Prevent Inability To Control Urination

Urinary Incontinence Clinical Trial

Official title:

Promoting Self -Care to Prevent Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075114
• Other study ID #: 1R01NR007618-01
• Secondary ID: R01NR007618
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2004
• Last updated: January 14, 2015
• Start date: September 2000
• Est. completion date: April 2006

Study information

• Verified date: January 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: April 2006
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Behavioral:
• Bladder Health Class
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of incontinence episodes		Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline	No
Secondary	Pelvic floor muscle strength		Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline	No
Secondary	Length of voiding interval		Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline	No
Secondary	Self-efficacy		Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline	No