Acupuncture for Urinary Incontinence

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-07-31

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.

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Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Acupuncture twice weekly for 6 weeks.

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.

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type OTHER

Twice a week for 6 weeks

Interventions

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Acupuncture

Acupuncture twice weekly for 6 weeks.

Intervention Type PROCEDURE

Sham acupuncture

Twice a week for 6 weeks

Intervention Type OTHER

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

Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No