Noninvasive Ultrasound Assessment of Detrusor Dysfunction

NCT05652023 | Recruiting

• 1 other identifier: 21-011734
• Study Type: observational
• Target: 2,023
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder; BPH With Urinary Obstruction; Bladder Dysfunction

Keywords

Detrusor Pressure; Bladder Compliance; Ultrasound; Ultrasound Vibrometery

Outcome Measures

Primary Outcomes (1)

• Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure

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

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

Secondary Outcomes (1)

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

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Aim 1:Cohort: Adults (male and female) with non-neurogenic lower urinary tract symptoms from one of the following conditions/symptoms: overactive bladder, benign prostatic hyperplasia, urinary frequency, incomplete bladder emptying, decreased force of urinary stream. N=200 Aim2:Cohort: Male adults with non-neurogenic lower urinary tract symptoms secondary to benign prostatic

You may qualify if:

• Aim1:
• Age \>18 scheduled to undergo UDS for their clinical care for one of the included diagnoses.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Azra Alizad, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azra Alizad, MD

CONTACT

5075381727; alizad.azra@mayo.edu

Kathryn (Katie) Barthels

CONTACT

5075385772; Barthels.Kathryn@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: April 20, 2023
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)