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Further Enhancing Non-pharmacologic Therapy for Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177541
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 8, 2017
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Neil Resnick, University of Pittsburgh

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 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.

Condition or disease Intervention/treatment Phase
Urge Urinary Incontinence Behavioral: Biofeedback, pelvic floor muscle training, fMRI Not Applicable

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 true for non-pharmacologic therapies, which are at least as effective as drugs but safer, and recommended as the initial approach by every national panel. If therapies such as biofeedback (which targets pelvic muscles and detrusor suppression) are to become more widely used, they will require simplification, fewer and briefer sessions, less expensive equipment, and less sophisticated therapists. Unfortunately, such protocols cannot yet be devised because it is unknown which components are essential. We postulate that the mechanisms mediating effectiveness can be identified and that such knowledge will make it possible to enhance efficacy and to formulate more feasible and cost-effective protocols. Since reduction in UI correlates weakly with improved quality of life, however, it is important that biofeedback's impact on life quality be assessed concomitantly to ensure that formulation of such streamlined methods does not eliminate components essential for improved quality of life, even if they have no physiological correlates. We will address these issues by treating at least 150 elderly subjects with urge UI in an 8-week course of biofeedback. We will collect clinical and quality of life data and perform extensive physiologic testing on each subject at baseline and 8 weeks later. Improvement will be correlated with change in physiologic and quality of life parameters to identify the parameters that likely mediated it. Knowledge from this study should identify predictors and mechanisms mediating success of biofeedback; suggest ways that it could be further improved; facilitate development of less expensive, quicker, and more feasible protocols to deliver it (potentially permitting application to less motivated or cognitively impaired patients); and shed insight into mechanisms that may even improve efficacy of other interventions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Further Enhancing Non-pharmacologic Therapy for Incontinence
Study Start Date : February 2004
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Biofeedback
Biofeedback assisted pelvic floor muscle therapy (3 visits)
Behavioral: Biofeedback, pelvic floor muscle training, fMRI
Biofeedback, pelvic floor muscle training, fMRI

Primary Outcome Measures :
  1. Percentage reduction in urge incontinence episodes at 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Various urodynamic parameters such as, e.g.: [ Time Frame: 12 weeks ]
  2. Increase in functional bladder capacity at 12 weeks [ Time Frame: 12 weeks ]
  3. Volume at first detrusor overactivity at 12 weeks [ Time Frame: 12 weeks ]
  4. Improvement in QoL at 12 weeks [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177541

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United States, Pennsylvania
Geriatric Continence Research Unit, NE547 Montefiore UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Institute on Aging (NIA)
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Principal Investigator: Neil M Resnick, MD University of Pittsburgh
Study Director: Becky Clarkson, PhD University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Neil Resnick, Professor, University of Pittsburgh Identifier: NCT00177541    
Other Study ID Numbers: 5R01AG020629-02 ( U.S. NIH Grant/Contract )
5R01AG020629-02 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Keywords provided by Neil Resnick, University of Pittsburgh:
urge incontinence
pelvic floor muscle training
behavior modification
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms