Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-29 @ 5:28 PM
Study NCT ID:
NCT01122550
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2010-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility Study of Overactive 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': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-23', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OABSS', 'timeFrame': 'Weeks 0 and 2'}], 'secondaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': 'Weeks 0 and 2'}, {'measure': 'Quality of Life (QOL) score', 'timeFrame': 'Weeks 0 and 2'}, {'measure': 'Patient Perception of Bladder Condition (PPBC)', 'timeFrame': 'Weeks 0 and 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OABSS', 'IPSS', 'PPBC', '3-day micturition diary'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.'}, '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 3-day micturition diary prior to Visit 1, defined by:\n\n * Number of micturition per day ≥8\n * Number of urgency episodes in 3 days ≥1\n\nExclusion Criteria:\n\n* Significant stress incontinence or mixed stress/urge incontinence\n* Subjects with indwelling catheters or practicing intermittent self-catheterization\n* Symptomatic urinary tract infection, chronic inflammation\n* Diabetic neuropathy\n* Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks\n* Participation in any clinical trial in 30 days'}, 'identificationModule': {'nctId': 'NCT01122550', 'acronym': 'RESORT-1', 'briefTitle': 'Reproducibility Study of Overactive Bladder Symptom Score [OABSS]', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 1: Reproducibility -', 'orgStudyIdInfo': {'id': 'EQL-CRU.004-2009'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bandung', 'country': 'Indonesia', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}, {'city': 'Jakarta', 'country': 'Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Surabaya', 'country': 'Indonesia', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Indonesia Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Disclosure Director', 'oldOrganization': 'Astellas Pharma, Inc'}}}}