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

Far Eastern Memorial Hospital

Status and phase: Enrolling; Phase 4

Conditions: Overactive Bladder Syndrome

Treatments: Drug: daytime dosing of mirabegron; Drug: nighttime dosing of mirabegron

Study type: Interventional

Funder types: Other

Identifiers

NCT03251300

106001-F

Details and patient eligibility

About

The aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Allergy to mirabegron, urinary tract infections, unstable hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

group A

Experimental group

Description:

daytime dosing of mirabegron

Treatment:

Drug: daytime dosing of mirabegron

group B

Active Comparator group

Description:

nighttime dosing of mirabegron

Treatment:

Drug: nighttime dosing of mirabegron