- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00297427
Acupuncture for Urinary Incontinence
August 31, 2016 updated by: Sandra Engberg, University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See Brief Summary
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Urge or stress urinary incontinence at least twice a week on average for at least 3 months
Exclusion Criteria:
- 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
- Inability to toilet independently
- Current treatment with steroid
- Interstitial cystitis
- Chronic pelvic pain
- Current treatment with warfarin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Acupuncture
Subjects 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.
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Acupuncture twice weekly for 6 weeks.
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Sham Comparator: Sham acupuncture
Subjects 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.
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Twice a week for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Incontinent Episodes
Time Frame: Baseline to 1 Week post-intervention
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Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.
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Baseline to 1 Week post-intervention
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Percent Change in Incontinent Episodes
Time Frame: 4 weeks post true or sham acupuncture
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Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture
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4 weeks post true or sham acupuncture
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Physical Health-Related Quality of Live
Time Frame: 1 Week post-intervention
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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.
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1 Week post-intervention
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Physical Health-Related Quality of Life
Time Frame: 4-weeks post-intervention
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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.
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4-weeks post-intervention
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Mental Health Related Quality of Life
Time Frame: 1 week post-intervention
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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.
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1 week post-intervention
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Mental Health Related Quality of Life
Time Frame: 4 weeks post true or sham acupuncture
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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.
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4 weeks post true or sham acupuncture
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Incontinence-Specific Quality of Life
Time Frame: 1 Week post-intervention
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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.
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1 Week post-intervention
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Incontinence-Specific Quality of Life
Time Frame: 4-weeks post-intervention
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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.
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4-weeks post-intervention
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Duration of Any Beneficial Effects
Time Frame: monthly during follow-up up to 6 months
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Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)
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monthly during follow-up up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Bladder Capacity
Time Frame: Change from baseline to 4 weeks post-intervention
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Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.
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Change from baseline to 4 weeks post-intervention
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Urodynamic Diagnostic Impression of Stress Urinary Incontinence
Time Frame: Baseline and 4 weeks post-treatment
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Documentation of a diagnostic impression of stress urinary incontinence following urodynamics
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Baseline and 4 weeks post-treatment
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Urodynamic Impression of Urge Urinary Incontinence
Time Frame: Baseline and 4 weeks post true or sham acupuncture
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Documentation of a diagnostic impression of urge urinary incontinence following urodynamics
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Baseline and 4 weeks post true or sham acupuncture
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Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)
Time Frame: Baseline
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Glasses/cups per day of non-caffeinated fluids (including water) at baseline
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Baseline
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Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years
Time Frame: Baseline
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Duration of urinary incontinence in years
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Baseline
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Adherence to Treatment Protocol
Time Frame: 6 weeks
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Percentage of acupuncture (true or sham) visits completed as scheduled
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6 weeks
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Burden Associated With the Acupuncture Treatment Protocol
Time Frame: 1 week post-treatment
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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.
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1 week post-treatment
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Need for Booster Acupuncture During Follow-up
Time Frame: Monthly during the 6 month follow-up period
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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.
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Monthly during the 6 month follow-up period
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Response to Booster Acupuncture if Needed
Time Frame: After the booster sessions
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Change in the number of incontinent episodes per day following booster acupuncture
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After the booster sessions
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Pelvic Floor Muscle Strength
Time Frame: Baseline and 1 week post true or sham acupuncture
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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.
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Baseline and 1 week post true or sham acupuncture
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Pelvic Floor Muscle Strength
Time Frame: Baseline and 4 weeks post true or sham acupuncture
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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.
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Baseline and 4 weeks post true or sham acupuncture
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandra Engberg, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 24, 2006
First Submitted That Met QC Criteria
February 27, 2006
First Posted (Estimate)
February 28, 2006
Study Record Updates
Last Update Posted (Estimate)
October 24, 2016
Last Update Submitted That Met QC Criteria
August 31, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT002175-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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