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Acupuncture for Urinary Incontinence
This study is currently recruiting participants.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), July 2007
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00297427
  Purpose

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
Urinary Incontinence
Procedure: Acupuncture
Phase II

MedlinePlus related topics: Acupuncture Urinary Incontinence Urine and Urination
U.S. FDA Resources
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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Incontinent episodes
  • Health related quality of life
  • Duration of any beneficial effects

Secondary Outcome Measures:
  • Bladder capacity
  • Involuntary bladder contractions
  • Characteristics of responders
  • Burden associated with the acupuncture treatment protocol
  • Adverse events
  • Need for booster acupuncture during follow-up
  • Response to booster acupuncture if needed
  • Adherence to the treatment protocol
  • Pelvic floor muscle strength

Estimated Enrollment: 154
Study Start Date: October 2005
Estimated Study Completion Date: December 2009
Detailed Description:

See Brief Summary

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297427

Contacts
Contact: Sandra Engberg, PhD 412-624-1210 sje1@pitt.edu
Contact: Ali Smith, BA 412-624-1210 ajsst61@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Sandra Engberg, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Sandra Engberg, PhD University of Pittsburgh
  More Information

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
urinary incontinence

Study placed in the following topic categories:
Signs and Symptoms
Urologic Diseases
Urination Disorders
Urinary Incontinence

Additional relevant MeSH terms:
Urological Manifestations

ClinicalTrials.gov processed this record on January 15, 2009