Evaluation of an Incontinence Product

February 6, 2018 updated by: Hill-Rom
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States
        • Parkview Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute Care Unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 1
Subjects will use the incontinence pad with incontinence detection notifications turned on
Other: Incontinence Detection System
Phase 2
Subjects will use the incontinence pad with incontinence notification turned off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient exposure time following an incontinence event
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction surveys
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Staff satisfaction surveys
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Family/patient support member surveys
Time Frame: Through study completion, an average of 6 months
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
Through study completion, an average of 6 months
Incidence of pressure injuries
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hill-Rom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CR-CWS2016-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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