Prevent Inability To Control Urination

January 14, 2015 updated by: Carolyn Sampselle, University of Michigan

Promoting Self -Care to Prevent Urinary Incontinence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1 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.
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.
No Intervention: 2 Control Group
Participants randomized to this arm did not receive any interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean number of incontinence episodes
Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Pelvic floor muscle strength
Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Length of voiding interval
Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Self-efficacy
Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Carolyn M Sampselle, PhD, APH, University of Michigan, School of Nursing, MICHIN Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

February 1, 2002

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

January 2, 2004

First Submitted That Met QC Criteria

January 2, 2004

First Posted (Estimate)

January 5, 2004

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01NR007618-01 (U.S. NIH Grant/Contract)
  • R01NR007618 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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