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

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients and methods: 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.

Official Title
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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

Conditions
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Female Patients With Overactive Bladder Syndrome

Intervention / Treatment
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* Drug: tolterodine
* Drug: mirabegron
* Drug: tolterodine , mirabegron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >20 years old . female patients with overactive bladder syndrome Exclusion Criteria: Cases of hypersensitivity to mirabegron or tolterodine. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mirabegron<br>mirabegron 25 mg | Drug: mirabegron<br>* mirabegron 25 mg per day<br>|
| Active Comparator: tolterodine<br>tolterodine 4 mg | Drug: tolterodine<br>* tolterodine 4 mg per day<br>|
| Experimental: combined therapy<br>tolterodine 4 mg & mirabegron 25 mg | Drug: tolterodine , mirabegron<br>* tolterodine 4 mg and mirabegron 25 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of overactive bladder symptoms | Change of overactive bladder symptom score between groups | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of heart rate variability | Change of heart rate variability between groups | 12 weeks | 
| Change of bladder blood perfusion | Change of bladder blood perfusion between groups | 12 weeks |