Acupuncture for Urinary Incontinence

University of Pittsburgh

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence

Treatments: Other: Sham acupuncture; Procedure: Acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00297427

R01AT002175-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

See Brief Summary

Enrollment: 127 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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127 participants in 2 patient groups

Acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Acupuncture

Sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Other: Sham acupuncture