NCT01520948

Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Atlanta VA Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Urinary Incontinence
• Nocturia

Interventions

Type	Name	Description
BEHAVIORAL	Exercise-based behavioral therapy	Pelvic floor muscle exercise training, bladder training, fluid management, constipation management
BEHAVIORAL	Behavioral control	Mirrored star drawing

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2012-01-30
• Last updated: 2018-01-10

Locations

2 sites across 1 country: United States