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

January 8, 2018 updated by: Camille Vaughan, MD, Atlanta VA Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Birmingham Vamc
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bladder diary
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Questionnaire
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlanta VA Medical Center

Investigators

  • Principal Investigator: E. Camille Vaughan, MD, MS, Atlanta VAMC/Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (ESTIMATE)

January 30, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7892W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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