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

NCT05295823 | Completed FDA Device

• 1 other identifier: 2000031258
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Voiding Disorders; Voiding Dysfunction

Keywords

post void residual bladder volume; portable usltrasound

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  up to 6 months

Secondary Outcomes (1)

• Patient Reported Outcomes Questionnaire to asses ease of use, satisfaction, and preference of Butterfly Device

  up to 6 months

Study Arms (5)

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

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

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)

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)

Device: Butterfly portable ultrasound device with abstract bladder images

Interventions

Butterfly portable ultrasound device with bladder ultrasound images 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 bladder ultrasound images; Self PVR measurement using Butterfly and bladder ultrasound images

Butterfly portable ultrasound device with abstract bladder images DEVICE

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

Healthcare provider performed PVR measurement using Butterfly and abstract bladder images; Self PVR measurement using Butterfly and abstract bladder images

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• Butterfly Network, Inc: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Study Officials

• Jaime Cavallo, MD, MPHS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participant will be blinded to the results of the Urologic healthcare provider's measurements; and the Urologic healthcare provider will be blinded to the results of the patient's measurements.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 25, 2022
• Study Start: April 27, 2022
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)