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Completed

NCT Number: NCT00883220

Self Management in 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.

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Key information

Conditions

Urinary Retention Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Home Care Policy & Research, Visiting Nurse Service of New York, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Self-management of urinary catheter

Behavioral

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

Primary outcomes

  1. Symptomatic urinary tract infection

    Time frame: every two months for 12 months

Secondary outcomes

  1. Urinary catheter quality of life

    Time frame: 6 months and 12 months

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Visiting Nurse Service of New York

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 17, 2009
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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