TerminatedInterventionalNot ApplicableUpdated Dec 6, 2022
Evaluation of an Incontinence Product | NCT03023072 | Trialant
TerminatedObservationalUpdated Feb 8, 2018
Evaluation of an Incontinence Product
ClinicalTrials.gov ID
NCT03023072
Lead Sponsor
Hill-RomINDUSTRY
Overall Status
Terminated
Study Type
Observational
Enrollment
9Actual
Last Update Posted
Feb 8, 2018Actual
Start Date
Jan 2017Actual
Primary Completion Date
Jan 30, 2018Actual
Completion Date
Jan 30, 2018Actual
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.
Incontinence
Incontinence Detection System
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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