80 Participants Needed

Ultrasound Imaging for Lower Urinary Tract Symptoms

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Overseen ByRadiology Studies
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to evaluate lower urinary tract symptoms (LUTS) using ultrasound (US), which is more affordable and accessible than the current MRI method. It compares both imaging techniques to determine if US can effectively assess bladder function. The trial includes two groups: men with benign prostatic hyperplasia (BPH) or LUTS, which may involve symptoms like frequent or difficult urination, and healthy men without these symptoms. Participants should not have any recent urinary tract infections or significant neurological issues. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diagnostic methods for LUTS.

Will I have to stop taking my current medications?

If you are currently taking medications that affect the bladder, you may not be eligible to participate in this trial.

What prior data suggests that this ultrasound-based urodynamics evaluation is safe?

Previous studies have used ultrasound (US) for many medical evaluations, highlighting its safety and ease of tolerance. As a non-invasive imaging method, ultrasound does not involve surgery or entering the body. It uses sound waves to create images of the body's interior and generally does not cause serious side effects.

Research has shown that US technology is widely used in health care due to its safety and minimal risk of major problems. In this study, researchers are using US to examine how men urinate. This involves scanning during urination to understand the functioning of the bladder and urinary tract.

Overall, ultrasound is considered safe for use in humans, including when assessing the urinary system. Participants can expect a low risk of side effects from this non-invasive procedure.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of ultrasound imaging to better assess lower urinary tract symptoms (LUTS), particularly in men with benign prostatic hyperplasia (BPH). Unlike traditional methods that might rely on symptom questionnaires or invasive procedures, ultrasound offers a non-invasive and potentially more precise way to understand the condition. This technique could lead to more accurate diagnoses and tailored treatments, improving patient outcomes and comfort.

What evidence suggests that this ultrasound-based evaluation is effective for assessing voiding?

This trial will compare the use of ultrasound to study bladder function in two groups: healthy controls and those with known BPH/LUTS. Research has shown that ultrasound could be a promising method for detecting urination problems in individuals with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Current guidelines emphasize the need for accurate evaluation to manage BPH and LUTS, as these issues can significantly impact quality of life. Ultrasound, a non-invasive and affordable tool, is commonly used in medical imaging. It provides live images, making it easier to assess the bladder and other parts of the urinary system. While MRI is another option for this evaluation, ultrasound is more accessible and less costly. Although research on using ultrasound specifically for BPH/LUTS is still developing, its similarity to other well-established imaging methods suggests it could be effective.23678

Who Is on the Research Team?

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Alejandro Roldan-Alzate, PhD

Principal Investigator

UW Department of Mechanical Engineering and Radiology

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with an enlarged prostate causing urinary symptoms.
I have been diagnosed with an enlarged prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Imaging and Urodynamics Assessment

Participants undergo MRI and ultrasound imaging to assess voiding metrics and validate the US-UDS methodology

2.5 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging assessments

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • US-UDS

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Known BPH/LUTSExperimental Treatment1 Intervention
Group II: Healthy ControlsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Wisconsin Partnership Program

Collaborator

Trials
9
Recruited
590+

Citations

Urologic Diseases in America: Annual Data Report 2024 - NIH

This document reports and discusses findings on Benign Prostatic. Hyperplasia and Associated Lower Urinary Tract Symptoms (BPH/LUTS). Other ...

Lower Urinary Tract Symptoms Due to Benign Prostatic ...

Patients with benign prostatic hyperplasia will suffer less lower urinary tract symptoms (LUTS) after conducting self-management intervention than before ...

Benign Prostatic Hyperplasia: Rapid Evidence Review

This article provides a review of the available patient-oriented evidence to evaluate and manage lower urinary tract symptoms from BPH.

Benign Prostatic Hyperplasia (BPH) Guideline

The goal of this revised guideline is to provide a useful reference on the effective evidence-based surgical management of male lower urinary tract symptoms ...

AUA Guideline Amendment 2023

This guideline seeks to improve clinicians' ability to evaluate and treat patients with BPH/LUTS based on currently available evidence.

Benign Prostatic Hyperplasia - StatPearls - NCBI Bookshelf

Men with BPH are likely to report symptoms of nocturia, poor stream, hesitancy, or prolonged micturition. Red flags help point to more sinister causes of ...

Benign prostatic hyperplasia (BPH) - Symptoms and causes

An enlarged prostate can cause symptoms that may bother you, such as blocking the flow of urine out of the bladder. It also can cause bladder, ...

Benign Prostatic Hyperplasia: Rapid Evidence Review

Lower urinary tract symptoms from benign prostatic hyperplasia affect 25% of U.S. men, nearly one-half of whom have at least moderate symptoms.