Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-19 @ 7:34 PM
Study NCT ID:
NCT01819168
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-04', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bladder diary', 'timeFrame': '3 months', 'description': 'To clarity any difference of reduction in the episodes of nocturia between these two groups.'}], 'secondaryOutcomes': [{'measure': 'Frequency and Urgency', 'timeFrame': '3 months', 'description': 'To clarity any difference of reduction in the episodes of urinary frequency and urgency between these two groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more effective in treating patients with nocturia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We will perform a retrospective study to review the data of bladder diary, urodynamic studies and clinical data of patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \\& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \\& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01819168', 'briefTitle': 'Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'orgStudyIdInfo': {'id': '102026-E'}}, 'contactsLocationsModule': {'locations': [{'zip': '22050', 'city': 'Banqiao District', 'state': 'New Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Obstetrics & Gynecology', 'investigatorFullName': 'Sheng-Mou Hsiao', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}