Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence
NCT ID: NCT03787654
Last Updated: 2022-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
282 participants
INTERVENTIONAL
2019-03-01
2023-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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electroacupuncture group
Acupoints of bilateral Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) are stimulated by Huatuo Brand disposable needles and SDZ-V electronic apparatus.
electroacupuncture
BL33 and BL35 are inserted by needles of 0.30×75mm size till a depth of 60\~70mm. SP6 is inserted by needle of 0.30×40mm size till a depth of 25-30mm. After manipulation and deqi sensation generation, the electrodes will be attached to the acupoints transversely with 20Hz continuous wave and an electricity current of 2mA-6.5mA at BL33 and BL35, and 1-3.5mA at SP6. The current is adjusted from zero to the degree where patients can tolerate.
Subjects receive 3 sessions per week（every other day ideally) for 12 weeks, 36 sessions in total.
sham electroacupuncture group
Sham acupoints 1 cun(≈15mm) horizontally outwardly lateral to BL33 and BL35, and 0.5 cun(≈10mm) horizontally behind SP6 are stimulated superficially with a small electricity current by needles of 0.30×40mm size and SDZ-V electronic apparatus.
sham electroacupuncture
In sham electroacupuncture group, sham acupoints 1 cun(≈15mm） horizontally outwardly lateral to BL33 and BL35, and 0.5 cun (≈10mm) horizontally behind SP6 are stimulated by needles of 0.30×40mm size. The needles are inserted to a depth of 2-3mm to stand still, without any manipulation and sensation of deqi. The electrodes will also be attached to needles with an electricity current of 0.1-0.3mA.
The sessions will be the same as the electroacupuncture group.
Solifenacin group
subjects will orally take Solifenacin 5-10mg per day.
Solifenacin
Subjects take solifenacin 5-10mg per day for a succession of 36 weeks. The dose change is decided by doctors under a comprehensive consideration of side effects and Patient Global Symptom Control (PGSC), which is applied to evaluate the effectiveness of Solifenacin at the 4th, 8th, 12th and 24th week.The medicine can be discontinued at any time if the adverse effect is rather severe.
Interventions
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electroacupuncture
BL33 and BL35 are inserted by needles of 0.30×75mm size till a depth of 60\~70mm. SP6 is inserted by needle of 0.30×40mm size till a depth of 25-30mm. After manipulation and deqi sensation generation, the electrodes will be attached to the acupoints transversely with 20Hz continuous wave and an electricity current of 2mA-6.5mA at BL33 and BL35, and 1-3.5mA at SP6. The current is adjusted from zero to the degree where patients can tolerate.
Subjects receive 3 sessions per week（every other day ideally) for 12 weeks, 36 sessions in total.
sham electroacupuncture
In sham electroacupuncture group, sham acupoints 1 cun(≈15mm） horizontally outwardly lateral to BL33 and BL35, and 0.5 cun (≈10mm) horizontally behind SP6 are stimulated by needles of 0.30×40mm size. The needles are inserted to a depth of 2-3mm to stand still, without any manipulation and sensation of deqi. The electrodes will also be attached to needles with an electricity current of 0.1-0.3mA.
The sessions will be the same as the electroacupuncture group.
Solifenacin
Subjects take solifenacin 5-10mg per day for a succession of 36 weeks. The dose change is decided by doctors under a comprehensive consideration of side effects and Patient Global Symptom Control (PGSC), which is applied to evaluate the effectiveness of Solifenacin at the 4th, 8th, 12th and 24th week.The medicine can be discontinued at any time if the adverse effect is rather severe.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 80 years old;
3. Urgency index greater than stress index by MESA questionnaire\[12\];
4. At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary;
5. With MUI for at least 3 months, and more than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary;
6. Positive cough test;
7. A voluntarily-signed written informed content.
Exclusion Criteria
2. Uncontrolled urinary tract infection;
3. Tumor in urinary system or pelvic organs;
4. Pelvic organ prolapse≥degreeⅡ;
5. Residual urine volume≥100ml;
6. Maximum flow rate\<15ml/s;
7. Treated incontinence by acupuncture or positive medications, such as antimuscarinic drug within the past 1 month;
8. Underwent surgery of anti-incontinence or in pelvic area, metrectomy included;
9. Complication of uncontrolled diabetes and severe hypertension;
10. 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;
11. Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
12. Installed a cardiac pacemaker;
13. Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis, angle-closure glaucoma;
14. Allergic to metal or intolerant to the stimulation of electroacupuncture;
15. Already with child or plan to conceive in the future 1 year, or within 1 year after delivery.
18 Years
80 Years
FEMALE
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Liu Zhishun
Principle investigator
Principal Investigators
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Zhishun Liu, PhD
Role: PRINCIPAL_INVESTIGATOR
Guanganmen Hospital
Locations
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Guang An Men Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Sun Y, Liu Y, Su T, Sun J, Wu Y, Liu Z. Electroacupuncture versus solifenacin for women with urgency-predominant mixed urinary incontinence: a protocol for a three-armed non-inferiority randomized controlled trial. BMC Complement Med Ther. 2020 Jan 23;20(1):18. doi: 10.1186/s12906-019-2784-1.
Other Identifiers
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2018-163-KY
Identifier Type: -
Identifier Source: org_study_id
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