Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women (EAMUI)

October 5, 2020 updated by: Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

31 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients are female and meet the diagnosis criteria of mixed urinary incontinence;
  2. Patients are between age of 35 to 75 years old;
  3. Positive in cough stress test;
  4. 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
  5. 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:

  1. Patients have simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence and neurogenic bladder, etc.;
  2. Patients have uncontrolled urinary tract infection with urinary pain and urge;
  3. Patients have urogenital system tumours and/or pelvic organ tumours;
  4. 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;
  5. Patients have history of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy;
  6. Patients have pelvic organ prolapse ≥ II degree;
  7. Patients have residual urine ≥ 100ml;
  8. Patients have uncontrolled diabetes mellitus and severe hypertension;
  9. 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.;
  10. Patients have severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction;
  11. Patients are constrained or unable to complete movements like walking, going stairs up and down and running, etc.;
  12. Patients have poor compliance;
  13. Patients are at pregnancy, breastfeeding or postpartum period for less than 12 months;
  14. Patients have cardiac pacemaker, metal allergy or strong fear of needle;
  15. Patients are participants of other on-going studies; or
  16. Patients have received acupuncture in the past 3 months. Patients will be excluded if they meet any of the above criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: electroacupuncture
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.
Other: electroacupuncture
same as described in experimental arm.
Behavioral: life style counselling
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.
Sham Comparator: sham electroacupuncture
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.
Behavioral: life style counselling
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.
Other: sham electroacupuncture
same as described in sham comparator.
Other: 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.
Behavioral: life style counselling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at the 8th week after the last treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
data will be collected and evaluated by 72-hour incontinence episodes dairy
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
data will be collected and evaluated by 72-hour incontinence episodes dairy
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
data will be collected and evaluated by 72-hour incontinence episodes dairy
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
data will be collected by 1-hour pad test
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
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.
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
data will be collected via the Overactive Bladder Questionnaire-Short Form. The higher the total score is, the severer the condition is.
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
life style change, such as drinking, diet, weight control and etc, will be evaluated through questionnaire
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.
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.
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
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.
at baseline
blinding assessment
Time Frame: in 8th week after any acupuncture treatment
patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding
in 8th week after any acupuncture treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Shaanxi Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhishun Liu, PhD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZZ13-024-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We cannot share IPD under current regulation of Human Genetic Resources Management in China.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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