Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing

Study Overview
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Brief Summary
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The aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.

Detailed Description
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Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to elucidate whether night-time dosing can improve nocturia, compared with daytime dosing. Patients and Methods: The investigators will perform a prospective randomized controlled trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron. All enrolled OAB women will be allocated to two groups (group A and B). The women in group A will receive daytime dosing of mirabegron treatment; and the women in group B will receive nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron treatment. STATA software is used for statistical analyses. Possible Results: The investigators can answer whether night-time dosing of mirabegron can improve nocturia, compared with daytime dosing.

Official Title
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Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Drug: daytime dosing of mirabegron
* Drug: nighttime dosing of mirabegron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OAB symptoms for at least one month >20 years Exclusion Criteria: Allergy to mirabegron, urinary tract infections, unstable hypertension

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>daytime dosing of mirabegron | Drug: daytime dosing of mirabegron<br>* All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron<br>|
| Active Comparator: group B<br>nighttime dosing of mirabegron | Drug: nighttime dosing of mirabegron<br>* All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturia episodes | comparison of baseline and post-treatment nocturia episodes from bladder diary | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of nocturia | comparison of baseline and post-treatment severity of nocturia from questionnaires | 12 weeks |