Acupuncture for Stress-predominant Mixed Urinary Incontinence

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    232
  • sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Updated on 27 January 2021

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 waiting list (WL) on participants with stress-predominant mixed urinary incontinence (MUI).

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 recommends to initiate treatment targeted at predominant component of MUI. However, as to whether the interventions for stress urinary incontinence (SUI) can be effectively generalized to stress-predominant MUI, there is still no powerful evidence to support it. It is necessary to seek for interventions specific to stress-predominant MUI. Results of previous studies indicated that acupuncture might help to relieve the incontinence symptoms.

Details
Condition Mixed Urinary Incontinence, mixed incontinence
Treatment Electroacupuncture, Sham electroacupuncture
Clinical Study IdentifierNCT04299932
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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 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 Criteria

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
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
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