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
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.
Adult ICU patients requiring urine output monitoring as part of their fluid management strategy
Exclusion Criteria:
Adult male ICU patients with an indwelling urinary catheter for urine output monitoring
Device: Indwelling Urinary Catheter
Adult female ICU patients with an indwelling urinary catheter for urine output monitoring
Device: Indwelling Urinary Catheter
Adult male ICU patients with an external urinary catheter for urine output monitoring
Device: External Urinary Catheter
Adult female ICU patients with an external urinary catheter for urine output monitoring
Device: External 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
A non-sterile, external catheter intended for non-invasive urine output management
Also known as: PureWick
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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C. R. Bard