US Imaging for the Assessment of LUTS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorUniversity of Wisconsin, Madison
About this trial
The purpose of this research is to develop an ultrasound (US) based urodynamics (UDS) evaluation of voiding based on successful magnetic resonance imaging (MRI)-UDS evaluation. Both US and MRI are non-invasive imaging techniques, but US is a more cost-effective and widely available technology. 80 participants will be enrolled and will be on study for up to 2.5 hours (1.5 hour MRI and 1 hour US).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-80 years old
Diagnosed with BPH/LUTS with or without obstruction
Disqualifiers
Patients with contraindication to MRI and/or GBCA contrast agent. Diabetic subjects will not receive contrast.
History of overt neurologic disease other than diabetic neuropathy, urinary tract infection within the last 4 weeks or recent history of urinary retention (within the last 4 weeks).
Patients with contraindication to MRI and/or GBCA contrast agent.
Currently taking medications with known effects on the bladder, overt neurologic disease other than diabetic neuropathy, urinary tract infection within the last 4 weeks or urinary retention symptoms.
Trial population
1. Men diagnosed with BPH/LUTS 2. Healthy volunteers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI-UDS; US-UDS; MCUD
DeviceImaging procedures will include a comprehensive protocol of dynamic MRI, 3D ultrasound and MCUD to evaluate and validate this entirely novel methodology.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Healthy Controls1 intervention
Group B: Known BPH/LUTS1 intervention
Trial outcomes
Primary outcomes
1
MRI Urodynamics - Change in Bladder Volume
MRI-based CFD technique (MRI - UDS) provides voiding flow rates and bladder pressures which can be used to calculate the widely used metrics of obstruction (bladder outlet obstruction index, BOOI) and contractility (bladder contractility index, BCI). Bladder volumes are quantified from the time resolved volumetric data acquired during the void event in each patient. The outcomes from the MRI based CFD simulations of the voiding event are urine velocity and pressure in the bladder and urethra at the different time points during the void.
Time frame
Research visit 1 day2
MRI Urodynamics - Change in Urine Velocity
MRI-based CFD technique (MRI - UDS) provides voiding flow rates and bladder pressures which can be used to calculate the widely used metrics of obstruction (bladder outlet obstruction index, BOOI) and contractility (bladder contractility index, BCI). Flow rates are derived from the volume change of the bladder. Volumes are quantified from the time resolved volumetric data acquired during the void in each patient. Calculated flow rate is used to computationally estimate the pressure required to drive that flow using computational fluid dynamics. In summary, the outcome from the MRI acquisition is bladder volume as well as urethral anatomy during the void event. The outcomes from the MRI based CFD simulations of the voiding event are urine velocity and pressure in the bladder and urethra at the different time points during the void.
Time frame
Research visit 1 day3
MRI Urodynamics - Change in Pressure
MRI-based CFD technique (MRI - UDS) provides voiding flow rates and bladder pressures which can be used to calculate the widely used metrics of obstruction (bladder outlet obstruction index, BOOI) and contractility (bladder contractility index, BCI). Flow rates are derived from the volume change of the bladder. Volumes are quantified from the time resolved volumetric data acquired during the void in each patient. Calculated flow rate is used to computationally estimate the pressure required to drive that flow using computational fluid dynamics. In summary, the outcome from the MRI acquisition is bladder volume as well as urethral anatomy during the void event. The outcomes from the MRI based CFD simulations of the voiding event are urine velocity and pressure in the bladder and urethra at the different time points during the void.
Time frame
Research visit 1 day4
Bladder outlet obstruction index (BOOI)
Bladder outlet obstruction index (BOOI): A metric of obstruction calculated from MRI flow rates and bladder pressures then compared to US values. BOOI, is derived from the equation PdetQmax - 2Qmax. Scores: \<20 means unobstructed, 20-40 means equivocol, \>40 means obstructed.
Time frame
Research visit 1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Wisconsin Partnership Program
Collaborator
Source ClinicalTrials.gov