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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mirabegron | Active Comparator | mirabegron 25 mg |
|
| tolterodine | Active Comparator | tolterodine 4 mg |
|
| combined therapy | Experimental | tolterodine 4 mg & mirabegron 25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolterodine | Drug | tolterodine 4 mg per day |
| |
| mirabegron |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of overactive bladder symptoms | Change of overactive bladder symptom score between groups | 12 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of quality of life | Change of King's Health Questionnaire score between groups | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital | Recruiting | Banqiao District | New Taipei | 22050 | Taiwan |
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| Drug |
mirabegron 25 mg per day |
|
| tolterodine , mirabegron | Drug | tolterodine 4 mg and mirabegron 25 mg per day |
|
| 12 weeks |
| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| C520025 | mirabegron |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
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