Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-28 @ 3:34 PM
Study NCT ID:
NCT01619995
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2012-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-21', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['urge incontinence'], 'conditions': ['Urge Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to evaluate the applicability of non-invasive optical imaging for the measurement of brain function during investigation of the lower urinary tract.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women over 60 years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ambulatory women over age 60, who are incontinent at least five times weekly for 3 months despite correction of potentially reversible causes.\n* urinary incontinence (urge or predominantly urge) by clinical criteria.\n* able to accurately complete a voiding diary, to perform a 24-hour pad test under direction.\n\nExclusion Criteria:\n\n* significant mental impairment \\[mini mental status exam (MMSE) ≤ 20)\n* urethral obstruction\n* history of bladder cancer\n* spinal cord lesions\n* multiple sclerosis\n* pelvic radiation\n* interstitial cystitis\n* artificial sphincter implant\n* expected to have changes in medications/doses during the trial\n* medically unstable\n* Patients with factors that could cause transient UI \\[e.g., current urinary tract infection (UTI), acute confusion\\] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.\n* conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)"}, 'identificationModule': {'nctId': 'NCT01619995', 'acronym': 'NIRS/fBFB', 'briefTitle': "Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder", 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': "Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder", 'orgStudyIdInfo': {'id': 'PRO10020240'}, 'secondaryIdInfos': [{'id': '1R03AG038583-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03AG038583-01', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geriatric Continence Research Unit, NE547 Montefiore UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Werner Schaaefer, DI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Instructor in Medicine', 'investigatorFullName': 'Becky Clarkson', 'investigatorAffiliation': 'University of Pittsburgh'}}}}