Incontinence Management System ICU Field Evaluation

Not Applicable

Completed

• Conditions: Fecal Incontinence; Urinary Incontinence
• Interventions: Device: Incontinence Management System

• Registration Number: NCT03628833
• Lead Sponsor: Hill-Rom

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-09
• Study Start: 2018-07-10
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Primary Completion: 2018-12-03
• Study Completion: 2018-12-03
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Incontinence Management system	Incontinence Management System	-

Primary Outcome Measures

Name	Time	Method
Staff satisfaction surveys on product performance	Through study completion, an average of 4 months	Following product use, staff can complete an optional, Likert scale survey

Secondary Outcome Measures

Name	Time	Method
Patient exposure time following an incontinence event	Through study completion, an average of 4 months

Trial Locations

Locations (1)

Saint Joseph Hospital; 🇺🇸 Lexington, Kentucky, United States