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

July 31, 2026 updated by: C. R. Bard

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Murray, Utah, United States, 84111
        • Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male Indwelling Catheter
Adult male ICU patients with an indwelling urinary catheter for urine output monitoring
Device: Indwelling Urinary Catheter
A thin, flexible, sterile tube that is inserted through the urethra into the bladder to drain urine, typically into a urine meter
Other Names:
  • Foley catheter
Female Indwelling Catheter
Adult female ICU patients with an indwelling urinary catheter for urine output monitoring
Device: Indwelling Urinary Catheter
A thin, flexible, sterile tube that is inserted through the urethra into the bladder to drain urine, typically into a urine meter
Other Names:
  • Foley catheter
Male External Catheter
Adult male ICU patients with an external urinary catheter for urine output monitoring
Device: External Urinary Catheter
A non-sterile, external catheter intended for non-invasive urine output management
Other Names:
  • PureWick
Female External Catheter
Adult female ICU patients with an external urinary catheter for urine output monitoring
Device: External Urinary Catheter
A non-sterile, external catheter intended for non-invasive urine output management
Other Names:
  • PureWick

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately every 4 hours for up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Clinician Acceptability
Time Frame: From start of the observation period to the end of the observation period, up to 72 hours
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.
From start of the observation period to the end of the observation period, up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Collaborators

Becton, Dickinson and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 31, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • UCC-24AC024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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