NUADD: Noninvasive Ultrasound Assessment of Detrusor Dysfunction

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05652023

Collaborator

(none)

2,023

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.

Condition or Disease	Intervention/Treatment	Phase
Bladder Dysfunction Overactive Bladder BPH With Urinary Obstruction

Detailed Description

The purpose of this study is to evaluate the effectiveness of quantitative ultrasound bladder vibrometry (QUBV) as a noninvasive tool for detrusor overactivity assessment and for benign prostatic hyperplasia (BPH) treatment selection. Participants in this study will have a QUBV ultrasound performed at the same time as a urodynamic study that had been ordered as part of their regular clinical care.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2023 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Noninvasive Ultrasound Assessment of Detrusor Dysfunction

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure [time Frame: Up to study completion, an average of 1 year]
Will be reported including 95% confidence intervals derived from the cross-validation procedure.

Secondary Outcome Measures

Accuracy of quantitative ultrasound vibrometry for selecting BPH patients for de-obstructive surgery [time Frame: Up to study completion, an average of 1 year]
Will be reported including 95% confidence intervals derived from the cross-validation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aim1:

Age >18 scheduled to undergo UDS for their clinical care for one of the included diagnoses.

-Aim2: Inclusions: Age >45 scheduled to undergo selective photovaporization of the prostate.

Exclusion Criteria:

Aim1:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as for uterine or colorectal cancer), prior bladder surgery (including prostate resection), and pregnant or breast-feeding women.
Aim2:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as colorectal cancer).