Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence
- Conditions
- Mixed Urinary Incontinence
- Interventions
- Other: ElectroacupunctureOther: Sham electroacupuncture
- Registration Number
- NCT05505526
- Lead Sponsor
- Shi Hangyu
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 222
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroacupuncture 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. Sham electroacupuncture 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.
- Primary Outcome Measures
Name Time Method the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes. week 8 72-hour incontinence episodes dairy
- Secondary Outcome Measures
Name Time Method the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes week 4, 20, 32 72-hour incontinence episodes dairy
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 72-hour incontinence episodes dairy
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 72-hour incontinence episodes dairy
the change from baseline in the amount of urine leakage measured by the 1-hour pad test baseline, week 8 1-hour pad test
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 data will be collected via International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF). The total score(0-21scores) is an accumulated scores from question 1 to 3. The higher the total score is, the severer the incontinence is.
the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores week 4, 8, 20, 32 data will be collected via the Overactive Bladder Questionnaire-Short Form (0-15 scores). The higher the total score is, the severer the condition is.
incidence rate of any adverse events up to 32 weeks adverse event will be documented as soon as it is reported during treatments and follow-ups
patients' expectation to treatment baseline patients will be asked about their expected effect of the treatment via question: In your expectation, how is your incontinence like in a two month time. Five choices will be provided 1) much better; 2) slightly better; 3) I don't know; 4) no change; 5) worse.
blinding assessment week 8 patients will be asked whether they received electroacupuncture or sham electroacupuncture
Trial Locations
- Locations (1)
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
🇨🇳Beijing, China