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Evaluation of an Incontinence Product

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03023072
Enrollment
9
Registered
2017-01-18
Start date
2017-01-31
Completion date
2018-01-30
Last updated
2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence

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

OTHERIncontinence Detection System

Sponsors

Hill-Rom
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frame
Patient exposure time following an incontinence eventThrough study completion, an average of 6 months

Secondary

MeasureTime frame
Patient satisfaction surveysThrough study completion, an average of 6 months
Staff satisfaction surveysThrough study completion, an average of 6 months
Family/patient support member surveysThrough study completion, an average of 6 months
Incidence of incontinence associated skin irritation and breakdown issuesThrough study completion, an average of 6 months
Incidence of pressure injuriesThrough study completion, an average of 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026