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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

July 23, 2007
July 25, 2007
July 25, 2007
September 2000
Not Provided
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. [ Time Frame: Every 6 months for 4 years ]
Same as current
No Changes Posted
  • 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 ]
  • Digital measurement during clinical examination of pelvic muscle function (pressure and displacement). [ Time Frame: 1/year for four years ]
  • Paper towel bladder test [ Time Frame: 1/year for four years ]
  • Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives [ Time Frame: 1 time ]
Same as current
Not Provided
Not Provided
 
Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
  • Urinary Incontinence
  • Bladder Control
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
Same as current
August 2006
Not Provided

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
Sexes Eligible for Study: Female
55 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00506766
5R01NR007618-02( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Not Provided
University of Michigan
Not Provided
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
University of Michigan
July 2007

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