Automated Urine MonitoringNCT07384325
Gravity in Flow: Automating Diuresis
A study testing FlowSure Automated Urine Output Monitor and Manual Urine Monitoring System in people with Automated Urine Monitoring and Urine Output, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Automated Urine Monitoring, Urine Output, Fluid Balance
- What is being tested?
- FlowSure Automated Urine Output Monitor and Manual Urine Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jun 2025to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No urinary catheter in place.
- Diuresis < 30 mL per hour at screening.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, Locatie AMC
Amsterdam, North Holland, 1105 AZ
About this study
Official title: Gravity of Flow: Automating Diuresis
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:
Read more
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.
Read the detailed description
Accurate monitoring of urine output is essential in the management of hospitalized patients, particularly those with hemodynamic instability or fluid balance disorders. Currently, diuresis monitoring is performed manually by nursing staff, which is labor intensive and prone to transcription or timing errors. The FlowSure system is an automated urine output monitoring device designed to continuously measure and record urine production and transfer these data directly to the electronic medical record (EMR). Automation may improve data quality, reduce nursing workload, and enhance patient safety.
This study consists of two parts. Part A is a technical feasibility study in which patients are simultaneously monitored using both manual and automated FlowSure systems to evaluate concordance between the two methods under real-world conditions. Part B is a two-arm randomized, non-blinded intervention study comparing automated versus manual urine output monitoring. Patients will be randomized in a 1:1 ratio to either standard manual monitoring or automated FlowSure monitoring. Randomization occurs after insertion of a urinary catheter, which is placed for medical reasons unrelated to the study.
The primary objective of Part B is to assess the accuracy of urine production measurement by the automated FlowSure monitor compared with manual monitoring over two time frames: (1) an 8-hour nursing shift and (2) a full 24-hour period. The primary endpoint is the completeness and accuracy of hourly diuresis registration between the two monitoring methods. Secondary analyses will include evaluation of data recording efficiency and the rate of missing or incorrect entries in the EMR.
There is no direct therapeutic benefit to participants. The anticipated scientific and societal benefit lies in improving the reliability and efficiency of diuresis monitoring, potentially enhancing patient care and reducing nursing workload. The risks associated with participation are minimal. In Part A, the automated monitor operates in addition to the manual system; in Part B, patients are monitored using only one method. In case of device malfunction or data loss, urine output can be estimated from total collected volume over time. Given the low risk profile and the potential to improve clinical monitoring practices, the overall risk-benefit balance of the study is considered favorable.
- Being tested
- FlowSure Automated Urine Output Monitor, Manual Urine Monitoring System
- Keywords
- Automated urine monitoring, Diuresis monitoring, Indwelling urinary catheter, Fluid balance monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowSure Automated Urine Output MonitorDevice
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.
Manual Urine Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: FlowSure Automated Urine Output Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage of expected hourly urine output entries successfully recorded in the electronic medical record during the 8-hour and 24-hour measurement periods.
Measured: Over a single 8-hour nursing shift and a full 24-hour monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start2 Jun 2025
- Primary completion15 Jan 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Automated Urine MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.E. Knops, Amsterdam Universitair Medische Centra
- Investigators
- Tom Brouwer, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384325
- Sponsor's protocol ID
- NL84838.018.23
- Other IDs
- NL-005919
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data because this is a single-center device validation study with limited sample size. Aggregated results will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gravity of Flow: Automating Diuresis
- ClinicalTrials.gov ID
- NCT07384325
- Acronym / sponsor ID
- NL84838.018.23
- Keywords
- Automated urine monitoring, Diuresis monitoring, Indwelling urinary catheter, Fluid balance monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Accurate monitoring of urine output is essential in the management of hospitalized patients, particularly those with hemodynamic instability or fluid balance disorders. Currently, diuresis monitoring is performed manually by nursing staff, which is labor intensive and prone to transcription or timing errors. The FlowSure system is an automated urine output monitoring device designed to continuously measure and record urine production and transfer these data directly to the electronic medical record (EMR). Automation may improve data quality, reduce nursing workload, and enhance patient safety.
This study consists of two parts. Part A is a technical feasibility study in which patients are simultaneously monitored using both manual and automated FlowSure systems to evaluate concordance between the two methods under real-world conditions. Part B is a two-arm randomized, non-blinded intervention study comparing automated versus manual urine output monitoring. Patients will be randomized in a 1:1 ratio to either standard manual monitoring or automated FlowSure monitoring. Randomization occurs after insertion of a urinary catheter, which is placed for medical reasons unrelated to the study.
The primary objective of Part B is to assess the accuracy of urine production measurement by the automated FlowSure monitor compared with manual monitoring over two time frames: (1) an 8-hour nursing shift and (2) a full 24-hour period. The primary endpoint is the completeness and accuracy of hourly diuresis registration between the two monitoring methods. Secondary analyses will include evaluation of data recording efficiency and the rate of missing or incorrect entries in the EMR.
There is no direct therapeutic benefit to participants. The anticipated scientific and societal benefit lies in improving the reliability and efficiency of diuresis monitoring, potentially enhancing patient care and reducing nursing workload. The risks associated with participation are minimal. In Part A, the automated monitor operates in addition to the manual system; in Part B, patients are monitored using only one method. In case of device malfunction or data loss, urine output can be estimated from total collected volume over time. Given the low risk profile and the potential to improve clinical monitoring practices, the overall risk-benefit balance of the study is considered favorable.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Manual Urine Monitoring | Active comparator | Device: Manual Urine Monitoring SystemParticipants 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. |
| Automated Monitoring | Experimental | Device: FlowSure Automated Urine Output MonitorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- No urinary catheter in place.
- Diuresis < 30 mL per hour at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlowSure Automated Urine Output MonitorA 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. | Device | Automated Monitoring |
| Manual Urine Monitoring SystemThe 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. | Device | Manual Urine Monitoring |
Primary outcome
Accuracy of urine output measurement using the FlowSure automated monitoring device compared with manual monitoring
Time frame: Over a single 8-hour nursing shift and a full 24-hour monitoring period
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.
1 secondary outcome
Completeness of hourly urine output registration in the electronic medical record
Time frame: Over a single 8-hour nursing shift and a full 24-hour monitoring period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data because this is a single-center device validation study with limited sample size. Aggregated results will be published in peer-reviewed journals.
Related trials for Automated Urine Monitoring
Not yet recruitingObservational study
Automated System for Monitoring Urine Output in Intensive Care Patients
Acute Kidney Injury in the ICU
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Brouwer, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowSure Automated Urine Output Monitor and Manual Urine Monitoring System in people with Automated Urine Monitoring and Urine Output, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of urine output measurement using the FlowSure automated monitoring device compared with manual monitoring (time frame: Over a single 8-hour nursing shift and a full 24-hour monitoring period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.