Clinical trial NCT02452879: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Capital Medical University
name: Beijing Hospital
First posted: 2015-05-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in mean frequency of micturitions per 24 hours
timeFrame: 4, 8 weeks in treatment, 12th and 24th weeks of follow-up
Secondary outcomes:
measure: The response rate of improvement in symptoms
timeFrame: 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 outcomes:
measure: Patient-Rated Global Assessments of treatment Benefit, Satisfaction, and Willingness to Continue (The BSW)
timeFrame: Week 4th , 8th in treatment , 12nd and 24th of follow-up
measure: The mean number of daily urgency micturition, nocturia, leakage of urine, the mean degree of daily urgency micturition
timeFrame: 4 weeks, 8 weeks in treatment, 12nd and 24th weeks of follow-up.
measure: Daily mean incidence of urgency micturition (%), daily mean incidence of leakage of urine(%)
timeFrame: Week 0(baseline), 4, 8, 12 and 24 of follow-up
measure: Oab-Q
timeFrame: on Friday of week 0 (baseline), 4, 8, 12, 24
Locations:
city: Beijing
country: China
facility: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
name: Jia Baohui, Master
role: STUDY_CHAIR
References:
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.