Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT00784602
Status:
TERMINATED
Last Update Posted:
2018-01-03
First Post:
2008-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'whyStopped': "Shift in department's research interests", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-30', 'studyFirstSubmitDate': '2008-11-03', 'studyFirstSubmitQcDate': '2008-11-03', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires', 'timeFrame': 'Ongoing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prolapse', 'pelvic organ prolapse'], 'conditions': ['Genital Prolapse']}, 'descriptionModule': {'briefSummary': 'To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.', 'detailedDescription': "Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with genital prolapse.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Pelvic Organ Prolapse\n* Able to provide informed consent\n* Able to complete study assessments, per clinician judgment\n\nExclusion Criteria:\n\n* Age \\< 21 years\n* Currently pregnant or \\< 6 months post-partum'}, 'identificationModule': {'nctId': 'NCT00784602', 'briefTitle': 'Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes', 'orgStudyIdInfo': {'id': '2008-242'}}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Melissa Fischer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melissa Fischer, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Corewell Health East', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Melissa Fischer, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}