Female Patients With Overactive Bladder Syndrome
Conditions
Brief summary
To evaluate the impact of combined therapy on the heart rate variability, compared with monotherapy in women with overactive bladder syndrome. Secondary objective is to evaluate the impact of combined therapy on bladder blood perfusion.
Detailed description
Patients and methods: We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital, and will recruit 150 female patients with overactive bladder syndrome. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the urgency severity score, the overactive bladder symptom score questionnaire, and the King's health questionnaire before taking the drug and four weeks and twelve weeks after taking the drug. In addition, measurement of heart rate variability and bladder blood perfusion will be performed. Expected results: We will obtain the impact of monotherapy with tolterodine or mirabegron versus combined therapy on heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.
Interventions
DRUGtolterodine
tolterodine 4 mg per day
DRUGmirabegron
mirabegron 25 mg per day
DRUGtolterodine , mirabegron
tolterodine 4 mg and mirabegron 25 mg per day
Sponsors
Far Eastern Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>20 years old . * female patients with overactive bladder syndrome
Exclusion criteria
* Cases of hypersensitivity to mirabegron or tolterodine. * Betanley is contraindicated in the following patients: uncontrolled severe hypertension. * Dexotol is contraindicated in the following patients: known urethral diverticulum, known bladder malignancy, patients with urinary retention and gastric retention, patients with uncontrolled narrow-angle glaucoma, patients with renal dialysis, severe renal dysfunction (ie Inulin clearance rate (GFR\<30 ml/min) or liver dysfunction (i.e. liver cirrhosis), use strong CYP3A4 inhibitors such as ketoconazole. * Patients with myasthenia gravis. * The patient is taking drugs that interact with tolterodine or mirabegron.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of overactive bladder symptoms | 12 weeks | Change of overactive bladder symptom score between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of heart rate variability | 12 weeks | Change of heart rate variability between groups |
| Change of bladder blood perfusion | 12 weeks | Change of bladder blood perfusion between groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of quality of life | 12 weeks | Change of King's Health Questionnaire score between groups |
Countries
Taiwan
Outcome results
None listed