Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU
Starting soon
Conditions studied: Urine Output, ICU Patients
In brief
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.
Key facts
- Study ID
- NCT07744945
- Run by
- C. R. Bard
- People needed
- 32
- Starts
- 2026-08-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Intermountain Medical Center — Murray, Utah, United States
Full record on ClinicalTrials.gov
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