Simple Stress Urinary Incontinence Clinical 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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment