Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease (BETTUR PD)
Tracking Information | |||||
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First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | January 10, 2012 | ||||
Start Date ICMJE | October 2008 | ||||
Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Bladder diary [ Time Frame: 1 week ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00866710 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Quality of Life Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease | ||||
Official Title ICMJE | Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease | ||||
Brief Summary | Background: Parkinson's disease affects up to 3% of persons over the age of 65. Lower urinary tract symptoms are a frequent cause of diminished quality of life in elderly persons and occur in up to 40% of persons with Parkinson's disease. While the exact mechanisms have not been determined, detrusor hyperactivity (hyperactivity of the bladder muscle) leading to symptoms of overactive bladder and urge incontinence is common. Behavioral and exercise-based therapies have relatively no side effects and have been shown to be an effective treatment for urge symptoms of overactive bladder in the aged population. Hypothesis and Specific Aims: Behavioral therapy using pelvic floor muscle exercises will result in a 50% decrease in the number of incontinence episodes in elderly persons (age > 50) with Parkinson's disease. The specific aims for this pilot study include the following:
Methods: The first 20 participants will be enrolled in an 8-week treatment trial of behavioral therapies and pelvic floor muscle exercises with computer-assisted biofeedback. Ten additional participants will be enrolled in the 8-week treatment trial of behavioral therapy, but will not have computer-assisted biofeedback. Voiding diaries as well as urinary symptom and quality of life questionnaires will be used to assess response. If persons with Parkinson's disease can complete the treatment trial and achieve a reduction in episodes of urinary incontinence with behavioral techniques this would lay the foundation for a larger, placebo-controlled trial. Assessment of responsiveness associated with severity of Parkinson's disease would also provide important information about the utility of this treatment strategy. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Other: Exercise-based behavioral therapy
Participants will be taught pelvic floor muscle exercises as well as urge suppression strategies to overcome the urge to void. In the first 20 participants, computer-assisted biofeedback will also be utilized to help participants identify the pelvic floor muscles and contract and relax these muscles while keeping the abdominal muscles relaxed |
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Study Arm (s) | |||||
Publications * | |||||
* 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 | ||||
Enrollment ICMJE | 28 | ||||
Completion Date | October 2011 | ||||
Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866710 | ||||
Other Study ID Numbers ICMJE | 6-38941 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Camille Vaughan, MD, Atlanta VA Medical Center | ||||
Study Sponsor ICMJE | Atlanta VA Medical Center | ||||
Collaborators ICMJE | The John A. Hartford Foundation | ||||
Investigators ICMJE |
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Information Provided By | Atlanta VA Medical Center | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |