Clinical trial NCT00883220: Self Management in Urinary Catheter Users
Official title: Self-management of Urine Flow in Long-term Urinary Catheter Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Retention
Neurogenic Bladder
Keywords: self management
chronic condition
urinary catheter
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Visiting Nurse Service of New York
First posted: 2009-04-17
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Symptomatic urinary tract infection
timeFrame: every two months for 12 months
Secondary outcomes:
measure: Urinary catheter quality of life
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: New York City
country: United States
facility: Center for Home Care Policy & Research, Visiting Nurse Service of New York
state: New York
city: Rochester
country: United States
facility: Urinary of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Mary H. Wilde, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilde MH, Crean HF, McMahon JM, McDonald MV, Tang W, Brasch J, Fairbanks E, Shah S, Zhang F. Testing a Model of Self-Management of Fluid Intake in Community-Residing Long-term Indwelling Urinary Catheter Users. Nurs Res. 2016 Mar-Apr;65(2):97-106. doi: 10.1097/NNR.0000000000000140.
citation: Wilde MH, McMahon JM, McDonald MV, Tang W, Wang W, Brasch J, Fairbanks E, Shah S, Zhang F, Chen DG. Self-management intervention for long-term indwelling urinary catheter users: randomized clinical trial. Nurs Res. 2015 Jan-Feb;64(1):24-34. doi: 10.1097/NNR.0000000000000071.