Overactive Bladder Clinical Trial
Official title:
The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial
The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.
Patient registry: Participants experiencing overactive bladder will be recruited from
hospital outpatients and clinic-community. the diagnosis was made by the urologists. the
random number table was generated by the Computer.
Sample size: According to the preliminary experiment combined the literature. Sample size is
based on the primary outcome. The first step: one-tailed test: the electroacupuncture group
vs Solifenacin group is 79.5% VS 54.8%( α=0.05, β=0.20, n=51). The second step: two-tailed
test :the electroacupuncture group vs Placebo group is 54.5% VS 20.9%,(α=0.05, β=0.20,
n=37). To combine the first and second step, 51 cases in each group are needed. Allowing for
a 10% dropout, 57 cases in each group are needed. So we set the sample size is 60.
Quality control
1. Strict training on staff participating in the trial.
2. Rigorous control of the process of randomization.
3. Specific inclusion and exclusion criteria.
4. Strict outcome assessors and statisticians.
5. The standard of the drugs, acupuncture apparatus, inspection equipment are consistant.
6. Outcome assessment, completion of case report forms and data management will be under
strict supervision.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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