NCT06323109

US Imaging for the Assessment of LUTS

Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lower Urinary Tract Symptoms
• BPH

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-28
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-03-21
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study