Voiding DisordersNCT05295823
Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound
A study testing Butterfly portable ultrasound device with bladder ultrasound images and Butterfly portable ultrasound device with abstract bladder images in people with Voiding Disorders and Voiding Dysfunction, run by Yale University at 1 site in United States.
Trial summary
This study would be the first to demonstrate feasibility, accuracy, reliability, clinical care impact, and patient satisfaction with remote monitoring of post-void residual bladder volume (PVR) using the Butterfly portable ultrasound device in patients with obstructive voiding dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Voiding Disorders, Voiding Dysfunction
- What is being tested?
- Butterfly portable ultrasound device with bladder ultrasound images and Butterfly portable ultrasound device with abstract bladder images
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 3 Jun 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with capacity to consent to the study and completion of informed consent document
- Ability to speak and read English
Who cannot join
- Patient without capacity to consent to the study or incompletion of informed consent document
- Inability to speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
This study would be the first to demonstrate feasibility, accuracy, reliability, clinical care impact, and patient satisfaction with remote monitoring of post-void residual bladder volume (PVR) using the Butterfly portable ultrasound device in patients with obstructive voiding dysfunction.
Read the detailed description
This study would be the first to demonstrate feasibility, accuracy, reliability, and patient satisfaction with self measurement of PVR using the Butterfly portable ultrasound device.
In the current study protocol, participants will undergo routine clinical care with no additional clinical encounters for the purposes of this study. As part of routine clinical care, the patient will undergo 3 sequential measurements of patient PVR by the Urologic healthcare provider using the existing ultrasound technology, and a possible bladder catheterization for actual bladder volume measurement and to drain the bladder. Note that 3 sequential measurements are taken from which a mean and standard deviation are derived due to operator and technology-related variability in bladder volume measurement using ultrasound. Participants in the study will also undergo 3 sequential measurements of patient PVR by the Urologic healthcare provider using the Butterfly portable ultrasound device with ultrasound images of the bladder, and 3 sequential measurements of patient PVR by the Urologic healthcare provider using the Butterfly portable ultrasound device with abstract images of the bladder; and the participant will take 3 sequential self-measurements of PVR using the Butterfly portable ultrasound device with ultrasound images of the bladder and 3 sequential self-measurements of PVR using the Butterfly portable ultrasound device with abstract images of the bladder during the same clinic encounter. The Urologic healthcare provider might also perform a bladder catheterization of the patient to determine the actual PVR and to drain the bladder of the residual urine.
Ultimately, successful remote measurement of patient PVR may lead to a paradigm shift in how patients with voiding dysfunction are clinically monitored; and would be a critical tool in triaging patients with possible urinary retention at any time but most especially during a pandemic necessitating social distancing and judicious allocation of healthcare resources. Remote PVR measurement in patients with obstructive voiding dysfunction may lead to more accurate monitoring for urinary retention; early detection of and intervention for urinary retention and potential prevention of sequelae such as urinary tract infection/urosepsis, renal failure, and bladder failure; potential reduction in medical costs and travel burden by reducing unnecessary clinic and emergency room visits as well as the costs of treating potential sequelae of urinary retention; and better quality of life for patients with obstructive voiding dysfunction.
Ultrasound technology is non-invasive, uses sound waves (non-ionizing radiation) to produce a volume measurement, and is an exceptionally safe method of imaging with a very limited risk profile.
