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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00506766
Enrollment
360
Registered
2007-07-25
Start date
2000-09-30
Completion date
2006-08-31
Last updated
2007-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Control, Urinary Incontinence

Keywords

Urinary Incontinence, Self efficacy, Pelvic floor muscle training, Bladder training

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.

Interventions

BEHAVIORALBladder Health Class consisting of 6 weekly group sessions

1 time

BEHAVIORALPractice PFMT and BT

As needed for 4 years

BEHAVIORALClinic examination for pelvic muscle function

1/year for 4 years

BEHAVIORALRecord keeping in 3-day voiding diary

Every 6 months for 4 years

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diaryEvery 6 months for 4 years
Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).1/year for four years
Paper towel bladder test1/year for four years
Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives1 time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026