Status:
UNKNOWN
Acupuncture for Stress-predominant Mixed Urinary Incontinence
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Mixed Urinary Incontinence
Eligibility:
FEMALE
35-75 years
Phase:
NA
Brief Summary
The investigators plan to conduct this multi-center, three-armed, randomized controlled trial to evaluate the efficacy of electroacupuncture (EA), compared with sham electroacupuncture (SA) and waitin...
Detailed Description
MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recomm...
Eligibility Criteria
Inclusion
- Diagnosis of MUI by the coexistence of SUI and urgency urinary incontinence (UUI) symptoms in accordance with EAU guideline;
- Female participants aged between 35 and 75;
- Stress index \> urge index in accordance with Medical, Epidemiologic, and Social aspects of Aging(MESA) questionnaire；
- Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEF documented in 3-day voiding diary;
- Less than 12 micturition episodes in average 24 hours documented in 3-day voiding diary;
- Positive cough stress test;
- Urine leakage \> 1 g in 1-hour pad test;
- Voluntary participation in the trial and signed written informed content.
Exclusion
- Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) and neurogenic bladder;
- Uncontrolled symptomatic urinary tack infection;
- Tumor in urinary system and pelvic organ;
- Pelvic organ prolapse ≥ degree Ⅱ；
- Residual urine volume ≥ 100ml；
- History of treatments targeted at UI, such as acupuncture, PFMT and medications in the previous one month;
- History of surgery targeted at UI or in pelvic floor, including hysterectomy;
- Uncontrolled diabetes or severe high blood pressure;
- Nervous system diseases that may hamper the function of urinary system, such as Multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina nerve injury, or multiple system atrophy;
- Severe heart, lung, brain, liver, kidney, mental illness, coagulation dysfunction or with obvious cognitive dysfunction
- Installed cardiac pacemaker;
- Inconvenient or unable to walk, run, go up and down stairs;
- Allergy to metal, severely fear of acupuncture needles or unbearable to EA;
- Pregnant at present, plan to conceive in future one year, at lactation period or within 12 months after childbirth.
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT04299932
Start Date
October 9 2020
End Date
September 30 2023
Last Update
January 6 2021
Active Locations (5)
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1
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
2
The third affiliated hospital of Beijing university of Chinese Medicine
Beijing, Beijing Municipality, China
3
Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
Hengyang, Hunan, China
4
Jiangxi Provincial Hospital of traditional Chinese Medicine
Nanchang, Jiangxi, China