The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Urinary Stress Incontinence
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 504
- Locations
- 1
- Primary Endpoint
- value difference of 1h pad test, compared with the baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.
Detailed Description
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.
Investigators
Liu Baoyan
Vice President of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Meet the diagnosis of Simple female stress urinary incontinence
- •40-75 years old
- •Volunteered to join this research and signed the informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
value difference of 1h pad test, compared with the baseline
Time Frame: 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.
Secondary Outcomes
- Incidence of adverse events(the 1-6 weeks)
- Patient subjective effectiveness evaluation(the 6, 18, 30 week)
- 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)