Urine OutputNCT07744945
Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU
An observational study of Urine Output and ICU Patients, run by C. R. Bard at 1 site in United States.
Trial summary
The goal of this observational pilot study is to learn about the ability of the PureWick® Flex Female External Catheter and the PureWIck® Male External Catheter to capture urine output in adult ICU patients compared to indwelling urinary catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urine Output, ICU Patients
- What is being tested?
- Indwelling Urinary Catheter and External Urinary Catheter
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult ICU patients requiring urine output monitoring as part of their fluid management strategy
Who may be able to join
- Adult patients =18 years at the time of ICU admission
- Female and Male Patients requiring urine output monitoring
- Provision of a signed and dated informed consent form
Who cannot join
- Frequent episodes of bowel incontinence without a fecal management system in place; or
- Has moderate to heavy menstruation or vaginal bleeding and cannot use a tampon or menstrual cup; or
- Has urinary retention; or
- Is agitated, combative, restless, and/or uncooperative and may remove or dislodge the external catheter or indwelling catheter; or
- Presence of moderate to severe insensible fluid loss, including but not limited to: Diaphoresis; Anasarca; or, based on the investigator's assessment, is unlikely to provide accurate urine leakage measurements on the pad due to the presence of other fluids (e.g. blood, stool); or
- Any other condition that, in the opinion of the investigator, would preclude them from participating in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Observational Pilot Study Evaluating the Performance and Clinical Acceptance of PureWick® When Used in the ICU for Urine Output Monitoring
The goal of this observational pilot study is to learn about the ability of the PureWick® Flex Female External Catheter and the PureWIck® Male External Catheter to capture urine output in adult ICU patients compared to indwelling urinary catheters. The study will also gather feedback from ICU clinicians about the suitability of PureWick® urine output data to inform clinical decision-making.
- Conditions
- Urine Output, ICU Patients
- Being tested
- Indwelling Urinary Catheter, External Urinary Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling Urinary CatheterDevice
Also called Foley catheter
A thin, flexible, sterile tube that is inserted through the urethra into the bladder to drain urine, typically into a urine meter
External Urinary CatheterDevice
Also called PureWick
A non-sterile, external catheter intended for non-invasive urine output management
| Study group | Role | What they receive |
|---|---|---|
| Male Indwelling Catheter | Adult male ICU patients with an indwelling urinary catheter for urine output monitoring Receives: Device: Indwelling Urinary Catheter | |
| Female Indwelling Catheter | Adult female ICU patients with an indwelling urinary catheter for urine output monitoring Receives: Device: Indwelling Urinary Catheter | |
| Male External Catheter | Adult male ICU patients with an external urinary catheter for urine output monitoring Receives: Device: External Urinary Catheter | |
| Female External Catheter | Adult female ICU patients with an external urinary catheter for urine output monitoring Receives: Device: External Urinary Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Capture Rate
Capture rate is calculated as the weight of captured urine (post-void graduated cylinder weight - pre-void graduated cylinder weight) / total urine volume (captured urine + leaked urine (post-void absorbent pad weight - pre-void absorbent pad weight) * 100
Measured: Approximately every 4 hours for up to 72 hours
Secondary outcomes (1)
ICU Clinician Acceptability
A survey completed by ICU clinicians to assess the suitability of using urine output measurement data to inform clinical decision making on a 4-point Likert scale with lower scores indicating a better outcome.
Measured: From start of the observation period to the end of the observation period, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start2 Sep 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine OutputStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744945
- Sponsor's protocol ID
- UCC-24AC024
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Pilot Study Evaluating the Performance and Clinical Acceptance of PureWick® When Used in the ICU for Urine Output Monitoring
- ClinicalTrials.gov ID
- NCT07744945
- Acronym / sponsor ID
- UCC-24AC024
- Conditions
- Urine Output, ICU Patients
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Becton, Dickinson and Company
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- 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 goal of this observational pilot study is to learn about the ability of the PureWick® Flex Female External Catheter and the PureWIck® Male External Catheter to capture urine output in adult ICU patients compared to indwelling urinary catheters. The study will also gather feedback from ICU clinicians about the suitability of PureWick® urine output data to inform clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male Indwelling Catheter | – | Device: Indwelling Urinary CatheterAdult male ICU patients with an indwelling urinary catheter for urine output monitoring |
| Female Indwelling Catheter | – | Device: Indwelling Urinary CatheterAdult female ICU patients with an indwelling urinary catheter for urine output monitoring |
| Male External Catheter | – | Device: External Urinary CatheterAdult male ICU patients with an external urinary catheter for urine output monitoring |
| Female External Catheter | – | Device: External Urinary CatheterAdult female ICU patients with an external urinary catheter for urine output monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients requiring urine output monitoring as part of their fluid management strategy
Key inclusion criteria (3 listed)
- Adult patients =18 years at the time of ICU admission
- Female and Male Patients requiring urine output monitoring
- Provision of a signed and dated informed consent form
Key exclusion criteria (6 listed)
- Frequent episodes of bowel incontinence without a fecal management system in place; or
- Has moderate to heavy menstruation or vaginal bleeding and cannot use a tampon or menstrual cup; or
- Has urinary retention; or
- Is agitated, combative, restless, and/or uncooperative and may remove or dislodge the external catheter or indwelling catheter; or
- Presence of moderate to severe insensible fluid loss, including but not limited to: Diaphoresis; Anasarca; or, based on the investigator's assessment, is unlikely to provide accurate urine leakage measurements on the pad due to the presence of other fluids (e.g. blood, stool); or
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 |
|---|---|---|
| Indwelling Urinary CatheterAlso: Foley catheterA thin, flexible, sterile tube that is inserted through the urethra into the bladder to drain urine, typically into a urine meter | Device | Female Indwelling Catheter, Male Indwelling Catheter |
| External Urinary CatheterAlso: PureWickA non-sterile, external catheter intended for non-invasive urine output management | Device | Female External Catheter, Male External Catheter |
Primary outcome
Urine Capture Rate
Time frame: Approximately every 4 hours for up to 72 hours
Capture rate is calculated as the weight of captured urine (post-void graduated cylinder weight - pre-void graduated cylinder weight) / total urine volume (captured urine + leaked urine (post-void absorbent pad weight - pre-void absorbent pad weight) * 100
1 secondary outcome
ICU Clinician Acceptability
Time frame: From start of the observation period to the end of the observation period, up to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urine Output and ICU Patients, run by C. R. Bard at 1 site 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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Urine Capture Rate (time frame: Approximately every 4 hours for up to 72 hours). 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 2 Oct 2026.