Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Urinary Stress Incontinence

Treatments: Device: sham electroacupuncture group; Device: electroacupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT01784172

2012BAI24B01-2

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.

Full description

Stress urinary incontinence (SUI) is a common disease of female. The inconvenience caused by SUI affects the patients' quality of life and health seriously. To date, there has not specific therapy on SUI. Former research showed acupuncture may work for SUI. This multi-center randomized controlled clinical trial of acupuncture for simple female stress urinary incontinence is designed to confirm the efficacy and safety of EA. This project is conducted by Chinese researchers, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for simple female stress urinary incontinence.

Enrollment: 504 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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
• RUV>30ml
• Qmax<20ml/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, MSA, Injury of cauda equine, myeleterosis.
• During pregnancy or lactation period
• With cardiac pacemaker, Metal allergy or severe needle phobia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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504 participants in 2 patient groups

electroacupuncture group

Experimental group

Description:

Bilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward. Bilateral B L35 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 6 weeks for 3 sessions a week, 18 sessions for each patient in all.

Treatment:

Device: electroacupuncture group

sham electroacupuncture group

Experimental group

Description:

Bilateral sham BL33 and sham BL35 are given sham electroacupuncture with no current output. Every session lasts for 30 min per day. The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all.

Treatment:

Device: sham electroacupuncture group