Prevent Inability To Control Urination - Tabular View

Tracking Information

First Received Date ^ICMJE

January 2, 2004

Last Updated Date

September 17, 2008

Start Date ^ICMJE

September 2000

Primary Completion Date

February 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00075114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Prevent Inability To Control Urination

Official Title ^ICMJE

Promoting Self -Care to Prevent Urinary Incontinence

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Urinary Incontinence

Intervention ^ICMJE

Behavioral: Bladder Training

Study Arms / Comparison Groups

No Intervention: Control

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

417

Completion Date

April 2006

Primary Completion Date

February 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Women between 55-80

Gender

Female

Ages

55 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00075114

Responsible Party

Carolyn M. Sampselle, PhD, APN, University of Michigan School of Nursing

Study ID Numbers ^ICMJE

1-R01-NR007618-01

Study Sponsor ^ICMJE

National Institute of Nursing Research (NINR)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Carolyn M Sampselle, PhD, APH

University of Michigan, School of Nursing, MICHIN Center

Information Provided By

National Institute of Nursing Research (NINR)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP