Noninvasive Ultrasound Assessment of Detrusor Dysfunction

Overactive Bladder Clinical Trial

— NUADD  

Official title:

Noninvasive Ultrasound Assessment of Detrusor Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652023
• Other study ID #: 21-011734
• Status: Recruiting
• Start date: April 20, 2023
• Est. completion date: December 20, 2028

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Azra Alizad, MD
• Phone: 5075381727
• Email: alizad.azra[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2023
• Est. completion date: December 20, 2028
• Est. primary completion date: December 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bladder Dysfunction
• BPH With Urinary Obstruction
• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure	Will be reported including 95% confidence intervals derived from the cross-validation procedure.	time Frame: Up to study completion, an average of 1 year
Secondary	Accuracy of quantitative ultrasound vibrometry for selecting BPH patients for de-obstructive surgery	Will be reported including 95% confidence intervals derived from the cross-validation	time Frame: Up to study completion, an average of 1 year