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Prevent Inability To Control Urination

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00075114
First received: January 2, 2004
Last updated: September 17, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
 Behavioral: Bladder Training
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promoting Self -Care to Prevent Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Mean number of incontinence episodes [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pelvic floor muscle strength [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]
  • Length of voiding interval [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: September 2000
Study Completion Date: April 2006
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Bladder Training
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Women between 55-80

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075114

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Carolyn M Sampselle, PhD, APH University of Michigan, School of Nursing, MICHIN Center
  More Information

No publications provided

Responsible Party: Carolyn M. Sampselle, PhD, APN, University of Michigan School of Nursing
ClinicalTrials.gov Identifier: NCT00075114     History of Changes
Other Study ID Numbers: 1-R01-NR007618-01
Study First Received: January 2, 2004
Last Updated: September 17, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):
Self Care
Behavior Modification

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013