Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-29 @ 4:19 PM
Study NCT ID:
NCT07084766
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women', 'timeFrame': '1 day', 'description': 'To determine the difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uterine anteflexion', 'nulliparous women', 'full bladder', 'angle of anteflexion or retroflexion of the uterus', 'ultrasound measurements'], 'conditions': ['Uterine Anteflexion', 'Parous Women']}, 'descriptionModule': {'briefSummary': 'Intrauterine devices (IUDs) account for approximately 25% of contraceptive methods used in France. However, their insertion can be painful for patients and challenging for practitioners, particularly due to the passage through the cervix and the uterine flexion angle. An interventional study conducted by Cameron in 2013 examined the impact of bladder filling on the ease of IUD insertion. The results did not show a significant benefit, suggesting that a full bladder does not necessarily improve the procedure. An ongoing study, FLEXIMIX, led by the coordinator, explores the variation in the uterine flexion angle based on bladder filling in 250 nulliparous women. Preliminary results indicate a strong influence of bladder filling on the flexion angle. Additionally, the Valsalva maneuver, which involves increasing intra-abdominal pressure by forceful exhalation against a closed glottis, has been shown in two recent studies to facilitate gynecological interventions by improving cervical passage, thereby reducing the need for invasive instruments such as the tenaculum.What happens in parous women and during the Valsalva maneuver remains to be explored.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'have a uterus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women\n* Parous\n* Experiencing the need to urinate\n* Affiliated with a social security scheme or equivalent\n\nExclusion Criteria:\n\n* Pregnant women\n* Desire for pregnancy with ongoing conception process\n* Age \\> 65 years\n* History of hysterectomy\n* History of conization\n* Childbirth \\< 6 months\n* Irrepressible need to urinate\n* Inability or refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07084766', 'acronym': 'FLEXIMIX 2', 'briefTitle': 'The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.', 'orgStudyIdInfo': {'id': '29BRC25.0036'}, 'secondaryIdInfos': [{'id': 'ID RCB', 'type': 'OTHER', 'domain': '2025-A00826-43'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Transabdominal ultrasonography', 'description': 'Ultrasound measurements before and after bladder emptying', 'interventionNames': ['Procedure: ultrasonography, pelvic']}], 'interventions': [{'name': 'ultrasonography, pelvic', 'type': 'PROCEDURE', 'description': 'Ultrasound measurements will be taken before and after bladder emptying. The axes of the uterine body, cervix and vagina will be marked out by tracing the 3 corresponding lines on the image.', 'armGroupLabels': ['Transabdominal ultrasonography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'state': 'Finistere', 'country': 'France', 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}