Noninvasive Ultrasound Assessment of Detrusor Dysfunction

NCT ID: NCT05652023

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2023 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-20

Study Completion Date

2028-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Bladder Dysfunction Overactive Bladder BPH With Urinary Obstruction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Azra Alizad

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azra Alizad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Azra Alizad, MD

Role: CONTACT

5075381727

Kathryn (Katie) Barthels

Role: CONTACT

5075385772

Facility Contacts

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Katie Barthels

Role: primary

507-538-5772

Other Identifiers

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21-011734

Identifier Type: -

Identifier Source: org_study_id

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