Clinical trial NCT06323109: US Imaging for the Assessment of LUTS
Official title: Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Urinary Tract Symptoms
BPH
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Partnership Program
First posted: 2024-03-21
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Men diagnosed with BPH/LUTS
2. Healthy volunteers

Brief summary: 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.

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.

Primary outcomes:
measure: MRI Urodynamics - Change in Bladder Volume
timeFrame: Research visit 1 day
measure: MRI Urodynamics - Change in Urine Velocity
timeFrame: Research visit 1 day
measure: MRI Urodynamics - Change in Pressure
timeFrame: Research visit 1 day
measure: Bladder outlet obstruction index (BOOI)
timeFrame: Research visit 1 day
measure: Bladder contractility index (BOI)
timeFrame: Research visit 1 day
measure: International Prostate Symptom Score (IPSS)
timeFrame: Research visit 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW Department of Mechanical Engineering and Radiology
name: Alejandro Roldan-Alzate, PhD
role: PRINCIPAL_INVESTIGATOR
References: