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Urinary Stress IncontinencePhase 2NCT01784172

Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial

A Phase 2 study testing electroacupuncture group in people with Urinary Stress Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence. Read more about this study

Who is it for?
Ages 40 to 75 years, women only
Conditions the study is for
Urinary Stress Incontinence
What is being tested?
electroacupuncture group
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
504 participants
Where
1 siteChina
Study dates
Mar 2013to Dec 2014
Phase
Phase 2
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
  • No healthy volunteers
  • 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
  • RUV>30ml
  • Qmax<20ml/s
Show all 11Show 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, MSA, Injury of cauda equine, myeleterosis.
  • During pregnancy or lactation period
  • With cardiac pacemaker, Metal allergy or severe needle phobia

Trial locations and contacts

1 site in 1 country.

China1 site

  • China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality, 100700

Other trials in China

About this study

Official title: The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.

Read the detailed description

Stress urinary incontinence (SUI) is a common disease of female. The inconvenience caused by SUI affects the patients' quality of life and health seriously. To date, there has not specific therapy on SUI. Former research showed acupuncture may work for SUI. This multi-center randomized controlled clinical trial of acupuncture for simple female stress urinary incontinence is designed to confirm the efficacy and safety of EA. This project is conducted by Chinese researchers, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for simple female stress urinary incontinence.

Being tested
electroacupuncture group, sham electroacupuncture group
Keywords
efficacy, safety, electroacupuncture, simple female stress urinary incontinence
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electroacupuncture groupDevice

    Also called SDA-V electroacupuncture apparatus(Huatuo,made in China)

    Procedure: electro-acupuncture;Points: Bilateral Zhongliao (BL33) Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50～60mm 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 continuous wave,50 Hz and electric current 1- 5mA.Every session lasts for 30 min per day.The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.

  • sham electroacupuncture groupDevice

    Also called Sham SDZ-V electroacupuncture apparatus(Huatuo,China)

    Procedure: sham electroacupuncture;Points: Bilateral sham Zhongliao (BL33) sham Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Both sham BL33 and BL35 are given non-penetrating needling with blunt needle. Twirl, lift and thrust for 3 times. The sham electric stimulator is applied to bilateral sham BL33 and sham BL35. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.

Study groups in NCT01784172
Study groupRoleWhat they receive
electroacupuncture groupExperimentalBilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward. Bilateral B L35 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 6 weeks for 3 sessions a week, 18 sessions for each patient in all.
Receives: Device: electroacupuncture group
sham electroacupuncture groupExperimentalBilateral sham BL33 and sham BL35 are given sham electroacupuncture with no current output. Every session lasts for 30 min per day. The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all.
Receives: Device: sham electroacupuncture group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. value difference of 1h pad test, compared with the baseline

    quantity of fluid loss will be measured by 1h pad test, comparing the value of 6 weeks with the baseline(0 week), the primary outcome is the value difference.

    Measured: the 6 weeks

Secondary outcomes (7)

  1. average frequency difference of urinary incontinence in 72h

    1. The average frequency difference of urinary incontinence in 72h of the 6 weeks is the average frequency difference of urinary incontinence in 72h of 2nd, 4th, 6th weeks based on the '72h voiding diary'; 2. The average frequency difference of urinary incontinence in 72h of the15-18 weeks is the average frequency difference of urinary incontinence in 72h of 15-18 weeks based on the '72h voiding diary'; 3. The average frequency difference of urinary incontinence in 72h of the 27-30 weeks is the average frequency difference of urinary incontinence in 72h of 27-30 weeks based on the '72h voiding diary'.

    Measured: the 6 weeks, the15-18 weeks, 27-30 weeks

  2. 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 6, 18, 30 week

  3. Patient subjective effectiveness evaluation

    3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3

    Measured: the 6, 18, 30 week

  4. Weekly usage of pad

    The value of 6 weeks is the average weekly usage of pads during 1-6 week; The value of 7-18weeks is the average weekly usage of pads during 7-18 weeks; The value of 19-30 weeks is the average weekly usage of pads during 19-30 weeks.

    Measured: the 6 weeks, 7-18weeks, 19-30 weeks

  5. 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 1-6 weeks, 7-18 weeks and 19-30 weeks.

    Measured: the 6 weeks, 7-18weeks, 19-30 weeks

  6. subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence

    the 6th week: analyse the relevancy between 1h pad test and extent of urinary incontinence; the 18th and 30th weeks: analyse the relevancy between frequency of urinary incontinence in 72h and extent of urinary incontinence.

    Measured: the 6, 18, 30 week

  7. Incidence of adverse events

    Measured: the 1-6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01784172
Sponsor's protocol ID
2012BAI24B01-2
Status last verified
Dec 2014
First submitted
1 Feb 2013
Last updated
23 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9.

    PubMed 31919102

  • Jiao R, Liu Y, Liu B, Liu Z. Risk factors related to acupuncture response in postmenopausal women with stress urinary incontinence: Secondary analysis of a randomized controlled trial. Medicine (Baltimore). 2019 Apr;98(16):e15220. doi: 10.1097/MD.0000000000015220.

    PubMed 31008950

  • Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.

    PubMed 28655016

  • Liu Z, Xu H, Chen Y, He L, Liu J, Yan S, Du R, Wu J, Liu B. The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trial. Trials. 2013 Sep 30;14:315. doi: 10.1186/1745-6215-14-315.

    PubMed 24079823

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing electroacupuncture group in people with Urinary Stress Incontinence, 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 23 Dec 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

value difference of 1h pad test, compared with the baseline (time frame: the 6 weeks). 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 NCT01784172, which also lists 4 linked publications.

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 23 Dec 2014.

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