Noninvasive Ultrasound Assessment of Detrusor Dysfunction

Recruiting

• Conditions: Overactive Bladder; Bladder Dysfunction; BPH With Urinary Obstruction

• Registration Number: NCT05652023
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Study Start: 2023-04-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Primary Completion: 2027-12-20
• Study Completion: 2028-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2023

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States