Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT00271102
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2005-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D052858', 'term': 'Cystocele'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'D056887', 'term': 'Pelvic Organ Prolapse'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'orc@geisinger.edu', 'phone': '570-214-9628', 'title': 'Office of Research Compliance', 'organization': 'Geisinger'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for the time frame.', 'description': 'Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Anterior Colporrhaphy', 'description': 'Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paravaginal Defect Repair', 'description': 'Abdominal paravaginal defect repair cystocele (dropped bladder)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POP Q Stage', 'description': 'Prolapse stage at followed as measured by the POP-Q system'}], 'timeFrame': '4 years', 'description': 'POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.', 'reportingStatus': 'POSTED', 'populationDescription': 'Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).'}, {'type': 'SECONDARY', 'title': 'The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Complications', 'description': 'INtra-op and post-op complications'}], 'timeFrame': '4 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anterior Colporrhaphy', 'description': 'Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)'}, {'id': 'FG001', 'title': 'Paravaginal Defect Repair', 'description': 'Abdominal paravaginal defect repair cystocele (dropped bladder)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Dates of recruitment were between 2006 and 2010. Patients were recruited from the urogynecology outpatient clinic at Geisinger.', 'preAssignmentDetails': '90 patients were screened for eligibility and 70 were recruited. The remaining 20 either declined participation or were not eligible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anterior Colporrhaphy', 'description': 'Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)'}, {'id': 'BG001', 'title': 'Paravaginal Defect Repair', 'description': 'Abdominal paravaginal defect repair cystocele (dropped bladder)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '11', 'groupId': 'BG000'}, {'value': '53', 'spread': '13', 'groupId': 'BG001'}, {'value': '54', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-26', 'studyFirstSubmitDate': '2005-12-29', 'resultsFirstSubmitDate': '2011-08-17', 'studyFirstSubmitQcDate': '2005-12-29', 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-26', 'studyFirstPostDateStruct': {'date': '2005-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery', 'timeFrame': '4 years', 'description': 'POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.'}], 'secondaryOutcomes': [{'measure': 'The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cystocele, prolapse, anterior repair, colporrhaphy'], 'conditions': ['Prolapse']}, 'referencesModule': {'references': [{'pmid': '23508540', 'type': 'DERIVED', 'citation': 'Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourol Urodyn. 2014 Jan;33(1):72-7. doi: 10.1002/nau.22396. Epub 2013 Mar 18.'}], 'seeAlsoLinks': [{'url': 'http://www.geisinger.org/research/', 'label': 'Click here for more information about Clinical Trials at Geisinger Medical Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.', 'detailedDescription': 'It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.\n\nExclusion Criteria:\n\n* Patients with at least 2 previous prolapse surgeries\n* Patients who are pregnant or planning to have a pregnancy'}, 'identificationModule': {'nctId': 'NCT00271102', 'briefTitle': 'Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Geisinger Clinic'}, 'officialTitle': 'Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse', 'orgStudyIdInfo': {'id': '2005-0193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anterior colporrhaphy', 'description': 'Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)', 'interventionNames': ['Procedure: anterior vaginal repair (colporrhaphy)', 'Procedure: abdominal paravaginal defect repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paravaginal defect repair', 'description': 'Abdominal paravaginal defect repair cystocele (dropped bladder)', 'interventionNames': ['Procedure: anterior vaginal repair (colporrhaphy)', 'Procedure: abdominal paravaginal defect repair']}], 'interventions': [{'name': 'anterior vaginal repair (colporrhaphy)', 'type': 'PROCEDURE', 'description': 'vaginal repair', 'armGroupLabels': ['Anterior colporrhaphy', 'Paravaginal defect repair']}, {'name': 'abdominal paravaginal defect repair', 'type': 'PROCEDURE', 'description': 'abdominal repair', 'armGroupLabels': ['Anterior colporrhaphy', 'Paravaginal defect repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health System', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Vatche A Minassian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geisinger Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}