Skip to content

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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03251300
Enrollment
120
Registered
2017-08-16
Start date
2017-08-01
Completion date
2024-12-31
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome

Brief summary

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

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.

Interventions

DRUGdaytime dosing of mirabegron

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

DRUGnighttime dosing of mirabegron

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

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* OAB symptoms for at least one month * \>20 years

Exclusion criteria

* Allergy to mirabegron, urinary tract infections, unstable hypertension

Design outcomes

Primary

MeasureTime frameDescription
Nocturia episodes12 weekscomparison of baseline and post-treatment nocturia episodes from bladder diary

Secondary

MeasureTime frameDescription
Severity of nocturia12 weekscomparison of baseline and post-treatment severity of nocturia from questionnaires

Countries

Taiwan

Contacts

Primary ContactSheng-Mou Hsiao, MD
smhsiao2@gmail.com+886289667000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026