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

Voiding Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295823
• Other study ID #: 2000031258
• Status: Completed
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: June 3, 2022

Study information

• Verified date: March 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Voiding Disorders
• Voiding Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Butterfly Network, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	up to 6 months