NCT Number: NCT06323109
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).
Interested in participating?
Request Info18 year–80 year
Male
Observational
Madison, Wisconsin, 53705, United States
Location status: Recruiting
Alejandro Roldan-Alzate, PhD
PRINCIPAL_INVESTIGATOR
Giuseppe Toia, MD
SUB_INVESTIGATOR
Ivan Rosado-Mendez, PhD
SUB_INVESTIGATOR
Matt Grimes, MD
SUB_INVESTIGATOR
Wade Bushman, MD, PhD
SUB_INVESTIGATOR
The MRI - UDS technique 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). In a preliminary study, values for maximum flow (Qmax) and detrusor pressure at maximum flow (PdetQmax) were obtained from MRI-UDS for patients with BPH/LUTS. These results closely correlated with multichannel urodynamics (MCUD).
Men with BPH/LUTS and age-matched controls will undergo a comprehensive protocol of dynamic MRI, 3D ultrasound and multi-channel urodynamics (MCUD) to evaluate and validate this novel methodology.
Specific aims include:
Aim 1. Develop an ultrasound/CFD based urodynamics (US-UDS) method. A protocol combining 3D US imaging and CFD analysis will be developed. This approach will be validated both in vitro and in vivo, first in an anatomically realistic model and then in control human subjects.
Aim 2. Establish the accuracy of voiding metrics determined with ultrasound urodynamics (US-UDS). MCUD, MRI-UDS and the new US-UDS protocols will all be performed to evaluate voiding in patients with BPH/LUTS and healthy controls. Urodynamic metrics derived from ultrasound will be compared to those obtained from the reference clinical standard MCUD and MRI-UDS.
Aim 3. Develop an optical velocimetry methods that allows the non-invasive quantification of urine velocity while voiding. A setup of high speed cameras will be assembled and utilized to optically image the voiding stream in all subjects recruited for aims 1 and 2.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with BPH/LUTS
Exclusion criteria
Inclusion criteria
Healthy Volunteers
Exclusion criteria
Imaging procedures will include a comprehensive protocol of dynamic MRI, 3D ultrasound and MCUD to evaluate and validate this entirely novel methodology.
Time frame: Research visit 1 day
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 day
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 day
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 day
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 day
Bladder contractility index (BOI): a metric of bladder contractility calculated from MRI flow rates and bladder pressures then compared to US values.
BOI is derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong.
Time frame: Research visit 1 day
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).
Contact information is provided by the study sponsor or research team.
Radiology Studies
CONTACT
Suzanne Hanson, BS
CONTACT
University of Wisconsin, Madison
Other
Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms
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