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

Primary Purpose

Overactive Bladder

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Electroacupuncture

Sham Electroacupuncture

Solifenacin Succinate

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Electroacupuncture group

Placebo group

Solifenacin Succinate group

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%

Full Information

NCT ID

NCT02452879

First Posted

May 2, 2015

Last Updated

May 22, 2015

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

Capital Medical University, Beijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02452879

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

Capital Medical University, Beijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture group

Arm Type

Experimental

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Arm Title

Solifenacin Succinate group

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Electroacupuncture

Intervention Description

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

Intervention Name(s)

Sham Electroacupuncture

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Solifenacin Succinate

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in mean frequency of micturitions per 24 hours

Description

Time Frame

4, 8 weeks in treatment, 12th and 24th weeks of follow-up

Secondary Outcome Measure Information:

Title

The response rate of improvement in symptoms

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Patient-Rated Global Assessments of treatment Benefit, Satisfaction, and Willingness to Continue (The BSW)

Description

For therapeutic benefit scores, treatment will be regarded beneficial if scores are above (3). The patient-Rated global assessment of treatment benefit will be calculated according to scores of patients in each group. For treatment satisfaction scores, scores above (3) will be recorded as satisfaction. Treatment satisfaction scores will be calculated based on scores of patients in each group. The willing to continue the treatment scores, scores above (3) will be recorded as willing to continue the treatment scores, the scores will be calculated based on the scores of patients in each group.

Time Frame

Week 4th , 8th in treatment , 12nd and 24th of follow-up

Title

The mean number of daily urgency micturition, nocturia, leakage of urine, the mean degree of daily urgency micturition

Description

mean degree of daily urgency micturition will be captured at week 0(baseline), 2, 4, 6, 8, 20, 32 based on the micturition diary.

Time Frame

4 weeks, 8 weeks in treatment, 12nd and 24th weeks of follow-up.

Title

Daily mean incidence of urgency micturition (%), daily mean incidence of leakage of urine(%)

Description

Daily mean incidence of urgency micturition and leakage of urine will be calculated. Urgency incontinence, stress incontinence and unconscious leakage of urine will be included. Incidence of urgency micturition (%):the frequency of urgency micturition in a week based on three day urine diary/ three days' total times of urination in ×100% Incidence of leakage of urine (%): the frequency of leakage of urine in a week based on three day bladder diary/ three days' total times of urination ×100%

Time Frame

Week 0(baseline), 4, 8, 12 and 24 of follow-up

Title

Oab-Q

Description

The patients will be asked to write the questionnaires which have a total of 33 questions. The degree of which the patients suffer from overactive bladder including urgency micturition, pollakiuria , nocturia, urge incontinence will be assessed by the first 8 questions. 1-6 points will be given for each question and all the points will be added and converted to 0-100 points which suggest higher severity with higher scores. The effect of symptoms on life will be assessed by the rest questions which will be divided to disease problems, sociality, mood, sleeping. The points of each part which includes 2-5 questions will be added separately as subscale scores. All of them will be added and converted to 0-100 points which will be the score for quality of life representing better quality with higher points.

Time Frame

on Friday of week 0 (baseline), 4, 8, 12, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jia Baohui, Master

Phone

13520090050

myrroossee@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jia Baohui, Master

Organizational Affiliation

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

10053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jia Baohui, Master

Phone

13520090050

myrroossee@aliyun.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

36148895

Citation

Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.

Results Reference

derived

Learn more about this trial

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

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