Urinary incontinence (Ul) remains one of the most common chronic health problems in women with an estimated prevalence of 17% to 55%. Existing treatments for urinary incontinence, both pharmacological and non-pharmacological, are often of limited benefit, fail to help many individuals or have limited long-term efficacy. Based on the dominate Western view that acupuncture has its effects through modulation of nervous system activity and the increasing evidence that nervous system dysfunction is an important etiologic factor in urinary incontinence, there is a physiologic basis for believing that acupuncture may be efficacious in the management of Ul. Several small studies found that acupuncture reduced urge and/or mixed urge and stress Ul. There have been no published randomized, placebo controlled clinical trials examining the efficacy of acupuncture in the treatment of urinary incontinence. This study will (1) examine the short and long term effectiveness of acupuncture in reducing or eliminating urge and mixed urge and stress urinary incontinence; (2) examine the impact of acupuncture on self reported health related quality of life; (3) examine the impact of acupuncture on functional bladder capacity and, secondarily on detrusor instability; (4) identify the characteristics of individuals most likely to benefit from this intervention; (5) assess subject burden and adverse events associated with the acupuncture treatment; (6) examine subject adherence to the recommended number and frequency of treatment visits; (7) determine the time to relapse following acupuncture treatment and (8) examine the efficacy of booster acupuncture treatment in community-dwelling women between the ages of 40 and 70 years. Subjects will be randomized to an experimental or placebo (sham needle) acupuncture group. Acupuncture or sham needle treatments will be performed twice a week for 6 weeks. All subjects will be reassessed one and four weeks following the 6-week intervention phase. Following the 4-week post-treatment reassessment, control subjects will cross over to the acupuncture protocol. All subjects will be reassessed monthly for 6 months after the 1-month post-intervention assessment (7 months after completing the treatment protocol), and subjects who relapse will received one to two booster acupuncture sessions.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project (R01)
Project #
5R01AT002175-02
Application #
7104451
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Klein, Marguerite
Project Start
2005-08-01
Project End
2010-07-31
Budget Start
2006-08-01
Budget End
2007-07-31
Support Year
2
Fiscal Year
2006
Total Cost
$483,153
Indirect Cost
Name
University of Pittsburgh
Department
Miscellaneous
Type
Schools of Nursing
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213