Clinical trial NCT01784172: Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial
Official title: The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Stress Incontinence
Keywords: efficacy
safety
electroacupuncture
simple female stress urinary incontinence
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2013-02-05
Enrollment: 504
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* With cardiac pacemaker, Metal allergy or severe needle phobia

Primary outcomes:
measure: value difference of 1h pad test, compared with the baseline
timeFrame: the 6 weeks
Secondary outcomes:
measure: average frequency difference of urinary incontinence in 72h
timeFrame: the 6 weeks, the15-18 weeks, 27-30 weeks
measure: ICIQ-SF
timeFrame: the 6, 18, 30 week
measure: Patient subjective effectiveness evaluation
timeFrame: the 6, 18, 30 week
measure: Weekly usage of pad
timeFrame: the 6 weeks, 7-18weeks, 19-30 weeks
measure: Usage of specialty therapy for Simple female stress urinary incontinence
timeFrame: the 6 weeks, 7-18weeks, 19-30 weeks
measure: subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence
timeFrame: the 6, 18, 30 week
measure: Incidence of adverse events
timeFrame: the 1-6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Baoyan Liu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9.
citation: Jiao R, Liu Y, Liu B, Liu Z. Risk factors related to acupuncture response in postmenopausal women with stress urinary incontinence: Secondary analysis of a randomized controlled trial. Medicine (Baltimore). 2019 Apr;98(16):e15220. doi: 10.1097/MD.0000000000015220.
citation: Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
citation: Liu Z, Xu H, Chen Y, He L, Liu J, Yan S, Du R, Wu J, Liu B. The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trial. Trials. 2013 Sep 30;14:315. doi: 10.1186/1745-6215-14-315.