Prototyping a Device for Automating Stool and Urine Output Tracking

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.

Study Overview

• Status: Recruiting
• Conditions: Waste Output
• Intervention / Treatment: Device: Toilet seat that measures waste output

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lawrence David; Phone Number: 919-668-5388; Email: lawrence.david@duke.edu
• Study Contact Backup: Name: Veronica Carrion; Phone Number: 9197041523; Email: vmp19@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Recruiting
      • Duke University
      • Principal Investigator: Lawrence David
      • Contact: Veronica Palacios; Phone Number: 9197041523; Email: veronica.palacios@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• students or employees at Duke University since card access is required for our MSRB3 bathroom.
• 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.

Exclusion Criteria:

• People who use wheelchairs or other mobility devices won't be able to enroll, since at this moment the bathroom is not compliant with the requirements on The Americans with Disabilities Act (ADA) of 1990.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: apparatus use; 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.

Device: Toilet seat that measures waste output; Participants will use a toilet that includes a apparatus designed to measure waste output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of urine output correctly identified as measured by toilet seat apparatus .	This analysis is intended to determine how accurately the apparatus measures urine output.	Up to 3 months
Percent of stool output correctly identified as measured by toilet seat apparatus .	This analysis is intended to determine how accurately the apparatus measures stool output.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of urine weight correctly identified by toilet seat apparatus	Measured by comparing participant weight loss before and after toilet use	Up to 3 months
Percent of stool weight correctly identified by toilet seat apparatus	Measured by comparing participant weight loss before and after toilet use	Up to 3 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Lawrence David, Duke University - MGM

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: urine output; stool output
• Other Study ID Numbers: Pro00104899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No