Further Enhancing Non-pharmacologic Therapy for Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Werner Schaefer, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177541
First received: September 13, 2005
Last updated: February 9, 2012
Last verified: February 2012

September 13, 2005
February 9, 2012
February 2004
September 2013   (final data collection date for primary outcome measure)
Percentage reduction in urge incontinence episodes at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage reduction in incontinence episodes at 12 weeks
Complete list of historical versions of study NCT00177541 on ClinicalTrials.gov Archive Site
  • Various urodynamic parameters such as, e.g.: [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Increase in functional bladder capacity at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Volume at first detrusor overactivity at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in QoL at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Various urodynamic parameters such as, e.g.:
  • Increase in functional bladder capacity at 12 weeks
  • Volume at first detrusor overactivity at 12 weeks
  • Improvement in QoL at 12 weeks
Not Provided
Not Provided
 
Further Enhancing Non-pharmacologic Therapy for Incontinence
Further Enhancing Non-pharmacologic Therapy for Incontinence

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urge Urinary Incontinence
Behavioral: Biofeedback, pelvic floor muscle training, fMRI
Biofeedback, pelvic floor muscle training, fMRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Female
60 Years and older
No
Contact: Mary Jo Sychak (412) 647-1272 mjs138@pitt.edu
Contact: Werner Schaefer, DI (412) 647-1274 wes11@pitt.edu
United States
 
NCT00177541
5 R01 AG020629-02, 5 R01 AG020629-02
Yes
Werner Schaefer, University of Pittsburgh
University of Pittsburgh
National Institutes of Health (NIH)
Principal Investigator: Neil M Resnick, MD University of Pittsburgh
Study Director: Werner Schaefer, DI University of Pittsburgh
University of Pittsburgh
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP