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Clinical Trials/NCT00506766
NCT00506766
Completed
Phase 3

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

University of Michigan1 site in 1 country360 target enrollmentSeptember 2000

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
University of Michigan
Enrollment
360
Locations
1
Primary Endpoint
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.
Status
Completed
Last Updated
18 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2000
End Date
August 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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

Study Sites (1)

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