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

Phase 3

Completed

• Conditions: Bladder Control; Urinary Incontinence

• Registration Number: NCT00506766
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2000-09
• Study Completion: 2006-08
• Status Verified: 2007-07
• Study First Submitted: 2007-07-23
• Study First Submitted QC: 2007-07-23
• Last Update Submitted: 2007-07-23
• Study First Posted: 2007-07-25
• Last Update Posted: 2007-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.	Every 6 months for 4 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States