Automated Waste Tracking Device for Excretion Monitoring

Overseen By Lawrence David

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Wheelchair use, Mobility devices

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test an electronic apparatus for measuring stool and urine output in an accurate and easy way. Participants will have one in-person or virtual visit with the study team prior to starting the study events. Participants that enroll in this study will have the freedom to choose when to begin and stop using the toilet apparatus when it is available for human testing. This apparatus will be located in a private bathroom in either the CIEMAS building or MSRB III Building.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Automated Stool and Urine Output Tracking Device, Smart Toilet, Automated Stool and Urine Output Tracking Device treatment?

Research shows that automated devices for tracking urine and stool can accurately measure and record outputs, reducing the workload on healthcare staff and minimizing human error. A 'smart' toilet system has been shown to analyze urine and stool with accuracy comparable to trained medical personnel, which can help in monitoring and diagnosing health conditions over time. ^{1 2 3 4 5}

Is the Automated Waste Tracking Device safe for human use?

The 'smart' toilet system described in the research is designed to operate autonomously and securely, using sensors and encrypted data storage, which suggests a focus on user safety and privacy. However, specific safety data for human use is not detailed in the available research. ^{1 2 3 6 7}

How does the Automated Waste Tracking Device for Excretion Monitoring differ from other treatments?

The Automated Waste Tracking Device is unique because it uses a 'smart' toilet system to monitor health by analyzing urine and stool with sensors and computer vision, providing continuous and personalized health data without the need for manual recording, unlike traditional methods that rely on manual logs or periodic checks. ^{2 3 8 9 10}

Research Team

Lawrence David

Principal Investigator

Duke University - MGM

Eligibility Criteria

This trial is for Duke University students or employees who can safely use a private bathroom in the CIEMAS building or MSRB III Building. It's open to those frequently present in these buildings, but not for individuals using wheelchairs or mobility devices due to ADA compliance issues.

Inclusion Criteria

People who spend most of their time in these buildings so we can assure the use of the toilet

If the recruitment number is slow, enrollment will include people from the closest buildings

People who are able to use the private bathroom at no risk to themselves in the CIEMAS building (B508) or the bathroom located in room 4002, 4th floor of MSRB3

Exclusion Criteria

I do not use a wheelchair or mobility device.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person or virtual)

Apparatus Use

Participants use the electronic apparatus for measuring stool and urine output in a private bathroom

Up to 3 months

Follow-up

Participants are monitored for accuracy of the apparatus in measuring stool and urine output

Up to 3 months

Treatment Details

Interventions

• Automated Stool and Urine Output Tracking Device

Trial Overview The study is testing a new toilet seat designed to measure stool and urine output automatically. Participants will have one meeting with the team and then use the device at their convenience during the test period.

Participant Groups

Group I: apparatus use Experimental Treatment 1 Intervention

All participants will use the apparatus following the same procedures. They will weigh themselves on a scale located in the bathroom, use the apparatus with or without "hats" ("hats" refer to a plastic container used to catch stool/urine that needs to be placed between the toilet rim and the toilet seat and discarded after each use) and weigh themselves after using the toilet.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

A new sensor system has been developed to detect incontinence events in elderly individuals, which can help identify patterns in their incontinence and support the creation of personalized toileting regimes.

Implementing these regimes can potentially reduce the reliance on incontinence pads, leading to improved quality of life for residents and lower care costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A system for logging incontinence events using a simple disposable sensor. Cusick, G., Birkett, A., Clarke-O'Neill, S., et al.[2019]

The novel device for automatically recording a voiding diary showed a strong correlation with manual measurements in healthy volunteers (R2 = 0.9935) and a good correlation in hospitalized patients (R2 = 0.9117), indicating its accuracy in tracking voiding.

Most participants preferred the automated method over traditional manual recording, suggesting that this device could enhance convenience and compliance in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A small pilot study to evaluate the accuracy and feasibility of a novel automated voiding diary device for recording urine output measurements. Takai, S., Matsukawa, Y., Hashizume, N., et al.[2021]

The 'smart' toilet technology autonomously analyzes urine and stool, providing actionable health data through methods like colorimetric assays and deep learning, which can match the accuracy of trained medical personnel.

