The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- value difference of 1h pad test, compared with the baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.
详细描述
Stress urinary incontinence (SUI) is a common disease of female. The inconvenience caused by SUI affects the patients' quality of life and health seriously. To date, there has not specific therapy on SUI. Former research showed acupuncture may work for SUI. This multi-center randomized controlled clinical trial of acupuncture for simple female stress urinary incontinence is designed to confirm the efficacy and safety of EA. This project is conducted by Chinese researchers, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for simple female stress urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnosis of Simple female stress urinary incontinence
- •40-75 years old
- •Volunteered to join this research and signed the informed consent
排除标准
- •urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence, etc
- •After operation for urinary incontinence or pelvic floor operation
- •Edeoptosis≥Degree 2
- •Symptomatic urinary tract infection
- •RUV>30ml
- •Qmax<20ml/s
- •Constrained movement of walking, stairs climbing, running
- •Patients with continuous treatment for stress urinary incontinence or medicine for bladder function
- •With serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, MSA, Injury of cauda equine, myeleterosis.
- •During pregnancy or lactation period
- •With cardiac pacemaker, Metal allergy or severe needle phobia
研究组 & 干预措施
electroacupuncture group
Bilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward. Bilateral B L35 are given acupuncture of 50～60mm to outward and upward. The electric stimulator is applied to bilateral BL33 and BL35.
Every session lasts for 30 min per day. The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all.
干预措施: electroacupuncture group (Device)
sham electroacupuncture group
Bilateral sham BL33 and sham BL35 are given sham electroacupuncture with no current output.
Every session lasts for 30 min per day. The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all.
干预措施: sham electroacupuncture group (Device)
结局指标
主要结局
value difference of 1h pad test, compared with the baseline
时间窗: the 6 weeks
quantity of fluid loss will be measured by 1h pad test, comparing the value of 6 weeks with the baseline(0 week), the primary outcome is the value difference.
次要结局
- Patient subjective effectiveness evaluation(the 6, 18, 30 week)
- Incidence of adverse events(the 1-6 weeks)
- subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence(the 6, 18, 30 week)
- average frequency difference of urinary incontinence in 72h(the 6 weeks, the15-18 weeks, 27-30 weeks)
- ICIQ-SF(the 6, 18, 30 week)
- Weekly usage of pad(the 6 weeks, 7-18weeks, 19-30 weeks)
- Usage of specialty therapy for Simple female stress urinary incontinence(the 6 weeks, 7-18weeks, 19-30 weeks)
研究者
Liu Baoyan
Vice President of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences