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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
tolterodine 4 mg per day
mirabegron 25 mg per day
tolterodine 4 mg and mirabegron 25 mg per day
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, Taiwan
RECRUITINGImprovement of overactive bladder symptoms
Change of overactive bladder symptom score between groups
Time frame: 12 weeks
Change of heart rate variability
Change of heart rate variability between groups
Time frame: 12 weeks
Change of bladder blood perfusion
Change of bladder blood perfusion between groups
Time frame: 12 weeks
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