Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence

Shi Hangyu

Status: Not yet enrolling

Conditions: Mixed Urinary Incontinence

Treatments: Other: Electroacupuncture; Other: Sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05505526

2022-174-KY

Details and patient eligibility

About

The investigators plan to conduct this randomized sham-controlled clinical trial to evaluate the efficacy and safety of electroacupuncture (EA), compared with sham electroacupuncture (SA) on women with mixed urinary incontinence (MUI).

Full description

MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recommends to initiate treatment targeted at predominant component of MUI. Electroacupuncture has been proved not inferior to pelvic floor muscle training plus solifenacin in decreasing the 72-hour IEF and shows promise as an effective alternative for the treatment of MUI. The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.

Enrollment: 222 estimated patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female, 35 to 75 years old
• Diagnosed as mixed urinary incontinence
• Positive in cough stress test
• Experiencing persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in baseline screening
• Sign the informed consent form

Exclusion criteria

• Diagnosed as simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence or neurogenic bladder, etc.
• Uncontrolled urinary tract infection with urinary pain and urge
• Urogenital system tumours and/or pelvic organ tumours
• Patients have taken drugs for urinary incontinence treatment or drugs possibly affect the function of lower urinary tract, or received non-drug treatment for urinary incontinence (i.e. electrical stimulation, bladder training, pelvic floor muscle training, and etc.) in the past one month
• History of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy; Patients have pelvic organ prolapse ≥ II degree
• Residual urine ≥ 100ml
• Uncontrolled diabetes mellitus and severe hypertension
• Diseases affecting lower urinary tract function
• Severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction
• Constrained or unable to complete movements like walking, going stairs up and down and running, etc.
• At pregnancy, breastfeeding or postpartum period for less than 12 months
• Cardiac pacemaker, metal allergy or strong fear of needle
• Patients have received acupuncture in the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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222 participants in 2 patient groups

Electroacupuncture

Experimental group

Description:

Participants in EA group will receive treatment at bilateral Bladder Meridian (BL) 33 \[Zhongliao\], BL35 \[Huiyang\] and Spleen Meridian (SP) 6 \[Sanyinjiao\]. The EA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks.

Treatment:

Other: Electroacupuncture

Sham electroacupuncture

Sham Comparator group

Description:

Participants in SA group will receive treatment at bilateral sham BL33 \[Zhongliao\], sham BL35 \[Huiyang\] and sham SP6 \[Sanyinjiao\]. The SA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks.

Treatment:

Other: Sham electroacupuncture