Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05295823
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2022-03-15
Brief Title:
Patient Self Measurement of Post-Void Residual Bladder Volume PVR Using Ultrasound
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Patient Self Measurement of Post-Void Residual Bladder Volume PVR Using Ultrasound
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infectionurosepsis 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
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 infectionurosepsis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None