Prototyping a Device for Automating Stool and Urine Output Tracking

Not Applicable

Recruiting

• Conditions: Waste Output
• Interventions: Device: Toilet seat that measures waste output

• Registration Number: NCT05438199
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Study Start: 2022-11-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apparatus use	Toilet seat that measures waste output	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States