Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial
The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
1 other identifier
interventional
504
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 23, 2014
December 1, 2014
1.8 years
February 1, 2013
December 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
value difference of 1h pad test, compared with the baseline
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.
the 6 weeks
Secondary Outcomes (7)
average frequency difference of urinary incontinence in 72h
the 6 weeks, the15-18 weeks, 27-30 weeks
ICIQ-SF
the 6, 18, 30 week
Patient subjective effectiveness evaluation
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
- +2 more secondary outcomes
Study Arms (2)
electroacupuncture group
EXPERIMENTALBilateral 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.
sham electroacupuncture group
EXPERIMENTALBilateral 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.
Interventions
Procedure: electro-acupuncture;Points: Bilateral Zhongliao (BL33) Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50～60mm to outward and upward by 75mm filiform needle. Twirl, lift and thrust for 3 times, until local sour and heavy feeling coming.The electric stimulator is applied to bilateral BL33 and BL35, with continuous wave,50 Hz and electric current 1- 5mA.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. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.
Procedure: sham electroacupuncture;Points: Bilateral sham Zhongliao (BL33) sham Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Both sham BL33 and BL35 are given non-penetrating needling with blunt needle. Twirl, lift and thrust for 3 times. The sham electric stimulator is applied to bilateral sham BL33 and sham BL35. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.
Eligibility Criteria
You may qualify if:
- Meet the diagnosis of Simple female stress urinary incontinence
- years old
- Volunteered to join this research and signed the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700, China
Related Publications (4)
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.
PMID: 31919102DERIVEDJiao 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.
PMID: 31008950DERIVEDLiu 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.
PMID: 28655016DERIVEDLiu 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.
PMID: 24079823DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baoyan Liu, Master
China Academy of Chinese Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President of China Academy of Chinese Medical Sciences
Study Record Dates
First Submitted
February 1, 2013
First Posted
February 5, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 23, 2014
Record last verified: 2014-12