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Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up

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ClinicalTrials.gov Identifier: NCT00506766
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
Sponsor:
Information provided by:
University of Michigan

Brief Summary:
This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Bladder Control Behavioral: Bladder Health Class consisting of 6 weekly group sessions Behavioral: Practice PFMT and BT Behavioral: Clinic examination for pelvic muscle function Behavioral: Record keeping in 3-day voiding diary Phase 3

Detailed Description:
The study was designed to determine the capacity of self-efficacy to predict maintenance of the practices of PFMT and BT. Women in the treatment arm of the RCT attended a Bladder Health Class (PFMT & BT) to prevent UI. The class content emphasized self-efficacy. At 3-months post intervention the self-efficacy of participants was measured; these results were collected to analyze for predictive capacity of training adherence. For four years participants in both the treatment and control (no class) arms were followed with both questionnaires and 3-day bladder diaries (2/year) and clinic evaluations of (1/year). In addition, qualitative analyses of the narratives of Bladder Health Class participants identified individual attitudes and strategies that either facilitated or deterred adherence.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Study Start Date : September 2000
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Behavioral: Bladder Health Class consisting of 6 weekly group sessions
    1 time
    Behavioral: Practice PFMT and BT
    As needed for 4 years
    Behavioral: Clinic examination for pelvic muscle function
    1/year for 4 years
    Behavioral: Record keeping in 3-day voiding diary
    Every 6 months for 4 years


Primary Outcome Measures :
  1. Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. [ Time Frame: Every 6 months for 4 years ]

Secondary Outcome Measures :
  1. Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary [ Time Frame: Every 6 months for 4 years ]
  2. Digital measurement during clinical examination of pelvic muscle function (pressure and displacement). [ Time Frame: 1/year for four years ]
  3. Paper towel bladder test [ Time Frame: 1/year for four years ]
  4. Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives [ Time Frame: 1 time ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 55 years or older who report 5 or fewer episodes of UI / year, no prior treatment for UI, no neurological disease, no difficulties performing activities of daily living

Exclusion Criteria:

  • Less than 55 years old, UI episodes greater that 5 per year, score of less than 24 on Mini Mental Status Examination

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 ClinicalTrials.gov identifier (NCT number): NCT00506766


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Carolyn M Sampselle, PhD,RNC,FAAN University of Michigan School of Nursing
Study Director: Sandra H Hines, PhD, RNC University of Michigan School of Nursing

Publications:
Longworth, J, Davila, Y, Sampselle, CM. (2003) La perdida de orina: Hispanic women's experience of urinary incontinence. Hispanic Health Care International (The official Journal of the National Association of Hispanic Nurses), Vol. 2(1), 13-21.

ClinicalTrials.gov Identifier: NCT00506766     History of Changes
Other Study ID Numbers: 5R01NR007618-02 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007

Keywords provided by University of Michigan:
Urinary Incontinence
Self efficacy
Pelvic floor muscle training
Bladder training

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders