Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT01669694
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2012-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Physical Therapy-Biomarkers Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015415', 'term': 'Biomarkers'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in biomarkers pre- and post-pelvic floor PT', 'timeFrame': 'pre- and post- pelvic floor PT', 'description': 'Interim Analysis to be done as PI determines.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of biomarkers in relation to clinical findings', 'timeFrame': 'pre- and post- pelvic floor PT', 'description': 'Clinical data and biomarkers will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic Pain', 'Pelvic Floor Physical Therapy', 'Biomarkers'], 'conditions': ['Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points.', 'detailedDescription': 'Collection points will be baseline, and at the last PT visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.\n\nExclusion Criteria:\n\n* all others"}, 'identificationModule': {'nctId': 'NCT01669694', 'briefTitle': 'Pelvic Floor Physical Therapy-Biomarkers Project', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': "Women's Urology Center-Physical Therapy-Biomarkers Project", 'orgStudyIdInfo': {'id': '2011-317'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with Pelvic Pain', 'description': "Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center", 'interventionNames': ['Other: Pelvic floor PT with biomarkers']}], 'interventions': [{'name': 'Pelvic floor PT with biomarkers', 'type': 'OTHER', 'description': 'Pelvic floor physical therapy and collection of urine for biomarker analysis.', 'armGroupLabels': ['Women with Pelvic Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': "Beaumont Women's Urology Center", 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Donna J Carrico, NP, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}, {'name': 'Kenneth Peters, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kenneth Peters, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Kenneth Peters, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}