Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women

Urinary Incontinence, Mixed Clinical Trial

— EAMUI  

Official title:

Efficacy and Safety of Electroacupuncture on Mixed Urinary Incontinence Among Women: a Multi-centre, Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04531683
• Other study ID #: ZZ13-024-9
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Huan Chen, MPH, MD
• Phone: +86 10 88002331
• Email: chen.huan[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 460
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Mixed

Intervention

Other:
• electroacupuncture
same as described in experimental arm.
• sham electroacupuncture
same as described in sham comparator.

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.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor

Collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Guangdong Provincial Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, 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, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Yueyang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at the 8th week after the last treatment
Secondary	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	at baseline, 4th, 20th and 32nd week
Secondary	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	at baseline, 4th, 8th 20th and 32nd week
Secondary	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	at baseline, 4th, 8th, 20th and 32nd week
Secondary	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	at baseline, and the 8th week
Secondary	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.	at baseline, 4th, 8th, 20th and 32nd week
Secondary	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.	at baseline 4th, 8th, 20th and 32nd week
Secondary	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	at the 4th, 8th, 20th and 32nd week
Secondary	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.	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.
Secondary	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.	at baseline
Secondary	blinding assessment	patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding	in 8th week after any acupuncture treatment