Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Efficacy Study

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.

Inclusion Criteria:

1. Clinical diagnosis of overactive bladder.
2. Frequent micturition.（average urinary frequency of ≥8 voids per day）
3. No relevant drug use within 2 weeks and no acupuncture treatment within 1 month before the study; not in other clinical trials.
4. Self-reported bladder symptoms ≥3 months
5. Capable of giving informed consent .
6. Capable and willing to follow all study-related procedures

Exclusion Criteria:

• Frequent micturition and urinary urgency are secondary to other diseases.
• Clinical diagnosis of simple stress urinary incontinence.
• Patients with urinary track infection and vagenal infection.
• Patients with implantable pelvic stimulator.
• Current use of electric therapy on pelvic area/back/legs.
• Current use of clostridium botulinum therapy on vesical or pelvic muscles.
• participation in any clinical inverstigation involving or impacting gynecological/urinary/renal function.
• Suffering from severe cardiac/hepatic/renal injury or cognitive disorder/aphasia/ dysphrenia/malnutrition, or in poor perform status and unable to cooperate.
• Patients in gestation and in lactation period.
• Patients in coagulation disorders or taking anticoagulation drugs.
• People with cardiac pacemaker or metal allergy.
• Patients having got eletroacupunture therapy or solifenacin in 4 weeks before the study.
• Patients are afraid of needles.