Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-27 @ 5:50 AM
Study NCT ID:
NCT00576004
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2007-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-17', 'studyFirstSubmitDate': '2007-12-17', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test.', 'timeFrame': '2002-2006'}], 'secondaryOutcomes': [{'measure': 'changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires', 'timeFrame': '2002-2206'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery'], 'conditions': ['Pelvic Organ Prolapse', 'Urinary Incontinence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.unipg.it', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair', 'detailedDescription': 'Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Study inclusion criteria were POP \\> 2, UI as was defined by ICS \\[2\\], age ≥ 18 and ≤ 75 yrs.\n\nExclusion Criteria:\n\n* Benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)\n* Active pelvic inflammatory disease,\n* Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)\n* Pregnancy or lactation\n* Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and\n* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results."}, 'identificationModule': {'nctId': 'NCT00576004', 'briefTitle': 'Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial', 'orgStudyIdInfo': {'id': 'EC_ML_001'}, 'secondaryIdInfos': [{'id': 'EC_ML_001s'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'Pelvic organ prolapse repair plus concomitant Burch Colposuspension', 'interventionNames': ['Procedure: Pelvic organ prolapse repair and Burch colposuspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'Pelvic organ prolapse without Burch colposuspension', 'interventionNames': ['Procedure: Pelvic organ prolapse repair and Burch colposuspension']}], 'interventions': [{'name': 'Pelvic organ prolapse repair and Burch colposuspension', 'type': 'PROCEDURE', 'description': 'Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Perugia', 'state': 'Perugia', 'country': 'Italy', 'facility': 'University of Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}], 'overallOfficials': [{'name': 'Elisabetta Costantini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Of Perugia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'responsibleParty': {'oldOrganization': 'Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology'}}}}