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
  Purpose

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 Intervention
Urge Urinary Incontinence
Behavioral: Biofeedback, pelvic floor muscle training, fMRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Further Enhancing Non-pharmacologic Therapy for Incontinence

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Percentage reduction in urge incontinence episodes at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: February 2004
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Biofeedback, pelvic floor muscle training, fMRI
    Biofeedback, pelvic floor muscle training, fMRI
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177541

Contacts
Contact: Mary Jo Sychak (412) 647-1272 mjs138@pitt.edu
Contact: Werner Schaefer, DI (412) 647-1274 wes11@pitt.edu

Locations
United States, Pennsylvania
Geriatric Continence Research Unit, NE547 Montefiore UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Soni Elliott, RN,MPH    412-647-1270    sle27@pitt.edu   
Contact: Mary Jo Sychak    (412) 647-1272    mjs138@pitt.edu   
Principal Investigator: Neil M Resnick, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Neil M Resnick, MD University of Pittsburgh
Study Director: Werner Schaefer, DI University of Pittsburgh
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Werner Schaefer, Co Investigator and Director of Lab, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177541     History of Changes
Other Study ID Numbers: 5 R01 AG020629-02, 5 R01 AG020629-02
Study First Received: September 13, 2005
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
urge incontinence
biofeedback
pelvic floor muscle training
behavior modification

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014