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CompletedNCT00883220Updated Sep 18, 2012

Self Management in Urinary Catheter Users

A Phase 2 interventional study of Self-management of urinary catheter in Urinary Retention and Neurogenic Bladder, sponsored by University of Rochester. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-18.

Sponsored by University of Rochester · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Urinary Retention
  • Neurogenic Bladder

Keywords

  • self management
  • chronic condition
  • urinary catheter
03

In context

Urinary Bladder, Neurogenic

185 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.

This study's enrollment of 202 is above the median of 36 across 124 interventional studies indexed under Urinary Bladder, Neurogenic.

Browse Urinary Bladder, Neurogenic studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
202 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Self-management of urinary catheter

  • No intervention
    Usual care 2

    Usual care for urinary catheter. Home care and/or clinic care is the usual care for people with long-term urinary catheters.

Interventions

  • BehavioralSelf-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.

    Also known as: self-management, self-monitoring, urinary catheter self care

06

What researchers measure

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

07

Study locations

2 sites
  • Center for Home Care Policy & Research, Visiting Nurse Service of New York
    New York City, New York 10001, United States
  • Urinary of Rochester
    Rochester, New York 14642, United States
08

References and documents

Publications

  • 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. PubMed 26938358 ↗
  • 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. PubMed 25502058 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00883220
Lead sponsor
University of Rochester
Collaborators
Visiting Nurse Service of New York
Responsible party
Mary Wilde (Associate Professor, University of Rochester) — Principal investigator
First posted
Apr 17, 2009
Start date
Jun 2009
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Sep 18, 2012

Study contacts

Mary H. Wilde, RN, PhD
principal investigator · University of Rochester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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