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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 1, 2013
First Posted Date  ICMJE February 5, 2013
Last Update Posted Date December 23, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
  • 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'.
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • Incidence of adverse events [ Time Frame: the 1-6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
  • 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'.
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • Incidence of adverse events [ Time Frame: the 1-6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial
Official Title  ICMJE The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Urinary Stress Incontinence
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.

    Intervention: Device: electroacupuncture group
  • 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.

    Intervention: Device: sham electroacupuncture group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2014)
504
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2013)
500
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01784172
Other Study ID Numbers  ICMJE 2012BAI24B01-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Liu Baoyan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministry of Science and Technology of the People´s Republic of China
Investigators  ICMJE
Principal Investigator: Baoyan Liu, Master China Academy of Chinese Medical Sciences
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP