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

NCT03872518 | Completed FDA Device

• 1 other identifier: Pro00049729
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence, Urinary

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• Development of urinary tract infection after using Urovac

  24 hours after patient is given instructions on how to use Urovac device.

• Average hours of daily use of Urovac by patient

  24 hours after patient is given instructions on how to use Urovac device.

Interventions

Urovac DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study participants may be biologically female or male, but must have male genitalia (a penis) to participate.
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Dignity Medical Solutions: collaborator
• California Rehabilitation Institute: collaborator

Study Sites (1)

California Rehabilitation Institute

Los Angeles, California, 90067, United States

Location

Related Publications (1)

• 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.

  PMID: 24837121 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Pevnick, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Associate Director, Division of Informatics

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 13, 2019
• Study Start: April 17, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)