Simple Stress Urinary IncontinenceNCT01940432
The Efficacy of Electroacupuncture for Treatment of Simple Female Stress Urinary Incontinence: Comparison With Pelvic Floor Muscle Training-a Multicenter Randomized Controlled Trial
A study testing electroacupuncture group and pelvic floor muscle training group in people with Simple Stress Urinary Incontinence, run by Shaanxi Hospital of Traditional Chinese Medicine at 2 sites in China.
Trial summary
This research is primarily to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress urinary incontinence (SUI). Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simple Stress Urinary Incontinence
- What is being tested?
- electroacupuncture group and pelvic floor muscle training group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2014to Dec 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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet the diagnosis of Simple female stress urinary incontinence
- 40-75 years old
- Volunteered to join this research and signed the informed consent
Who cannot join
- Urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence, etc
- After operation for urinary incontinence or pelvic floor operation
- Edeoptosis>Degree 2
- Symptomatic urinary tract infection
- Residual urine volume>30m1
- Qmax<20m1/s
Show all 12Show fewer
- Constrained movement of walking, stairs climbing, running
- Patients with continuous treatment for stress urinary incontinence or medicine for bladder function .With serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, Injury of cauda equine,myeleterosis.
- During pregnancy or lactation period
- With cardiac pacemaker, Metal allergy or severe needle phobia
- Senile dementia
- Lunatic
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Shaanxi Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, 710003
Tong sheng Su, M.D., 008615929562568, chinasuts@126.com
Tong Sheng Su, M.D.
- Recruiting
Tongsheng Su
Xi'an, Shaanxi, 710003
Tong Sheng Su, Master, 02987231294, chinasuts@126.com
Jing Zhou, master
About this study
This research is primarily to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress urinary incontinence (SUI). The early clinical research is a randomized controlled trial (RCT) with a small sample,consisting of two arms of electroacupuncture group and sham electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks. The result indicates that electroacupuncture is an optimal method for SUI. As a further study, this research is a large sample multicenter trial with two parallel arms of electroacupuncture group and pelvic floor muscle training group. The primary purpose is to value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is to evaluate safety of electroacupuncture therapy, and compare acceptance of electroacupuncture treatment and pelvic floor muscle training.
Read the detailed description
Urinary incontinence (UI) is defined as a complaint of involuntary leakage. Researches show that 9%-72% women between age 17-79 are urinary incontinence, in which stress urinary incontinence (SUI) is the most prevalent type of urinary incontinence. The morbidity rate of UI through the world is 27.6%, which SUI take percentage of 50.Morbidity rate of UI in Beijing is 46.5%,and among which 59.6% is SUI. Aging is a high risk for SUI, which will increase morbidity rate of SUI. Totally, 61.9% women over 50 year-old have SUI. SUI is defined as a complaint of involuntary leakage during sneezing or coughing, which make patients embarrassed and can not attend social activity normally, decreasing the quality of their lives. Attending social activity is very important for people's health, otherwise, people will get a series of diseases, like osteoporosis, obesity, diabetes, hypertension, coronary heart disease,etc The International Consultation on Urological Diseases recommended pelvic floor muscle training as A level evidence treating simple mild and moderate stress urinary incontinence, which curative rate varies 30% to 60%. But the length of treatment should last at least 3 month. Therefore, patients' compliance is a key to the effectiveness. While, electroacupuncture is verified as a better treatment for SUI, which length of treatment is shorter than pelvic floor muscle training, and effective rate is over 80%, showing potential advantages. Early clinical research show that electroacupuncture for SUI is effective.
This subject is primary to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for SUI. The early clinical research is a randomized controlled trial (RCT) with a small sample, which consists of two arms, electroacupuncture group and sham electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks. The result indicates that electroacupuncture is effective.
As a further study, this research is a large sample multicenter trial with two parallel arms of electroacupuncture group and pelvic floor muscle training group. The primary purpose is to value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is to evaluate safety of electroacupuncture therapy, and compare acceptance of electroacupuncture treatment and pelvic floor muscle training.
