Evaluation of an Incontinence Product

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: Incontinence
• Intervention / Treatment: Other: Incontinence Detection System

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hill-Rom

Study record dates

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