- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00866710
Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease (BETTUR PD)
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:
- 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.
- Determine the proportion of these patients who achieve a 50% or greater reduction in UI episodes.
- 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).
- 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30033
- Atlanta VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of Parkinson's disease
- ≥4 weekly episodes of UI with >50% of accidents associated with feelings of urgency where urgency is defined as the complaint of a sudden compelling desire to pass urine, which is difficult to defer
- Willingness to attend clinic visits
- Willingness to keep bladder diaries
Exclusion criteria:
- Cognitive impairment, as evidenced by a Folstein mini-mental status examination (MMSE) of < 24, or inability to produce an interpretable 7-day bladder diary
- Use of an indwelling urinary catheter
- Suggestion of bladder outlet obstruction as evidenced by having been prescribed in-and-out catheterization in the past 12 months, having a post-void residual by bladder ultrasound of ≥300 milliliters or a peak voiding flow rate of ≤ 4 mL/min on a void ≥ 125 mL in volume
- Severe uterine prolapse past the vaginal introitus
- Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of >8.0%
- Chronic renal failure and on hemodialysis
- Poorly controlled congestive heart failure or poorly controlled chronic obstructive pulmonary disease as evidenced on physical exam
- Genitourinary cancer with ongoing surgical or external beam radiation treatment
- Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bladder diary
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life Questionnaire
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth C Vaughan, MD, Birmingham/Atlanta VA Geriatric Research Education and Clinical Center & Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Elimination Disorders
- Urinary Incontinence
- Parkinson Disease
- Enuresis
Other Study ID Numbers
- 6-38941
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Ludwig-Maximilians - University of MunichUnknownIncontinence, Overactive Bladder, Stress Urinary IncontinenceGermany
-
San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
-
Copenhagen University Hospital at HerlevZealand University HospitalTerminatedStress Urinary Incontinence | Urge Urinary IncontinenceDenmark
-
ScitonCompletedUrinary Incontinence | Stress Urinary Incontinence | Urge IncontinenceUnited States
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
University of ZurichCompletedStress Urinary Incontinence | Urge Urinary Incontinence
Clinical Trials on Exercise-based behavioral therapy
-
Atlanta VA Medical CenterCompletedUrinary Incontinence | NocturiaUnited States
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)WithdrawnDepression | Diabetes Mellitus, Type 2
-
University of BahrainNot yet recruitingChronic Knee Pain
-
Emory UniversityAlzheimer's AssociationCompleted
-
Education University of Hong KongCompletedIntellectual Disability | Autism Spectrum DisorderHong Kong
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)CompletedSocial Anxiety DisorderUnited States
-
Colorado State UniversityUniversity of Colorado, Denver; National Institute of Diabetes and Digestive...RecruitingDepressive Disorder | Depression | Glucose Metabolism Disorders | Mood Disorders | Insulin Resistance | Hyperinsulinism | Metabolic Disease | Mental Disorder in AdolescenceUnited States
-
University of Turin, ItalyCompleted
-
Karolinska InstitutetCompletedObsessive-compulsive DisorderSweden
-
University GhentTerminatedHypermobile Ehlers-Danlos Syndrome | Hypermobility Syndrome | Multidirectional Subluxation of ShoulderBelgium