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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device that accurately measures stool and urine output, aiming to simplify tracking for users. Participants will use the Automated Stool and Urine Output Tracking Device in a private bathroom at Duke University, with the flexibility to choose when to start and stop using it. Individuals who spend most of their time in the CIEMAS or MSRB III buildings and can safely use the bathroom there might be suitable candidates. However, this trial is not suitable for those who use wheelchairs or other mobility devices, as the bathroom is not currently ADA-compliant. As an unphased trial, this study offers participants the chance to contribute to innovative research that could simplify health tracking for many.

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 prior data suggests that this device is safe for excretion monitoring?

Research has shown that smart toilets used for health tracking are generally safe and easy to use. These devices analyze urine and stool to detect signs of illness without causing discomfort or harm. Studies have found that these automated systems provide important health information by measuring factors like urine flow and stool consistency.

The reviewed studies reported no problems or side effects from using these devices. Since this trial tests a non-invasive device, safety concerns are much lower compared to treatments involving medication or surgery. Participants in similar studies reported no major issues, indicating that the device is safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the automated stool and urine output tracking device because it offers a new, tech-driven approach to monitoring excretion. Unlike traditional methods that rely on manual recording or estimation, this device provides precise, real-time data by automatically tracking waste output. This innovative method aims to improve accuracy in monitoring fluid balance and patient health, potentially leading to better health outcomes and more personalized care strategies.

What evidence suggests that this device is effective for excretion monitoring?

Research has shown that smart toilets, such as the Automated Stool and Urine Output Tracking Device used in this trial, can monitor health by analyzing urine and stool. A study from Stanford found that these devices can identify signs of illness through automatic analysis. They measure stool thickness and drop time, offering real-time health information. Additionally, they assess urine color and volume, which can help detect possible urinary tract infections. Overall, smart toilets are promising tools for monitoring health at home. ^{1 2 4 6 7}

Who Is on the Research Team?

Lawrence David

Principal Investigator

Duke University - MGM

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10311987/

Passive monitoring by smart toilets for precision health - PMC Smart toilets are a key tool for enabling precision health monitoring in the home, but such passive monitoring has ethical considerations.

2. advanced.onlinelibrary.wiley.com advanced.onlinelibrary.wiley.com/doi/10.1002/advs.202503247

AI‐Driven Defecation Analysis by Smart Healthcare Toilet ... A healthcare toilet system is introduced to passively measure defecation behavior. Real-time data on stool dropping duration, thickness, ...

3. med.stanford.edu med.stanford.edu/news/all-news/2020/04/smart-toilet-monitors-for-signs-of-disease.html

'Smart toilet' monitors for signs of disease - Stanford Medicine A disease-detecting “precision health” toilet can sense multiple signs of illness through automated urine and stool analysis, a new Stanford study reports.

4. withpower.com withpower.com/trial/automated-fluid-output-tracking-device-for-monitoring-hospital-patients-0e813

Automated Fluid Output Tracking Device for Monitoring ... The 'smart' toilet technology autonomously analyzes urine and stool, providing actionable health data through methods like colorimetric assays and deep ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S2291522223001420

Older Adults' Perceptions About Using Intelligent Toilet ... Smart toilets can also track urine and stool properties such as color, volume, concentration, and frequency to detect possible urinary tract infections ...

6. mhealth.jmir.org mhealth.jmir.org/2023/1/e46430

Older Adults' Perceptions About Using Intelligent Toilet Seats ... Smart toilet seats can detect multiple signs of illness through automated urine and stool analyses. This early detection can help users address ...

7. medicalxpress.com medicalxpress.com/news/2023-03-human-feces-urine-motherlode-health.html

Human feces and urine contain a motherlode of health data The smart toilet analyzes urine flow rate, stream time and total volume. Stool consistencies are also analyzed. "An optical scanner doesn't ...