Incontinence
Conditions
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient exposure time following an incontinence event | Through study completion, an average of 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States