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

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ClinicalTrials.gov Identifier: NCT01784172
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Baoyan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Device: electroacupuncture group Device: sham electroacupuncture group Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 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.
Other Name: SDA-V electroacupuncture apparatus(Huatuo,made in China)
Experimental: sham electroacupuncture group

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
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 Name: Sham SDZ-V electroacupuncture apparatus(Huatuo,China)


Outcome Measures
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Primary Outcome Measures :
  1. value difference of 1h pad test, compared with the baseline [ Time Frame: the 6 weeks ]
    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 :
  1. average frequency difference of urinary incontinence in 72h [ Time Frame: the 6 weeks, the15-18 weeks, 27-30 weeks ]
    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'.

  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 weeks, 7-18weeks, 19-30 weeks ]
    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.

  5. Usage of specialty therapy for Simple female stress urinary incontinence [ Time Frame: the 6 weeks, 7-18weeks, 19-30 weeks ]
    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.

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

  7. Incidence of adverse events [ Time Frame: the 1-6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784172


Locations
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China, Beijing
China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100700
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
Investigators
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Principal Investigator: Baoyan Liu, Master China Academy of Chinese Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Liu Baoyan, Vice President of China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01784172    
Other Study ID Numbers: 2012BAI24B01-2
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Liu Baoyan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
efficacy
safety
electroacupuncture
simple female stress urinary incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders