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Could a less invasive catheter replace the tube in intensive care?

NCT ID NCT07744945

Knowledge-focused Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This pilot study is testing whether an external catheter called PureWick can measure urine output in adult ICU patients as accurately as the standard indwelling catheter (Foley tube). The study will compare how much urine each method captures and will ask ICU clinicians whether they would trust the external catheter's data for making treatment decisions. If it works, this could offer a more comfortable and less invasive option for monitoring urine in critically ill patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
External urinary catheter (PureWick) compared to an indwelling urinary catheter (Foley catheter)
What this could lead to
If the external catheter captures urine as accurately as the standard tube, it could offer a less invasive way to monitor urine output in intensive care, potentially improving patient comfort and reducing infection risk.
What could go wrong
This is a small pilot study, so results may not apply broadly. The external catheter may not capture urine as reliably, and clinicians might not find the data trustworthy enough for critical decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult ICU patients requiring urine output monitoring as part of their fluid management strategy

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients =18 years at the time of ICU admission 2. Female and Male Patients requiring urine output monitoring 3. Provision of a signed and dated informed consent form Exclusion Criteria: 1. Frequent episodes of bowel incontinence without a fecal management system in place; or 2. Has moderate to heavy menstruation or vaginal bleeding and cannot use a tampon or menstrual cup; or 3. Has urinary retention; or 4. Is agitated, combative, restless, and/or uncooperative and may remove or dislodge the external catheter or indwelling catheter; or 5. 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 6. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Icu patients Urine output

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Intermountain Medical Center

    Murray, Utah, 84111, United States

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