Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-25 @ 1:18 PM
Study NCT ID:
NCT01095159
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2010-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TVTO™ X TVTS ™ for Treatment of Stress Urinary 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-28', 'studyFirstSubmitDate': '2010-03-29', 'studyFirstSubmitQcDate': '2010-03-29', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TVTO', 'TVTSecur', 'Mini sling', 'stress urinary incontinence'], 'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '37888839', 'type': 'DERIVED', 'citation': 'Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.'}, {'pmid': '24643378', 'type': 'DERIVED', 'citation': 'Bianchi-Ferraro AM, Jarmy-DiBella ZI, de Aquino Castro R, Bortolini MA, Sartori MG, Girao MJ. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results. Int Urogynecol J. 2014 Oct;25(10):1343-8. doi: 10.1007/s00192-014-2352-7. Epub 2014 Mar 19.'}, {'pmid': '23208003', 'type': 'DERIVED', 'citation': 'Bianchi-Ferraro AM, Jarmy-Di Bella ZI, Castro Rde A, Bortolini MA, Sartori MG, Girao MJ. Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2013 Sep;24(9):1459-65. doi: 10.1007/s00192-012-1998-2. Epub 2012 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress incontinence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and urodynamic for stress urinary\n\nExclusion Criteria:\n\n* Detrusor overactivity (urodynamic study)\n* Urodynamic changes suggesting reduced vesical capacity\n* Associated neurological diseases\n* Coagulopathies\n* Pregnancy\n* Foreign matter sensitiveness history\n* Acute urinary tract infection\n* Sequel from high ionizing radiation exposure\n* Use of drugs that may result in high surgical risk and/or significant postoperative complication\n* Anesthetic procedure contraindication\n* Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported'}, 'identificationModule': {'nctId': 'NCT01095159', 'acronym': 'TVTOxTVTS', 'briefTitle': 'TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'UNIFESP-TVTOxTVTS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TVT-O', 'description': 'Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).', 'interventionNames': ['Device: TVT-O']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TVT-S', 'description': 'Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).', 'interventionNames': ['Device: TVT-S']}], 'interventions': [{'name': 'TVT-O', 'type': 'DEVICE', 'otherNames': ['TVT-O™ (Gynecare™, USA).'], 'description': 'Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).', 'armGroupLabels': ['TVT-O']}, {'name': 'TVT-S', 'type': 'DEVICE', 'otherNames': ['TVT-Secur™ (Gynecare™, USA).'], 'description': 'Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).', 'armGroupLabels': ['TVT-S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0-4023- 062', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo - Unifesp', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Ana Maria HM BIANCHI, FELLOW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ana Maria Homem de Mello Bianchi', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}