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
No
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
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.
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