Trials / Unknown
UnknownNCT04531683
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
- Sex
- Female
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | electroacupuncture | same as described in experimental arm. |
| OTHER | 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. |
Timeline
- Start date
- 2020-10-30
- Primary completion
- 2021-12-31
- Completion
- 2022-06-30
- First posted
- 2020-08-28
- Last updated
- 2020-10-08
Source: ClinicalTrials.gov record NCT04531683. Inclusion in this directory is not an endorsement.