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Acupuncture for Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Sandra Engberg, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00297427
First received: February 24, 2006
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Urinary Incontinence
Procedure: Acupuncture
Other: Sham acupuncture
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture in Treating Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Percent Change in Incontinent Episodes [ Time Frame: Baseline to 1 Week post-intervention ] [ Designated as safety issue: No ]
    Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.

  • Percent Change in Incontinent Episodes [ Time Frame: 4 weeks post true or sham acupuncture ] [ Designated as safety issue: No ]
    Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture

  • Physical Health-Related Quality of Live [ Time Frame: 1 Week post-intervention ] [ Designated as safety issue: No ]
    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.

  • Physical Health-Related Quality of Life [ Time Frame: 4-weeks post-intervention ] [ Designated as safety issue: No ]
    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.

  • Mental Health Related Quality of Life [ Time Frame: 1 week post-intervention ] [ Designated as safety issue: No ]
    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.

  • Mental Health Related Quality of Life [ Time Frame: 4 weeks post true or sham acupuncture ] [ Designated as safety issue: No ]
    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.

  • Incontinence-Specific Quality of Life [ Time Frame: 1 Week post-intervention ] [ Designated as safety issue: No ]
    Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire

  • Incontinence-Specific Quality of Life [ Time Frame: 4-weeks post-intervention ] [ Designated as safety issue: No ]
    Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire

  • Duration of Any Beneficial Effects [ Time Frame: monthly during follow-up up to 6 months ] [ Designated as safety issue: No ]
    Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)


Secondary Outcome Measures:
  • Change in Bladder Capacity [ Time Frame: Change from baseline to 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.

  • Urodynamic Diagnostic Impression of Stress Urinary Incontinence [ Time Frame: Baseline and 4 weeks post-treatment ] [ Designated as safety issue: No ]
    Documentation of a diagnostic impression of stress urinary incontinence following urodynamics

  • Urodynamic Impression of Urge Urinary Incontinence [ Time Frame: Baseline and 4 weeks post true or sham acupuncture ] [ Designated as safety issue: No ]
    Documentation of a diagnostic impression of urge urinary incontinence following urodynamics

  • Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Glasses/cups per day of non-caffeinated fluids (including water) at baseline

  • Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Duration of urinary incontinence in years

  • Adherence to Treatment Protocol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Percentage of acupuncture (true or sham) visits completed as scheduled

  • Burden Associated With the Acupuncture Treatment Protocol [ Time Frame: 1 week post-treatment ] [ Designated as safety issue: No ]
    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.

  • Need for Booster Acupuncture During Follow-up [ Time Frame: Monthly during the 6 month follow-up period ] [ Designated as safety issue: No ]
    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.

  • Response to Booster Acupuncture if Needed [ Time Frame: After the booster sessions ] [ Designated as safety issue: No ]
    Change in the number of incontinent episodes per day following booster acupuncture

  • Pelvic Floor Muscle Strength [ Time Frame: Baseline and 1 week post true or sham acupuncture ] [ Designated as safety issue: No ]
    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.

  • Pelvic Floor Muscle Strength [ Time Frame: Baseline and 4 weeks post true or sham acupuncture ] [ Designated as safety issue: No ]
    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.


Enrollment: 127
Study Start Date: October 2005
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Acupuncture
Acupuncture twice weekly for 6 weeks.
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.
Other: Sham acupuncture
Twice a week for 6 weeks

Detailed Description:
See Brief Summary
  Eligibility

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297427

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Sandra Engberg, PhD University of Pittsburgh
  More Information

Responsible Party: Sandra Engberg, Professor and Associate Dean for Graduate Clinical Education, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00297427     History of Changes
Obsolete Identifiers: NCT00177450
Other Study ID Numbers: R01AT002175-01A1 
Study First Received: February 24, 2006
Results First Received: January 14, 2016
Last Updated: June 20, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016