Self Management in Urinary Catheter Users

September 17, 2012 updated by: Mary Wilde, University of Rochester

Self-management of Urine Flow in Long-term Urinary Catheter Users

Learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urinary catheter users commonly experience adverse health effects, such as urinary tract infection (UTI), blockage, dislodgement, and leakage, leading to poor quality of life indicators. Catheter-related problems often require health care utilization resulting in increased health care costs. Self-management of urine flow is an essential part of self-care for people with long-term urinary catheters and may lead to prevention or reduction of catheter-related problems and improved quality of life.This study tests the effectiveness of a urinary catheter self-management intervention in a randomized trial of 220 patients, with 12 months of follow-up. The experimental intervention is designed to enhance self-management of urine flow in individuals with long-term urinary catheters, with the goal of decreasing catheter related complications and enhancing quality of life.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2

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
    • New York
      • New York City, New York, United States, 10001
        • Center for Home Care Policy & Research, Visiting Nurse Service of New York
      • Rochester, New York, United States, 14642
        • Urinary of Rochester

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year.
  • Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City.
  • Able to complete study measurements alone or with the help of a family member or caregiver.
  • Able to communicate with the study personnel in English.
  • Have access to a telephone for data collection.

Exclusion Criteria:

  • Terminally ill
  • Cognitively impaired
  • No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-management of urinary catheter
Intervention: Self-management group--teaching behavioral approaches(awareness, self-monitoring, and self-management) to prevent or minimize urinary catheter complications.
Behavioral: Self-management of urinary catheter
Awareness, self-monitoring, and self-management of urine flow are taught. Focus is on attaining adequate and consistent levels of fluid intake and preventing catheter dislodgement.
Other Names:
  • self-management
  • self-monitoring
  • urinary catheter self care
No Intervention: Usual care 2
Usual care for urinary catheter. Home care and/or clinic care is the usual care for people with long-term urinary catheters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptomatic urinary tract infection
Time Frame: every two months for 12 months
every two months for 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary catheter quality of life
Time Frame: 6 months and 12 months
6 months and 12 months

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

Visiting Nurse Service of New York

Investigators

  • Principal Investigator: Mary H. Wilde, RN, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01NR010553-01 (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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