Urinary Incontinence, MixedEAMUINCT04531683
Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women
A study testing electroacupuncture and life style counselling in people with Urinary Incontinence, Mixed, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence, Mixed
- What is being tested?
- electroacupuncture and life style counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Electroacupuncture on Mixed Urinary Incontinence Among Women: a Multi-centre, Randomised Controlled Trial
The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.
Read the 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.
- Conditions
- Urinary Incontinence, Mixed
- Being tested
- electroacupuncture, sham electroacupuncture, life style counselling
- Keywords
- acupuncture, randomised controlled trial, sham acupuncture
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
same as described in experimental arm.
sham electroacupunctureOther
same as described in sham comparator.
life style counsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture | Experimental | 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. Receives: Other: electroacupuncture; Behavioral: life style counselling |
| sham electroacupuncture | Sham comparator | 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. Receives: Other: sham electroacupuncture; Behavioral: life style counselling |
| life style counselling group | Other | 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. Receives: Behavioral: life style counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the 8th week after the last treatment
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: at baseline
blinding assessment
patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding
Measured: in 8th week after any acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start30 Oct 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, MixedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531683
- Sponsor's protocol ID
- ZZ13-024-9
- Acronym
- EAMUI
- Status last verified
- Oct 2020
- First submitted
- 20 Aug 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We cannot share IPD under current regulation of Human Genetic Resources Management in China.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Electroacupuncture on Mixed Urinary Incontinence Among Women: a Multi-centre, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04531683
- Acronym / sponsor ID
- EAMUI / ZZ13-024-9
- Conditions
- Urinary Incontinence, Mixed
- Keywords
- acupuncture, randomised controlled trial, sham acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- 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
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture | Experimental | Other: electroacupuncture, Behavioral: life style counsellingpatients 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. |
| sham electroacupuncture | Sham comparator | Other: sham electroacupuncture, Behavioral: life style counsellingpatient 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. |
| life style counselling group | Other | Behavioral: life style counsellingpatients 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupuncturesame as described in experimental arm. | Other | electroacupuncture |
| sham electroacupuncturesame as described in sham comparator. | Other | sham electroacupuncture |
| life style counsellinglife 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. | Behavioural | electroacupuncture, life style counselling group, sham electroacupuncture |
Primary outcome
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
Time frame: at the 8th week after the last treatment
data will be collected and evaluated by 72-hour incontinence episodes dairy
10 secondary outcomes
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
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
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
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
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
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
Time frame: at baseline 4th, 8th, 20th and 32nd week
number of patients with one or more life style change
Time frame: at the 4th, 8th, 20th and 32nd week
incidence rate of any adverse events
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
Time frame: at baseline
blinding assessment
Time frame: in 8th week after any acupuncture treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No. We cannot share IPD under current regulation of Human Genetic Resources Management in China.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, PhD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture and life style counselling in people with Urinary Incontinence, Mixed, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Chen, MPH, MD (+86 10 88002331, chen.huan@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes. (time frame: at the 8th week after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.