US Imaging for the Assessment of LUTS

Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms

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).

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; BPH
• Intervention / Treatment: Device: MRI-UDS; US-UDS; MCUD

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:

Aim1. 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.

Aim2. 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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Gemma Gliori, MS; Phone Number: 608.262.7269; Email: ggliori@uwhealth.org
• Study Contact Backup: Name: Suzanne Hanson, BS; Phone Number: 608.262.7269; Email: shanson@uwhealth.org

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Gemma Gliori, MS; Email: ggliori@uwhealth.org
      • Contact: Suzanne Hanson, BS; Email: shanson@uwhealth.org
      • Principal Investigator: Alejandro Roldan-Alzate, PhD
      • Sub-Investigator: Wade Bushman, MD, PhD
      • Sub-Investigator: Matt Grimes, MD
      • Sub-Investigator: Giuseppe Toia, MD
      • Sub-Investigator: Ivan Rosado-Mendez, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

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.
• History of pelvic surgery or radiation, 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Controls; Age-matched healthy men with no lower urinary tract symptoms	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.
Known BPH/LUTS; Adult men diagnosed with BPH/LUTS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Wisconsin Partnership Program
• Investigators: Principal Investigator: Alejandro Roldan-Alzate, PhD, UW Department of Mechanical Engineering and Radiology

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 2023-1331; A196200 (Other Identifier: UW Madison); Protocol Version 12/21/23 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No