Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-31 @ 10:12 AM
Study NCT ID:
NCT04227392
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2020-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2020-01-01', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of vaginal laxity score from baseline', 'timeFrame': 'baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session', 'description': 'subjective vaginal laxity'}], 'secondaryOutcomes': [{'measure': 'change of FSFI score from baseline', 'timeFrame': 'baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session', 'description': 'female sexual function index, higher is better'}, {'measure': 'change of FSDS score from baseline', 'timeFrame': 'baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session', 'description': 'female sexual distress scale, lower is better'}, {'measure': 'change of vaginal pressure from baseline', 'timeFrame': 'baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session', 'description': 'vaginal pressure measured with manometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Laxity']}, 'descriptionModule': {'briefSummary': 'To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vaginal laxity score \\>= 3\n* negative pregnancy test within 2 months\n\nExclusion Criteria:\n\n* genital anomaly\n* pelvic prolapse stage \\>= stage 3\n* active genital infection\n* vulvar pain or deformity\n* disease related to sexual behavior\n* current, chronic NSAIDs intake\n* fever\n* any acute illness\n* cognitive disorder\n* pacemaker insertion\n* metal implants'}, 'identificationModule': {'nctId': 'NCT04227392', 'acronym': 'ROSE', 'briefTitle': 'Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial', 'orgStudyIdInfo': {'id': 'E-1801-444-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'women who undergo radiofrequency therapy', 'interventionNames': ['Device: vaginal radiofrequency']}], 'interventions': [{'name': 'vaginal radiofrequency', 'type': 'DEVICE', 'description': '2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463707', 'city': 'Seongnam-si', 'state': 'Gyenggi DO', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}