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

NCT07744945 · tracked via the Priya Life Science USA tracker

Sponsor

C. R. Bard

Phase

Observational

Started

2026-09-02

Last updated

2026-10-02

Condition(s) studied

Urine OutputICU Patients

Investigational drug(s) / intervention(s)

Indwelling Urinary CatheterExternal Urinary Catheter

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

External Urinary Catheter: A non-sterile, external catheter intended for non-invasive urine output management

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Urine Capture Rate — 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

Trial sites (1)

Facility	City	Region	Status
Intermountain Medical Center	Murray	Utah

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07744945 on ClinicalTrials.gov ↗ ← All trials in the USA