Back to resultsEffect of Electroacupuncture on Mixed Urinary Incontinence Among Women (EAMUI)
Primary Purpose
Urinary Incontinence, Mixed
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electroacupuncture
sham electroacupuncture
life style counselling
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Mixed focused on measuring acupuncture, randomised controlled trial, sham acupuncture
Eligibility Criteria
Inclusion Criteria:
- Patients are female and meet the diagnosis criteria of mixed urinary incontinence;
- Patients are between age of 35 to 75 years old;
- Positive in cough stress test;
- Experience persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in 72 hours in baseline screening; and
- Patients have signed informed consent form and are willing to participate the study voluntarily.
Patients will be included if all above 5 items are met.
Exclusion criteria:
- Patients have simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence and neurogenic bladder, etc.;
- Patients have uncontrolled urinary tract infection with urinary pain and urge;
- Patients have 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;
- Patients have history of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy;
- Patients have pelvic organ prolapse ≥ II degree;
- Patients have residual urine ≥ 100ml;
- Patients have uncontrolled diabetes mellitus and severe hypertension;
- Patients have diseases affecting lower urinary tract function, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina injury and multiple system atrophy, etc.;
- Patients have severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction;
- Patients are constrained or unable to complete movements like walking, going stairs up and down and running, etc.;
- Patients have poor compliance;
- Patients are at pregnancy, breastfeeding or postpartum period for less than 12 months;
- Patients have cardiac pacemaker, metal allergy or strong fear of needle;
- Patients are participants of other on-going studies; or
- Patients have received acupuncture in the past 3 months. Patients will be excluded if they meet any of the above criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
electroacupuncture
sham electroacupuncture
life style counselling group
Arm Description
patients will receive electroacupuncture at 3 acupoints (Bladder meridian of foot-taiyang 33 and 35（BL33 and BL35), and Spleen meridian of foot-taiyin 33(SP6)) 3 times/week for 8 weeks(24 times in total), followed with 24-weeks follow up. Disposable acupuncture needles with size of 0.30 × 75 mm will be used at BL 33 and BL 35, and needles with size of 0.30 × 40 mm at SP 6. Standardised electroacupuncture apparatuses will be used, and the stimulation will last for 30 minutes with a continuous wave of 20 Hz, and a current intensity of 2 to 6.5 mA at BL33 and BL 35, and 1 to 3.5 mA at SP6. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.
patient will receive sham electroacupuncture with the same frequency and amount as applied in the electroacupuncture group, as well as the follow-up period. Disposable acupuncture needles with size of 0.30 × 40 mm will be applied and penetrate the skin of patients for 2 to 3mm at sham acupoints to the 3 acupoints mentioned above. The stimulation will only last for 30-second with a very weak currency intensity and a continuous wave of 20 Hz. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.
patients randomised to this group will receive a one-time life style counselling at the enrolment to improve their daily behaviour to expedite the recovery of their mixed urinary incontinence. Then the patients will be followed up for 20 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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.
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.
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
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.
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.
blinding assessment
patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding
Full Information
NCT ID
NCT04531683
First Posted
August 20, 2020
Last Updated
October 5, 2020
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Shaanxi Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04531683
Brief Title
Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women
Acronym
EAMUI
Official Title
Efficacy and Safety of Electroacupuncture on Mixed Urinary Incontinence Among Women: a Multi-centre, Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Shaanxi Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Mixed
Keywords
acupuncture, randomised controlled trial, sham acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who sign the informed consent form and are eligible for the study entry at week 0 will be randomised to one of the three groups: electro-acupuncture group, sham electroacupuncture group and life style consultation group. The three group will be assessed in a paralleled manner, and patients in the first two groups will be treated 3 times per week for 8 weeks and followed up for 24 weeks, while patients in the third group will be provided with life style improvement information once and followed-up for 20 weeks.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participants, investigator and outcome assessor will be masked. The care provider will be different from investigator and outcome assessor.
