CClinicalTrials.gg
Not yet recruitingNCT07744945Updated Aug 4, 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. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by C. R. Bard · Observational

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

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

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

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
04

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

05

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

06

Study locations

1 site
  • Intermountain Medical Center
    Murray, Utah 84111, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

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

Study contacts

Josh Hobson
Contact
joshua.hobson@bd.com
484-790-4982
Kirsten Hammitt
Contact
Kirsten.Hammitt@bd.com

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion