Urinary Incontinence Clinical Trial
Official title:
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial
A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).
Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A
gynecologist or urologist will make the diagnosis. Central randomization will be performed by
the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing.
Sample size: Sample size is based on the primary outcome. According to literature, the
investigators predict that MUI patient's average 72-h incontinence episode frequency of the
week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin.
The number of the acupuncture group is 57%. For the assessment of noninferiority, 250
participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%).
Quality control: A 3-level monitoring system (monitors responsible for one center, monitors
responsible for all centers and monitors responsible for the whole trial) will be established
to check the performance of the trial in time. Outcome assessment, completion of case report
forms and data management will be under strict supervision.
Data management: The Remote Dara Capture (RDC) system will be used for data entering. Both
paper and electronic case report form will be reserved. A data verification plan is made.
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