Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease

NCT00866710 | Completed

• 1 other identifier: 6-38941
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Determine the proportion of these patients who achieve a 50% or greater reduction in UI episodes.
3. 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. 4.Assess the effectiveness of behavioral therapy without the use of computer-assisted biofeedback instruction in 10 additional subjects with PD and UI.

Conditions

Urinary Incontinence; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Bladder diary

  1 week

Secondary Outcomes (1)

• Quality of Life Questionnaire

  4 weeks

Interventions

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlanta VA Medical Center: lead
• The John A. Hartford Foundation: collaborator

Study Sites (1)

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth C Vaughan, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Staff Physician

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

US (1)