Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03872518
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2019-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Case Series Analysis of Initial Users of the Urovac Device
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
A Prospective Case Series Analysis of Initial Users of the Urovac Device
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To document usage of the Urovac device among 30 initial users of the device in an acute rehabilitation facility, with analysis of whether and how patients benefitted, challenges encountered, and how benefits and challenges varied by patient type.
Detailed Description:
The Urovac device holds the promise of improving care for many of these patients in a manner that may also significantly decrease costs. The aim of the study is to determine if this device may increase quality of life for patients by reducing urine spills, reducing falls by avoiding urgent situations where patients try to ambulate to the bathroom to avoid wetting sheets, reducing skin breakdown by avoiding urine spills, reducing excoriation of the glans penis, and reducing urinary tract infections.
The Urovac is simply a regular plastic handheld urinal attached by tubing to a pump that evacuates urine to a reservoir. There is also a removable cloth-covered platform to reduce spills. Allowing for the evacuation of urine from the urinal significantly improves its functionality. The Urovac can be left in place without risk of overflow or other spillage, such that a patient with UI requires less assistance. Improving the handheld urinal in this manner should thus allow for reduced usage of diapers, catheterization, and institutionalization. For patients with UI requiring hospitalization or institutionalization for other reasons, the Urovac could potentially reduce the associated labor and complication costs. Despite the clear clinical promise of the Urovac, it has only been used by a small number of patients to date. This study will document usage of the Urovac among 30 of the initial users of the device to better understand the benefits and challenges.
The Urovac is simply a regular plastic handheld urinal attached by tubing to a pump that evacuates urine to a reservoir. There is also a removable cloth-covered platform to reduce spills. Allowing for the evacuation of urine from the urinal significantly improves its functionality. The Urovac can be left in place without risk of overflow or other spillage, such that a patient with UI requires less assistance. Improving the handheld urinal in this manner should thus allow for reduced usage of diapers, catheterization, and institutionalization. For patients with UI requiring hospitalization or institutionalization for other reasons, the Urovac could potentially reduce the associated labor and complication costs. Despite the clear clinical promise of the Urovac, it has only been used by a small number of patients to date. This study will document usage of the Urovac among 30 of the initial users of the device to better understand the benefits and challenges.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: