Overactive BladderNCT02452879
Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Efficacy Study
A study testing Electroacupuncture and Solifenacin Succinate in people with Overactive Bladder, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Electroacupuncture and Solifenacin Succinate
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 10053
Jia Baohui, Master, 13520090050, myrroossee@aliyun.com
About this study
Official title: The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial
The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Electroacupuncture, Sham Electroacupuncture, Solifenacin Succinate
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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 ElectroacupunctureDevice
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 SuccinateDrug
made by the Anse Tailai Pharmaceutical (China) R \& D limited company) 5mg / tablet
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | 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. Receives: Device: Electroacupuncture |
| Placebo group | Placebo comparator | 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. Receives: Device: Sham Electroacupuncture |
| Solifenacin Succinate group | Active comparator | 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. Receives: Drug: Solifenacin Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4, 8 weeks in treatment, 12th and 24th weeks of follow-up
Secondary outcomes (1)
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%
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University, Beijing Hospital
- Responsible party
- Principal investigator, Baohui Jia, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jia Baohui, Master, Study chair, Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452879
- Sponsor's protocol ID
- Z121107001012148
- Status last verified
- May 2015
- First submitted
- 2 May 2015
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36148895
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02452879
- Acronym / sponsor ID
- Z121107001012148
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Capital Medical University, Beijing Hospital
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Device: ElectroacupunctureNeedle 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. |
| Placebo group | Placebo comparator | Device: Sham Electroacupuncturewith 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 | Active comparator | Drug: Solifenacin SuccinateSolifenacin 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureFor 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 | Electroacupuncture group |
| Sham Electroacupuncturewith 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. | Device | Placebo group |
| Solifenacin Succinatemade by the Anse Tailai Pharmaceutical (China) R \& D limited company) 5mg / tablet | Drug | Solifenacin Succinate group |
Primary outcome
Change from baseline in mean frequency of micturitions per 24 hours
Time frame: 4, 8 weeks in treatment, 12th and 24th weeks of follow-up
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.
1 secondary outcome
The response rate of improvement in symptoms
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Derived from this study: PubMed 36148895Hargreaves 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Baohui, Master study chair
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Solifenacin Succinate in people with Overactive Bladder, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Baohui, Master (13520090050, myrroossee@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean frequency of micturitions per 24 hours (time frame: 4, 8 weeks in treatment, 12th and 24th weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.