Acupuncture for Urinary Incontinence

Phase 2

Completed

Conditions: Urinary Incontinence

Interventions: Other: Sham acupuncture
Procedure: Acupuncture

Registration Number: NCT00297427

Lead Sponsor: University of Pittsburgh

Brief Summary: 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.

Detailed Description: See Brief Summary

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 127

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham acupuncture	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.
Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Percent Change in Incontinent Episodes	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Change in Bladder Capacity	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	Baseline and 4 weeks post-treatment	Documentation of a diagnostic impression of stress urinary incontinence following urodynamics
Urodynamic Impression of Urge Urinary Incontinence	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)	Baseline	Glasses/cups per day of non-caffeinated fluids (including water) at baseline
Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years	Baseline	Duration of urinary incontinence in years
Adherence to Treatment Protocol	6 weeks	Percentage of acupuncture (true or sham) visits completed as scheduled
Burden Associated With the Acupuncture Treatment Protocol	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	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	After the booster sessions	Change in the number of incontinent episodes per day following booster acupuncture
Pelvic Floor Muscle Strength	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.