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
NCT ID: NCT05946902
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2023-09-12
2024-07-31
Brief Summary
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Detailed Description
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We 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.
Expected results:
We 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mirabegron
mirabegron 25 mg
mirabegron
mirabegron 25 mg per day
tolterodine
tolterodine 4 mg
tolterodine
tolterodine 4 mg per day
combined therapy
tolterodine 4 mg \& mirabegron 25 mg
tolterodine , mirabegron
tolterodine 4 mg and mirabegron 25 mg per day
Interventions
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tolterodine
tolterodine 4 mg per day
mirabegron
mirabegron 25 mg per day
tolterodine , mirabegron
tolterodine 4 mg and mirabegron 25 mg per day
Eligibility Criteria
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Inclusion Criteria
* female patients with overactive bladder syndrome
Exclusion Criteria
* Betanley is contraindicated in the following patients: uncontrolled severe hypertension.
* 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.
* Patients with myasthenia gravis.
* The patient is taking drugs that interact with tolterodine or mirabegron.
20 Years
FEMALE
No
Sponsors
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Far Eastern Memorial Hospital
OTHER
Responsible Party
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Sheng-Mou Hsiao
Chief and Professor, Department of Obstetrics and Gynecology
Locations
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Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, Taiwan
Countries
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Facility Contacts
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Other Identifiers
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112019-F
Identifier Type: -
Identifier Source: org_study_id
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