- Conditions
- Voiding Disorders, Voiding Dysfunction
- Being tested
- Butterfly portable ultrasound device with bladder ultrasound images, Butterfly portable ultrasound device with abstract bladder images
- Keywords
- post void residual bladder volume, portable usltrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly portable ultrasound device with bladder ultrasound imagesDevice
Point-of-care PVR measurement using existing ultrasound technology (3 consecutive measurements during the same encounter) the Butterfly portable ultrasound device with bladder ultrasound images
Butterfly portable ultrasound device with abstract bladder imagesDevice
Point-of-care PVR measurement using the Butterfly portable ultrasound device with abstract bladder images
| Study group | Role | What they receive |
|---|---|---|
| Healthcare provider performed standard PVR measurement using existing ultrasound technology | No intervention | The Urologic healthcare provider will perform standard point-of-care PVR measurement on the participant (3 consecutive measurements during the same encounter) using existing ultrasound technology |
| Healthcare provider performed PVR measurement using Butterfly and bladder ultrasound images | Experimental | The Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images Receives: Device: Butterfly portable ultrasound device with bladder ultrasound images |
| Healthcare provider performed PVR measurement using Butterfly and abstract bladder images | Experimental | The Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images Receives: Device: Butterfly portable ultrasound device with abstract bladder images |
| Self PVR measurement using Butterfly and bladder ultrasound images | Experimental | The participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images (prior to catheterization, if needed) Receives: Device: Butterfly portable ultrasound device with bladder ultrasound images |
| Self PVR measurement using Butterfly and abstract bladder images | Experimental | The participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images (prior to catheterization, if needed) Receives: Device: Butterfly portable ultrasound device with abstract bladder images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the Butterfly with abstract bladder images measured by Bland-Altman analysis.
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the Butterfly portable ultrasound device with abstract bladder images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Measured: up to 6 months
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with bladder ultrasound images measured by Bland-Altman analysis.
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly portable ultrasound device with bladder ultrasound images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Measured: up to 6 months
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with abstract bladder images measured by Bland-Altman analysis.
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly portable ultrasound device with abstract bladder images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Measured: up to 6 months
Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the existing ultrasound technology measured by Bland-Altman analysis.
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the existing ultrasound technology during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Measured: up to 6 months
Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's bladder catheterization of the patient measured by Bland-Altman analysis.
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements from bladder catheterization of the patient during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Measured: up to 6 months
Secondary outcomes (1)
Patient Reported Outcomes Questionnaire to asses ease of use, satisfaction, and preference of Butterfly Device
Patient Reported Outcomes Questionnaire to assess patient-reported ease of use, satisfaction, and preference between using bladder ultrasound images or abstract bladder images for self measurement of PVR with the Butterfly device using a patient questionnaire at the conclusion of patient self measurements. A mix of open-ended and multiple-choice questions using a 5-point Likert scale of responses.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start27 Apr 2022
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Butterfly Network, Inc
- Responsible party
- Sponsor
- Investigators
- Jaime Cavallo, MD, MPHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295823
- Sponsor's protocol ID
- 2000031258
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound
- ClinicalTrials.gov ID
- NCT05295823
- Acronym / sponsor ID
- 2000031258
- Conditions
- Voiding Disorders, Voiding Dysfunction
- Keywords
- post void residual bladder volume, portable usltrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Butterfly Network, Inc
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 25 Mar 2022 (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.
This study would be the first to demonstrate feasibility, accuracy, reliability, clinical care impact, and patient satisfaction with remote monitoring of post-void residual bladder volume (PVR) using the Butterfly portable ultrasound device in patients with obstructive voiding dysfunction.
Detailed description
This study would be the first to demonstrate feasibility, accuracy, reliability, and patient satisfaction with self measurement of PVR using the Butterfly portable ultrasound device.
In the current study protocol, participants will undergo routine clinical care with no additional clinical encounters for the purposes of this study. As part of routine clinical care, the patient will undergo 3 sequential measurements of patient PVR by the Urologic healthcare provider using the existing ultrasound technology, and a possible bladder catheterization for actual bladder volume measurement and to drain the bladder. Note that 3 sequential measurements are taken from which a mean and standard deviation are derived due to operator and technology-related variability in bladder volume measurement using ultrasound. Participants in the study will also undergo 3 sequential measurements of patient PVR by the Urologic healthcare provider using the Butterfly portable ultrasound device with ultrasound images of the bladder, and 3 sequential measurements of patient PVR by the Urologic healthcare provider using the Butterfly portable ultrasound device with abstract images of the bladder; and the participant will take 3 sequential self-measurements of PVR using the Butterfly portable ultrasound device with ultrasound images of the bladder and 3 sequential self-measurements of PVR using the Butterfly portable ultrasound device with abstract images of the bladder during the same clinic encounter. The Urologic healthcare provider might also perform a bladder catheterization of the patient to determine the actual PVR and to drain the bladder of the residual urine.