Allocation
Randomized
Enrollment
460 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
electroacupuncture
Arm Type
Experimental
Arm Description
patients will receive electroacupuncture at 3 acupoints (Bladder meridian of foot-taiyang 33 and 35（BL33 and BL35), and Spleen meridian of foot-taiyin 33(SP6)) 3 times/week for 8 weeks(24 times in total), followed with 24-weeks follow up. Disposable acupuncture needles with size of 0.30 × 75 mm will be used at BL 33 and BL 35, and needles with size of 0.30 × 40 mm at SP 6. Standardised electroacupuncture apparatuses will be used, and the stimulation will last for 30 minutes with a continuous wave of 20 Hz, and a current intensity of 2 to 6.5 mA at BL33 and BL 35, and 1 to 3.5 mA at SP6. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.
Arm Title
sham electroacupuncture
Arm Type
Sham Comparator
Arm Description
patient will receive sham electroacupuncture with the same frequency and amount as applied in the electroacupuncture group, as well as the follow-up period. Disposable acupuncture needles with size of 0.30 × 40 mm will be applied and penetrate the skin of patients for 2 to 3mm at sham acupoints to the 3 acupoints mentioned above. The stimulation will only last for 30-second with a very weak currency intensity and a continuous wave of 20 Hz. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.
Arm Title
life style counselling group
Arm Type
Other
Arm Description
patients randomised to this group will receive a one-time life style counselling at the enrolment to improve their daily behaviour to expedite the recovery of their mixed urinary incontinence. Then the patients will be followed up for 20 weeks.
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
same as described in experimental arm.
Intervention Type
Other
Intervention Name(s)
sham electroacupuncture
Intervention Description
same as described in sham comparator.
Intervention Type
Behavioral
Intervention Name(s)
life style counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
Description
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time Frame
at the 8th week after the last treatment
Secondary Outcome Measure Information:
Title
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
Description
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time Frame
at baseline, 4th, 20th and 32nd week
Title
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes
Description
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time Frame
at baseline, 4th, 8th 20th and 32nd week
Title
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes
Description
data will be collected and evaluated by 72-hour incontinence episodes dairy
Time Frame
at baseline, 4th, 8th, 20th and 32nd week
Title
the change from baseline in the amount of urine leakage measured by the 1-hour pad test
Description
data will be collected by 1-hour pad test
Time Frame
at baseline, and the 8th week
Title
the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores
Description
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
at baseline, 4th, 8th, 20th and 32nd week
Title
the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores
Description
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
Title
number of patients with one or more life style change
Description
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
Title
incidence rate of any adverse events
Description
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.
Title
patients' expectation to treatment
Description
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
Title
blinding assessment
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are female and meet the diagnosis criteria of mixed urinary incontinence;
Patients are between age of 35 to 75 years old;
Positive in cough stress test;
Experience persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in 72 hours in baseline screening; and
Patients have signed informed consent form and are willing to participate the study voluntarily.
Patients will be included if all above 5 items are met.
Exclusion criteria:
Patients have simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence and neurogenic bladder, etc.;
Patients have uncontrolled urinary tract infection with urinary pain and urge;
Patients have 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;
Patients have history of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy;
Patients have pelvic organ prolapse ≥ II degree;
Patients have residual urine ≥ 100ml;
Patients have uncontrolled diabetes mellitus and severe hypertension;
Patients have diseases affecting lower urinary tract function, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina injury and multiple system atrophy, etc.;
Patients have severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction;
Patients are constrained or unable to complete movements like walking, going stairs up and down and running, etc.;
Patients have poor compliance;
Patients are at pregnancy, breastfeeding or postpartum period for less than 12 months;
Patients have cardiac pacemaker, metal allergy or strong fear of needle;
Patients are participants of other on-going studies; or
Patients have received acupuncture in the past 3 months. Patients will be excluded if they meet any of the above criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huan Chen, MPH, MD
Phone
+86 10 88002331
Email
chen.huan@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishun Liu, PhD,MD
Phone
+86 10 88002331
Email
liuzhishun@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, PhD
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We cannot share IPD under current regulation of Human Genetic Resources Management in China.
Learn more about this trial
Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women
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