Status:
COMPLETED
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
Lead Sponsor:
Atlanta VA Medical Center
Conditions:
Urinary Incontinence
Nocturia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Low...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01520948
Start Date
September 1 2012
End Date
August 1 2017
Last Update
January 10 2018
Active Locations (2)
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1
Birmingham VAMC
Birmingham, Alabama, United States, 35233
2
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033