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History of Changes for Study: NCT01784172
Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial
Latest version (submitted December 21, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 4, 2013 None (earliest Version on record)
2 June 1, 2013 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures and Conditions
3 January 13, 2014 Outcome Measures, Study Status, Arms and Interventions and Study Identification
4 August 12, 2014 Recruitment Status, Study Status and Contacts/Locations
5 December 21, 2014 Recruitment Status, Study Status, Study Design
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Study NCT01784172
Submitted Date:  February 4, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2012BAI24B01-2
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 SSimple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2013
Overall Status: Not yet recruiting
Study Start: March 2013
Primary Completion: February 2014 [Anticipated]
Study Completion: December 2014 [Anticipated]
First Submitted: February 1, 2013
First Submitted that
Met QC Criteria:
February 4, 2013
First Posted: February 5, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 4, 2013
Last Update Posted: February 5, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Responsible Party: Principal Investigator
Investigator: Liu Baoyan
Official Title: Vice President of China Academy of Chinese Medical Sciences
Affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: Ministry of Science and Technology of the People´s Republic of China
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.
Open or close this module Conditions
Conditions: Urinary Stress Incontinence
Electroacupuncture
Keywords: efficacy
safety
electroacupuncture
simple female stress urinary incontinence
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: electroacupuncture group

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
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 dilatational 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.
Other Names:
  • SDA-V electroacupuncture apparatus(Huatuo,made in China)
Experimental: sham eletroacupuncture group

Bilateral sham BL33 and sham BL35 are given sham eletroacupuncture 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 eletroacupuncture group
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.
Other Names:
  • Sham SDZ-V electroacupuncture apparatus(Huatuo,China)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. value difference of 1h pad test, compared with the baseline
[ Time Frame: the 0,2,6 week ]

quantity of fluid loss will be measured by 1h pad test, comparing the value of 2nd and 6th week with the baseline(0 week), the primary outcome is the value difference.
Secondary Outcome Measures:
1. average frequency difference of urinary incontinence in 72h
[ Time Frame: the 6, 18, 30 week ]

1. The average frequency difference of urinary incontinence in 72h of the 6th week 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 the 18th week 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 30th week is the average frequency difference of urinary incontinence in 72h of 27-30 weeks based on the '72h voiding diary'.
2. ICIQ-SF
[ Time Frame: the 6, 18, 30 week ]

International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives
3. Patient subjective effectiveness evaluation
[ Time Frame: the 6, 18, 30 week ]

3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3
4. Weekly usage of pad
[ Time Frame: the 6, 18, 30 week ]

The value of 6th week is the average weekly usage of pads during 1-6 week; The value of 18th week is the average weekly usage of pads during 7-18 week; The value of 30th week is the average weekly usage of pads during 19-30 week
5. Usage of specialty therapy for Simple female stress urinary incontinence
[ Time Frame: the 6, 18, 30 week ]

Compare the differece 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.
6. subgroup analysis: Relevency between 1h pad test, frequncy of urinary incontinence in 72h and extent of urinary incontinence
[ Time Frame: the 6, 18, 30 week ]

the 6th week: analyse the relevency between 1h pad test and extent of urinary incontinence; the 18th and 30th weeks: analyse the relevency between frequncy of urinary incontinence in 72h and extent of urinary incontinence.
7. Incidence of adverse events
[ Time Frame: the 1-6 weeks ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 75 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Zhishun Liu, M.D.
Telephone: 0086-1365106313
Email: liuzhishun@yahoo.com.cn
Central Contact Backup: Jia Liu, M.D.
Telephone: 0086-18810877011
Email: marie_liujia@yahoo.com.cn
Study Officials: Baoyan Liu, Master
Principal Investigator
China Academy of Chinese Medical Sciences
Locations: China, Beijing
China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100700
Open or close this module IPDSharing
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