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NCT Number: NCT00866710

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 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.

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.

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Key information

Conditions

Urinary Incontinence Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise-based behavioral therapy

Other

Participants will be taught pelvic floor muscle exercises as well as urge suppression strategies to overcome the urge to void. In the first 20 participants, 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

Primary outcomes

  1. Bladder diary

    Time frame: 1 week

Secondary outcomes

  1. Quality of Life Questionnaire

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Atlanta VA Medical Center

Fed

Collaborators

  • The John A. Hartford Foundation

Registry information

Acronym: BETTUR PD

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 20, 2009
Registry last updated
Jan 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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