Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223821
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2005-09-14
Brief Title:
Enhancing Conservative Treatment for Urge Incontinence
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Enhancing Conservative Treatment for Urge Incontinence
Status:
COMPLETED
Status Verified Date:
2013-10
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:
COMBO
Brief Summary:
The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training including pelvic floor muscle rehabilitation results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women
Detailed Description:
Urinary incontinence in women 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 and drug interventions are effective but do not cure most patients Thus there is a need to improve conservative treatment for urge incontinence in women The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training including pelvic floor muscle rehabilitation results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women This project is a randomized controlled clinical trial Sixty-four women with predominantly urge incontinence have been randomized Stratification and blocked randomization procedures are used to assign a subject to 8 weeks of drug therapy alone or 8 weeks of drug therapy enhanced with components of behavioral training that can be administered in most any outpatient clinic The drug therapy is extended release oxybutynin a well-established pharmacologic agent with a state of the art drug delivery system that has the lowest rates of side-effect The behavioral treatment is an innovative comprehensive behavioral training program which includes pelvic floor muscle rehabilitation teaching urge suppression and other skills to improve bladder control and self-monitoring with bladder diaries Bladder diaries completed by subjects before and after the treatment are used to calculate reduction in the frequency of incontinence Secondary outcomes measures include a patient satisfaction questionnaire and three impactquality of life measures Incontinence Impact Questionnaire Uro-Genital Distress Index SF-12 Health Survey The second objective of the study is to examine the cost-effectiveness of adding behavioral components to drug therapy With the changing health care environment there is increased concern with the costs of providing treatment This project will compare the relative costs and value of combined intervention using the methods of cost-effectiveness analysis the most widely adopted method for the economic evaluation of health interventions The third objective of the study is to examine further the mechanisms by which these therapies reduce incontinence including changes in bladder capacity thresholds for bladder sensation pelvic muscle strength use of pelvic muscles in response to the sensation of urgency and frequency of urination Pre-post changes in these parameters are measured to examine the effects of the treatment on these variables and structural equation modeling will be used to examine whether changes in each of these measures are related to treatment outcome
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