Evaluation of an Incontinence Product

Terminated

• Conditions: Incontinence
• Interventions: Other: Incontinence Detection System

• Registration Number: NCT03023072
• Lead Sponsor: Hill-Rom

Brief Summary

The purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• English speaking/reading adults, age ≥ 18 years
• Incontinent (fecal, urine, or dual incontinence)
• Patients with dual incontinence who require use of a fecal management system (but no urinary catheter)
• Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator
• Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent

Exclusion Criteria

• Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator
• Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy
• Is considered to be near death or requires hospice care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase 1	Incontinence Detection System	Subjects will use the incontinence pad with incontinence detection notifications turned on

Primary Outcome Measures

Name	Time	Method
Patient exposure time following an incontinence event	Through study completion, an average of 6 months

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction surveys	Through study completion, an average of 6 months
Staff satisfaction surveys	Through study completion, an average of 6 months
Family/patient support member surveys	Through study completion, an average of 6 months
Incidence of incontinence associated skin irritation and breakdown issues	Through study completion, an average of 6 months
Incidence of pressure injuries	Through study completion, an average of 6 months

Trial Locations

Locations (1)

Parkview Regional Medical Center; 🇺🇸 Fort Wayne, Indiana, United States