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

Primary Purpose

Urinary Stress Incontinence

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
electroacupuncture group
sham electroacupuncture group
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Stress Incontinence focused on measuring efficacy, safety, electroacupuncture, simple female stress urinary incontinence

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

electroacupuncture group

sham electroacupuncture group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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'.
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
Patient subjective effectiveness evaluation
3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3
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.
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.
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.
Incidence of adverse events

Full Information

First Posted
February 1, 2013
Last Updated
December 21, 2014
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT01784172
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
efficacy, safety, electroacupuncture, simple female stress urinary incontinence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham electroacupuncture group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
electroacupuncture group
Other Intervention Name(s)
SDA-V electroacupuncture apparatus(Huatuo,made in China)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham electroacupuncture group
Other Intervention Name(s)
Sham SDZ-V electroacupuncture apparatus(Huatuo,China)
Intervention Description
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.
Primary Outcome Measure Information:
Title
value difference of 1h pad test, compared with the baseline
Description
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.
Time Frame
the 6 weeks
Secondary Outcome Measure Information:
Title
average frequency difference of urinary incontinence in 72h
Description
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'.
Time Frame
the 6 weeks, the15-18 weeks, 27-30 weeks
Title
ICIQ-SF
Description
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives
Time Frame
the 6, 18, 30 week
Title
Patient subjective effectiveness evaluation
Description
3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3
Time Frame
the 6, 18, 30 week
Title
Weekly usage of pad
Description
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.
Time Frame
the 6 weeks, 7-18weeks, 19-30 weeks
Title
Usage of specialty therapy for Simple female stress urinary incontinence
Description
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.
Time Frame
the 6 weeks, 7-18weeks, 19-30 weeks
Title
subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence
Description
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.
Time Frame
the 6, 18, 30 week
Title
Incidence of adverse events
Time Frame
the 1-6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoyan Liu, Master
Organizational Affiliation
China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31919102
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.
Results Reference
derived
PubMed Identifier
31008950
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.
Results Reference
derived
PubMed Identifier
28655016
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.
Results Reference
derived
PubMed Identifier
24079823
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.
Results Reference
derived

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

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