NCT04023253招募中3 期
Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Global response assessment
研究概览
简要总结
To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and bladder blood flow.
详细描述
To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and blood flow.
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
- •Overactive bladder syndrome
排除标准
- •Allergy to mirabegron or solifenacin.
- •Patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of CYP3A4 such as ketoconazole.
研究组 & 干预措施
mirabegron
Experimental
Receive mirabegron 2 mg treatment per day
干预措施: Mirabegron (Drug)
solifenacin
Experimental
Receive solifenacin 5 mg treatment per day
干预措施: Solifenacin (Drug)
结局指标
主要结局
Global response assessment
时间窗: 12 weeks
Between-group difference in the score of Global response assessment
次要结局
- Female sexual function index(12 weeks)
- Total score of Brief Symptoms Rating Scales(12 weeks)
- Bladder wall thickness(12 weeks)
- Blood flow index of the bladder(12 weeks)
研究者
Sheng-Mou Hsiao
Chief and Associate Professor, Department of Obstetrics and Gynecology
Far Eastern Memorial Hospital
研究点 (1)
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