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

NCT02452879 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-05-25

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Capital Medical University

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Jia Baohui, Master · Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-31
Completion
2016-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452879 on ClinicalTrials.gov