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

Urinary Stress Incontinence Clinical Trial

Official title:

The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784172
• Other study ID #: 2012BAI24B01-2
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2013
• Last updated: December 21, 2014
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	value difference of 1h pad test, compared with the baseline	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.	the 6 weeks
Secondary	average frequency difference of urinary incontinence in 72h	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'.	the 6 weeks, the15-18 weeks, 27-30 weeks
Secondary	ICIQ-SF	International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives	the 6, 18, 30 week
Secondary	Patient subjective effectiveness evaluation	3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3	the 6, 18, 30 week
Secondary	Weekly usage of pad	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.	the 6 weeks, 7-18weeks, 19-30 weeks
Secondary	Usage of specialty therapy for Simple female stress urinary incontinence	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.	the 6 weeks, 7-18weeks, 19-30 weeks
Secondary	subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence	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.	the 6, 18, 30 week
Secondary	Incidence of adverse events		the 1-6 weeks