- Conditions
- Simple Stress Urinary Incontinence
- Being tested
- electroacupuncture group, pelvic floor muscle training group
- Keywords
- simple stress urinary incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture groupDevice
Also called SDZ-V electroacupuncture, apparatus(Huatuo,made in China)
Procedure: electro-acupuncture;Points: Bilateral Zhong Liao (BL33) Hui Yang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50一60mm with 30一45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50一60mm to outward and upward by 75mm filiform needle. Twirl, lift and thrust for 3 times, until local sour and heavy feeling coming.The electric stimulator is applied to bilateral BL33 and BL35, with dilatational wave,50 Hz and electric current 1一5mA(milliampere).Every session lasts for 30 min per day.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.
pelvic floor muscle training groupBehavioural
Also called Kegel Exercise
Procedure:first,identify anal sphincter/feel anus, and try to raise it from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting; second, identify levator ani and try to raise vagina from chair (without adding abdominal, thigh, and buttock muscles) with a position of Sitting, bent forward, elbows on knees; third, contract levator ani with a position of sitting, lying, and standing; fourth, contract anal sphincter with a position of sitting, lying, and standing. Length of Treatment and the treatment sessions are the same as treatment group.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture group | Experimental | Bilateral BL33 are given acupuncture of 50-60mm with 30-45°angle to inward and downward. Bilateral BL35 are given acupuncture of 50-60mm to outward and upward. The electric stimulator is applied to bilateral BL33 and BL35.Every session lasts for 30 min per day.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. Receives: Device: electroacupuncture group |
| pelvic floor muscle training group | Experimental | Standing/sitting/lying on back, knees bent to chest. A set consists of three contractions, each lasting 10s, with a 10s break between contractions. Counting or measuring the duration of contractions and breaks is accomplished without effort by taking advantage of the duration of normal breaths. As most men take about 10 breaths per minute, each breath can be used as 6s timing device.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. Receives: Behavioral: pelvic floor muscle training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of frequency of leakage in mean 24h based on 72h diary, compared with the baseline
Since the average frequency difference of urinary incontinence in mean 24h of the 8th week is the average frequency difference of urinary incontinence in mean 24h of 2nd, 4th, 6th, 8th weeks based on the "72 voiding diary", which is 12 times treatment totally. Therefore, frequency of leakage in mean 24h is calculated by total frequency of leakage in week of 2th , 4th, 6th and 8th divided 12.
Measured: the 2, 4, 6, 8 week
Difference of amount of leakage in mean 24h based on 72h diary, compared with the baseline
The quantity of fluid loss in mean 24h will be measured by "72h voiding diary", comparing the value of 2nd, 4th, 6th and 8th weeks with the baseline (0 week) in 8th week. And the quantity of fluid loss in mean 24h is calculated by total quantity of fluid loss of 12 times treatment divided 12.
Measured: the 2, 4, 6, 8 week
Secondary outcomes (6)
Difference of 1h pad test, compared with the baseline
Quantity of fluid loss will be measured by 1 h pad test, comparing the value of 2nd and 6th week with the baseline(0 week), the primary outcome is the value difference.
Measured: the 8, 20, 32 week
ICIQ-SF
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives
Measured: the 8, 20, 32 week
Patient subjective effectiveness evaluation
3 point scoring: no help=0; Small help=1;Medium help=2; Great help=3
Measured: the 8, 20, 32 week
Weekly usage of pad
The value of 8th week is the average weekly usage of pads during 1-8 weeks ; The value of 20th week is the average weekly usage of pads during 9-20 weeks; The value of 32th week is the average weekly usage of pads during 21-32 weeks.
Measured: the 8, 20, 32 week
Usage of specialty therapy for Simple female stress urinary incontinence
Compare the difference of uase of specialty therapy for Simple female stress urinary incontinence between the 2 groups during the 1-8 weeks, 9-20 weeks and 21-32 weeks.
