Skip to main content
Clinical Trials/NCT00883220
NCT00883220
Completed
Phase 2

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

University of Rochester2 sites in 1 country202 target enrollmentJune 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Urinary Retention
Sponsor
University of Rochester
Enrollment
202
Locations
2
Primary Endpoint
Symptomatic urinary tract infection
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
June 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Wilde

Associate Professor

University of Rochester

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Symptomatic urinary tract infection

Time Frame: every two months for 12 months

Secondary Outcomes

  • Urinary catheter quality of life(6 months and 12 months)

Study Sites (2)

Loading locations...

Similar Trials