Status:
COMPLETED
Further Enhancing Non-pharmacologic Therapy for Incontinence
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Urge Urinary Incontinence
Eligibility:
FEMALE
60+ years
Phase:
NA
Brief Summary
To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle exercises and biofeedback for urge urinary incontinence, as well as the characteristics of patients most likely to...
Detailed Description
Urinary incontinence (UI) is prevalent and morbid in the elderly, and its associated costs exceed $26 billion annually. Although effective therapy exists, it is underutilized. This is particularly tru...
Eligibility Criteria
Inclusion
- ambulatory women over age 60, who are incontinent at least twice weekly for 3 months despite correction of potentially reversible causes.
- urinary incontinence (urge or predominantly urge) by clinical criteria.
- able to accurately complete a voiding diary, to perform a 24-hour pad test under direction, and to undergo instruction in biofeedback.
Exclusion
- significant mental impairment \[mini mental status exam (MMSE) ≤ 20)
- urethral obstruction
- history of bladder cancer
- spinal cord lesions
- multiple sclerosis
- pelvic radiation
- interstitial cystitis
- artificial sphincter implant
- expected to have changes in medications/doses during the trial
- medically unstable
- Patients with factors that could cause transient UI \[e.g., current urinary tract infection (UTI), acute confusion\] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
- conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)
- being unable to undergo fMRI because of claustrophobia or any metallic objects in the body, such pacemakers, metallic prostheses, aneurism clips or others.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00177541
Start Date
February 1 2004
End Date
September 1 2016
Last Update
August 8 2017
Active Locations (1)
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1
Geriatric Continence Research Unit, NE547 Montefiore UPMC
Pittsburgh, Pennsylvania, United States, 15213