Self Management in Urinary Catheter Users

This study has been completed.
Sponsor:
Collaborator:
Visiting Nurse Service of New York
Information provided by (Responsible Party):
Mary Wilde, University of Rochester
ClinicalTrials.gov Identifier:
NCT00883220
First received: April 15, 2009
Last updated: September 17, 2012
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Urinary Retention
Neurogenic Bladder
Behavioral: Self-management of urinary catheter
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Self-management of Urine Flow in Long-term Urinary Catheter Users

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Symptomatic urinary tract infection [ Time Frame: every two months for 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Urinary catheter quality of life [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: June 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883220

Locations
United States, New York
Center for Home Care Policy & Research, Visiting Nurse Service of New York
New York City, New York, United States, 10001
Urinary of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Visiting Nurse Service of New York
Investigators
Principal Investigator: Mary H. Wilde, RN, PhD University of Rochester
  More Information

No publications provided

Responsible Party: Mary Wilde, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00883220     History of Changes
Other Study ID Numbers: 1 R01 NR010553-01, 1 R01 NR010553-01
Study First Received: April 15, 2009
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
self management
chronic condition
urinary catheter

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Retention
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Urination Disorders

ClinicalTrials.gov processed this record on April 22, 2014