Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-25 @ 5:44 PM
Study NCT ID:
NCT02899520
Status:
TERMINATED
Last Update Posted:
2020-01-03
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Programs of Reeducation for Urinary Incontinence in Woman
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Change in the clinical practices', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-31', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'USP (Urinary Symptoms Profile) score', 'timeFrame': '38 weeks', 'description': 'Urinary Symptoms Profile score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients more than 18 years old and less than 75 years\n* Patients presenting an urinary incontinence of effort or mixed symptomatic associated with a pelvic statics disorder\n* Patients with a perineale reeducation prescription\n* Patients affiliated to a national insurance scheme or benefiting from such a program\n* Patients having given her written consent form\n\nExclusion Criteria:\n\n* Nulliparous woman\n* Patients already operated for their incontinence\n* Patients with a prolapse of higher level at the stage II of the classification POP-Q (Pelvic Organ Prolapse Quantification)\n* Pregnant women\n* Patients presenting an associated anal incontinence,\n* Patients presenting a cancellation (section of marrow, syringomyelia for example) or an inversion of perineum control\n* Patients having given birth less than 6 months before the care\n* Patients having benefited from a pelvi-périnéale reeducation in the previous 12 months,\n* Patients presenting psychiatric disease\n* Patients presenting a vaginismus,\n* Patients presenting a contraindication to the practice of the electrostimulation.'}, 'identificationModule': {'nctId': 'NCT02899520', 'acronym': 'ReedPerinee', 'briefTitle': 'Evaluation of Programs of Reeducation for Urinary Incontinence in Woman', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'orgStudyIdInfo': {'id': '2014/09'}, 'secondaryIdInfos': [{'id': '2014-A00709-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Reference method', 'interventionNames': ['Other: Reference method']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'CMP ® method (Knowledge and Control of Perineum)', 'interventionNames': ['Other: CMP ® method']}], 'interventions': [{'name': 'Reference method', 'type': 'OTHER', 'description': 'Electrostimulation associated to perineal training', 'armGroupLabels': ['Group A']}, {'name': 'CMP ® method', 'type': 'OTHER', 'description': 'Method based on Knowledge and Control of Perineum', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Sophie FLANDIN-CRETINON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}