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

Yale University

Status: Completed

Conditions: Voiding Dysfunction; Voiding Disorders

Treatments: Device: Butterfly portable ultrasound device with abstract bladder images; Device: Butterfly portable ultrasound device with bladder ultrasound images

Study type: Interventional

Funder types: Other

Identifiers

NCT05295823

2000031258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 5 patient groups

Healthcare provider performed standard PVR measurement using existing ultrasound technology

No Intervention group

Description:

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 group

Description:

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

Treatment:

Device: Butterfly portable ultrasound device with bladder ultrasound images

Healthcare provider performed PVR measurement using Butterfly and abstract bladder images

Experimental group

Description:

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

Treatment:

Device: Butterfly portable ultrasound device with abstract bladder images

Self PVR measurement using Butterfly and bladder ultrasound images

Experimental group

Description:

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)

Treatment:

Device: Butterfly portable ultrasound device with bladder ultrasound images

Self PVR measurement using Butterfly and abstract bladder images

Experimental group

Description:

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)

Treatment:

Device: Butterfly portable ultrasound device with abstract bladder images