Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-25 @ 5:39 PM
Study NCT ID:
NCT01057550
Status:
COMPLETED
Last Update Posted:
2010-01-27
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-03', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-26', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate at improving symptom of stress urinary incontinence', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'completely dry rates', 'timeFrame': '1 year'}, {'measure': 'quality of life scores', 'timeFrame': '1 year'}, {'measure': 'intra & post-operative complications', 'timeFrame': '1 year'}, {'measure': 're-operation rates', 'timeFrame': '1 year'}, {'measure': 'hospital stay', 'timeFrame': '5 days'}, {'measure': 'operative time', 'timeFrame': 'hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stress urinary Incontinence', 'autologous slings', 'slings', 'tvt', 'grafts', 'surgery'], 'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '20939862', 'type': 'RESULT', 'citation': 'Guerrero KL, Emery SJ, Wareham K, Ismail S, Watkins A, Lucas MG. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG. 2010 Nov;117(12):1493-502. doi: 10.1111/j.1471-0528.2010.02696.x. Epub 2010 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women requiring surgery for SUI following failed conservative treatment\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Previous surgery for SUI\n* Evidence of neurological disease\n* Pelvic Organ Prolapse (POP) greater than Grade 2\n* Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment'}, 'identificationModule': {'nctId': 'NCT01057550', 'briefTitle': 'Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Abertawe Bro Morgannwg University NHS Trust'}, 'officialTitle': 'A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women', 'orgStudyIdInfo': {'id': '2000.117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Autologous Fascial Sling', 'description': 'Retropubic, bottom up autologous sling', 'interventionNames': ['Procedure: Autologous fascial sling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TVT', 'description': 'Standard retropubic TVT', 'interventionNames': ['Procedure: TVT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvicol', 'description': 'Retropubic mid urethral sling made from Pelvicol', 'interventionNames': ['Procedure: Pelvicol']}], 'interventions': [{'name': 'Autologous fascial sling', 'type': 'PROCEDURE', 'description': 'Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia', 'armGroupLabels': ['Autologous Fascial Sling']}, {'name': 'TVT', 'type': 'PROCEDURE', 'description': 'Standard TVT as described by Ulmsten 1996', 'armGroupLabels': ['TVT']}, {'name': 'Pelvicol', 'type': 'PROCEDURE', 'description': 'retropubic mid urethral sling made from Pelvicol', 'armGroupLabels': ['Pelvicol']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SA2 8QA', 'city': 'Swansea', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'ABM University Hospital NHS trust', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Malcolm G Lucas', 'role': 'STUDY_CHAIR', 'affiliation': 'ABM University Hospital NHS trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abertawe Bro Morgannwg University NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'C. R. Bard', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr Karen Guerrero', 'oldOrganization': 'ABM University Hospital NHS Trust'}}}}