Urinary incontinence in the elderly is a major problem with significant medical, psychological, and social consequences. Previous research on urge incontinence, a common form of incontinence, has demonstrated that behavioral interventions and drug treatments are effective for many individuals. However, it is clear that no one method has been 100% effective and all methods have disadvantages. The broad objective of the proposed research is to improve the treatment of urge incontinence 1) by improving the efficacy of individual treatment modalities, 2) by combining treatments that have additive effects, and 3) by improving selection criteria. This project will be a prospective, randomized trial comparing the effects of behavioral training, drug therapy (oxybutynin) and placebo on urge incontinence in ambulatory, community-dwelling women aged 55 years and older. Although the two treatments have been studied individually, their effects have never been compared. Approximately 390 women will be evaluated for participation with the expectation that 195 will complete the protocol. Stratified and blocked randomization procedures will be used to assign subjects to 4 sessions (8 weeks) of biofeedback-assisted behavioral training, 4 sessions (8 weeks) of treatment with oxybutynin, or 4 sessions(8 weeks) of placebo. Bladder diaries completed by subjects prior to randomization and following the last treatment session will be used to calculate reduction in the frequency of incontinence. Urodynamic evaluation conducted prior to and following intervention will be used to objectively document change in bladder or sphincter function. The second purpose of the study is to evaluate the combined effects of the two interventions. Using a conditional cross-over design, patients who do not achieve total continence following one intervention will receive the alternate intervention in addition. Finally, the third purpose of the study is to characterize patients on clinical variables that may influence response to each treatment and eventually aid us in predicting treatment outcome.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project (R01)
Project #
5R01AG008010-03
Application #
3119417
Study Section
Nursing Research Study Section (NURS)
Project Start
1989-07-01
Project End
1994-06-30
Budget Start
1991-07-01
Budget End
1992-06-30
Support Year
3
Fiscal Year
1991
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Type
Schools of Medicine
DUNS #
053785812
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Burgio, Kathryn L; Goode, Patricia S; Richter, Holly E et al. (2006) Global ratings of patient satisfaction and perceptions of improvement with treatment for urinary incontinence: validation of three global patient ratings. Neurourol Urodyn 25:411-7
Goode, Patricia S (2004) Predictors of treatment response to behavioral therapy and pharmacotherapy for urinary incontinence. Gastroenterology 126:S141-5
Goode, Patricia S (2004) Behavioral and drug therapy for urinary incontinence. Urology 63:58-64
Burgio, Kathryn L; Goode, Patricia S; Locher, Julie L et al. (2003) Predictors of outcome in the behavioral treatment of urinary incontinence in women. Obstet Gynecol 102:940-7
Locher, Julie L; Burgio, Kathryn L; Goode, Patricia S et al. (2002) Effects of age and causal attribution to aging on health-related behaviors associated with urinary incontinence in older women. Gerontologist 42:515-21
Goode, Patricia S; Burgio, Kathryn L; Locher, Julie L et al. (2002) Urodynamic changes associated with behavioral and drug treatment of urge incontinence in older women. J Am Geriatr Soc 50:808-16
Burgio, Kathryn L; Goode, Patricia S; Locher, Julie L et al. (2002) Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA 288:2293-9
Burgio, K L; Locher, J L; Roth, D L et al. (2001) Psychological improvements associated with behavioral and drug treatment of urge incontinence in older women. J Gerontol B Psychol Sci Soc Sci 56:P46-51
Locher, J L; Goode, P S; Roth, D L et al. (2001) Reliability assessment of the bladder diary for urinary incontinence in older women. J Gerontol A Biol Sci Med Sci 56:M32-5
Burgio, K L; Locher, J L; Goode, P S (2000) Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc 48:370-4

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