Incontinence Management System ICU Field Evaluation

Urinary Incontinence Clinical Trial

Official title:

Hill-Rom Incontinence Management System ICU Field Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628833
• Other study ID #: CR-CWS2018-002
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: December 3, 2018

Study information

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

Clinical Trial Summary

The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 3, 2018
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with urinary, fecal, or dual incontinence who are = 18 years old

• The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent

Exclusion Criteria:

• Patients that are considered to be near death or require palliative care

Related Conditions & MeSH terms

• Enuresis
• Fecal Incontinence
• Urinary Incontinence

Intervention

Device:
• Incontinence Management System
Incontinence detection device

Locations

Country	Name	City	State
United States	Saint Joseph Hospital	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staff satisfaction surveys on product performance	Following product use, staff can complete an optional, Likert scale survey	Through study completion, an average of 4 months
Secondary	Patient exposure time following an incontinence event		Through study completion, an average of 4 months