Acupuncture for Stress-predominant Mixed Urinary Incontinence
NCT ID: NCT04299932
Last Updated: 2021-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
232 participants
INTERVENTIONAL
2020-10-09
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Electroacupuncture(EA) group
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.
Electroacupuncture
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 Electroacupuncture (SA) group
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.
Sham electroacupuncture
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.
Waiting List (WL) group
Participants in WL group will be followed up for 20 weeks. Participants only receive healthcare education and advice on lifestyle modification, which will be received by all the participants in the three groups.
No interventions assigned to this group
Interventions
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Electroacupuncture
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 electroacupuncture
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female participants aged between 35 and 75;
3. Stress index \> urge index in accordance with Medical, Epidemiologic, and Social aspects of Aging(MESA) questionnaire；
4. Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEF documented in 3-day voiding diary;
5. Less than 12 micturition episodes in average 24 hours documented in 3-day voiding diary;
6. Positive cough stress test;
7. Urine leakage \> 1 g in 1-hour pad test;
8. Voluntary participation in the trial and signed written informed content.
Exclusion Criteria
2. Uncontrolled symptomatic urinary tack infection;
3. Tumor in urinary system and pelvic organ;
4. Pelvic organ prolapse ≥ degree Ⅱ；
5. Residual urine volume ≥ 100ml；
6. History of treatments targeted at UI, such as acupuncture, PFMT and medications in the previous one month;
7. History of surgery targeted at UI or in pelvic floor, including hysterectomy;
8. Uncontrolled diabetes or severe high blood pressure;
9. Nervous system diseases that may hamper the function of urinary system, such as Multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina nerve injury, or multiple system atrophy;
10. Severe heart, lung, brain, liver, kidney, mental illness, coagulation dysfunction or with obvious cognitive dysfunction
11. Installed cardiac pacemaker;
12. Inconvenient or unable to walk, run, go up and down stairs;
13. Allergy to metal, severely fear of acupuncture needles or unbearable to EA;
14. Pregnant at present, plan to conceive in future one year, at lactation period or within 12 months after childbirth.
35 Years
75 Years
FEMALE
No
Sponsors
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Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Liu Zhishun
Dean of Acupuncture Department of Guang'anmen Hospital
Principal Investigators
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Zhishun Liu
Role: STUDY_CHAIR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Locations
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Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The third affiliated hospital of Beijing university of Chinese Medicine
Beijing, Beijing Municipality, China
Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
Hengyang, Hunan, China
Jiangxi Provincial Hospital of traditional Chinese Medicine
Nanchang, Jiangxi, China
Yantai Hospital of Traditional Chinese Medicine
Yantai, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Sun Y, Liu Y, Chen H, Yan Y, Liu Z. Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial. BMJ Open. 2021 Jan 7;11(1):e038452. doi: 10.1136/bmjopen-2020-038452.
Other Identifiers
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2019-241-KY
Identifier Type: -
Identifier Source: org_study_id
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