Status:
UNKNOWN
Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Mixed Urinary Incontinence
Urgency-predominant Mixed Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief 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 elec...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT03787654
Start Date
March 1 2019
End Date
June 30 2023
Last Update
February 4 2022
Active Locations (1)
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1
Guang An Men Hospital
Beijing, China, 100053