Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT05946902
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068737', 'term': 'Tolterodine Tartrate'}, {'id': 'C520025', 'term': 'mirabegron'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of quality of life', 'timeFrame': '12 weeks', 'description': "Change of King's Health Questionnaire score between groups"}], 'primaryOutcomes': [{'measure': 'Improvement of overactive bladder symptoms', 'timeFrame': '12 weeks', 'description': 'Change of overactive bladder symptom score between groups'}], 'secondaryOutcomes': [{'measure': 'Change of heart rate variability', 'timeFrame': '12 weeks', 'description': 'Change of heart rate variability between groups'}, {'measure': 'Change of bladder blood perfusion', 'timeFrame': '12 weeks', 'description': 'Change of bladder blood perfusion between groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Female Patients With Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of combined therapy on the heart rate variability, compared with monotherapy in women with overactive bladder syndrome. Secondary objective is to evaluate the impact of combined therapy on bladder blood perfusion.', 'detailedDescription': "Patients and methods:\n\nWe will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital, and will recruit 150 female patients with overactive bladder syndrome. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the urgency severity score, the overactive bladder symptom score questionnaire, and the King's health questionnaire before taking the drug and four weeks and twelve weeks after taking the drug. In addition, measurement of heart rate variability and bladder blood perfusion will be performed.\n\nExpected results:\n\nWe will obtain the impact of monotherapy with tolterodine or mirabegron versus combined therapy on heart rate variability and bladder blood perfusion in women with overactive bladder syndrome."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>20 years old .\n* female patients with overactive bladder syndrome\n\nExclusion Criteria:\n\n* Cases of hypersensitivity to mirabegron or tolterodine.\n* Betanley is contraindicated in the following patients: uncontrolled severe hypertension.\n* Dexotol is contraindicated in the following patients: known urethral diverticulum, known bladder malignancy, patients with urinary retention and gastric retention, patients with uncontrolled narrow-angle glaucoma, patients with renal dialysis, severe renal dysfunction (ie Inulin clearance rate (GFR\\<30 ml/min) or liver dysfunction (i.e. liver cirrhosis), use strong CYP3A4 inhibitors such as ketoconazole.\n* Patients with myasthenia gravis.\n* The patient is taking drugs that interact with tolterodine or mirabegron.'}, 'identificationModule': {'nctId': 'NCT05946902', 'briefTitle': 'Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '112019-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mirabegron', 'description': 'mirabegron 25 mg', 'interventionNames': ['Drug: mirabegron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tolterodine', 'description': 'tolterodine 4 mg', 'interventionNames': ['Drug: tolterodine']}, {'type': 'EXPERIMENTAL', 'label': 'combined therapy', 'description': 'tolterodine 4 mg \\& mirabegron 25 mg', 'interventionNames': ['Drug: tolterodine , mirabegron']}], 'interventions': [{'name': 'tolterodine', 'type': 'DRUG', 'description': 'tolterodine 4 mg per day', 'armGroupLabels': ['tolterodine']}, {'name': 'mirabegron', 'type': 'DRUG', 'description': 'mirabegron 25 mg per day', 'armGroupLabels': ['mirabegron']}, {'name': 'tolterodine , mirabegron', 'type': 'DRUG', 'description': 'tolterodine 4 mg and mirabegron 25 mg per day', 'armGroupLabels': ['combined therapy']}]}, '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': '1818'}], 'facility': 'Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief and Professor, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Sheng-Mou Hsiao', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}