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Completed

NCT Number: NCT00297427

Acupuncture for 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.

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

See Brief Summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

Acupuncture twice weekly for 6 weeks.

Sham Acupuncture

Other

Twice a week for 6 weeks

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

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

    Time frame: Baseline

    Duration of urinary incontinence in years

  6. Adherence to Treatment Protocol

    Time frame: 6 weeks

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

  7. 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.

  8. 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.

  9. Response to Booster Acupuncture if Needed

    Time frame: After the booster sessions

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

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Efficacy of Acupuncture in Treating Urinary Incontinence

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2006
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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