Clinical trial NCT05295823: Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound
Official title: Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voiding Disorders
Voiding Dysfunction
Keywords: post void residual bladder volume
portable usltrasound
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Butterfly Network, Inc
First posted: 2022-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patient with capacity to consent to the study and completion of informed consent document
* Ability to speak and read English

Exclusion Criteria:

* Patient without capacity to consent to the study or incompletion of informed consent document
* Inability to speak and read English

Primary outcomes:
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.
timeFrame: up to 6 months
measure: 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.
timeFrame: up to 6 months
measure: 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.
timeFrame: up to 6 months
measure: 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.
timeFrame: up to 6 months
measure: 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.
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient Reported Outcomes Questionnaire to asses ease of use, satisfaction, and preference of Butterfly Device
timeFrame: up to 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Jaime Cavallo, MD, MPHS
role: PRINCIPAL_INVESTIGATOR
References: