Far Eastern Memorial Hospital
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Improvement of overactive bladder symptoms
研究概览
简要总结
The optimal medication for women with nocturia remains uncertain. This clinical trial aimed to determine the most effective medication for women with overactive bladder and nocturia. Its primary objectives were to answer the following questions:
Which medication is most effective for women with nocturia? Which medication has the least effect on heart rate variability in women with nocturia?
详细描述
We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the questionnaires and before taking the drug and four weeks and twelve weeks after taking the medication. In addition, measurement of heart rate variability will be performed before and twelve weeks after taking the medication. All enrolled women will be randomized to receive nighttime mirabegron, solifenacin, tolterodine or oxybutynin for 12 weeks.
The aims of this study is to obtain the impact of nighttime dosing of mirabegron, solifenacin, tolterodine or oxybutynin versus combined therapy on nocturia, psychologic distress, sexual function, cognition, 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years old.
- •female patients with overactive bladder syndrome
排除标准
- •Clinically significant dysuria (inability to urinate, difficulty urinating).
- •Severe stress urinary incontinence (urinary incontinence caused by coughing).
- •Mixed urinary incontinence mainly caused by stress urinary incontinence (urinary incontinence caused by coughing as the main symptom).
- •Contraindications to antimuscarinic drugs or adrenergic receptor agonists.
研究组 & 干预措施
mirabegron
mirabegron 25 mg
干预措施: Mirabegron 25mg (Drug)
Solifenacin
Solifenacin 5mg
干预措施: Solifenacin 5 mg (Drug)
Tolterodine
Tolterodine 4mg
干预措施: Tolterodine 4 mg (Drug)
Oxybutynin ER
Oxybutynin ER 5mg
干预措施: Oxybutynin ER 5 mg (Drug)
结局指标
主要结局
Improvement of overactive bladder symptoms
时间窗: 12 weeks
Comparisons of the changes 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