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Not yet recruiting NCT07744945

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

— Observational Urine Output ICU Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indwelling Urinary Catheter, External Urinary Catheter.
Who it may be relevant to
Registry conditions: Urine Output, ICU Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Observational Pilot Study Evaluating the Performance and Clinical Acceptance of PureWick® When Used in the ICU for Urine Output Monitoring

Overview

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.

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

Primary outcome measures

  • Urine Capture Rate [Time frame: Approximately every 4 hours for up to 72 hours]
Secondary outcome measures (1)
  • ICU Clinician Acceptability [Time frame: From start of the observation period to the end of the observation period, up to 72 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Intermountain Medical Center — Murray

Identifiers

NCT: NCT07744945 · UCC-24AC024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