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

Study Overview
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Brief Summary
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The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.

Detailed Description
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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 Strict training on staff participating in the trial. Rigorous control of the process of randomization. Specific inclusion and exclusion criteria. Strict outcome assessors and statisticians. The standard of the drugs, acupuncture apparatus, inspection equipment are consistant. Outcome assessment, completion of case report forms and data management will be under strict supervision.

Official Title
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The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Electroacupuncture
* Device: Sham Electroacupuncture
* Drug: Solifenacin Succinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of overactive bladder. Frequent micturition.（average urinary frequency of ≥8 voids per day） No relevant drug use within 2 weeks and no acupuncture treatment within 1 month before the study; not in other clinical trials. Self-reported bladder symptoms ≥3 months Capable of giving informed consent . 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture group<br>Needle on bilateral BL33 acupoint 50-60mm with a 60°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3). Needle with 75mm long needle. An electric stimulator is put on. SDZ-V electric stimulator (produced by Suzhou Medical Instrument Co.Ltd). continuous wave(CW), 10Hz. Stop turning up the current intensity when patients could not stand. 3 times a week. Once every other day. The treatment period lasts eight weeks. totally 24 times.30min/time. | Device: Electroacupuncture<br>* For the deep needling acupoint group, needle on bilateral BL33 50-60mm with a 60°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3). Needle with 75mm long needle. An electric stimulator is put on. SDZ-V Hua Tuo Brand electric stimulator (produced by Suzhou Medical Instrument Co.Ltd). continuous wave(CW), 10Hz. Stop turning up the current intensity when patients could not stand. 3 times a week. Once every other day The treatment period lasts eight weeks. totally 24 times.30min/time.<br>|
| Placebo Comparator: Placebo group<br>with the patient in the prone position. The acupoint routine disinfection of skin, and then the fixed pad is adhered on the acupoint. The 1.5 inches blunt tip needle pierce through the fixed pad, then it reaches the surface of the skin, uniform lifting thrusting and twirling all 3 times but do not pierce the skin. Then connect the electric acupuncture apparatus with special power supply wire electrode (special power line as the middle wire cut, looks as normal; that electroacupuncture instrument display connected to the state, but the actual without electricity), in the bilateral Zhongliao points, Hui Yang points on the needle handle; the period of treatment and the other manipulation of the placebo group are same as the deep needling acupoint group. | Device: Sham Electroacupuncture<br>* with the patient in the prone position. The acupoint routine disinfection of skin, and then the fixed pad is adhered on the acupoint. The 1.5 inches blunt tip needle pierce through the fixed pad, then it reaches the surface of the skin, uniform lifting thrusting and twirling all 3 times but do not pierce the skin. Then connect the electric acupuncture apparatus with special power supply wire electrode (special power line as the middle wire cut, looks as normal; that electroacupuncture instrument display connected to the state, but the actual without electricity), in the bilateral Zhongliao points, Hui Yang points on the needle handle; the period of treatment and the other manipulation of the placebo group are same as the deep needling acupoint group.<br>|
| Active Comparator: Solifenacin Succinate group<br>Solifenacin Succinate Tablets (made by the Anse Tailai Pharmaceutical (China) R & D limited company) 5mg, 1 tablets each time, 1 times / day, oral administration of 30min before meal, even for 8 weeks. | Drug: Solifenacin Succinate<br>* made by the Anse Tailai Pharmaceutical (China) R & D limited company) 5mg / tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean frequency of micturitions per 24 hours | Mean daily micturition frequency = Sum of 3-day micturition frequency in a week/3 . The investigator gets the frequency of mictuitions by micturition diary.Mean daily micturition frequency will be calculated based on the micturition diary at week 0(baseline), 2, 4, 6, 8, 20, 32. | 4, 8 weeks in treatment, 12th and 24th weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response rate of improvement in symptoms | GRA（Global response assessments）will be used to grade: The overall response will be assessed by patient self-rating scale. There are seven levels which will be graded by patients based on their situation: significant deterioration, moderate deterioration, mild deterioration, no change, mild improvement, moderate improvement, significant improvement in symptoms (compared with their condition before treatment). The moderate and significant improvement will be defined as effective treatment while others will be defined as ineffective ones according to the patients' options. The response rate will be calculated separately. Response rate= Effective number of patients in each group/ Total number of patients in each group×100% | 8 weeks in treatment, The average response rate of improvement in global response during 8 weeks in treatment. The response rate in first 4 weeks in treatment, 12 and 24 weeks of follow-up will also be evaluated |