Trial Outcomes & Findings for Wetness Sensing System (NCT NCT05454813)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

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).

Results posted on

2023-10-03

Participant Flow

All participants are combined in one arm for the analysis because the first two positions are the same for all participants.

Participant milestones

Participant milestones
Measure	All Participants 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.
Overall Study STARTED	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=56 Participants 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.
Age, Categorical <=18 years	0 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=56 Participants
Age, Categorical >=65 years	37 Participants n=56 Participants
Sex/Gender, Customized Male	18 Participants n=56 Participants
Sex/Gender, Customized Female	38 Participants n=56 Participants
Sex/Gender, Customized Other	0 Participants n=56 Participants
Sex/Gender, Customized Decline to Answer	0 Participants n=56 Participants
Region of Enrollment United States	56 participants n=56 Participants

PRIMARY outcome

Timeframe: 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).

Population: Four participants were removed from the analysis because of deviations. The measure type mean was chosen below because the unit of measure is the percentage of passes.

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.

Outcome measures

Outcome measures
Measure	All Participants n=52 Participants 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. Wetness Sensing System Validation: Participants will use the Wetness Sensing System in a simulated setting in the sitting, supine and side position (participants are randomized to either the left or right side position).
Sensor Detection	96.15 percentage of passes Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 10 minutes after the 360 milliliters saline is poured into the brief.

Population: A convenient subset of the first 22 completed participants was recruited. The unit of measure below is percent change in paper weight from dry. for the rewet procedure.

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.

Outcome measures

Outcome measures
Measure	All Participants n=22 Participants 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. Wetness Sensing System Validation: Participants will use the Wetness Sensing System in a simulated setting in the sitting, supine and side position (participants are randomized to either the left or right side position).
Rewet Test	18.73 percent change Standard Deviation 25.36

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Miller

Medline Industries, L:P

Phone: 630-418-6891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER