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Self Management in Urinary Catheter Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883220
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : September 18, 2012
Visiting Nurse Service of New York
Information provided by (Responsible Party):
Mary Wilde, University of Rochester

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Self-management of Urine Flow in Long-term Urinary Catheter Users
Study Start Date : June 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Symptomatic urinary tract infection [ Time Frame: every two months for 12 months ]

Secondary Outcome Measures :
  1. Urinary catheter quality of life [ Time Frame: 6 months and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883220

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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
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Principal Investigator: Mary H. Wilde, RN, PhD University of Rochester
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mary Wilde, Associate Professor, University of Rochester Identifier: NCT00883220    
Other Study ID Numbers: 1R01NR010553-01 ( U.S. NIH Grant/Contract )
1R01NR010553-01 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: July 2011
Keywords provided by Mary Wilde, University of Rochester:
self management
chronic condition
urinary catheter
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Retention
Urination Disorders
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases