Actively Recruiting

Age: 18Years - 80Years
MALE
Healthy Volunteers
ID06323109

Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms

Led by University of Wisconsin, Madison · Updated on 2025-12-22

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

W

Wisconsin Partnership Program

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new ultrasound-based method to evaluate urinary flow and bladder pressure in men with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). This study aims to develop and validate this ultrasound urodynamics technique by comparing it to existing methods like MRI-urodynamics and multichannel urodynamics in both affected patients and healthy controls. The goal is to provide a more accessible and cost-effective way to assess urinary function. The study involves imaging procedures including dynamic MRI, 3D ultrasound, and multichannel urodynamics to measure voiding flow rates and bladder pressures. Men with BPH/LUTS and age-matched healthy men will undergo these evaluations during a single visit lasting up to 2.5 hours. Researchers will develop new analytic methods combining ultrasound and fluid dynamics modeling and will also use optical imaging to measure urine velocity during voiding. Participants will be assessed during one research visit involving MRI and ultrasound imaging along with clinical symptom scoring using the International Prostate Symptom Score (IPSS). The study will measure changes in bladder volume, urine velocity, pressure, and calculate standard indices related to bladder outlet obstruction and contractility. The total participation time is about 2.5 hours, and the study includes healthy volunteers as well as men diagnosed with BPH/LUTS. Safety is monitored by excluding participants with contraindications to MRI or recent urinary infections.

CONDITIONS

Brief Title

US Imaging for the Assessment of LUTS

Who Can Participate

Age: 18Years - 80Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 to 80 years
  • Diagnosed with BPH or lower urinary tract symptoms with or without obstruction
  • Healthy male volunteers aged 18 to 80 years without symptoms of lower urinary tract symptoms
Not Eligible

You will not qualify if you...

  • Patients with contraindications to MRI and/or gadolinium-based contrast agents
  • Diabetic subjects will not receive contrast
  • History of overt neurologic disease other than diabetic neuropathy
  • Urinary tract infection within the last 4 weeks
  • Recent history of urinary retention within the last 4 weeks
  • Currently taking medications known to affect the bladder (for healthy volunteers)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to confirm eligibility and collect medical history

Diagnostic Evaluation

Duration - 1 day

Participants undergo imaging and urodynamic assessments including dynamic MRI, 3D ultrasound, and multichannel urodynamics (MCUD) to evaluate urinary tract function.

1 research visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants may be observed for changes in urinary tract symptoms and function without receiving treatment as this is an observational study.

Follow-up visits as needed depending on participant status

Trial Site Locations

Total: 1 location

1

University of Wisconsin

Madison, Wisconsin, United States, 53705

Actively Recruiting

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Research Team

R

Radiology Studies

S

Suzanne Hanson, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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