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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008640
• Other study ID #: 20191822
• Secondary ID: 20191822TLSD-001
• Status: Completed
• Start date: November 14, 2019
• Est. completion date: June 18, 2021

Study information

• Verified date: August 2021
• Source: Toi Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 18, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Diarrhea
• Digestive System Diseases
• Dysentery
• GastroIntestinal Bleeding
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Hemorrhage
• Infection
• Infectious Diarrhea
• Urinary Tract Infections

Intervention

Device:
• TrueLoo™
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.

Locations

Country	Name	City	State
United States	Carlton Senior Living (Concord)	Concord	California
United States	Carlton Senior Living (Davis)	Davis	California
United States	Carlton Senior Living (Elk Grove)	Elk Grove	California
United States	Eskaton Lodge Cameron Park	Sacramento	California
United States	Eskaton Village Carmichael	Sacramento	California
United States	Masonic Homes	Union City	California

Sponsors (1)

Lead Sponsor	Collaborator
Toi Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identification of anomalous toileting patterns in TrueLoo™ data	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
Primary	Bowel movement and urinary event dataset creation	Number of urinations and bowel movements exhibited from each participant during the study period, as observed by TrueLoo™ image analysis.	Week 16 - 30
Secondary	Comparison with current methodologies	Error rate of bowel movement and urinary event tracking from current caregiver-reported and self-reported methods.	Week 16 - 30