Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease (BETTUR PD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Atlanta VA Medical Center
Sponsor:
Information provided by (Responsible Party):
Camille Vaughan, MD, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT01520948
First received: January 26, 2012
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI), urgency, and/or nocturia, are common non-motor symptoms that further diminish the already compromised quality of life for adults living with PD. Behavioral interventions for UI - including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized controlled trials and are free of side effects. Exercise-based behavioral therapy for UI requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral strategy that incorporates the PFME to suppress urinary urgency and prevent UI.

We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month follow-up is planned in the treatment group.

We hypothesize that:

  1. PD participants who are randomized to the exercise-based behavioral therapy group (Group A) will report a significant reduction in weekly frequency of UI episodes compared to PD participants in the behavioral control group (Group B). The primary outcome, frequency of UI, will be measured using a seven-day bladder diary.
  2. Compared to PD participants in Group B, the reduction in UI frequency in Group A will be clinically meaningful as measured by a corresponding improvement on questionnaires of satisfaction and quality of life as well as a decline in other urinary symptoms including urgency and nocturia.

Condition Intervention Phase
Urinary Incontinence
Nocturia
Behavioral: Exercise-based behavioral therapy
Behavioral: Behavioral control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease

Resource links provided by NLM:


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: 60
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise-based behavioral therapy
Pelvic floor muscle exercise-based behavioral therapy
Behavioral: Exercise-based behavioral therapy
Pelvic floor muscle exercise training, bladder training, fluid management, constipation management
Placebo Comparator: Behavioral control
Mirrored Star Drawing
Behavioral: Behavioral control
Mirrored star drawing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders
  • ≥ 4 weekly episodes of UI and at least one episode per week associated with feelings of urgency, where urgency is defined as the complaint of a sudden compelling desire to void which is difficult to defer
  • Willingness to attend clinic visits
  • Willingness to keep 7-day bladder diaries throughout the study period

Exclusion Criteria:

  • Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of < 18.
  • Inability to produce an interpretable 7-day bladder diary at baseline
  • Previous intensive PFME training
  • Clinically significant depression as measured by a Geriatric Depression Scale-Short Form score ≥ 10 which could affect motivation to fully engage in the intervention
  • Use of an indwelling urinary catheter
  • Bladder outlet obstruction defined as having been prescribed in-and-out catheterization in the past 12 months, having a post-void residual urine volume by bladder ultrasound of ≥ 200 mL 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520948

Contacts
Contact: Sean Halpin, MA 4043216111 ext 5141 sean.halpin@va.gov

Locations
United States, Alabama
Birmingham VAMC Recruiting
Birmingham, Alabama, United States, 35233
Contact: Susan Barnacastle    205-933-8101 ext 7305    susan.barnacastle@va.gov   
Principal Investigator: Kathryn L. Burgio, PhD         
Sub-Investigator: Patricia S. Goode, MSN, MD         
United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Sean Halpin, MA    4043216111 ext 5141    sean.halpin@va.gov   
Principal Investigator: E. Camille Vaughan, MD, MS         
Sub-Investigator: Theodore M. Johnson, MD, MPH         
Sponsors and Collaborators
Atlanta VA Medical Center
Investigators
Principal Investigator: E. Camille Vaughan, MD, MS Atlanta VAMC/Emory University
  More Information

No publications provided

Responsible Party: Camille Vaughan, MD, Staff Physician, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT01520948     History of Changes
Other Study ID Numbers: D7892W
Study First Received: January 26, 2012
Last Updated: April 1, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Atlanta VA Medical Center:
Parkinson disease
Incontinence

Additional relevant MeSH terms:
Nocturia
Parkinson Disease
Urinary Incontinence
Urological Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014