This innovative system allows for continuous health monitoring and could be particularly useful for screening and diagnosing specific patient populations, integrating seamlessly into clinical workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mountable toilet system for personalized health monitoring via the analysis of excreta. Park, SM., Won, DD., Lee, BJ., et al.[2022]

Automating urine output (UOP) monitoring in the intensive care unit using a weight-based device can significantly improve the timeliness of documentation, as many current manual recordings are often delayed by an average of 85 minutes.

The novel device demonstrated accuracy in UOP measurements, with values only differing by an average of 27 ml from nurse-documented values, indicating it can effectively reduce nursing workload without sacrificing precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Fluid Output Monitoring in the Intensive Care Unit. Kushnir, A., Palte, E., Morris, N., et al.[2022]

A new low-cost device has been developed to automatically sense and supervise urine output in critical care units, addressing a significant gap in current monitoring technologies.

The device uses a magnetic float and reed switches to measure urine collection and employs a siphon mechanism for automatic emptying, reducing the workload on healthcare staff and minimizing human error.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low cost device for monitoring the urine output of critical care patients. Otero, A., Palacios, F., Akinfiev, T., et al.[2021]

The SENS-U is a new wearable bladder sensor designed to help children with functional daytime urinary incontinence by providing real-time feedback on bladder filling, potentially improving their ability to recognize the sensation before wetting accidents.

This study will evaluate the effectiveness and cost-effectiveness of the SENS-U compared to a SHAM device in a randomized controlled trial involving 480 children, aiming to reduce the number of wetting accidents after 3 months of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a parallel-group randomized controlled multi-center trial evaluating the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence (SENS-U trial). de Wall, LL., Nieuwhof-Leppink, AJ., van de Wetering, EHM., et al.[2022]

The developed sensor and electronics system effectively monitors urine leakage from continence pads, providing real-time feedback to users by vibrating when a leak is detected.

This innovative technology aims to enhance the quality of life for individuals with urinary incontinence, particularly benefiting those using continence pads in community settings or care homes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary incontinence: a vibration alert system for detecting pad overflow. Fernandes, B., Gaydecki, P., Jowitt, F., et al.[2012]

A new home health monitoring system was developed for elderly and disabled individuals, allowing for automated health signal measurement without interfering with daily activities like sleeping or bathing.

Initial testing with a young healthy subject showed that the system successfully collected data from various monitoring devices, indicating its potential for improving health care and quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fully automated health monitoring system in the home. Tamura, T., Togawa, T., Ogawa, M., et al.[2019]

The Urine Monitoring Device (UMOD) is designed to enhance postoperative care by allowing real-time monitoring of urine flow, which helps healthcare providers track patient recovery more efficiently.

By automating urine monitoring and reducing the need for manual checks, the UMOD alleviates the workload on nursing staff, allowing them to focus on other critical patient care tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UMOD: A Device for Monitoring Postoperative Urination. Katzis, K., Despotou, G., Jones, RW.[2018]

The 'Safe Embrace' device was developed specifically to prevent falls among seniors using the toilet, addressing a significant safety concern that existing products did not meet.

After positive evaluations from health teams, patients, and caregivers during testing in a geriatric ward, the device was patented to promote its use in other institutions, highlighting its efficacy and commitment to user safety and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Embrace: technological innovation for elderly safety in the use of toilets. Niwa, LMS., Radovich, NMF., Ciosak, SI.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A system for logging incontinence events using a simple disposable sensor. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A small pilot study to evaluate the accuracy and feasibility of a novel automated voiding diary device for recording urine output measurements. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A mountable toilet system for personalized health monitoring via the analysis of excreta. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Improving Fluid Output Monitoring in the Intensive Care Unit. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A low cost device for monitoring the urine output of critical care patients. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol for a parallel-group randomized controlled multi-center trial evaluating the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence (SENS-U trial). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Urinary incontinence: a vibration alert system for detecting pad overflow. [2012]

8. England pubmed.ncbi.nlm.nih.gov

Fully automated health monitoring system in the home. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

UMOD: A Device for Monitoring Postoperative Urination. [2018]

10. Brazil pubmed.ncbi.nlm.nih.gov

Safe Embrace: technological innovation for elderly safety in the use of toilets. [2021]