Evaluation of an Incontinence Product
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ClinicalTrials.gov Identifier: NCT03023072 |
Recruitment Status :
Terminated
(Site no longer met criteria)
First Posted : January 18, 2017
Last Update Posted : February 8, 2018
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Condition or disease | Intervention/treatment |
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Incontinence | Other: Incontinence Detection System |
Study Type : | Observational |
Actual Enrollment : | 9 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | January 30, 2018 |
Actual Study Completion Date : | January 30, 2018 |
Group/Cohort | Intervention/treatment |
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Phase 1
Subjects will use the incontinence pad with incontinence detection notifications turned on
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Other: Incontinence Detection System |
Phase 2
Subjects will use the incontinence pad with incontinence notification turned off
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- Patient exposure time following an incontinence event [ Time Frame: Through study completion, an average of 6 months ]
- Patient satisfaction surveys [ Time Frame: Through study completion, an average of 6 months ]
- Staff satisfaction surveys [ Time Frame: Through study completion, an average of 6 months ]
- Family/patient support member surveys [ Time Frame: Through study completion, an average of 6 months ]
- Incidence of incontinence associated skin irritation and breakdown issues [ Time Frame: Through study completion, an average of 6 months ]
- Incidence of pressure injuries [ Time Frame: Through study completion, an average of 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023072
United States, Indiana | |
Parkview Regional Medical Center | |
Fort Wayne, Indiana, United States |
Responsible Party: | Hill-Rom |
ClinicalTrials.gov Identifier: | NCT03023072 |
Other Study ID Numbers: |
CR-CWS2016-001 |
First Posted: | January 18, 2017 Key Record Dates |
Last Update Posted: | February 8, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |