Overactive Bladder Syndrome
Conditions
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
All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron
All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron
Sponsors
Study design
Eligibility
Inclusion criteria
* OAB symptoms for at least one month * \>20 years
Exclusion criteria
* Allergy to mirabegron, urinary tract infections, unstable hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturia episodes | 12 weeks | comparison of baseline and post-treatment nocturia episodes from bladder diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of nocturia | 12 weeks | comparison of baseline and post-treatment severity of nocturia from questionnaires |
Countries
Taiwan