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

NCT ID: NCT01940432

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-12-31

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.

Detailed Description

Urinary incontinence (UI) is defined as a complaint of involuntary leakage. Researches show that 9%-72% women between age 17-79 are urinary incontinence, in which stress urinary incontinence (SUI) is the most prevalent type of urinary incontinence. The morbidity rate of UI through the world is 27.6%, which SUI take percentage of 50.Morbidity rate of UI in Beijing is 46.5%,and among which 59.6% is SUI. Aging is a high risk for SUI, which will increase morbidity rate of SUI. Totally, 61.9% women over 50 year-old have SUI. SUI is defined as a complaint of involuntary leakage during sneezing or coughing, which make patients embarrassed and can not attend social activity normally, decreasing the quality of their lives. Attending social activity is very important for people's health, otherwise, people will get a series of diseases, like osteoporosis, obesity, diabetes, hypertension, coronary heart disease,etc The International Consultation on Urological Diseases recommended pelvic floor muscle training as A level evidence treating simple mild and moderate stress urinary incontinence, which curative rate varies 30% to 60%. But the length of treatment should last at least 3 month. Therefore, patients' compliance is a key to the effectiveness. While, electroacupuncture is verified as a better treatment for SUI, which length of treatment is shorter than pelvic floor muscle training, and effective rate is over 80%, showing potential advantages. Early clinical research show that electroacupuncture for SUI is effective.

This subject is primary to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for SUI. The early clinical research is a randomized controlled trial (RCT) with a small sample, which consists of two arms, 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 effective.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

electroacupuncture group

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.

Group Type: EXPERIMENTAL

electroacupuncture group

Intervention Type: 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.

pelvic floor muscle training group

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.

Group Type: EXPERIMENTAL

pelvic floor muscle training group

Intervention Type: 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.

Interventions

electroacupuncture group

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.

Intervention Type: DEVICE

pelvic floor muscle training group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SDZ-V electroacupuncture; apparatus(Huatuo,made in China); Kegel Exercise

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: collaborator

Shaanxi Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shaanxi Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, China

Site Status: NOT_YET_RECRUITING

Tongsheng Su

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Tong sheng Su, M.D.

Role: primary

chinasuts@126.com

008615929562568

Tong Sheng Su, Master

Role: primary

chinasuts@126.com

02987231294

References

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.

Reference Type: DERIVED

PMID: 25887231 (View on PubMed)

Other Identifiers

2012BAI24B01-2

Identifier Type: -

Identifier Source: org_study_id