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

Conditions

• ICU Patients
• Urine Output

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Indwelling Urinary Catheter — DEVICE
  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 — DEVICE
  A non-sterile, external catheter intended for non-invasive urine output management

Study Details

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 Dates

First listed

Aug 4, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

32 participants (estimated)

Arms

• Arm: Male Indwelling Catheter
  Adult male ICU patients with an indwelling urinary catheter for urine output monitoring
• Arm: Female Indwelling Catheter
  Adult female ICU patients with an indwelling urinary catheter for urine output monitoring
• Arm: Male External Catheter
  Adult male ICU patients with an external urinary catheter for urine output monitoring
• Arm: Female External Catheter
  Adult female ICU patients with an external urinary catheter for urine output monitoring

Primary Outcome Measure

Urine Capture Rate [ Time Frame: Approximately every 4 hours for up to 72 hours ]

Central Contacts

• Josh Hobson
  484-790-4982
  [email protected]
• Kirsten Hammitt
  [email protected]

Locations (1)

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