of self-esteem: appearance, attribution and weight. The score is between 23 and 115, and the higher it is, the higher the body esteem and the appearance evaluated positively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plastic Surgery']}, 'descriptionModule': {'briefSummary': 'Reduction nymphoplasty is the treatment of benign hyperplasia of the labia minora. This surgery is indicated in the event of functional, aesthetic or sexual discomfort. There has been a growing demand for this surgery over the past twenty years. It is necessary to remain vigilant because a request for cosmetic surgery can also be part of an obsession with body dysmorphism, former dysmorphophobia.\n\nInvestigators wish to study the postoperative results concerning sexuality, self-esteem and obsession with body dysmorphia in a cohort of patients followed prospectively and at more than 3 years postoperatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated on a reduction nymphoplasty, for uni or bilateral labia minora hypertrophy', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients informed of the objectives of the study and its progress,\n\nExclusion Criteria:\n\nPatients in a period of exclusion determined by another study. Patients under judicial safeguard, guardianship or curatorship. Patients for whom it is impossible to give informed information.'}, 'identificationModule': {'nctId': 'NCT05900869', 'acronym': 'NYRESED', 'briefTitle': 'Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia', 'orgStudyIdInfo': {'id': 'NYRESED-Local/2023/JS-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FSFI', 'type': 'OTHER', 'description': 'Female Sexual Function Index questionnaire'}, {'name': 'BES', 'type': 'OTHER', 'description': 'Body Esteem Scale questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Jenifer SALERNO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}