Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT00901251
Status:
COMPLETED
Last Update Posted:
2011-03-15
First Post:
2009-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reproducibility Study of Over Active Bladder Symptom Score [OABSS]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'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': '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-13', 'studyFirstSubmitDate': '2009-05-11', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OABSS', 'timeFrame': 'Weeks of 0 and 2'}], 'secondaryOutcomes': [{'measure': '3-day micturition diary', 'timeFrame': '2 times in 2-week interval'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OABSS'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Symptomatic OAB patients having urgency episodes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms OAB for 3 months or longer\n* At least 1 urgency episode in last 3 days\n* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:\n\n * Number of micturition ≥8 times/day\n * Number of urgency episode in 3 days ≥1\n\nExclusion Criteria:\n\n* Indwelling catheters or practicing intermittent self-catheterization\n* Symptomatic urinary tract infection, chronic inflammation\n* Diabetic neuropathy'}, 'identificationModule': {'nctId': 'NCT00901251', 'acronym': 'RESORT', 'briefTitle': 'Reproducibility Study of Over Active Bladder Symptom Score [OABSS]', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Reproducibility Study of OABSS and Its Response to Treatment - Part 1: Reproducibility -', 'orgStudyIdInfo': {'id': 'VESOABCN02'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Wuhan', 'country': 'China', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma China, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma China, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Disclosure Director', 'oldOrganization': 'Astellas Pharma, Inc'}}}}