The Efficacy of Electroacupuncture for Treatment of Simple Female Stress Urinary Incontinence: Comparison With Pelvic Floor Muscle Training-a Multicenter Randomized Controlled Trial

NCT01940432 | Unknown DMC

• 1 other identifier: 2012BAI24B01-2
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

This research is primarily to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress urinary incontinence (SUI). The early clinical research is a randomized controlled trial (RCT) with a small sample,consisting of two arms of electroacupuncture group and sham electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks. The result indicates that electroacupuncture is an optimal method for SUI. As a further study, this research is a large sample multicenter trial with two parallel arms of electroacupuncture group and pelvic floor muscle training group. The primary purpose is to value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is to evaluate safety of electroacupuncture therapy, and compare acceptance of electroacupuncture treatment and pelvic floor muscle training.

Conditions

Simple Stress Urinary Incontinence

Keywords

simple stress urinary incontinence

Outcome Measures

Primary Outcomes (2)

• Difference of frequency of leakage in mean 24h based on 72h diary, compared with the baseline

  Since the average frequency difference of urinary incontinence in mean 24h of the 8th week is the average frequency difference of urinary incontinence in mean 24h of 2nd, 4th, 6th, 8th weeks based on the "72 voiding diary", which is 12 times treatment totally. Therefore, frequency of leakage in mean 24h is calculated by total frequency of leakage in week of 2th , 4th, 6th and 8th divided 12.

  the 2, 4, 6, 8 week

• Difference of amount of leakage in mean 24h based on 72h diary, compared with the baseline

  The quantity of fluid loss in mean 24h will be measured by "72h voiding diary", comparing the value of 2nd, 4th, 6th and 8th weeks with the baseline (0 week) in 8th week. And the quantity of fluid loss in mean 24h is calculated by total quantity of fluid loss of 12 times treatment divided 12.

  the 2, 4, 6, 8 week

Secondary Outcomes (6)

• Difference of 1h pad test, compared with the baseline

  the 8, 20, 32 week

• ICIQ-SF

  the 8, 20, 32 week

• Patient subjective effectiveness evaluation

  the 8, 20, 32 week

• Weekly usage of pad

  the 8, 20, 32 week

• Usage of specialty therapy for Simple female stress urinary incontinence

  the 8, 20, 32 week

Study Arms (2)

electroacupuncture group

EXPERIMENTAL

Bilateral BL33 are given acupuncture of 50-60mm with 30-45°angle to inward and downward. Bilateral BL35 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 8 weeks for 3 sessions a week, 24 sessions for each patient in all.

Device: electroacupuncture group

pelvic floor muscle training group

EXPERIMENTAL

Standing/sitting/lying on back, knees bent to chest. A set consists of three contractions, each lasting 10s, with a 10s break between contractions. Counting or measuring the duration of contractions and breaks is accomplished without effort by taking advantage of the duration of normal breaths. As most men take about 10 breaths per minute, each breath can be used as 6s timing device.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all.

Behavioral: pelvic floor muscle training group

Interventions

electroacupuncture group DEVICE

Procedure: electro-acupuncture;Points: Bilateral Zhong Liao (BL33) Hui Yang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50一60mm with 30一45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50一60mm 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 dilatational wave,50 Hz and electric current 1一5mA(milliampere).Every session lasts for 30 min per day.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.

Also known as: SDZ-V electroacupuncture, apparatus(Huatuo,made in China)

electroacupuncture group

pelvic floor muscle training group BEHAVIORAL

Procedure:first,identify anal sphincter/feel anus, and try to raise it from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting; second, identify levator ani and try to raise vagina from chair (without adding abdominal, thigh, and buttock muscles) with a position of Sitting, bent forward, elbows on knees; third, contract levator ani with a position of sitting, lying, and standing; fourth, contract anal sphincter with a position of sitting, lying, and standing. Length of Treatment and the treatment sessions are the same as treatment group.

Also known as: Kegel Exercise

pelvic floor muscle training group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnosis of Simple female stress urinary incontinence
• years old
• Volunteered to join this research and signed the informed consent

You may not qualify if:

• 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
• Residual urine volume\>30m1
• Qmax\<20m1/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, multiple system atrophy, Injury of cauda equine,myeleterosis.
• During pregnancy or lactation period
• With cardiac pacemaker, Metal allergy or severe needle phobia
• Senile dementia
• Lunatic

Sponsors & Collaborators

• Shaanxi Hospital of Traditional Chinese Medicine: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (2)

Shaanxi Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, 710003, China

NOT YET RECRUITING

Tongsheng Su

Xi'an, Shaanxi, 710003, China

RECRUITING

Related Publications (1)

• Su T, Zhou J, Liu Z, Chen Y, Zhang W, Chu H, Luo Q, Lu J, An J, Liu B. The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial. Trials. 2015 Feb 8;16:45. doi: 10.1186/s13063-015-0560-1.

  PMID: 25887231 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 12, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)