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

NCT07744945 | Not Yet Recruiting FDA Device

• 1 other identifier: UCC-24AC024
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Urine Capture Rate

  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

  Approximately every 4 hours for up to 72 hours

Secondary Outcomes (1)

• ICU Clinician Acceptability

  From start of the observation period to the end of the observation period, up to 72 hours

Study Arms (4)

Male Indwelling Catheter

Adult male ICU patients with an indwelling urinary catheter for urine output monitoring

Device: Indwelling Urinary Catheter

Female Indwelling Catheter

Adult female ICU patients with an indwelling urinary catheter for urine output monitoring

Device: Indwelling Urinary Catheter

Male External Catheter

Adult male ICU patients with an external urinary catheter for urine output monitoring

Device: External Urinary Catheter

Female External Catheter

Adult female ICU patients with an external urinary catheter for urine output monitoring

Device: External Urinary Catheter

Interventions

External Urinary Catheter DEVICE

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

Also known as: PureWick

Female External Catheter; Male External Catheter

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

Also known as: Foley catheter

Female Indwelling Catheter; Male Indwelling Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients requiring urine output monitoring as part of their fluid management strategy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84111, United States

Location

Central Study Contacts

Josh Hobson

CONTACT

484-790-4982; joshua.hobson@bd.com

Kirsten Hammitt

CONTACT

Kirsten.Hammitt@bd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)