Last updated: January 5, 2021
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
Urinary Incontinence
Enuresis
Treatment
N/AClinical Study ID
NCT04299932
2019-241-KY
Ages 35-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 Socialaspects of Aging(MESA) questionnaire;
- Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEFdocumented in 3-day voiding diary;
- Less than 12 micturition episodes in average 24 hours documented in 3-day voidingdiary;
- Positive cough stress test;
- Urine leakage > 1 g in 1-hour pad test;
- Voluntary participation in the trial and signed written informed content.
Exclusion
Exclusion Criteria:
- Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) andneurogenic 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 theprevious 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 asMultiple 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 orwith 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 orwithin 12 months after childbirth.
Study Design
Total Participants: 232
Study Start date:
October 09, 2020
Estimated Completion Date:
September 30, 2023
Study Description
Connect with a study center
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing
ChinaActive - Recruiting
The third affiliated hospital of Beijing university of Chinese Medicine
Beijing, Beijing
ChinaActive - Recruiting
Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
Hengyang, Hunan
ChinaActive - Recruiting
Jiangxi Provincial Hospital of traditional Chinese Medicine
Nanchang, Jiangxi
ChinaActive - Recruiting
Yantai Hospital of Traditional Chinese Medicine
Yantai, Shandong
ChinaActive - Recruiting

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