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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
222
BL33 is located in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; and SP6 posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. BL33 will be inserted by needles of 0.30×75mm size at the angle of 45°, inward and downward, till the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, till the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm till the depth of 25-30mm. All the needles will be lifted, thrust and twisted evenly for three times, right after insertion, to induce the sensation of deqi. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20 Hertz (Hz), electric current of 2-6.5 milliampere (mA) for BL33 and BL35, and 1mA-3.5mA for SP6.
Sham BL33 is in the area of 1 cun (≈20mm) horizontally outside BL33; sham BL35, 1 cun (≈20mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The three pairs of acupoints will be inserted by needles of 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20Hz and minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on.
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijing, China
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
72-hour incontinence episodes dairy
Time frame: week 8
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
72-hour incontinence episodes dairy
Time frame: week 4, 20, 32
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes
72-hour incontinence episodes dairy
Time frame: 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
72-hour incontinence episodes dairy
Time frame: week 4, 8, 20, 32
the change from baseline in the amount of urine leakage measured by the 1-hour pad test
1-hour pad test
Time frame: baseline, week 8
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.
Time frame: week 4, 8, 20, 32
the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores
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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.
Time frame: week 4, 8, 20, 32
incidence rate of any adverse events
adverse event will be documented as soon as it is reported during treatments and follow-ups
Time frame: up to 32 weeks
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: baseline
blinding assessment
patients will be asked whether they received electroacupuncture or sham electroacupuncture
Time frame: week 8