Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing
NCT ID: NCT03251300
Last Updated: 2023-03-29
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
120 participants
INTERVENTIONAL
2017-08-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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group A
daytime dosing of mirabegron
daytime dosing of mirabegron
All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron
group B
nighttime dosing of mirabegron
nighttime dosing of mirabegron
All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron
Interventions
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daytime dosing of mirabegron
All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron
nighttime dosing of mirabegron
All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron
Eligibility Criteria
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Inclusion Criteria
* \>20 years
Exclusion Criteria
20 Years
FEMALE
No
Sponsors
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Far Eastern Memorial Hospital
OTHER
Responsible Party
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Sheng-Mou Hsiao
Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
Locations
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Far Eastern Memorial Hospital
Banqiao District, New Taipei, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Tsai KH, Hsiao SM, Lin HH. Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia. J Obstet Gynaecol Res. 2017 Nov;43(11):1719-1725. doi: 10.1111/jog.13438. Epub 2017 Jul 16.
Hsiao SM. Mirabegron nighttime versus daytime dosing for women with overactive bladder syndrome: a randomized controlled trial. Sci Rep. 2025 Aug 21;15(1):30687. doi: 10.1038/s41598-025-15780-5.
Other Identifiers
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106001-F
Identifier Type: -
Identifier Source: org_study_id
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