Acupuncture for Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
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

February 24, 2006
June 22, 2012
October 2005
May 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Incontinent episodes
  • Health related quality of life
  • Duration of any beneficial effects
Complete list of historical versions of study NCT00297427 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Acupuncture for Urinary Incontinence
Efficacy of Acupuncture in Treating Urinary Incontinence
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.
See Brief Summary
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urinary Incontinence
  • Procedure: Acupuncture
    Acupuncture twice weekly for 6 weeks.
  • Other: Sham acupuncture
    Twice a week for 6 weeks
  • Experimental: Acupuncture
    Intervention: Procedure: Acupuncture
  • Sham Comparator: Sham acupuncture
    Intervention: Other: Sham acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
July 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297427
R01AT002175-01A1, R01AT002175-01A1
Yes
Not Provided
Not Provided
University of Pittsburgh
University of Pittsburgh
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Sandra Engberg, PhD University of Pittsburgh
University of Pittsburgh
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP