Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

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.

• tolterodine (Drug): tolterodine 4 mg per day
• mirabegron (Drug): mirabegron 25 mg per day
• tolterodine , mirabegron (Drug): tolterodine 4 mg and mirabegron 25 mg per day

Primary outcomes

• Improvement of overactive bladder symptoms [12 weeks]: Change of overactive bladder symptom score between groups

Secondary outcomes

• 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 outcomes

• Change of quality of life [12 weeks]: Change of King's Health Questionnaire score between groups

Sex: Female, ages: 20 Years to any

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.