Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01392651
Status:
COMPLETED
Last Update Posted:
2014-07-03
First Post:
2011-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-02', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of stress incontinence', 'timeFrame': '12 months', 'description': 'We will collect data from the files, question the women for possible urinary stress incontinence after one month, 6 months and 12 months after surgery. Data of physical examination will also be incorporated.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of side effects: tape erosion, pain, bleeding', 'timeFrame': '12 months', 'description': 'We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary stress incontinence', 'TVT'], 'conditions': ['Urinary Stress Incontinence']}, 'descriptionModule': {'briefSummary': 'Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with stress urinary incontinence who underwent surgery, by TVT methos, either TVTO or TVTS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with USI who underwent TVTS or TVTO procedure, more than 6 months ago\n\nExclusion Criteria:\n\n* Women who have not undergone TVT procedure'}, 'identificationModule': {'nctId': 'NCT01392651', 'briefTitle': 'Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Outcome of Treatment of Women With Urinary Stress Incontinence Treated by Tension-free-vaginal-tape-obturator (TVTO) Compared to Tension-free-vaginal-tape-Secur (TVTS)', 'orgStudyIdInfo': {'id': '920090039'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with urinary stress incontinence'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nahariya', 'country': 'Israel', 'facility': 'Department of Obstetrics and Gynecology, Western Galilee Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'Clinics of Dr Neuman', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'menahem neuman', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}