Measured: the 8, 20, 32 week
Subgroup analysis: amount of leakage with 1h pad test as a measure of curative effect of electroacupuncture for different extent of simple female stress urinary incontinence.
The 8th week: difference of 1 h pad test for simple female stress urinary incontinence, compared with the baseline; the 20th and 32th weeks: difference of 1h pad test for simple female stress urinary incontinence, compared with the baseline.
Measured: the 8, 20, 32 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 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 Simple Stress Urinary IncontinenceStudies 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940432
- Sponsor's protocol ID
- 2012BAI24B01-2
- Status last verified
- Jul 2016
- First submitted
- 28 Aug 2013
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Su T, Zhou J, Liu Z, Chen Y, Zhang W, Chu H, Luo Q, Lu J, An J, Liu B. The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial. Trials. 2015 Feb 8;16:45. doi: 10.1186/s13063-015-0560-1.
PubMed 25887231
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Electroacupuncture for Treatment of Simple Female Stress Urinary Incontinence: Comparison With Pelvic Floor Muscle Training-a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01940432
- Acronym / sponsor ID
- 2012BAI24B01-2
- Conditions
- Simple Stress Urinary Incontinence
- Keywords
- simple stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shaanxi Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Sep 2013 (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.
This research is primarily to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress urinary incontinence (SUI). The early clinical research is a randomized controlled trial (RCT) with a small sample,consisting of two arms of electroacupuncture group and sham electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks. The result indicates that electroacupuncture is an optimal method for SUI. As a further study, this research is a large sample multicenter trial with two parallel arms of electroacupuncture group and pelvic floor muscle training group. The primary purpose is to value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is to evaluate safety of electroacupuncture therapy, and compare acceptance of electroacupuncture treatment and pelvic floor muscle training.
Detailed description
Urinary incontinence (UI) is defined as a complaint of involuntary leakage. Researches show that 9%-72% women between age 17-79 are urinary incontinence, in which stress urinary incontinence (SUI) is the most prevalent type of urinary incontinence. The morbidity rate of UI through the world is 27.6%, which SUI take percentage of 50.Morbidity rate of UI in Beijing is 46.5%,and among which 59.6% is SUI. Aging is a high risk for SUI, which will increase morbidity rate of SUI. Totally, 61.9% women over 50 year-old have SUI. SUI is defined as a complaint of involuntary leakage during sneezing or coughing, which make patients embarrassed and can not attend social activity normally, decreasing the quality of their lives. Attending social activity is very important for people's health, otherwise, people will get a series of diseases, like osteoporosis, obesity, diabetes, hypertension, coronary heart disease,etc The International Consultation on Urological Diseases recommended pelvic floor muscle training as A level evidence treating simple mild and moderate stress urinary incontinence, which curative rate varies 30% to 60%. But the length of treatment should last at least 3 month. Therefore, patients' compliance is a key to the effectiveness. While, electroacupuncture is verified as a better treatment for SUI, which length of treatment is shorter than pelvic floor muscle training, and effective rate is over 80%, showing potential advantages. Early clinical research show that electroacupuncture for SUI is effective.
This subject is primary to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for SUI. The early clinical research is a randomized controlled trial (RCT) with a small sample, which consists of two arms, electroacupuncture group and sham electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks. The result indicates that electroacupuncture is effective.
