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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | 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. All individuals will be followed for 6 months after completing the acupuncture treatments.
Condition | Intervention | Phase |
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Urinary Incontinence |
Procedure: Acupuncture |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Acupuncture in Treating Urinary Incontinence |
Estimated Enrollment: | 154 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | December 2009 |
See Brief Summary
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandra Engberg, PhD | 412-624-1210 | sje1@pitt.edu |
Contact: Ali Smith, BA | 412-624-1210 | ajsst61@pitt.edu |
United States, Pennsylvania | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Principal Investigator: Sandra Engberg, PhD |
Principal Investigator: | Sandra Engberg, PhD | University of Pittsburgh |
Study ID Numbers: | R01 AT002175-01A1 |
Study First Received: | February 24, 2006 |
Last Updated: | July 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00297427 |
Health Authority: | United States: Federal Government |
urinary incontinence |
Signs and Symptoms Urologic Diseases Urination Disorders Urinary Incontinence |
Urological Manifestations |