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

This study is currently recruiting participants.
Verified January 2017 by Camille Vaughan, MD, Atlanta VA Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520948
First Posted: January 30, 2012
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Camille Vaughan, MD, Atlanta VA Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Camille Vaughan, MD, Atlanta VA Medical Center:

Primary Outcome Measures:
  • Bladder diary [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Quality of Life Questionnaire [ Time Frame: 4 weeks ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: March 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520948


Contacts
Contact: E Camille Vaughan, MD, MS 4043216111 ext 3710 camille.vaughan@emory.edu

Locations
United States, Alabama
Birmingham VAMC Recruiting
Birmingham, Alabama, United States, 35233
Contact: Galen Hale    205-933-8101 ext 5637    galenhale@uabmc.edu   
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: E Camille Vaughan, MD, MS    4043216111 ext 3710    camille.vaughan@emory.edu   
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

Responsible Party: Camille Vaughan, MD, Staff Physician, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT01520948     History of Changes
Other Study ID Numbers: D7892W
First Submitted: January 26, 2012
First Posted: January 30, 2012
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Camille Vaughan, MD, Atlanta VA Medical Center:
Parkinson disease
Incontinence

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