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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-04-30

Brief Summary

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

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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

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

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Electroacupuncture group

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.

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type DEVICE

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.

Placebo group

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.

Group Type PLACEBO_COMPARATOR

Sham Electroacupuncture

Intervention Type DEVICE

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.

Solifenacin Succinate group

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.

Group Type ACTIVE_COMPARATOR

Solifenacin Succinate

Intervention Type DRUG

made by the Anse Tailai Pharmaceutical (China) R \& D limited company) 5mg / tablet

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Solifenacin Succinate

made by the Anse Tailai Pharmaceutical (China) R \& D limited company) 5mg / tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No