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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Shaanxi Hospital of Traditional Chinese Medicine
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Shaanxi Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01940432
First received: August 28, 2013
Last updated: June 11, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Simple Stress Urinary Incontinence
Device: electroacupuncture group
Behavioral: pelvic floor muscle training group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Electroacupuncture for Treatment of Simple Female Stress Urinary Incontinence: Comparison With Pelvic Floor Muscle Training-a Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shaanxi Hospital of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Difference of frequency of leakage in mean 24h based on 72h diary, compared with the baseline [ Time Frame: the 2, 4, 6, 8 week ] [ Designated as safety issue: No ]
    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.

  • Difference of amount of leakage in mean 24h based on 72h diary, compared with the baseline [ Time Frame: the 2, 4, 6, 8 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Difference of 1h pad test, compared with the baseline [ Time Frame: the 8, 20, 32 week ] [ Designated as safety issue: No ]
    Quantity of fluid loss will be measured by 1 h pad test, comparing the value of 2nd and 6th week with the baseline(0 week), the primary outcome is the value difference.

  • ICIQ-SF [ Time Frame: the 8, 20, 32 week ] [ Designated as safety issue: No ]
    International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives

  • Patient subjective effectiveness evaluation [ Time Frame: the 8, 20, 32 week ] [ Designated as safety issue: No ]
    3 point scoring: no help=0; Small help=1;Medium help=2; Great help=3

  • Weekly usage of pad [ Time Frame: the 8, 20, 32 week ] [ Designated as safety issue: No ]
    The value of 8th week is the average weekly usage of pads during 1-8 weeks ; The value of 20th week is the average weekly usage of pads during 9-20 weeks; The value of 32th week is the average weekly usage of pads during 21-32 weeks.

  • Usage of specialty therapy for Simple female stress urinary incontinence [ Time Frame: the 8, 20, 32 week ] [ Designated as safety issue: No ]
    Compare the difference of uase of specialty therapy for Simple female stress urinary incontinence between the 2 groups during the 1-8 weeks, 9-20 weeks and 21-32 weeks.

  • Subgroup analysis: amount of leakage with 1h pad test as a measure of curative effect of electroacupuncture for different extent of simple female stress urinary incontinence. [ Time Frame: the 8, 20, 32 week ] [ Designated as safety issue: No ]
    The 8th week: difference of 1 h pad test for simple female stress urinary incontinence, compared with the baseline; the 20th and 32th weeks: difference of 1h pad test for simple female stress urinary incontinence, compared with the baseline.


Estimated Enrollment: 320
Study Start Date: March 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Other Names:
  • SDZ-V electroacupuncture
  • apparatus(Huatuo,made in China)
Experimental: 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.
Behavioral: 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.
Other Name: Kegel Exercise

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940432

Locations
China, Shaanxi
Shaanxi Hospital of Traditional Chinese Medicine Not yet recruiting
Xi'an, Shaanxi, China, 710003
Contact: Tong sheng Su, M.D.    008615929562568    chinasuts@126.com   
Principal Investigator: Tong Sheng Su, M.D.         
Tongsheng Su Recruiting
Xi'an, Shaanxi, China, 710003
Contact: Tong Sheng Su, Master    02987231294    chinasuts@126.com   
Principal Investigator: Jing Zhou, master         
Sponsors and Collaborators
Shaanxi Hospital of Traditional Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
  More Information

No publications provided

Responsible Party: Shaanxi Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01940432     History of Changes
Other Study ID Numbers: 2012BAI24B01-2
Study First Received: August 28, 2013
Last Updated: June 11, 2014
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Shaanxi Hospital of Traditional Chinese Medicine:
simple stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 29, 2014