Evaluation of an Incontinence Product

NCT03023072 | Terminated

• 1 other identifier: CR-CWS2016-001
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence

Outcome Measures

Primary Outcomes (1)

• Patient exposure time following an incontinence event

  Through study completion, an average of 6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Interventions

Incontinence Detection System OTHER

Phase 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Care Unit

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 18, 2017
• Study Start: January 1, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)