AzTrials
AzTrials

Urinary IncontinencePhase 2NCT00297427

Acupuncture for Urinary Incontinence

A Phase 2 study testing Acupuncture in people with Urinary Incontinence, run by University of Pittsburgh at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

This research study will evaluate the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions over 6 weeks. Read more about this study

Who is it for?
Ages 25 years and older, women only
Conditions the study is for
Urinary Incontinence
What is being tested?
Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
1 siteUnited States
Study dates
Oct 2005to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 25 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Urge or stress urinary incontinence at least twice a week on average for at least 3 months

Who cannot join

  • History of previous acupuncture
  • History of a neurologic problem such as Parkinson's disease or multiple sclerosis that could affect bladder function
  • Current treatment with overactive bladder medications or medications that relax the bladder
  • Urinary catheter
  • Pregnancy
  • Inability to empty the bladder effectively
Show all 11Show fewer
  • Inability to toilet independently
  • Current treatment with steroid
  • Interstitial cystitis
  • Chronic pelvic pain
  • Current treatment with warfarin

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Efficacy of Acupuncture in Treating Urinary Incontinence

This research study will evaluate the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo) acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not actually inserted into the body) on the frequency and volume of involuntary (accidental) urine loss after completing the intervention, and again one month later. Individuals participating in this study will be randomly assigned to receive either the actual or sham acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study participants will not know which group (actual or sham acupuncture) they were assigned to until one month after completing the 6-weeks of treatment. The sham acupuncture needles look similar to the real acupuncture needles and feel like they penetrate the skin, but do not actually do so. If individuals are assigned to the sham acupuncture group, they will be eligible to receive the actual acupuncture one month after completing the sham acupuncture if they wanted to. All individuals will be followed for 6 months after completing the acupuncture treatments.

Read the detailed description

See Brief Summary

Being tested
Acupuncture, Sham acupuncture
Keywords
urinary incontinence
Medical subject headings
Urinary Incontinence

What participants receive

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

  • AcupunctureProcedure or surgery

    Acupuncture twice weekly for 6 weeks.

  • Sham acupunctureOther

    Twice a week for 6 weeks

Study groups in NCT00297427
Study groupRoleWhat they receive
AcupunctureExperimentalSubjects will 12 acupuncture treatments over 6 weeks; treatment sessions occur twice a week. A total of 12 acupuncture needles will be inserted bilaterally at two leg points and four back points. Needles are manually inserted through a standard guide tube contained within a fitted sheath and the basal ring secured to the skin by double-sided tape. The needles remain in place for 25 minutes and are manually stimulated twice during each treatment.
Receives: Procedure: Acupuncture
Sham acupunctureSham comparatorSubjects will receive 12 sham acupuncture treatments (delivered twice a week) over 6 weeks. The sham needle is blunted needle whose shaft telescopes into the handle when tapped. While the needle appears to have been inserted, it does not actually penetrate the skin. It is held in place by the same standard guide tube used in the true acupuncture group. The acupuncture points and duration of treatment are the same as for the true acupuncture group.
Receives: Other: Sham acupuncture

What is being measured

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

  1. Percent Change in Incontinent Episodes

    Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.

    Measured: Baseline to 1 Week post-intervention

  2. Percent Change in Incontinent Episodes

    Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture

    Measured: 4 weeks post true or sham acupuncture

  3. Physical Health-Related Quality of Live

    Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.

    Measured: 1 Week post-intervention

  4. Physical Health-Related Quality of Life

    Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.

    Measured: 4-weeks post-intervention

  5. Mental Health Related Quality of Life

    Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.

    Measured: 1 week post-intervention

  6. Mental Health Related Quality of Life

    Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.

    Measured: 4 weeks post true or sham acupuncture

  7. Incontinence-Specific Quality of Life

    Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.

    Measured: 1 Week post-intervention

  8. Incontinence-Specific Quality of Life

    Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.

    Measured: 4-weeks post-intervention

  9. Duration of Any Beneficial Effects

    Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)

    Measured: monthly during follow-up up to 6 months

Secondary outcomes (11)

  1. Change in Bladder Capacity

    Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.

    Measured: Change from baseline to 4 weeks post-intervention

  2. Urodynamic Diagnostic Impression of Stress Urinary Incontinence

    Documentation of a diagnostic impression of stress urinary incontinence following urodynamics

    Measured: Baseline and 4 weeks post-treatment

  3. Urodynamic Impression of Urge Urinary Incontinence

    Documentation of a diagnostic impression of urge urinary incontinence following urodynamics

    Measured: Baseline and 4 weeks post true or sham acupuncture

  4. Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)

    Glasses/cups per day of non-caffeinated fluids (including water) at baseline

    Measured: Baseline

  5. Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years

    Duration of urinary incontinence in years

    Measured: Baseline

  6. Adherence to Treatment Protocol

    Percentage of acupuncture (true or sham) visits completed as scheduled

    Measured: 6 weeks

  7. Burden Associated With the Acupuncture Treatment Protocol

    Subjects' report of burden (difficulty) associated with the frequency, number and duration of treatment) and the position they had to remain in during the true and sham treatments. Subjects rate the difficulty associated with each of the four aspects of treatment on a 10-point scale ranging from 1 (not at all difficult) to 10 (extremely difficult). The burden score was calculated as the average of the scores on the 4 items with a possible range of 1 to 10 with higher scores indicating greater burden.

    Measured: 1 week post-treatment

  8. Need for Booster Acupuncture During Follow-up

    The number of participants who were received true acupuncture (as their initial intervention or after initially receiving sham acupuncture) and were eligible to receive a booster (had a 50% or greater reduction in incontinent episodes following true acupuncture) and completed at least one month of follow-up and experienced a 30% or greater increase in incontinent episodes during follow up.

    Measured: Monthly during the 6 month follow-up period

  9. Response to Booster Acupuncture if Needed

    Change in the number of incontinent episodes per day following booster acupuncture

    Measured: After the booster sessions

  10. Pelvic Floor Muscle Strength

    Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.

    Measured: Baseline and 1 week post true or sham acupuncture

  11. Pelvic Floor Muscle Strength

    Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.

    Measured: Baseline and 4 weeks post true or sham acupuncture

Timeline

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

  1. First posted28 Feb 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionMay 2011
  4. Study completionJul 2011

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297427
Sponsor's protocol ID
R01AT002175-01A1
Other IDs
R01AT002175-01A1
Status last verified
Aug 2016
First submitted
24 Feb 2006
Last updated
24 Oct 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acupuncture in people with Urinary Incontinence, run by University of Pittsburgh at 1 site in United States.

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 1 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 24 Oct 2016. 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 United States. 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.

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?

Yes. Results are posted in the registry (first posted 1 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Incontinent Episodes (time frame: Baseline to 1 Week post-intervention). The study lists 9 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 NCT00297427.

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 24 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in