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NCT00866710 · ClinicalTrials.gov registry record · NA
Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease
A NA study, sponsored by Atlanta VA Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT00866710 is a NA study that has completed, run by Atlanta VA Medical Center. The registered enrollment target is 28 participants.
The verdict
NCT00866710, a NA study, has completed, sponsored by Atlanta VA Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study 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: 1. Complete a course of behavioral therapy using computer-assisted biofeedback in 20 subjects with UI associated with PD and determine how many potential subjects need to be screened and enrolled to achieve this sample size. 2. Determine the proportion of these patients who achieve a 50% or greater reduction in UI episodes. 3. Examine whether responsiveness is associated with characteristics of the Parkinson's disease, in particular disease severity as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). 4. Assess the effectiveness of behavioral therapy without the use of computer-assisted biofeedback instruction in 10 additional subjects with PD and UI. 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. I
Interventions
- OTHER Exercise-based behavioral therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00866710
The ClinicalTrials.gov registry entry for NCT00866710 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlanta VA Medical Center, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Exercise-based behavioral therapy is the first listed.
NCT00866710 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00866710 about?
NCT00866710 is a clinical study titled "Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease". 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...
What is the current status of trial NCT00866710?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2008-10. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00866710?
The interventions under investigation include: Exercise-based behavioral therapy (OTHER).
Who is sponsoring clinical trial NCT00866710?
This trial is sponsored by Atlanta VA Medical Center, which has 12 total clinical trials registered on ClinicalTrials.gov.
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