Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence (EASE-UMUI)
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- STATUS
- Recruiting
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- End date
- Jun 30, 2023
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- participants needed
- 282
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- sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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 Identifier | NCT03787654 |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| Last Modified on | 25 March 2022 |
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