ClinicalTrials.gg
Enrolling by invitationNCT07744945Updated Oct 2, 2026

Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU

An observational study in Urine Output and ICU Patients, sponsored by C. R. Bard. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Observational

Updated Oct 2, 2026Now Enrolling by invitationStart date movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study 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. The study will also gather feedback from ICU clinicians about the suitability of PureWick® urine output data to inform clinical decision-making.

02

Conditions studied

  • Urine Output
  • ICU Patients
03

In context

Lead sponsor

C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.

First submitted after C. R. Bard became part of Becton, Dickinson and Company.

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
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (estimated)
Patient registry
No

Groups and cohorts

  • Male Indwelling Catheter

    Adult male ICU patients with an indwelling urinary catheter for urine output monitoring

    Device: Indwelling Urinary Catheter

  • Female Indwelling Catheter

    Adult female ICU patients with an indwelling urinary catheter for urine output monitoring

    Device: Indwelling Urinary Catheter

  • Male External Catheter

    Adult male ICU patients with an external urinary catheter for urine output monitoring

    Device: External Urinary Catheter

  • Female External Catheter

    Adult female ICU patients with an external urinary catheter for urine output monitoring

    Device: External Urinary Catheter

Interventions

  • DeviceIndwelling Urinary Catheter

    A thin, flexible, sterile tube that is inserted through the urethra into the bladder to drain urine, typically into a urine meter

    Also known as: Foley catheter

  • DeviceExternal Urinary Catheter

    A non-sterile, external catheter intended for non-invasive urine output management

    Also known as: PureWick

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: From start of the observation period to the end of the observation period, up to 72 hours

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Sep 2026 (actual). Primary completion is estimated for Oct 2026, 1 month after the start.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 2, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2026
First posted
Aug 4, 2026
StartActual
Sep 2, 2026was Aug 2026
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2026
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Enrolling by invitation
changed Oct 2, 2026
Start date
Aug 2026→Sep 2, 2026 (actual)
Oct 2, 2026
Contact
No study contact listed any more: removed j•••@bd.com · •••4982; removed K•••@bd.com
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Not yet recruiting→Enrolling by invitation
    Start date Aug 2026→Sep 2, 2026 (now actual)
    Contact No study contact listed any more: removed j•••@bd.com · •••4982; removed K•••@bd.com
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07744945
Lead sponsor
C. R. Bard
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Sep 2, 2026
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Oct 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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