Clinical trial NCT01940432: The Efficacy of Electroacupuncture for Treatment of Simple Female Stress Urinary Incontinence: Comparison With Pelvic Floor Muscle Training-a Multicenter Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simple Stress Urinary Incontinence
Keywords: simple stress urinary incontinence
Lead sponsor: Shaanxi Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2013-09-12
Enrollment: 320
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference of frequency of leakage in mean 24h based on 72h diary, compared with the baseline
timeFrame: the 2, 4, 6, 8 week
measure: Difference of amount of leakage in mean 24h based on 72h diary, compared with the baseline
timeFrame: the 2, 4, 6, 8 week
Secondary outcomes:
measure: Difference of 1h pad test, compared with the baseline
timeFrame: the 8, 20, 32 week
measure: ICIQ-SF
timeFrame: the 8, 20, 32 week
measure: Patient subjective effectiveness evaluation
timeFrame: the 8, 20, 32 week
measure: Weekly usage of pad
timeFrame: the 8, 20, 32 week
measure: Usage of specialty therapy for Simple female stress urinary incontinence
timeFrame: the 8, 20, 32 week
measure: 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.
timeFrame: the 8, 20, 32 week
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Hospital of Traditional Chinese Medicine
state: Shaanxi
city: Xi'an
country: China
facility: Tongsheng Su
state: Shaanxi
Study officials:
References:
citation: 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.