As a further study, this research is a large sample multicenter trial with two parallel arms of electroacupuncture group and pelvic floor muscle training group. The primary purpose is to value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is to evaluate safety of electroacupuncture therapy, and compare acceptance of electroacupuncture treatment and pelvic floor muscle training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture group | Experimental | Device: electroacupuncture groupBilateral BL33 are given acupuncture of 50-60mm with 30-45°angle to inward and downward. Bilateral BL35 are given acupuncture of 50-60mm to outward and upward. The electric stimulator is applied to bilateral BL33 and BL35.Every session lasts for 30 min per day.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. |
| pelvic floor muscle training group | Experimental | Behavioral: pelvic floor muscle training groupStanding/sitting/lying on back, knees bent to chest. A set consists of three contractions, each lasting 10s, with a 10s break between contractions. Counting or measuring the duration of contractions and breaks is accomplished without effort by taking advantage of the duration of normal breaths. As most men take about 10 breaths per minute, each breath can be used as 6s timing device.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the diagnosis of Simple female stress urinary incontinence
- 40-75 years old
- Volunteered to join this research and signed the informed consent
Key exclusion criteria (12 listed)
- Urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence, etc
- After operation for urinary incontinence or pelvic floor operation
- Edeoptosis>Degree 2
- Symptomatic urinary tract infection
- Residual urine volume>30m1
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 |
|---|---|---|
| electroacupuncture groupAlso: SDZ-V electroacupuncture, apparatus(Huatuo,made in China)Procedure: electro-acupuncture;Points: Bilateral Zhong Liao (BL33) Hui Yang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50一60mm with 30一45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50一60mm to outward and upward by 75mm filiform needle. Twirl, lift and thrust for 3 times, until local sour and heavy feeling coming.The electric stimulator is applied to bilateral BL33 and BL35, with dilatational wave,50 Hz and electric current 1一5mA(milliampere).Every session lasts for 30 min per day.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus. | Device | electroacupuncture group |
| pelvic floor muscle training groupAlso: Kegel ExerciseProcedure:first,identify anal sphincter/feel anus, and try to raise it from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting; second, identify levator ani and try to raise vagina from chair (without adding abdominal, thigh, and buttock muscles) with a position of Sitting, bent forward, elbows on knees; third, contract levator ani with a position of sitting, lying, and standing; fourth, contract anal sphincter with a position of sitting, lying, and standing. Length of Treatment and the treatment sessions are the same as treatment group. | Behavioural | pelvic floor muscle training group |
Primary outcome
Difference of frequency of leakage in mean 24h based on 72h diary, compared with the baseline
Time frame: the 2, 4, 6, 8 week
Since the average frequency difference of urinary incontinence in mean 24h of the 8th week is the average frequency difference of urinary incontinence in mean 24h of 2nd, 4th, 6th, 8th weeks based on the "72 voiding diary", which is 12 times treatment totally. Therefore, frequency of leakage in mean 24h is calculated by total frequency of leakage in week of 2th , 4th, 6th and 8th divided 12.
Difference of amount of leakage in mean 24h based on 72h diary, compared with the baseline
Time frame: the 2, 4, 6, 8 week
The quantity of fluid loss in mean 24h will be measured by "72h voiding diary", comparing the value of 2nd, 4th, 6th and 8th weeks with the baseline (0 week) in 8th week. And the quantity of fluid loss in mean 24h is calculated by total quantity of fluid loss of 12 times treatment divided 12.
6 secondary outcomes
Difference of 1h pad test, compared with the baseline
Time frame: the 8, 20, 32 week
ICIQ-SF
Time frame: the 8, 20, 32 week
Patient subjective effectiveness evaluation
Time frame: the 8, 20, 32 week
Weekly usage of pad
Time frame: the 8, 20, 32 week
Usage of specialty therapy for Simple female stress urinary incontinence
Time frame: the 8, 20, 32 week
Subgroup analysis: amount of leakage with 1h pad test as a measure of curative effect of electroacupuncture for different extent of simple female stress urinary incontinence.
Time frame: the 8, 20, 32 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 25887231Su T, Zhou J, Liu Z, Chen Y, Zhang W, Chu H, Luo Q, Lu J, An J, Liu B. The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial. Trials. 2015 Feb 8;16:45. doi: 10.1186/s13063-015-0560-1.
- Individual participant dataSharing planned: Yes
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture group and pelvic floor muscle training group in people with Simple Stress Urinary Incontinence, run by Shaanxi Hospital of Traditional Chinese Medicine at 2 sites 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 3 inclusion and 12 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of frequency of leakage in mean 24h based on 72h diary, compared with the baseline (time frame: the 2, 4, 6, 8 week). The study lists 2 primary outcomes in all. 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 NCT01940432, 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 20 Jul 2016.