Clinical trial NCT04531683: Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women
Official title: Efficacy and Safety of Electroacupuncture on Mixed Urinary Incontinence Among Women: a Multi-centre, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence, Mixed
Keywords: acupuncture
randomised controlled trial
sham acupuncture
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shaanxi Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: Hubei Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
name: Shanghai University of Traditional Chinese Medicine
name: Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2020-08-28
Enrollment: 460
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
timeFrame: at the 8th week after the last treatment
Secondary outcomes:
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
timeFrame: at baseline, 4th, 20th and 32nd week
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes
timeFrame: at baseline, 4th, 8th 20th and 32nd week
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes
timeFrame: at baseline, 4th, 8th, 20th and 32nd week
measure: the change from baseline in the amount of urine leakage measured by the 1-hour pad test
timeFrame: at baseline, and the 8th week
measure: the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores
timeFrame: at baseline, 4th, 8th, 20th and 32nd week
measure: the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores
timeFrame: at baseline 4th, 8th, 20th and 32nd week
measure: number of patients with one or more life style change
timeFrame: at the 4th, 8th, 20th and 32nd week
measure: incidence rate of any adverse events
timeFrame: 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.
measure: patients' expectation to treatment
timeFrame: at baseline
measure: blinding assessment
timeFrame: in 8th week after any acupuncture treatment
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: