Urinary RetentionPhase 2NCT00883220
Self Management in Urinary Catheter Users
A Phase 2 study testing Self-management of urinary catheter in people with Urinary Retention and Neurogenic Bladder, run by University of Rochester at 2 sites in United States.
Trial summary
Learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention, Neurogenic Bladder
- What is being tested?
- Self-management of urinary catheter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Home Care Policy & Research, Visiting Nurse Service of New York
New York, New York, 10001
Urinary of Rochester
Rochester, New York, 14642
About this study
Official title: Self-management of Urine Flow in Long-term Urinary Catheter Users
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.
- Conditions
- Urinary Retention, Neurogenic Bladder
- Being tested
- Self-management of urinary catheter
- Keywords
- self management, chronic condition, urinary catheter
- Medical subject headings
- Urinary Retention, Urinary Bladder, Neurogenic, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management of urinary catheterBehavioural
Also called self-management, self-monitoring, urinary catheter self care
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-management of urinary catheter | Experimental | Intervention: Self-management group--teaching behavioral approaches(awareness, self-monitoring, and self-management) to prevent or minimize urinary catheter complications. Receives: Behavioral: Self-management of urinary catheter |
| Usual care 2 | No intervention | Usual care for urinary catheter. Home care and/or clinic care is the usual care for people with long-term urinary catheters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic urinary tract infection
Measured: every two months for 12 months
Secondary outcomes (1)
Urinary catheter quality of life
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Visiting Nurse Service of New York
- Responsible party
- Principal investigator, Mary Wilde, University of Rochester
- Investigators
- Mary H. Wilde, RN, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883220
- Sponsor's protocol ID
- 1R01NR010553-01
- Other IDs
- 1R01NR010553-01
- Status last verified
- Jul 2011
- First submitted
- 15 Apr 2009
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 26938358Wilde 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management of Urine Flow in Long-term Urinary Catheter Users
- ClinicalTrials.gov ID
- NCT00883220
- Acronym / sponsor ID
- 1R01NR010553-01
- Conditions
- Urinary Retention, Neurogenic Bladder
- Keywords
- self management, chronic condition, urinary catheter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Visiting Nurse Service of New York
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management of urinary catheter | Experimental | Behavioral: Self-management of urinary catheterIntervention: Self-management group--teaching behavioral approaches(awareness, self-monitoring, and self-management) to prevent or minimize urinary catheter complications. |
| Usual care 2 | No intervention | –Usual care for urinary catheter. Home care and/or clinic care is the usual care for people with long-term urinary catheters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management of urinary catheterAlso: self-management, self-monitoring, urinary catheter self careAwareness, 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. | Behavioural | Self-management of urinary catheter |
Primary outcome
Symptomatic urinary tract infection
Time frame: every two months for 12 months
1 secondary outcome
Urinary catheter quality of life
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Derived from this study: PubMed 26938358Wilde 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.
- Derived from this study: PubMed 25502058Wilde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary H. Wilde, RN, PhD principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-management of urinary catheter in people with Urinary Retention and Neurogenic Bladder, run by University of Rochester at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic urinary tract infection (time frame: every two months for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883220, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.