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Recruiting

NCT Number: NCT05652023

Noninvasive Ultrasound Assessment of Detrusor Dysfunction

The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Azra Alizad, MD

PRINCIPAL_INVESTIGATOR

Katie Barthels

CONTACT

[email protected]

507-538-5772

About this study

The purpose of this study is to evaluate the effectiveness of quantitative ultrasound bladder vibrometry (QUBV) as a noninvasive tool for detrusor overactivity assessment and for benign prostatic hyperplasia (BPH) treatment selection. Participants in this study will have a QUBV ultrasound performed at the same time as a urodynamic study that had been ordered as part of their regular clinical care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aim1:

Age >18 scheduled to undergo UDS for their clinical care for one of the included diagnoses.

-Aim2: Inclusions: Age >45 scheduled to undergo selective photovaporization of the prostate.

Exclusion criteria

  • Aim1:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as for uterine or colorectal cancer), prior bladder surgery (including prostate resection), and pregnant or breast-feeding women.
  • Aim2:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as colorectal cancer).

Treatment and study plan

Primary outcomes

  1. Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure

    Time frame: time Frame: Up to study completion, an average of 1 year

    Will be reported including 95% confidence intervals derived from the cross-validation procedure.

Secondary outcomes

  1. Accuracy of quantitative ultrasound vibrometry for selecting BPH patients for de-obstructive surgery

    Time frame: time Frame: Up to study completion, an average of 1 year

    Will be reported including 95% confidence intervals derived from the cross-validation

Study contacts

Contact information is provided by the study sponsor or research team.

Azra Alizad, MD

CONTACT

[email protected]

5075381727

Kathryn (Katie) Barthels

CONTACT

[email protected]

5075385772

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: NUADD

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 15, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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