University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT00297427
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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Notify Me25 year and older
Female
Interventional
Phase 2
Pittsburgh, Pennsylvania, 15213, United States
See Brief Summary
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acupuncture twice weekly for 6 weeks.
Twice a week for 6 weeks
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.
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
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.
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.
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.
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.
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.
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.
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)
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.
Time frame: Baseline and 4 weeks post-treatment
Documentation of a diagnostic impression of stress urinary incontinence following urodynamics
Time frame: Baseline and 4 weeks post true or sham acupuncture
Documentation of a diagnostic impression of urge urinary incontinence following urodynamics
Time frame: Baseline
Glasses/cups per day of non-caffeinated fluids (including water) at baseline
Time frame: Baseline
Duration of urinary incontinence in years
Time frame: 6 weeks
Percentage of acupuncture (true or sham) visits completed as scheduled
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.
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.
Time frame: After the booster sessions
Change in the number of incontinent episodes per day following booster acupuncture
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.
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.
University of Pittsburgh
Other
Efficacy of Acupuncture in Treating Urinary Incontinence
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