Ultimately, successful remote measurement of patient PVR may lead to a paradigm shift in how patients with voiding dysfunction are clinically monitored; and would be a critical tool in triaging patients with possible urinary retention at any time but most especially during a pandemic necessitating social distancing and judicious allocation of healthcare resources. Remote PVR measurement in patients with obstructive voiding dysfunction may lead to more accurate monitoring for urinary retention; early detection of and intervention for urinary retention and potential prevention of sequelae such as urinary tract infection/urosepsis, renal failure, and bladder failure; potential reduction in medical costs and travel burden by reducing unnecessary clinic and emergency room visits as well as the costs of treating potential sequelae of urinary retention; and better quality of life for patients with obstructive voiding dysfunction.
Ultrasound technology is non-invasive, uses sound waves (non-ionizing radiation) to produce a volume measurement, and is an exceptionally safe method of imaging with a very limited risk profile.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthcare provider performed standard PVR measurement using existing ultrasound technology | No intervention | –The Urologic healthcare provider will perform standard point-of-care PVR measurement on the participant (3 consecutive measurements during the same encounter) using existing ultrasound technology |
| Healthcare provider performed PVR measurement using Butterfly and bladder ultrasound images | Experimental | Device: Butterfly portable ultrasound device with bladder ultrasound imagesThe Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images |
| Healthcare provider performed PVR measurement using Butterfly and abstract bladder images | Experimental | Device: Butterfly portable ultrasound device with abstract bladder imagesThe Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images |
| Self PVR measurement using Butterfly and bladder ultrasound images | Experimental | Device: Butterfly portable ultrasound device with bladder ultrasound imagesThe participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images (prior to catheterization, if needed) |
| Self PVR measurement using Butterfly and abstract bladder images | Experimental | Device: Butterfly portable ultrasound device with abstract bladder imagesThe participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images (prior to catheterization, if needed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with capacity to consent to the study and completion of informed consent document
- Ability to speak and read English
Key exclusion criteria (2 listed)
- Patient without capacity to consent to the study or incompletion of informed consent document
- Inability to speak and read English
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 |
|---|---|---|
| Butterfly portable ultrasound device with bladder ultrasound imagesPoint-of-care PVR measurement using existing ultrasound technology (3 consecutive measurements during the same encounter) the Butterfly portable ultrasound device with bladder ultrasound images | Device | Healthcare provider performed PVR measurement using Butterfly and bladder ultrasound images, Self PVR measurement using Butterfly and bladder ultrasound images |
| Butterfly portable ultrasound device with abstract bladder imagesPoint-of-care PVR measurement using the Butterfly portable ultrasound device with abstract bladder images | Device | Healthcare provider performed PVR measurement using Butterfly and abstract bladder images, Self PVR measurement using Butterfly and abstract bladder images |
Primary outcome
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the Butterfly with abstract bladder images measured by Bland-Altman analysis.
Time frame: up to 6 months
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the Butterfly portable ultrasound device with abstract bladder images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with bladder ultrasound images measured by Bland-Altman analysis.
Time frame: up to 6 months
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly portable ultrasound device with bladder ultrasound images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with abstract bladder images measured by Bland-Altman analysis.
Time frame: up to 6 months
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly portable ultrasound device with abstract bladder images during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the existing ultrasound technology measured by Bland-Altman analysis.
Time frame: up to 6 months
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the existing ultrasound technology during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's bladder catheterization of the patient measured by Bland-Altman analysis.
Time frame: up to 6 months
Accuracy of the patient self-measurement of PVR using the Butterfly portable ultrasound device with bladder ultrasound images compared to the healthcare provider's measurements from bladder catheterization of the patient during the same encounter. It is measured by Bland-Altman analysis which describes agreement between two quantitative measurements. More agreement means less difference between measurements.
1 secondary outcome
Patient Reported Outcomes Questionnaire to asses ease of use, satisfaction, and preference of Butterfly Device
Time frame: up to 6 months
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 15 Mar 2023.
- 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.
Jaime Cavallo, MD, MPHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly portable ultrasound device with bladder ultrasound images and Butterfly portable ultrasound device with abstract bladder images in people with Voiding Disorders and Voiding Dysfunction, run by Yale University 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 15 Mar 2023. 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?
Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the Butterfly with abstract bladder images measured by Bland-Altman analysis. (time frame: up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2023.