Self Management in Urinary Catheter Users - Full Text View

Sponsors and Collaborators:	University of Rochester Visiting Nurse Service of New York
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00883220

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 II

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Self-Management of Urine Flow in Long-Term Urinary Catheter Users

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 ]

Estimated Enrollment:	220
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Self-management group	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.
2: No Intervention Usual care for urinary catheter

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.
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

Contacts

Contact: Mary H. Wilde, RN, PhD	585-275-9682	mary_wilde@urmc.rochester.edu
Contact: Eileen Fairbanks, RN, MS, PNP	585-275-6639	eileen_fairbanks@urmc.rochester.edu

Locations

United States, New York
Urinary of Rochester
Rochester, New York, United States, 14642
Visiting Nurse Service of New York
New York City, New York, United States, 10001

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:	University of Rochester ( Mary H. Wilde, Principal Investigator )
Study ID Numbers:	1 R01 NR010553-01, 1 R01 NR010553-01
Study First Received:	April 15, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00883220 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

self management
chronic condition
urinary catheter

Study placed in the following topic categories:

Urinary Bladder, Neurogenic
Signs and Symptoms
Cystocele
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Neurologic Manifestations
Urinary Retention

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic
Signs and Symptoms
Urologic Diseases
Urination Disorders

Urinary Bladder Diseases
Nervous System Diseases
Neurologic Manifestations
Urinary Retention

ClinicalTrials.gov processed this record on May 06, 2009