Electroacupuncture for Women With Mixed Urinary Incontinence: a Sham-controlled Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 222
- Locations
- 1
- Primary Endpoint
- the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
Study Overview
Brief Summary
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Electroacupuncture
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.
Intervention: Electroacupuncture (Other)
Sham electroacupuncture
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.
Intervention: Sham electroacupuncture (Other)
Outcomes
Primary Outcomes
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
Time Frame: week 8
72-hour incontinence episodes dairy
Secondary Outcomes
- the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes(week 4, 20, 32)
- the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes(week 4, 8, 20, 32)
- the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes(week 4, 8, 20, 32)
- the change from baseline in the amount of urine leakage measured by the 1-hour pad test(baseline, week 8)
- the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores(week 4, 8, 20, 32)
- the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores(week 4, 8, 20, 32)
- incidence rate of any adverse events(up to 32 weeks)
- patients' expectation to treatment(baseline)
- blinding assessment(week 8)
Investigators
Shi Hangyu
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences