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The optimal medication for women with nocturia remains uncertain. This clinical trial aimed to determine the most effective medication for women with overactive bladder and nocturia. Its primary objectives were to answer the following questions:
Which medication is most effective for women with nocturia? Which medication has the least effect on heart rate variability in women with nocturia?
We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the questionnaires and before taking the drug and four weeks and twelve weeks after taking the medication. In addition, measurement of heart rate variability will be performed before and twelve weeks after taking the medication. All enrolled women will be randomized to receive nighttime mirabegron, solifenacin, tolterodine or oxybutynin for 12 weeks.
The aims of this study is to obtain the impact of nighttime dosing of mirabegron, solifenacin, tolterodine or oxybutynin versus combined therapy on nocturia, psychologic distress, sexual function, cognition, 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 |
|
| Solifenacin | Active Comparator | Solifenacin 5mg |
|
| Tolterodine | Active Comparator | Tolterodine 4mg |
|
| Oxybutynin ER | Active Comparator | Oxybutynin ER 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron 25mg | Drug | Taking 25 mg mirabegron in the nighttime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of overactive bladder symptoms | Comparisons of the changes of overactive bladder symptom score between groups | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of heart rate variability | Comparisons of the changes of heart rate variability between groups | 12 weeks |
| Change of bladder blood perfusion | Comparisons of the changes of bladder blood perfusion between groups |
| Measure | Description | Time Frame |
|---|---|---|
| Change of quality of life | Comparisons of the 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, | Banqiao District | New Taipei | 22050 | Taiwan |
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| Solifenacin 5 mg |
| Drug |
Taking 5 mg solifenacin in the nighttime |
|
| Tolterodine 4 mg | Drug | Taking 5 mg tolterodine in the nighttime |
|
| Oxybutynin ER 5 mg | Drug | Taking 5 mg oxybutynin ER in the nighttime |
|
| 12 weeks |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000069464 | Solifenacin Succinate |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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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