Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU | NCT07744945

NCT07744945

Overview

NCT ID: NCT07744945
Lead Sponsor: C. R. BardINDUSTRY
Official Title: A Prospective, Observational Pilot Study Evaluating the Performance and Clinical Acceptance of PureWick® When Used in the ICU for Urine Output Monitoring
Brief 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.
Conditions: Urine Output
ICU Patients
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Oct 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 32Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: Josh HobsonContact
joshua.hobson@bd.com

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