Acupuncture for Urinary Incontinence

Overview

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.

Full Title of Study: “Efficacy of Acupuncture in Treating Urinary Incontinence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2011

Detailed Description

See Brief Summary

Interventions

  • Procedure: Acupuncture
    • Acupuncture twice weekly for 6 weeks.
  • Other: Sham acupuncture
    • Twice a week for 6 weeks

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percent Change in Incontinent Episodes
    • Time Frame: Baseline to 1 Week post-intervention
    • 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
    • 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
    • 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
    • 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.
  • Mental Health Related Quality of Life
    • Time Frame: 1 week post-intervention
    • 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
    • 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
    • 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.
  • Incontinence-Specific Quality of Life
    • Time Frame: 4-weeks post-intervention
    • 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.
  • Duration of Any Beneficial Effects
    • Time Frame: monthly during follow-up up to 6 months
    • Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)

Secondary Measures

  • Change in Bladder Capacity
    • Time Frame: Change from baseline to 4 weeks post-intervention
    • 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
    • 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
    • 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
    • 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
    • Duration of urinary incontinence in years
  • Adherence to Treatment Protocol
    • Time Frame: 6 weeks
    • Percentage of acupuncture (true or sham) visits completed as scheduled
  • Burden Associated With the Acupuncture Treatment Protocol
    • Time Frame: 1 week post-treatment
    • 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
    • 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
    • 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
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Collaborator
    • National Center for Complementary and Integrative Health (NCCIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sandra Engberg, Professor and Associate Dean for Graduate Clinical Education – University of Pittsburgh
  • Overall Official(s)
    • Sandra Engberg, PhD, Principal Investigator, University of Pittsburgh

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