Acupuncture for Stress-predominant Mixed Urinary Incontinence

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/A

Clinical Study ID

NCT04299932
2019-241-KY
  • Ages 35-75
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of MUI by the coexistence of SUI and urgency urinary incontinence (UUI)symptoms in accordance with EAU guideline;
  2. Female participants aged between 35 and 75;
  3. Stress index > urge index in accordance with Medical, Epidemiologic, and Socialaspects of Aging(MESA) questionnaire;
  4. Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEFdocumented in 3-day voiding diary;
  5. Less than 12 micturition episodes in average 24 hours documented in 3-day voidingdiary;
  6. Positive cough stress test;
  7. Urine leakage > 1 g in 1-hour pad test;
  8. Voluntary participation in the trial and signed written informed content.

Exclusion

Exclusion Criteria:

  1. Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) andneurogenic bladder;
  2. Uncontrolled symptomatic urinary tack infection;
  3. Tumor in urinary system and pelvic organ;
  4. Pelvic organ prolapse ≥ degree Ⅱ;
  5. Residual urine volume ≥ 100ml;
  6. History of treatments targeted at UI, such as acupuncture, PFMT and medications in theprevious one month;
  7. History of surgery targeted at UI or in pelvic floor, including hysterectomy;
  8. Uncontrolled diabetes or severe high blood pressure;
  9. 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;
  10. Severe heart, lung, brain, liver, kidney, mental illness, coagulation dysfunction orwith obvious cognitive dysfunction
  11. Installed cardiac pacemaker;
  12. Inconvenient or unable to walk, run, go up and down stairs;
  13. Allergy to metal, severely fear of acupuncture needles or unbearable to EA;
  14. 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

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.

Connect with a study center

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing
    China

    Active - Recruiting

  • The third affiliated hospital of Beijing university of Chinese Medicine

    Beijing, Beijing
    China

    Active - Recruiting

  • Hengyang Hospital Affiliated to Hunan University of Chinese Medicine

    Hengyang, Hunan
    China

    Active - Recruiting

  • Jiangxi Provincial Hospital of traditional Chinese Medicine

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Yantai Hospital of Traditional Chinese Medicine

    Yantai, Shandong
    China

    Active - Recruiting

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