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Prevent Inability To Control Urination

Promoting Self -Care to Prevent Urinary Incontinence

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00075114
Enrollment
417
Registered
2004-01-05
Start date
2000-09-30
Completion date
2006-04-30
Last updated
2015-01-15

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

Conditions

Urinary Incontinence

Keywords

Self Care, Behavior Modification

Brief summary

The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.

Detailed description

This is a study that will monitor and compare attitudes and strategies that women use to maintain behavior changes that prevent urination problems. Women will complete questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and 4 years post intervention.

Interventions

A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Inclusion and

Exclusion criteria

1. Female 55 through 80 years old 2. Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy. 3. Continent of urine (using the MESA definition of continence) defined as: 1. No previous incontinence episode except during pregnancy and/or postpartum period. 2. Urine loss less than 6 days during the last 365 days 3. No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy. 4. No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma. 5. No reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating. Additional criteria are applied at a physical examination: 1. Mini Mental Status of at least 24 2. Negative for objective urine loss during coughing.

Design outcomes

Primary

MeasureTime frame
Mean number of incontinence episodesBaseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Secondary

MeasureTime frame
Pelvic floor muscle strengthBaseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Length of voiding intervalBaseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Self-efficacyBaseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Countries

United States

Outcome results

None listed

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