Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence (EASE-UMUI)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    282
  • sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Updated on 25 March 2022

Summary

The study is to determine the effect of electroacupuncture in female patients with urgency-predominant mixed urinary incontinence. A three-arm non-inferior randomized controlled trial (RCT) using electroacupuncture, sham electroacupuncture and solifenacin with a total sample of 282 is proposed.

The hypothesis is that the improvement (difference in number of urgency urinary incontinence episodes between baseline and 12-week evaluation) in the electroacupuncture group would be 50% or less of the difference in the improvement between the Solifenacin and the sham electroacupuncture groups.

Description

Mixed urinary incontinence (MUI) features complaint or involuntary loss of urine associated with urgency and also with effort or physical exertion or on sneezing or coughing. It is regarded as urgency-predominant mixed urinary incontinence (UMUI) when sudden sensation of voiding accompanied by uncontrolled incontinence domains the symptoms. UMUI can bring shame and inconvenience to patients.

As first-line medicine for urge-predominant urinary incontinence, Solifenacin can reduce urgency urinary incontinence episodes in 24 hours. However, the side effects tend to bring about poor compliance among patients.

Acupuncture might be effective in treating UMUI. Previous research indicated that electroacupuncture might be noninferior to pelvic floor muscle training plus Solifenacin in reducing the urgency incontinence episodes of UMUI women. However, that study didn't focuse on UMUI exclusively, thus unable to decide whether electroacupuncture is effective in the treatment of UMUI.

Details
Condition Mixed Urinary Incontinence, Urgency-predominant Mixed Urinary Incontinence
Treatment Electroacupuncture, Sham electroacupuncture, Solifenacin
Clinical Study IdentifierNCT03787654
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients diagnosed with mixed urinary incontinence in accordance with EAU guideline by history intaking and physical examination[8]
Age between 18 and 80 years old
Urgency index greater than stress index by MESA questionnaire[12]
At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary
With MUI for at least 3 months, and more than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary
Positive cough test
A voluntarily-signed written informed content

Exclusion Criteria

Having pure stress urinary incontinence, pure urgency urinary incontinence, overflow urinary incontinence or neurogenic bladder
Uncontrolled urinary tract infection
Tumor in urinary system or pelvic organs
Pelvic organ prolapse≥degreeⅡ
Residual urine volume≥100ml
Maximum flow rate<15ml/s
Treated incontinence by acupuncture or positive medications, such as antimuscarinic drug within the past 1 month
Underwent surgery of anti-incontinence or in pelvic area, metrectomy included
Complication of uncontrolled diabetes and severe hypertension
Complicated diseases in nerves system that could hamper hypourethral function, such as Multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, cauda equina nerve injury and multiple system atrophy
Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability
Installed a cardiac pacemaker
Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis, angle-closure glaucoma
Allergic to metal or intolerant to the stimulation of electroacupuncture
Already with child or plan to conceive in the future 1 year, or within 1 year after delivery
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