NCT02452879

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	Electroacupuncture	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.
DEVICE	Sham Electroacupuncture	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.
DRUG	Solifenacin Succinate	made by the Anse Tailai Pharmaceutical (China) R \& D limited company) 5mg / tablet

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-10-01
• Completion: 2016-04-01
• First posted: 2015-05-25
• Last updated: 2015-05-25

Locations

1 site across 1 country: China