Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women

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.

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.

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.