Clinical trial NCT03872518: A Prospective Case Series Analysis of Initial Users of the Urovac Device
Official title: A Prospective Case Series Analysis of Initial Users of the Urovac Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence, Urinary
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Dignity Medical Solutions
name: California Rehabilitation Institute
First posted: 2019-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with urinary incontinence, defined as a condition in which patients have difficulty getting to and using the toilet to evacuate urine.

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.

Eligibility criteria: Inclusion Criteria:

* Male patients who identify as having difficulty with functional urinary incontinence, such that it may be difficult to get to the toilet in time to urinate
* Patients age 18 or older

Exclusion Criteria:

* Patients with leg wounds or dysfunction which could be worsened by Urovac device placement
* Patients under age 18

Primary outcomes:
measure: Patient satisfaction with Urovac device: 5-point scale
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Patient perception of urine spills after using Urovac
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Patient perception of dignity preservation after using Urovac
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Patient perception of ulcer prevention
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Patient perception of reduced risk of falls
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Patient perception of caregiver time spent on helping patient use bathroom
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Clinician perception of Urovac effectiveness in avoiding foley catheterization or condom catheter
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Clinician perception of Urovac effectiveness of decreasing development or severity of decubitus ulcers.
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Clinician perception of Urovac effectiveness of decreasing risk of falls when going to the toilet
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Clinician perception of Urovac effectiveness of decreasing risk of hospitalization or skilled nursing facility
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Clinician satisfaction with Urovac device: 5-point scale
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
Secondary outcomes:
measure: Development of urinary tract infection after using Urovac
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
measure: Average hours of daily use of Urovac by patient
timeFrame: 24 hours after patient is given instructions on how to use Urovac device.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Rehabilitation Institute
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Joshua Pevnick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grigoryan L, Abers MS, Kizilbash QF, Petersen NJ, Trautner BW. A comparison of the microbiologic profile of indwelling versus external urinary catheters. Am J Infect Control. 2014 Jun;42(6):682-4. doi: 10.1016/j.ajic.2014.02.028.