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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement of overactive bladder symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>20 years old .
- •female patients with overactive bladder syndrome
排除标准
- •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.
研究组 & 干预措施
mirabegron
mirabegron 25 mg
干预措施: mirabegron (Drug)
tolterodine
tolterodine 4 mg
干预措施: tolterodine (Drug)
combined therapy
tolterodine 4 mg & mirabegron 25 mg
干预措施: tolterodine , mirabegron (Drug)
结局指标
主要结局
Improvement of overactive bladder symptoms
时间窗: 12 weeks
Change of overactive bladder symptom score between groups
次要结局
- Change of heart rate variability(12 weeks)
- Change of bladder blood perfusion(12 weeks)
研究者
Sheng-Mou Hsiao
Chief and Professor, Department of Obstetrics and Gynecology
Far Eastern Memorial Hospital