Self Management in Urinary Catheter Users

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883220
• Other study ID #: 1R01NR010553-01
• Secondary ID: 1R01NR010553-01
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2009
• Last updated: September 17, 2012
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2011
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urinary Retention

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Visiting Nurse Service of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic urinary tract infection		every two months for 12 months	Yes
Secondary	Urinary catheter quality of life		6 months and 12 months	No