Further Enhancing Non-pharmacologic Therapy for Incontinence
Completed · Not applicable
Conditions studied: Urge Urinary Incontinence
In brief
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 respond. By identifying the key components of this treatment, we hope to simplify it and make it more easily applicable, more effective, less expensive, and thus more useful for people with urge incontinence in the future.
Key facts
- Study ID
- NCT00177541
- Run by
- University of Pittsburgh
- People needed
- 123
- Starts
- 2004-02-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2017-08-08
Who can join
Age: 60 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Geriatric Continence Research Unit, NE547 Montefiore UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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