Acupuncture for Urinary Incontinence

Study Overview
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Brief Summary
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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
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See Brief Summary

Official Title
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Efficacy of Acupuncture in Treating Urinary Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: Acupuncture
* Other: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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. | Procedure: Acupuncture<br>* Acupuncture twice weekly for 6 weeks.<br>|
| Sham Comparator: Sham acupuncture<br>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. | Other: Sham acupuncture<br>* Twice a week for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Incontinent Episodes | Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline. | Baseline to 1 Week post-intervention | 
| Percent Change in Incontinent Episodes | Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture | 4 weeks post true or sham acupuncture | 
| Physical Health-Related Quality of Live | 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. | 1 Week post-intervention | 
| Physical Health-Related Quality of Life | 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. | 4-weeks post-intervention | 
| Mental Health Related Quality of Life | 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. | 1 week post-intervention | 
| Mental Health Related Quality of Life | 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. | 4 weeks post true or sham acupuncture | 
| Incontinence-Specific Quality of Life | 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. | 1 Week post-intervention | 
| Incontinence-Specific Quality of Life | 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. | 4-weeks post-intervention | 
| Duration of Any Beneficial Effects | Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants) | monthly during follow-up up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bladder Capacity | Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate. | Change from baseline to 4 weeks post-intervention | 
| Urodynamic Diagnostic Impression of Stress Urinary Incontinence | Documentation of a diagnostic impression of stress urinary incontinence following urodynamics | Baseline and 4 weeks post-treatment | 
| Urodynamic Impression of Urge Urinary Incontinence | Documentation of a diagnostic impression of urge urinary incontinence following urodynamics | Baseline and 4 weeks post true or sham acupuncture | 
| Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water) | Glasses/cups per day of non-caffeinated fluids (including water) at baseline | Baseline | 
| Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years | Duration of urinary incontinence in years | Baseline | 
| Adherence to Treatment Protocol | Percentage of acupuncture (true or sham) visits completed as scheduled | 6 weeks | 
| Burden Associated With the Acupuncture Treatment Protocol | 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. | 1 week post-treatment | 
| Need for Booster Acupuncture During Follow-up | 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. | Monthly during the 6 month follow-up period | 
| Response to Booster Acupuncture if Needed | Change in the number of incontinent episodes per day following booster acupuncture | After the booster sessions | 
| Pelvic Floor Muscle Strength | 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. | Baseline and 1 week post true or sham acupuncture | 
| Pelvic Floor Muscle Strength | 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. | Baseline and 4 weeks post true or sham acupuncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence