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

Phase 4

Recruiting

• Conditions: Overactive Bladder Syndrome
• Interventions: Drug: daytime dosing of mirabegron; Drug: nighttime dosing of mirabegron

• Registration Number: NCT03251300
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-13
• Study First Posted: 2017-08-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• OAB symptoms for at least one month
• >20 years

Exclusion Criteria

• Allergy to mirabegron, urinary tract infections, unstable hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	daytime dosing of mirabegron	daytime dosing of mirabegron
group B	nighttime dosing of mirabegron	nighttime dosing of mirabegron

Primary Outcome Measures

Name	Time	Method
Nocturia episodes	12 weeks	comparison of baseline and post-treatment nocturia episodes from bladder diary

Secondary Outcome Measures

Name	Time	Method
Severity of nocturia	12 weeks	comparison of baseline and post-treatment severity of nocturia from questionnaires

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan