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
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Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Urinary Stress Incontinence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
504 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |