Evaluation of an Incontinence Product

Terminated

• Conditions: Incontinence

• 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

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