Further Enhancing Non-pharmacologic Therapy for Incontinence

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2004

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage reduction in urge incontinence episodes at 12 weeks [12 weeks]

Secondary Outcome Measures

Various urodynamic parameters such as, e.g.: [12 weeks]
Increase in functional bladder capacity at 12 weeks [12 weeks]
Volume at first detrusor overactivity at 12 weeks [12 weeks]
Improvement in QoL at 12 weeks [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.