Acupuncture for Stress-predominant Mixed Urinary Incontinence

  • STATUS
    Recruiting
  • days left to enroll
    2
  • 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note