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

Phase 2

Completed

• Conditions: Urinary Stress Incontinence
• Interventions: Device: electroacupuncture group; Device: sham electroacupuncture group

• Registration Number: NCT01784172
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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 Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-05
• Study Start: 2013-03
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-21
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 504

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electroacupuncture group	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.
sham electroacupuncture group	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.

Primary Outcome Measures

Name	Time	Method
value difference of 1h pad test, compared with the baseline	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

Name	Time	Method
Incidence of adverse events	the 1-6 weeks
Patient subjective effectiveness evaluation	the 6, 18, 30 week	3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3
subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence	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.
average frequency difference of urinary incontinence in 72h	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	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
Weekly usage of pad	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	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.

Trial Locations

Locations (1)

China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China