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NCT Number: NCT07744945

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center

Murray, Utah, 84111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Indwelling urinary catheter

Device

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

External Urinary Catheter

Device

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

Other names: PureWick

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Josh Hobson

CONTACT

[email protected]

484-790-4982

Kirsten Hammitt

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Collaborators

  • Becton, Dickinson and Company

Registry information

Official study title

A Prospective, Observational Pilot Study Evaluating the Performance and Clinical Acceptance of PureWick® When Used in the ICU for Urine Output Monitoring

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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