Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease (BETTUR PD)
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|ClinicalTrials.gov Identifier: NCT01520948|
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : January 10, 2018
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI), urgency, and/or nocturia, are common non-motor symptoms that further diminish the already compromised quality of life for adults living with PD. Behavioral interventions for UI - including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized controlled trials and are free of side effects. Exercise-based behavioral therapy for UI requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral strategy that incorporates the PFME to suppress urinary urgency and prevent UI.
We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month follow-up is planned in the treatment group.
We hypothesize that:
- PD participants who are randomized to the exercise-based behavioral therapy group (Group A) will report a significant reduction in weekly frequency of UI episodes compared to PD participants in the behavioral control group (Group B). The primary outcome, frequency of UI, will be measured using a seven-day bladder diary.
- Compared to PD participants in Group B, the reduction in UI frequency in Group A will be clinically meaningful as measured by a corresponding improvement on questionnaires of satisfaction and quality of life as well as a decline in other urinary symptoms including urgency and nocturia.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Nocturia||Behavioral: Exercise-based behavioral therapy Behavioral: Behavioral control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Experimental: Exercise-based behavioral therapy
Pelvic floor muscle exercise-based behavioral therapy
Behavioral: Exercise-based behavioral therapy
Pelvic floor muscle exercise training, bladder training, fluid management, constipation management
Placebo Comparator: Behavioral control
Mirrored Star Drawing
Behavioral: Behavioral control
Mirrored star drawing
- Bladder diary [ Time Frame: 1 week ]
- Quality of Life Questionnaire [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520948
|United States, Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Georgia|
|Atlanta VA Medical Center|
|Decatur, Georgia, United States, 30033|
|Principal Investigator:||E. Camille Vaughan, MD, MS||Atlanta VAMC/Emory University|