NCT03251300

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Far Eastern Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DRUG	daytime dosing of mirabegron	All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron
DRUG	nighttime dosing of mirabegron	All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron

Timeline

• Start date: 2017-08-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2017-08-16
• Last updated: 2023-03-29

Locations

1 site across 1 country: Taiwan