Self Management in Urinary Catheter Users

Phase 2

Completed

• Conditions: Urinary Retention; Neurogenic Bladder
• Interventions: Behavioral: Self-management of urinary catheter

• Registration Number: NCT00883220
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-17
• Study Start: 2009-06
• Status Verified: 2011-07
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management of urinary catheter	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.

Primary Outcome Measures

Name	Time	Method
Symptomatic urinary tract infection	every two months for 12 months

Secondary Outcome Measures

Name	Time	Method
Urinary catheter quality of life	6 months and 12 months

Trial Locations

Locations (2)

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

Urinary of Rochester; 🇺🇸 Rochester, New York, United States