Evaluation of an Incontinence Product

Incontinence Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03023072
• Other study ID #: CR-CWS2016-001
• Status: Terminated
• Phase: N/A
• First received: January 12, 2017
• Last updated: February 6, 2018
• Start date: January 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: February 2018
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Incontinence

Intervention

Other:
• Incontinence Detection System

Locations

Country	Name	City	State
United States	Parkview Regional Medical Center	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient exposure time following an incontinence event		Through study completion, an average of 6 months
Secondary	Patient satisfaction surveys		Through study completion, an average of 6 months
Secondary	Staff satisfaction surveys		Through study completion, an average of 6 months
Secondary	Family/patient support member surveys		Through study completion, an average of 6 months
Secondary	Incidence of incontinence associated skin irritation and breakdown issues		Through study completion, an average of 6 months
Secondary	Incidence of pressure injuries		Through study completion, an average of 6 months