The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.
After being informed about the study and potential risk, all patients giving written informed consent form will be undergo a 1-week screening period to determine eligibility for study entry. Eligible patients will be randomly assigned to one of the three groups 1) electroacupuncture group: electroacupuncture will be provided to patients at BL33, BL35 and SP6 for 3 time per week for 8 weeks; 2) sham electroacupuncture group: sham electroacupuncture will be provided to patients at sham acupoints to BL33, BL35 and SP6 for 3 time per week for 8 weeks.The follow-up time for the first two groups are 24 weeks and life style counselling will be provided once when receiving the first acupuncture treatment(contents are the same as the life style counselling group). 3) life style counselling group: life style advice will be provided to patients at enrolment with content on drinking, diet, weight control, lung disease, urinary track infection control, and etc. Patients in this group will be followed up for 20 weeks. Primary and secondary outcome will be measured at 4, 8, 20, 32 weeks, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
460
same as described in experimental arm.
same as described in sham comparator.
life style counselling to patients with mixed urinary incontinence contains advice on daily drinking, caffeine intake, diet, constipation, exercise, heavy lifting, lung disease, urinary track infection and etc.
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time frame: at the 8th week after the last treatment
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time frame: at baseline, 4th, 20th and 32nd week
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time frame: at baseline, 4th, 8th 20th and 32nd week
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time frame: at baseline, 4th, 8th, 20th and 32nd week
the change from baseline in the amount of urine leakage measured by the 1-hour pad test
data will be collected by 1-hour pad test
Time frame: at baseline, and the 8th week
the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores
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.
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Time frame: at baseline, 4th, 8th, 20th and 32nd week
the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores
data will be collected via the Overactive Bladder Questionnaire-Short Form. The higher the total score is, the severer the condition is.
Time frame: at baseline 4th, 8th, 20th and 32nd week
number of patients with one or more life style change
life style change, such as drinking, diet, weight control and etc, will be evaluated through questionnaire
Time frame: at the 4th, 8th, 20th and 32nd week
incidence rate of any adverse events
adverse event associated either with or without acupuncture will be documented as soon as it is reported in any centres. The type of conditions, time of on-set and relief, its relation with the intervention, treatment to the adverse event, whether the patient's participation is terminated or not due to the adverse event, etc.
Time frame: this is a case-based data reported by each centre from the start of treatment to the end of follow-up, up to 1 year and 4 months.
patients' expectation to treatment
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.
Time frame: at baseline
blinding assessment
patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding
Time frame: in 8th week after any acupuncture treatment