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

February 24, 2006
June 20, 2016
October 2005
May 2011   (final data collection date for primary outcome measure)
  • 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)
  • Incontinent episodes
  • Health related quality of life
  • Duration of Any Beneficial Effects
Complete list of historical versions of study NCT00297427 on ClinicalTrials.gov Archive Site
  • 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.
  • Bladder capacity
  • Involuntary bladder contractions
  • Characteristics of responders
  • Burden associated with the acupuncture treatment protocol
  • Adverse events
  • Need for Booster Acupuncture During Follow-up
  • Response to Booster Acupuncture if Needed
  • Adherence to the treatment protocol
  • Pelvic Floor Muscle Strength
Not Provided
Not Provided
 
Acupuncture for Urinary Incontinence
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.
See Brief Summary
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urinary Incontinence
  • Procedure: Acupuncture
    Acupuncture twice weekly for 6 weeks.
  • Other: Sham acupuncture
    Twice a week for 6 weeks
  • 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.
    Intervention: Procedure: Acupuncture
  • 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.
    Intervention: Other: Sham acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
July 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
25 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297427
R01AT002175-01A1, R01AT002175-01A1
Yes
Not Provided
Not Provided
Sandra Engberg, University of Pittsburgh
University of Pittsburgh
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Sandra Engberg, PhD University of Pittsburgh
University of Pittsburgh
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP