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

NCT ID: NCT03251300

Last Updated: 2023-03-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2024-12-31

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.

Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group A

daytime dosing of mirabegron

Group Type EXPERIMENTAL

daytime dosing of mirabegron

Intervention Type DRUG

All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron

group B

nighttime dosing of mirabegron

Group Type ACTIVE_COMPARATOR

nighttime dosing of mirabegron

Intervention Type DRUG

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

Intervention Type DRUG

nighttime dosing of mirabegron

All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Mou Hsiao, MD

Role: CONTACT

+886289667000 ext. 1818

Facility Contacts

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Sheng-Mou Hsiao, M.D.

Role: primary

+886-2-89667000 ext. 1424

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.

Reference Type RESULT
PMID: 28714288 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40841399 (View on PubMed)

Other Identifiers

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106001-F

Identifier Type: -

Identifier Source: org_study_id

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