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

NCT07744945 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2026-08-04

No results posted yet for this 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.

Conditions

  • Urine Output
  • ICU Patients

Interventions

DEVICE

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

DEVICE

External Urinary Catheter

A non-sterile, external catheter intended for non-invasive urine output management

Sponsors & Collaborators

  • Becton, Dickinson and Company

    collaborator INDUSTRY

  • C. R. Bard

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744945 on ClinicalTrials.gov