A Prospective Case Series Analysis of Initial Users of the Urovac Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Case Series Analysis of Initial Users of the Urovac Device

Conditions
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Incontinence, Urinary

Intervention / Treatment
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* Device: Urovac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Urovac|The Urovac is simply a regular plastic handheld urinal attached by tubing to a pump that evacuates urine to a reservoir. 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with Urovac device: 5-point scale | Patient satisfaction with the Urovac device after two-hour use of the device, as measured by the statement: I would recommend it to someone in a similar situation. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Patient perception of urine spills after using Urovac | Patient perception of urine spills after using Urovac after two-hour use of the device, as measured by the statement: Urovac helped to avoid urine spills . The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Patient perception of dignity preservation after using Urovac | Patient perception of dignity preservation after using Urovac after two-hour use of the device, as measured by the statement: Urovac helped preserve dignity. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Patient perception of ulcer prevention | Patient perception of ulcer prevention after using Urovac after use of the device, as measured by the statement: Urovac helped avoid decubitus ulcers, or helped keep them dry. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Patient perception of reduced risk of falls | Patient perception of reduced risk of falls after using Urovac after use of the device, as measured by the statement: Urovac helped reduce risk of falls related to getting to a toilet. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Patient perception of caregiver time spent on helping patient use bathroom | Patient perception of caregiver time spent on helping patient use bathroom after using Urovac after use of the device, as measured by the statement: Urovac helped save patient/caregiver time. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Clinician perception of Urovac effectiveness in avoiding foley catheterization or condom catheter | Clinician perception of Urovac effectiveness in avoiding foley catheterization or condom catheter, as measured by the statement: Urovac helped patient to avoid foley catheterization or condom catheter. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Clinician perception of Urovac effectiveness of decreasing development or severity of decubitus ulcers. | Clinician perception of Urovac effectiveness of decreasing development or severity of decubitus ulcers, as measured by the statement: Urovac helped patient with decubitus ulcers. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Clinician perception of Urovac effectiveness of decreasing risk of falls when going to the toilet | Clinician perception of Urovac effectiveness of risk of falls when going to the toilet, as measured by the statement: Urovac helped reduce risk of falls related to getting to a toilet. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Clinician perception of Urovac effectiveness of decreasing risk of hospitalization or skilled nursing facility | Clinician perception of Urovac effectiveness of decreasing risk of hospitalization or skilled nursing facility, as measured by the statement: Urovac helped patient avoid hospitalization or skilled nursing facility admission. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Clinician satisfaction with Urovac device: 5-point scale | Clinician satisfaction with Urovac device, as measured by the statement: I would recommend it to a physician colleague. The 5-point scale goes from 1-5, with 1 being strongly disagree, 2 being somewhat disagree, 3 being neither agree nor disagree, 4 being somewhat agree, and 5 being strongly agree. | 24 hours after patient is given instructions on how to use Urovac device. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of urinary tract infection after using Urovac | Development of urinary tract infection after using Urovac, dichotomous measure (yes/no) measured by checking electronic health record for evidence of urinary tract infection after use of the device. | 24 hours after patient is given instructions on how to use Urovac device. | 
| Average hours of daily use of Urovac by patient | Average hours of daily use of Urovac by patient | 24 hours after patient is given instructions on how to use Urovac device. |