Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™

August 9, 2021 updated by: Toi Labs, Inc.

TrueLoo™: Determining the Feasibility of an Electronic Bowel Movement and Urinary Event Log Via In Situ Categorization of Physical Properties of Stool and Urine

The purpose of this study is to assess the feasibility of TrueLoo™, an Internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across Northern California.

Study Overview

Detailed Description

The logging and monitoring of bowel movements and urinary events is an important aspect of preventative care for residents in senior living facilities, providing early warning signs for conditions that may otherwise cause complications if dealt with reactively. However, this information is sporadically collected - if at all - and subjectively interpreted by caregivers, leading to inconsistencies and unreliable data. Toi Labs, Inc. has created TrueLoo™, an Internet-connected toilet seat, as a solution to these issues. TrueLoo™ acquires time-lapse images of a bowel movement or urinary event automatically and under controlled conditions. Residents enrolled in the current study will have a TrueLoo™ installed in their private bathroom, through which all bowel movements and urinary events will be tracked, anonymously, privately, and securely. As a result, an electronic bowel movement and urinary event log for each enrolled resident will be generated. Given sufficient data, the TrueLoo™ system will complete such electronic logs automatically, identify points in time where particular enrolled residents may have experienced anomalous toileting patterns, and determine the relevance of such events through targeted health history and urine sampling.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Concord, California, United States, 94520
        • Carlton Senior Living (Concord)
      • Davis, California, United States, 95618
        • Carlton Senior Living (Davis)
      • Elk Grove, California, United States, 95758
        • Carlton Senior Living (Elk Grove)
      • Sacramento, California, United States, 95608
        • Eskaton Village Carmichael
      • Sacramento, California, United States, 95682
        • Eskaton Lodge Cameron Park
      • Union City, California, United States, 94587
        • Masonic Homes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population was comprised of subjects that belong to the same study group, regardless of symptoms, disease diagnosis or state. Furthermore, there was no stratification of the population by sex, age, race or disease severity.

Description

Inclusion Criteria:

  • Must be willing to participate and provide consent for the study;
  • Must be a male or female, aged 55 or older;
  • Must be a resident of a senior living facility;
  • Must have regular access to a TrueLoo™.

Exclusion Criteria:

  • Candidates who are unwilling or unable to accept the requirements associated with installing TrueLoo™ in their residence, including power and Wi-Fi connectivity;
  • Candidates who use certain types of toileting assistance devices that at this time are not compatible with TrueLoo™ (e.g., padded toilet seat risers).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group (all subjects)
All subjects belonged to the same study group, regardless of symptoms, disease diagnosis or state. Furthermore, there was no stratification of the population by sex, age, race or disease severity.
TrueLoo™ is an Internet-connected, smart toilet seat that uses computer vision technology to log and capture daily bowel movements and urinations. This data is then categorized by physical excreta characteristics to train and develop machine learning algorithms that are intended to eventually identify significant changes in stool and urine in real-time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel movement and urinary event dataset creation
Time Frame: Week 16 - 30
Number of urinations and bowel movements exhibited from each participant during the study period, as observed by TrueLoo™ image analysis.
Week 16 - 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison with current methodologies
Time Frame: Week 16 - 30
Error rate of bowel movement and urinary event tracking from current caregiver-reported and self-reported methods.
Week 16 - 30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of anomalous toileting patterns in TrueLoo™ data
Time Frame: Week 16 - 30
Number of bowel movement and urinary event anomalies observed by TrueLoo™; ad-hoc health history collection and urine sampling will determine the relevance of these events.
Week 16 - 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Paul F Cristman, PhD, MS, BS, Toi Labs, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2019

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Infections

Clinical Trials on TrueLoo™

3
Subscribe