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Acupuncture for Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00297427
First received: February 24, 2006
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  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
Other: Sham acupuncture
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture in Treating Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Incontinent episodes [ Time Frame: baseline, 1 and 4 weeks post treatment and monthly during follow-up ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: Baseline, 1 & 4 weeks post-treatment and month 3 and 6 during follow-up ] [ Designated as safety issue: No ]
  • Duration of any beneficial effects [ Time Frame: monthly during follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bladder capacity [ Time Frame: Baseline and 4 weeks post-treatment ] [ Designated as safety issue: No ]
  • Involuntary bladder contractions [ Time Frame: Baseline and 4 weeks post-treatment ] [ Designated as safety issue: No ]
  • Characteristics of responders [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Burden associated with the acupuncture treatment protocol [ Time Frame: 1 & 4 weeks post-treatment ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: After each acupuncture treatment ] [ Designated as safety issue: Yes ]
  • Need for booster acupuncture during follow-up [ Time Frame: Monthly during follow-up ] [ Designated as safety issue: No ]
  • Response to booster acupuncture if needed [ Time Frame: After the booster sessions ] [ Designated as safety issue: No ]
  • Adherence to the treatment protocol [ Time Frame: Weekly during the acupuncture treatment ] [ Designated as safety issue: No ]
  • Pelvic floor muscle strength [ Time Frame: Baseline, 1 & 4 weeks post-treatment and month 3 and 6 during follow-up ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: October 2005
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture Procedure: Acupuncture
Acupuncture twice weekly for 6 weeks.
Sham Comparator: Sham acupuncture Other: Sham acupuncture
Twice a week for 6 weeks

Detailed Description:

See Brief Summary

  Eligibility

Ages Eligible for Study:   25 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

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Sandra Engberg, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00297427     History of Changes
Other Study ID Numbers: R01 AT002175-01A1, R01AT002175-01A1
Study First Received: February 24, 2006
Last Updated: June 22, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013