• PDtrials - Parkinson's Disease Clinical Trials
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Official Study Title: Behavioral Therapy  TherapyAnother word for “treatment”. to Treat Urinary Incontinence in Parkinson's Disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (BETTUR PD)
Sponsor: The John A. Hartford Foundation; Atlanta VA Medical Center
Clinicaltrials.gov ID: NCT00866710
Study ID: 6-38941

Summary

Parkinson's disease (PD) affects up to three percent 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 percent of persons with PD. 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  Side Effects Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include such symptoms as headache, nausea and upset stomach. In some cases, side-effects may cause more severe medical problems. and have been shown to be an effective treatment for urge symptoms of overactive bladder in the aged population.

Behavioral therapy with computer assisted biofeedback and pelvic floor muscle exercises will result in a 50 percent decrease in the number of incontinence episodes in elderly persons (people over 50) with PD. The specific aims for this pilot study include the following:

• Complete a course of behavioral therapy in 20 participants with urinary incontinence (UI) associated with PD, and determine how many potential participants need to be screened and enrolled to achieve this sample size.
• Determine the proportion of these participants who achieve a 50% or greater reduction in UI episodes.
• Examine whether responsiveness is associated with characteristics of the PD, in particular disease severity as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).

Participants will be enrolled in an eight-week treatment trial of behavioral therapies. Participants will also 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. Voiding diaries as well as urinary symptom and quality of life questionnaires will be used to assess response.

If people with PD 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 PD would also provide important information about the utility of this treatment strategy.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Urinary

Time Commitment

• Less than six months
• The visits typically occur every 2 weeks. There is only 1 week between visits 1 and 2 and then visits occur every 2 weeks thereafter.

Eligibility

• Gender(s) Accepted: Either

Inclusion Criteria

• Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. diagnosis of PD
• More than 4 weekly episodes of UI with more than 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  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment, 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
• Severe uterine prolapse (defined by a falling down from its normal place)
• Poorly controlled diabetes
• 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 as determined by principal investigator

Enrollment

Expected Enrollment: 20 (US)
Date Enrollment Began: Oct 2008
Date Enrollment Ends: Sep 2009
Last Updated Date: Jul 23 2009
Trial Post Date: Jul 23 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00866710?term=NCT00866710&rank=1

Primary Contacts and Locations

Georgia

• Zobair Nagamia, MD
  Atlanta VA Medical Center
  zobair.nagamia@va.gov
  Phone: (404) 321-6111 ext. 5308
  Atlanta, GA 30033
  USA