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

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ClinicalTrials.gov Identifier: NCT03872518
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
Dignity Medical Solutions
California Rehabilitation Institute
Information provided by (Responsible Party):
Josh Pevnick, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment
Incontinence, Urinary Device: Urovac

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Case Series Analysis of Initial Users of the Urovac Device
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : September 11, 2019
Estimated Study Completion Date : September 11, 2019

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Patient satisfaction with Urovac device: 5-point scale [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."

  2. Patient perception of urine spills after using Urovac [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."

  3. Patient perception of dignity preservation after using Urovac [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."

  4. Patient perception of ulcer prevention [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."

  5. Patient perception of reduced risk of falls [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."

  6. Patient perception of caregiver time spent on helping patient use bathroom [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."

  7. Clinician perception of Urovac effectiveness in avoiding foley catheterization or condom catheter [ Time Frame: 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, 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."

  8. Clinician perception of Urovac effectiveness of decreasing development or severity of decubitus ulcers. [ Time Frame: 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, 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."

  9. Clinician perception of Urovac effectiveness of decreasing risk of falls when going to the toilet [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."

  10. Clinician perception of Urovac effectiveness of decreasing risk of hospitalization or skilled nursing facility [ Time Frame: 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, 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."

  11. Clinician satisfaction with Urovac device: 5-point scale [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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."


Secondary Outcome Measures :
  1. Development of urinary tract infection after using Urovac [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    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.

  2. Average hours of daily use of Urovac by patient [ Time Frame: 24 hours after patient is given instructions on how to use Urovac device. ]
    Average hours of daily use of Urovac by patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study participants may be biologically female or male, but must have male genitalia (a penis) to participate.
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872518


Contacts
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Contact: Joshua Pevnick, MD 310-423-4683 joshua.pevnick@cshs.org

Locations
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United States, California
California Rehabilitation Institute Recruiting
Los Angeles, California, United States, 90067
Contact: Pamela Roberts, PhD    310-423-6660    pamela.roberts@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Dignity Medical Solutions
California Rehabilitation Institute
Investigators
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Principal Investigator: Joshua Pevnick, MD Cedars-Sinai Medical Center

Publications:
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Responsible Party: Josh Pevnick, Assistant Professor of Medicine and Associate Director, Division of Informatics, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03872518     History of Changes
Other Study ID Numbers: Pro00049729
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders