Overactive Bladder Clinical Trial
— NUADDOfficial title:
Noninvasive Ultrasound Assessment of Detrusor Dysfunction
NCT number | NCT05652023 |
Other study ID # | 21-011734 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 20, 2023 |
Est. completion date | December 20, 2028 |
Verified date | March 2024 |
Source | Mayo Clinic |
Contact | Azra Alizad, MD |
Phone | 5075381727 |
alizad.azra[@]mayo.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.
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). |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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 |
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