Incontinence, UrinaryNCT03872518
A Prospective Case Series Analysis of Initial Users of the Urovac Device
An observational study of Incontinence, Urinary, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence, Urinary
- What is being tested?
- Urovac
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Males with urinary incontinence, defined as a condition in which patients have difficulty getting to and using the toilet to evacuate urine.
Who may be able to join
- 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
Who cannot join
- Patients with leg wounds or dysfunction which could be worsened by Urovac device placement
- Patients under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
California Rehabilitation Institute
Los Angeles, California, 90067
About this study
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.
Read the 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.
- Conditions
- Incontinence, Urinary
- Being tested
- Urovac
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrovacDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 24 hours after patient is given instructions on how to use Urovac device.
Secondary outcomes (2)
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.
Measured: 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
Measured: 24 hours after patient is given instructions on how to use Urovac device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start17 Apr 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dignity Medical Solutions, California Rehabilitation Institute
- Responsible party
- Principal investigator, Josh Pevnick, Cedars-Sinai Medical Center
- Investigators
- Joshua Pevnick, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872518
- Sponsor's protocol ID
- Pro00049729
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2019
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 24837121
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Series Analysis of Initial Users of the Urovac Device
- ClinicalTrials.gov ID
- NCT03872518
- Acronym / sponsor ID
- Pro00049729
- Conditions
- Incontinence, Urinary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Dignity Medical Solutions, California Rehabilitation Institute
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Males with urinary incontinence, defined as a condition in which patients have difficulty getting to and using the toilet to evacuate urine.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with leg wounds or dysfunction which could be worsened by Urovac device placement
- Patients under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrovacThe 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. | Device | – |
Primary outcome
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."
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."
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."
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."
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."
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."
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."
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."
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."
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."
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."
2 secondary outcomes
Development of urinary tract infection after using Urovac
Time frame: 24 hours after patient is given instructions on how to use Urovac device.
Average hours of daily use of Urovac by patient
Time frame: 24 hours after patient is given instructions on how to use Urovac device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 24837121Grigoryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Pevnick, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incontinence, Urinary, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with Urovac device: 5-point scale (time frame: 24 hours after patient is given instructions on how to use Urovac device.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.