Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement of stress urinary incontinence
研究概览
简要总结
We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI.
详细描述
Background/Purpose: Pharmacologic treatments for female stress urinary incontinence (SUI) include duloxetine and imipramine. Duloxetine and Imipramine has been reported to have clinical significant therapeutic efficacy on female SUI and overactive bladder syndrome. However, there was no randomized controlled study to compare duloxetine and imipramine for the treatment of female SUI.
Patients and Methods: We will perform a prospective randomized controlled study to recruit 90 female SUI patients at the Obstetrics & Gynecology outpatient clinic of Far Eastern Memorial Hospital. All SUI female patients will be asked to complete ICIQ-UI, USS, OABSS, and bladder diary before and after 4 weeks' duloxetine versus imipramine treatment.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients over 25 years old with stress urinary incontinence.
- •Patients who are currently not considered for surgical treatment.
- •Patients who have undergone regular Kegel exercises but have poor results.
排除标准
- •The result of urodynamic examination, if the main cause of urinary incontinence is detrusor overactivity.
- •Those who are taking or plan to take monoamine oxidase inhibitor (MAOI) inhibitors.
- •Patients with acute myocardial infarction.
- •Those who are allergic to duloxetine, imipramine and dibenzazepine tricyclic antidepressants.
- •Patients with uncontrolled narrow-angle glaucoma.
- •Pregnant women.
- •Those who are contraindicated to duloxetine or imipramine.
- •Patients with suicidal ideation and behavior.
研究组 & 干预措施
Duloxetine
干预措施: duloxetine (Drug)
Imipramine
干预措施: Imipramine (Drug)
结局指标
主要结局
Improvement of stress urinary incontinence
时间窗: 4 weeks
Urinary Incontinence Questionnaire (by ICIQ-UI short form)
次要结局
- Improvement of overactive bladder symptoms(4 weeks)
- Improvement of urgency symptoms(4 weeks)
研究者
Sheng-Mou Hsiao
Chief and Professor, Department of Obstetrics and Gynecology
Far Eastern Memorial Hospital