Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.

Detailed Description
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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.

Official Title
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The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Device: electroacupuncture group
* Device: sham electroacupuncture group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture group<br>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. | Device: electroacupuncture group<br>* 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.<br>* Other names: SDA-V electroacupuncture apparatus(Huatuo,made in China);|
| Experimental: sham electroacupuncture group<br>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. | Device: sham electroacupuncture group<br>* 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.<br>* Other names: Sham SDZ-V electroacupuncture apparatus(Huatuo,China);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average frequency difference of urinary incontinence in 72h | 1. The average frequency difference of urinary incontinence in 72h of the 6 weeks is the average frequency difference of urinary incontinence in 72h of 2nd, 4th, 6th weeks based on the '72h voiding diary'; 2. The average frequency difference of urinary incontinence in 72h of the15-18 weeks is the average frequency difference of urinary incontinence in 72h of 15-18 weeks based on the '72h voiding diary'; 3. The average frequency difference of urinary incontinence in 72h of the 27-30 weeks is the average frequency difference of urinary incontinence in 72h of 27-30 weeks based on the '72h voiding diary'. | the 6 weeks, the15-18 weeks, 27-30 weeks | 
| ICIQ-SF | International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives | the 6, 18, 30 week | 
| Patient subjective effectiveness evaluation | 3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3 | the 6, 18, 30 week | 
| Weekly usage of pad | The value of 6 weeks is the average weekly usage of pads during 1-6 week; The value of 7-18weeks is the average weekly usage of pads during 7-18 weeks; The value of 19-30 weeks is the average weekly usage of pads during 19-30 weeks. | the 6 weeks, 7-18weeks, 19-30 weeks | 
| Usage of specialty therapy for Simple female stress urinary incontinence | Compare the difference of uase of specialty therapy for Simple female stress urinary incontinence between the 2 groups during the 1-6 weeks, 7-18 weeks and 19-30 weeks. | the 6 weeks, 7-18weeks, 19-30 weeks | 
| subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence | the 6th week: analyse the relevancy between 1h pad test and extent of urinary incontinence; the 18th and 30th weeks: analyse the relevancy between frequency of urinary incontinence in 72h and extent of urinary incontinence. | the 6, 18, 30 week | 
| Incidence of adverse events |  | the 1-6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, safety, electroacupuncture, simple female stress urinary incontinence