Back to resultsIncontinence Management System ICU Field Evaluation
Primary Purpose
Urinary Incontinence, Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incontinence Management System
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Saint Joseph Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Incontinence Management system
Arm Description
Outcomes
Primary Outcome Measures
Staff satisfaction surveys on product performance
Following product use, staff can complete an optional, Likert scale survey
Secondary Outcome Measures
Patient exposure time following an incontinence event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03628833
Brief Title
Incontinence Management System ICU Field Evaluation
Official Title
Hill-Rom Incontinence Management System ICU Field Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
December 3, 2018 (Actual)
Study Completion Date
December 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Fecal Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Incontinence Management system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Incontinence Management System
Intervention Description
Incontinence detection device
Primary Outcome Measure Information:
Title
Staff satisfaction surveys on product performance
Description
Following product use, staff can complete an optional, Likert scale survey
Time Frame
Through study completion, an average of 4 months
Secondary Outcome Measure Information:
Title
Patient exposure time following an incontinence event
Time Frame
Through study completion, an average of 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Saint Joseph Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Incontinence Management System ICU Field Evaluation
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