Evaluation of an Incontinence Product

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase 1

Subjects will use the incontinence pad with incontinence detection notifications turned on

Incontinence Detection System

Intervention Type OTHER

Phase 2

Subjects will use the incontinence pad with incontinence notification turned off

No interventions assigned to this group

Interventions

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Incontinence Detection System

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes