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

NCT01784172 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2014-12-23

No results posted yet for this study

Summary

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

Conditions

  • Urinary Stress Incontinence

Interventions

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.

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.

Sponsors & Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

    collaborator OTHER_GOV

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Baoyan Liu, Master · China Academy of Chinese Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01784172 on ClinicalTrials.gov