Enhancing Conservative Treatment for Urge Incontinence (COMBO)
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ClinicalTrials.gov Identifier: NCT00223821 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
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Sponsor:
US Department of Veterans Affairs
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )
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Tracking Information | ||||
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First Submitted Date ICMJE | September 14, 2005 | |||
First Posted Date ICMJE | September 22, 2005 | |||
Results First Submitted Date ICMJE | October 11, 2013 | |||
Results First Posted Date ICMJE | December 19, 2013 | |||
Last Update Posted Date | December 19, 2013 | |||
Study Start Date ICMJE | September 2003 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in Incontinent Episodes Immediately Post-treatment [ Time Frame: Baseline and immediately post-treatment - week 8 ] Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.
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Original Primary Outcome Measures ICMJE |
Reduction of incontinence episodes derived from bladder diaries immediately post-treatment and at 6 months and 12 months post-treatment. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Change in Incontinent Episodes at 12-month Follow-up [ Time Frame: Baseline and 12 months post-treatment ] Percent change from baseline in weekly frequency of incontinent episodes at 12-months post-treatment, derived from baseline and 12-month seven-day bladder diaries
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Original Secondary Outcome Measures ICMJE |
Patient self-report (Patient Satisfaction Questionnaire) and 3 impact/quality of life measures (Incontinence Impact Questionnaire, Uro-Genital Distress Index, SF-36 Health Survey) immediately post-treatment and at 6 months and 12 months post-treatment. | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Enhancing Conservative Treatment for Urge Incontinence | |||
Official Title ICMJE | Enhancing Conservative Treatment for Urge Incontinence | |||
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 impact/quality 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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Urinary Incontinence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Burgio KL, Goode PS, Richter HE, Markland AD, Johnson TM 2nd, Redden DT. Combined behavioral and individualized drug therapy versus individualized drug therapy alone for urge urinary incontinence in women. J Urol. 2010 Aug;184(2):598-603. doi: 10.1016/j.juro.2010.03.141. Epub 2010 Jun 19. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
166 | |||
Original Enrollment ICMJE |
300 | |||
Actual Study Completion Date ICMJE | December 2009 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Participants in this study were ambulatory, community-dwelling women (veterans and nonveterans) with persistent urge or predominantly urge incontinence. Participants must:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00223821 | |||
Other Study ID Numbers ICMJE | B2899-R | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | VA Office of Research and Development ( US Department of Veterans Affairs ) | |||
Study Sponsor ICMJE | US Department of Veterans Affairs | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | |||
Verification Date | October 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |