Urinary incontinence (UI) is a major problem for the elderly, threatening the ability to live independently and engendering a $15 billion annual cost that exceeds the entire NIH budget. The most common type of geriatric UI is urge UI, which is generally associated with involuntary bladder contractions-a condition known as detrusor overactivity (DO). Yet little is known about the pathogenesis of either urge UI or DO and the relationship between them is problematic. Moreover, it remains unclear how well drug therapy works for them, in whom it works, how it works, and whether patients themselves consider the improvement significant. Based on our pilot data, we postulate that there is a bimodal response, with many patients experiencing significant improvement while an equal proportion worsen. In addition, these data suggest for the first time that clinical and physiological variables may allow prediction of outcome, and significantly, provide insight into the mechanisms of improvement.
The specific aims of the proposed Intervention Development Study are to: 1) devise and validate a UI-specific quality of life measure to supplement the traditional as well as newer physiological parameters predict treatment outcome in community-dwelling elderly (controlling for placebo response); and 3) identify which parameters mediate both drug and placebo responses. To accomplish these goals we will first devise and refine a patient-based UI-related quality of life measure, and then enroll 250 urge incontinent community-dwelling elderly in a randomized controlled trial of oxybutynin. Outcome measures will include changes in incontinence frequency, urodynamic parameters, and the new outcome tool. By devising a patient-based outcome tool, evaluating newer physiological tests, identifying outcome predictors, providing insights into the mechanism(s) of treatment response, and determining estimates in community-dwelling elderly of the efficacy and failure rates of both placebo and the most commonly-used therapy for DO, the study should set the stage for a definitive randomized trial of oxybutynin and other bladder relaxants. Moreover, the physiologic insights gained should advance our understanding of the pathophysiology of urge incontinence associated with DO, thereby facilitating development of new therapeutic options essential to improving independence in older adults.
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