Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-02-25 @ 7:06 PM
Study NCT ID:
NCT03251300
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2017-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2017-08-13', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nocturia episodes', 'timeFrame': '12 weeks', 'description': 'comparison of baseline and post-treatment nocturia episodes from bladder diary'}], 'secondaryOutcomes': [{'measure': 'Severity of nocturia', 'timeFrame': '12 weeks', 'description': 'comparison of baseline and post-treatment severity of nocturia from questionnaires'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder Syndrome']}, 'referencesModule': {'references': [{'pmid': '28714288', 'type': 'RESULT', 'citation': 'Tsai KH, Hsiao SM, Lin HH. Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia. J Obstet Gynaecol Res. 2017 Nov;43(11):1719-1725. doi: 10.1111/jog.13438. Epub 2017 Jul 16.'}, {'pmid': '40841399', 'type': 'DERIVED', 'citation': 'Hsiao SM. Mirabegron nighttime versus daytime dosing for women with overactive bladder syndrome: a randomized controlled trial. Sci Rep. 2025 Aug 21;15(1):30687. doi: 10.1038/s41598-025-15780-5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.', 'detailedDescription': "Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to elucidate whether night-time dosing can improve nocturia, compared with daytime dosing.\n\nPatients and Methods: The investigators will perform a prospective randomized controlled trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron. All enrolled OAB women will be allocated to two groups (group A and B). The women in group A will receive daytime dosing of mirabegron treatment; and the women in group B will receive nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron treatment. STATA software is used for statistical analyses.\n\nPossible Results: The investigators can answer whether night-time dosing of mirabegron can improve nocturia, compared with daytime dosing."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OAB symptoms for at least one month\n* \\>20 years\n\nExclusion Criteria:\n\n* Allergy to mirabegron, urinary tract infections, unstable hypertension'}, 'identificationModule': {'nctId': 'NCT03251300', 'briefTitle': 'Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing', 'orgStudyIdInfo': {'id': '106001-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'daytime dosing of mirabegron', 'interventionNames': ['Drug: daytime dosing of mirabegron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'nighttime dosing of mirabegron', 'interventionNames': ['Drug: nighttime dosing of mirabegron']}], 'interventions': [{'name': 'daytime dosing of mirabegron', 'type': 'DRUG', 'description': 'All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron', 'armGroupLabels': ['group A']}, {'name': 'nighttime dosing of mirabegron', 'type': 'DRUG', 'description': 'All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22050', 'city': 'Banqiao District', 'state': 'New Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Sheng-Mou Hsiao, M.D.', 'role': 'CONTACT', 'email': 'smhsiao2@gmail.com', 'phone': '+886-2-89667000', 'phoneExt': '1424'}], 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}], 'centralContacts': [{'name': 'Sheng-Mou Hsiao, MD', 'role': 'CONTACT', 'email': 'smhsiao2@gmail.com', 'phone': '+886289667000', 'phoneExt': '1818'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital', 'investigatorFullName': 'Sheng-Mou Hsiao', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}