US Imaging for the Assessment of LUTS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI-UDS; US-UDS; MCUD.
- Who it may be relevant to
- Registry conditions: Lower Urinary Tract Symptoms, BPH. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms
Overview
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).
Detailed description
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.
Interventions
- Device MRI-UDS; US-UDS; MCUD
Imaging procedures will include a comprehensive protocol of dynamic MRI, 3D ultrasound and MCUD to evaluate and validate this entirely novel methodology.
Primary outcome measures
- MRI Urodynamics - Change in Bladder Volume [Time frame: Research visit 1 day]
- MRI Urodynamics - Change in Urine Velocity [Time frame: Research visit 1 day]
- MRI Urodynamics - Change in Pressure [Time frame: Research visit 1 day]
- Bladder outlet obstruction index (BOOI) [Time frame: Research visit 1 day]
- Bladder contractility index (BOI) [Time frame: Research visit 1 day]
- International Prostate Symptom Score (IPSS) [Time frame: Research visit 1 day]
Eligibility criteria
Inclusion Criteria: Patients with BPH/LUTS
- Age 18-80 years old
- Diagnosed with BPH/LUTS with or without obstruction
Exclusion criteria
- 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).
Inclusion Criteria: Healthy Volunteers
\- Age 18-80 years old not experiencing any symptoms consistent with LUTS
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Wisconsin — Madison
Identifiers
NCT: NCT06323109 · 2023-1331 · A196200 · Protocol Version 12/19/24