Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound

NCT ID: NCT05295823

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2022-06-03

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.

Conditions

Voiding Disorders; Voiding Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: DOUBLE

Study Groups

Healthcare provider performed standard PVR measurement using existing ultrasound technology

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthcare provider performed PVR measurement using Butterfly and bladder ultrasound images

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

Group Type: EXPERIMENTAL

Butterfly portable ultrasound device with bladder ultrasound images

Intervention Type: DEVICE

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

Healthcare provider performed PVR measurement using Butterfly and abstract bladder images

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

Group Type: EXPERIMENTAL

Butterfly portable ultrasound device with abstract bladder images

Intervention Type: DEVICE

Point-of-care PVR measurement using the Butterfly portable ultrasound device with abstract bladder images

Self PVR measurement using Butterfly and bladder ultrasound images

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)

Group Type: EXPERIMENTAL

Butterfly portable ultrasound device with bladder ultrasound images

Intervention Type: DEVICE

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

Self PVR measurement using Butterfly and abstract bladder images

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)

Group Type: EXPERIMENTAL

Butterfly portable ultrasound device with abstract bladder images

Intervention Type: DEVICE

Point-of-care PVR measurement using the Butterfly portable ultrasound device with abstract bladder images

Interventions

Butterfly portable ultrasound device with bladder ultrasound images

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

Intervention Type: DEVICE

Butterfly portable ultrasound device with abstract bladder images

Point-of-care PVR measurement using the Butterfly portable ultrasound device with abstract bladder images

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Butterfly Network, Inc

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime Cavallo, MD, MPHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000031258

Identifier Type: -

Identifier Source: org_study_id