Gravity in Flow: Automating Diuresis

NCT07384325 | Completed

• 2 other identifiers: NL84838.018.23NL-005919
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to evaluate the accuracy of automated urine output monitoring using the FlowSure system compared to standard manual urine monitoring in hospitalized patients with an indwelling urinary catheter. The main questions it aims to answer are: How accurate is the automated FlowSure monitoring compared with manual urine monitoring over defined time intervals (8-hour nursing shifts and 24-hour periods)? Does the automated system improve completeness of hourly urine output registration compared with manual documentation? Researchers will compare patients monitored with the automated FlowSure device to those monitored using the manual method to determine whether automation provides more accurate and complete diuresis data. Participants will: Be adult patients admitted to the hospital with a urinary catheter inserted for routine medical reasons (not related to this study). In Part B, be randomized to either manual urine monitoring or automated FlowSure monitoring for defined time intervals. There is no direct benefit to participants. The potential societal benefit lies in improving the accuracy, efficiency, and safety of diuresis monitoring through automation. The risks are minimal and limited to use of the FlowSure device in addition to, or instead of, standard monitoring; no additional procedures are performed.

Conditions

Automated Urine Monitoring; Urine Output; Fluid Balance; Urinary Catheters; Diuresis

Keywords

Automated urine monitoring; Diuresis monitoring; Indwelling urinary catheter; Fluid balance monitoring

Outcome Measures

Primary Outcomes (1)

• Accuracy of urine output measurement using the FlowSure automated monitoring device compared with manual monitoring

  Accuracy will be defined as the agreement between urine output measured by the FlowSure device and manual measurement (reference standard) over predefined time intervals of 8 hours and 24 hours.

  Over a single 8-hour nursing shift and a full 24-hour monitoring period

Secondary Outcomes (1)

• Completeness of hourly urine output registration in the electronic medical record

  Over a single 8-hour nursing shift and a full 24-hour monitoring period

Study Arms (2)

Manual Urine Monitoring

ACTIVE COMPARATOR

Participants in this arm will be monitored using the standard manual urine measurement system consisting of a measuring chamber and urine collection bag. Nursing staff will manually record hourly urine output in the electronic medical record according to routine hospital procedures.

Device: Manual Urine Monitoring System

Automated Monitoring

EXPERIMENTAL

Participants in this arm will be monitored using the investigational automated urine output monitoring device. The device continuously weighs the urine collection bag to calculate urine volume in milliliters per hour and automatically transfers data to the electronic medical record.

Device: FlowSure Automated Urine Output Monitor

Interventions

FlowSure Automated Urine Output Monitor DEVICE

A digital hanging scale that continuously weighs the urine collection bag to determine urine output in milliliters per hour. The device provides real-time diuresis data and automatically transfers measurements to the electronic medical record. FlowSure does not come into contact with the patient or urine and can be reused after surface disinfection.

Automated Monitoring

Manual Urine Monitoring System DEVICE

The current standard-of-care manual urine monitoring system consisting of a measuring chamber and urine collection bag. Nursing staff manually record hourly urine output in the electronic medical record according to routine hospital procedures.

Manual Urine Monitoring

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Currently hospitalized.
• Indwelling urinary catheter inserted for medical reasons unrelated to the study.
• Able and willing to provide written informed consent.
• No specific urological problems.

You may not qualify if:

• No urinary catheter in place.
• Diuresis \< 30 mL per hour at screening.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, Locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Study Officials

• Tom Brouwer, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study; care providers and investigators are aware of group assignment. Data analysis is based on objective device measurements.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: Part A: Single-arm technical feasibility using both manual and automated FlowSure monitoring simultaneously. Part B: Two-arm randomized, open-label comparison between manual and automated urine monitoring.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 3, 2026
• Study Start: June 2, 2025
• Primary Completion: January 15, 2026
• Study Completion: March 10, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)