Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorC. R. Bard
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Indwelling Urinary Catheter
- External Urinary Catheter
Treatment groups
32 Participants
are divided into 4 treatment groupsSponsors and collaborators
C. R. Bard
Lead sponsor
Becton, Dickinson and Company
Collaborator
Source ClinicalTrials.gov