Last updated: February 2, 2022
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
Enuresis
Urinary Incontinence
Treatment
N/AClinical Study ID
NCT03787654
2018-163-KY
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female patients diagnosed with mixed urinary incontinence in accordance with EAUguideline 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 episodesis urgency one in 72-hour voiding diary;
- Positive cough test;
- A voluntarily-signed written informed content.
Exclusion
Exclusion Criteria:
- Having pure stress urinary incontinence, pure urgency urinary incontinence, overflowurinary 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 antimuscarinicdrug 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 asMultiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, caudaequina nerve injury and multiple system atrophy;
- Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosologyand coagulation function, or obvious cognitive disability;
- Installed a cardiac pacemaker;
- Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinaryretention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerativecolitis, 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 afterdelivery.
Study Design
Total Participants: 282
Study Start date:
March 01, 2019
Estimated Completion Date:
June 30, 2023
Study Description
Connect with a study center
Guang An Men Hospital
Beijing, 100053
ChinaActive - Recruiting
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