Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease - Full Text View

Sponsors and Collaborators:	The John A. Hartford Foundation Atlanta VA Medical Center
Information provided by:	Atlanta VA Medical Center
ClinicalTrials.gov Identifier:	NCT00866710

Purpose

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 with computer assisted biofeedback and 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 in 20 patients 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).

Methods: Participants will be enrolled in an 8-week treatment trial of behavioral therapies and pelvic floor muscle exercises with 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.

Condition	Intervention
Urinary Incontinence Parkinson's Disease	Other: Exercise-based behavioral therapy

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Exercise and Physical Fitness Parkinson's Disease Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease

Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:

Bladder diary [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Participants will be taught pelvic floor muscle exercises as well as urge suppression strategies to overcome the urge to void. 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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866710

Contacts

Contact: Zobair Nagamia, MD

404 321 6111 ext 5308

zobair.nagamia@va.gov

Locations

United States, Georgia
Atlanta VA Medical Center	Recruiting
Atlanta, Georgia, United States, 30033

Sponsors and Collaborators

The John A. Hartford Foundation

Atlanta VA Medical Center

Investigators

Principal Investigator:

Elizabeth C Vaughan, MD

Birmingham/Atlanta VA Geriatric Research Education and Clinical Center & Emory University

More Information

No publications provided

Responsible Party:	Birmingham/Atlanta VA GRECC & Emory University ( Elizabeth Camille Vaughan, MD )
Study ID Numbers:	6-38941
Study First Received:	March 19, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00866710 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Study placed in the following topic categories:

Signs and Symptoms
Ganglion Cysts
Urologic Diseases
Movement Disorders
Urination Disorders
Parkinson Disease

Basal Ganglia Diseases
Central Nervous System Diseases
Urinary Incontinence
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Urination Disorders
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Urological Manifestations

Signs and Symptoms
Urologic Diseases
Parkinson Disease
Movement Disorders
Urinary Incontinence
Parkinsonian Disorders

ClinicalTrials.gov processed this record on May 07, 2009