Noninvasive Ultrasound Assessment of Detrusor Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorMayo Clinic
About this trial
The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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).
Trial population
Aim 1:Cohort: Adults (male and female) with non-neurogenic lower urinary tract symptoms from one of the following conditions/symptoms: overactive bladder, benign prostatic hyperplasia, urinary frequency, incomplete bladder emptying, decreased force of urinary stream. N=200 Aim2:Cohort: Male adults with non-neurogenic lower urinary tract symptoms secondary to benign prostatic
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure
Will be reported including 95% confidence intervals derived from the cross-validation procedure.
Time frame
time Frame: Up to study completion, an average of 1 yearSecondary outcomes
1
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
time Frame: Up to study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov