Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177541
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2005-09-13
Brief Title:
Further Enhancing Non-pharmacologic Therapy for Incontinence
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Further Enhancing Non-pharmacologic Therapy for Incontinence
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle exercises and biofeedback for urge urinary incontinence as well as the characteristics of patients most likely to respond By identifying the key components of this treatment we hope to simplify it and make it more easily applicable more effective less expensive and thus more useful for people with urge incontinence in the future
Detailed Description:
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 biofeedbacks 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG020629-02 | NIH | None | httpsreporternihgovquickSearch5R01AG020629-02 |