Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 7:11 AM
Study NCT ID:
NCT00762593
Status:
UNKNOWN
Last Update Posted:
2008-10-17
First Post:
2008-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-16', 'studyFirstSubmitDate': '2008-09-29', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Urodynamic investigation', 'timeFrame': '4 and 8 weeks'}, {'measure': 'Standardised Pad test', 'timeFrame': '4 and 8 weeks'}, {'measure': 'Number of severe urinary stress incontinence episodes', 'timeFrame': '4 and 8 weeks'}, {'measure': 'Number of sanitary napkins used', 'timeFrame': '4 and 8 weeks'}, {'measure': 'Leakage index', 'timeFrame': '4 and 8 weeks'}, {'measure': 'Subjective appreciation of patients', 'timeFrame': '4 and 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['urinary stress incontinence', 'urinary stress incontinence in women'], 'conditions': ['Urinary Stress Incontinence']}, 'descriptionModule': {'briefSummary': 'To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>=18 years old\n* Signed informed consent form\n* Women with urinary stress incontinence defined as follow\n* Involuntary loss of urine during increased abdominal pressure. In case of mix urinary incontinence (i.e., stress urinary incontinence associated to urge urinary incontinence) the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogic scale is higher for stress incontinence than for urge incontinence symptoms.\n* closure pressure between 10 and 60 cm H2O\n* the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogical scale is higher than 40/100\n* Patients never treated with transvaginal electrical stimulation\n* Vaginal muscle strength less than 3/5 on the muscular testing\n* Positive Pad test (\\>2 g of leakage measure by pad test with standardised bladder volume)\n\nExclusion Criteria:\n\n* Patient refusing to sign the consent form\n* patient unable to understand or follow the protocol\n* inadequate cognitive ability\n* patient participating in another research protocol within the 3 previous months\n* pregnancy\n* women with no contraception\n* pacemaker\n* history of recent (\\< 1 year) transvaginal electrical stimulation treatment at home\n* urinary incontinence other than stress incontinence\n* neurological disease\n* permanent metrorrhagia\n* ongoing urinary tract infections\n* vaginal prolapse \\> 2\n* untreated atrophic vaginitis\n* history of surgical treatment for urinary stress incontinence or genital prolapse\n* recent pelvic surgery (\\<6 months)\n* anatomic defect that preclude the use of the device\n* genitourinary cancer or colic cancer\n* patient already treated for urinary stress incontinence\n* Recent oestrogen treatment (less than 3 weeks)'}, 'identificationModule': {'nctId': 'NCT00762593', 'acronym': 'KEAT F1', 'briefTitle': 'Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akontis'}, 'officialTitle': 'A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence', 'orgStudyIdInfo': {'id': 'KEAT F1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks', 'interventionNames': ['Device: transvaginal electrical stimulation device']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks', 'interventionNames': ['Device: transvaginal placebo device']}], 'interventions': [{'name': 'transvaginal placebo device', 'type': 'DEVICE', 'description': 'Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks', 'armGroupLabels': ['2']}, {'name': 'transvaginal electrical stimulation device', 'type': 'DEVICE', 'description': 'Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': "Centre européen d'explorations gynécologiques", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akontis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jacques Croissandeau', 'oldOrganization': 'Akontis'}}}}