US Imaging for the Assessment of LUTS

NCT06323109 | Recruiting FDA Device

• 3 other identifiers: 2023-1331A196200Protocol Version 12/19/24
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Lower Urinary Tract Symptoms; BPH

Outcome Measures

Primary Outcomes (6)

• 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.

  Research visit 1 day

• 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.

  Research visit 1 day

• 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.

  Research visit 1 day

• 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.

  Research visit 1 day

• Bladder contractility index (BOI)

  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.

  Research visit 1 day

• International Prostate Symptom Score (IPSS)

  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).

  Research visit 1 day

Study Arms (2)

Healthy Controls

Age-matched healthy men with no lower urinary tract symptoms

Device: MRI-UDS; US-UDS; MCUD

Known BPH/LUTS

Adult men diagnosed with BPH/LUTS

Device: MRI-UDS; US-UDS; MCUD

Interventions

MRI-UDS; US-UDS; MCUD DEVICE

Imaging procedures will include a comprehensive protocol of dynamic MRI, 3D ultrasound and MCUD to evaluate and validate this entirely novel methodology.

Healthy Controls; Known BPH/LUTS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Patients targeted for enrollment will be based on the diagnosis of BPH.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Men diagnosed with BPH/LUTS 2. Healthy volunteers

You may qualify if:

• Age 18-80 years old
• Diagnosed with BPH/LUTS with or without obstruction

You may not qualify if:

• 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).
• \- Age 18-80 years old not experiencing any symptoms consistent with LUTS
• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Wisconsin Partnership Program: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alejandro Roldan-Alzate, PhD

  UW Department of Mechanical Engineering and Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; Radstudy@uwhealth.org

Suzanne Hanson, BS

CONTACT

608.262.7269; shanson@uwhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: November 28, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)