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

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.

Study Overview

• Status: Completed
• Conditions: Incontinence, Urinary
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90067
      • California Rehabilitation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Dignity Medical Solutions; California Rehabilitation Institute
• Investigators: Principal Investigator: Joshua Pevnick, MD, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: Pro00049729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes