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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02452879
• Other study ID #: Z121107001012148
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2015
• Last updated: May 22, 2015
• Start date: October 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2015
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jia Baohui, Master
• Phone: 13520090050
• Email: myrroossee[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-Rated Global Assessments of treatment Benefit, Satisfaction, and Willingness to Continue (The BSW)	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.	Week 4th , 8th in treatment , 12nd and 24th of follow-up	No
Other	The mean number of daily urgency micturition, nocturia, leakage of urine, the mean degree of daily urgency micturition	mean degree of daily urgency micturition will be captured at week 0(baseline), 2, 4, 6, 8, 20, 32 based on the micturition diary.	4 weeks, 8 weeks in treatment, 12nd and 24th weeks of follow-up.	No
Other	Daily mean incidence of urgency micturition (%), daily mean incidence of leakage of urine(%)	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%	Week 0(baseline), 4, 8, 12 and 24 of follow-up	No
Other	Oab-Q	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.	on Friday of week 0 (baseline), 4, 8, 12, 24	No
Primary	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	No
Secondary	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	No