BacteriuriaPhase 1NCT02052674
Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
A Phase 1 study testing Vented urinary drainage system and Non-vented urinary drainage system in people with Bacteriuria, run by University of Florida.
Trial summary
The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bacteriuria
- What is being tested?
- Vented urinary drainage system and Non-vented urinary drainage system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2015
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for a planned surgery
- Anticipated indwelling bladder catheter placement for greater than 24 hours
- Anticipated post-op admission to a surgical ICU
Who cannot join
- Unstable renal function as self-reported
- Anticipated bandaged postoperative suprapubic incisions
- Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
- Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature
About this study
The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.
If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.
Read the detailed description
During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.
- Conditions
- Bacteriuria
- Being tested
- Vented urinary drainage system, Non-vented urinary drainage system
- Keywords
- Precursor to CAUTI
- Medical subject headings
- Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vented urinary drainage systemDevice
Also called Covidien vented foley catheter, TopVent, Covidien Dover Precision Premium Drainage bag
This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Non-vented urinary drainage systemDevice
Also called Bard urine drainage system, Conventional catheter, Bard Silver-Coated
This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
| Study group | Role | What they receive |
|---|---|---|
| Vented urinary drainage system | Experimental | This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria. Receives: Device: Vented urinary drainage system |
| Non-vented urinary drainage system | Active comparator | This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria. Receives: Device: Non-vented urinary drainage system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriuria
Evidence of bacteriuria, a potential precursor to Catheter Associated Urinary Tract Infection (CAUTI), will be used to study the potential effect of the vented urinary drainage system intervention on CAUTI.
Measured: 7 days
Secondary outcomes (2)
Retained Urine
One potential source for the risk of developing a Urinary Tract Infection (UTI) is related to residual urine volume in the bladder
Measured: 7 days
Presence of biofilms in catheter materials
A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Unable to enroll any patients in the study due to other on-going studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteriuriaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William B. Smith, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052674
- Sponsor's protocol ID
- 201300634
- Status last verified
- Jul 2019
- First submitted
- 30 Jan 2014
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
- ClinicalTrials.gov ID
- NCT02052674
- Acronym / sponsor ID
- 201300634
- Conditions
- Bacteriuria
- Keywords
- Precursor to CAUTI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll any patients in the study due to other on-going studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Feb 2014 (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.
The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.
If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.
Detailed description
During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vented urinary drainage system | Experimental | Device: Vented urinary drainage systemThis group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria. |
| Non-vented urinary drainage system | Active comparator | Device: Non-vented urinary drainage systemThis group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for a planned surgery
- Anticipated indwelling bladder catheter placement for greater than 24 hours
- Anticipated post-op admission to a surgical ICU
Key exclusion criteria (4 listed)
- Unstable renal function as self-reported
- Anticipated bandaged postoperative suprapubic incisions
- Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
- Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature
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 |
|---|---|---|
| Vented urinary drainage systemAlso: Covidien vented foley catheter, TopVent, Covidien Dover Precision Premium Drainage bagThis group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria. | Device | Vented urinary drainage system |
| Non-vented urinary drainage systemAlso: Bard urine drainage system, Conventional catheter, Bard Silver-CoatedThis group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria. | Device | Non-vented urinary drainage system |
Primary outcome
Bacteriuria
Time frame: 7 days
Evidence of bacteriuria, a potential precursor to Catheter Associated Urinary Tract Infection (CAUTI), will be used to study the potential effect of the vented urinary drainage system intervention on CAUTI.
2 secondary outcomes
Retained Urine
Time frame: 7 days
Presence of biofilms in catheter materials
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
William B. Smith, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vented urinary drainage system and Non-vented urinary drainage system in people with Bacteriuria, run by University of Florida.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Bacteriuria (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2019.