• Percentage reduction in urge incontinence episodes at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  

• Various urodynamic parameters such as, e.g.: [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  
• Increase in functional bladder capacity at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  
• Volume at first detrusor overactivity at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  
• Improvement in QoL at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  

Behavioral: Biofeedback, pelvic floor muscle training
Biofeedback, pelvic floor muscle training

Urinary incontinence (UI) is prevalent and morbid in the elderly, and its associated costs exceed $26 billion annually. Although effective therapy exists, it is underutilized. This is particularly true for non-pharmacologic therapies, which are at least as effective as drugs but safer, and recommended as the initial approach by every national panel. If therapies such as biofeedback (which targets pelvic muscles and detrusor suppression) are to become more widely used, they will require simplification, fewer and briefer sessions, less expensive equipment, and less sophisticated therapists. Unfortunately, such protocols cannot yet be devised because it is unknown which components are essential. We postulate that the mechanisms mediating effectiveness can be identified and that such knowledge will make it possible to enhance efficacy and to formulate more feasible and cost-effective protocols. Since reduction in UI correlates weakly with improved quality of life, however, it is important that biofeedback's impact on life quality be assessed concomitantly to ensure that formulation of such streamlined methods does not eliminate components essential for improved quality of life, even if they have no physiological correlates. We will address these issues by treating at least 150 elderly subjects with urge UI in an 8-week course of biofeedback. We will collect clinical and quality of life data and perform extensive physiologic testing on each subject at baseline and 8 weeks later. Improvement will be correlated with change in physiologic and quality of life parameters to identify the parameters that likely mediated it. Knowledge from this study should identify predictors and mechanisms mediating success of biofeedback; suggest ways that it could be further improved; facilitate development of less expensive, quicker, and more feasible protocols to deliver it (potentially permitting application to less motivated or cognitively impaired patients); and shed insight into mechanisms that may even improve efficacy of other interventions.