Wetness Sensing System

Not Applicable

Completed

Brief Summary: The investigational product to be evaluated in this study is FitRight® ConnectTM Wetness Sensing System which includes: the FitRight® ConnectTM Pod, the FitRight® ConnectTM App, the FitRight® ConnectTM charger/adapter and the FitRight® ConnectTM Sensing Brief-(Medline Industries, LP) henceforth, referred to as FitRight® System, Pod, App, Charger, Alert Indicator and Brief. The purpose of this study is to validate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (\~90-360 milliliters (mL)) normal saline via simulated urinary void to trigger an alert to change the brief.

Detailed Description: Each participant will be provided with the FitRight® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. Each participant will be asked to wear at least three briefs so that they are wearing each brief during the simulated voids performed by the site staff. The site staff will perform the simulated void by addition of (90-360 mL normal saline to the brief. The FitRight® System will be assessed for alerts while participants are in the following positions: supine, sitting, and laying on either left or right side. Each participant will be randomized to either the left or right side. Twenty-two of the fifty-six participants will perform rewet testing procedures. The study results will be used to assess the reliability of the device's absorption to trigger an alert

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Individual is sensitive to the components of the study product(s).
Individual is considered inappropriate by the Principal Investigator (PI).
Individual has self-reported current skin condition(s) or issues around the sacral or perineal areas, such as open sores, sacral pressure injuries, rash, burns, surgical wounds and/or compromise of skin integrity.
Individuals who cannot complete all phases of the study requirements.
Individual requires use of an absorbent undergarment or catheter as the primary incontinence management strategy
Individuals who are pregnant

Arm && Interventions

Group	Intervention	Description
All	Wetness Sensing System Validation	Each participant will be provided with the FitRight ® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System.

Primary Outcome Measures

Name	Time	Method
Sensor Detection	5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position).	Evaluate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (\~90-360mL) normal saline via a simulated urinary void to trigger an alert to change the brief in the sitting, supine, and right or left side positions.

Secondary Outcome Measures

Name	Time	Method
Rewet Test	10 minutes after the 360 milliliters saline is poured into the brief.	Determine the FitRight Brief's residual volume capacity. In a subset of 22 participants, evaluate the FitRight Brief after the brief has absorbed the maximum amount of liquid normal saline via a simulated urinary void (360mL) in the sitting position and then weighed via the rewet procedure.