Noninvasive Ultrasound Assessment of Detrusor Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bladder Dysfunction, Overactive Bladder, BPH With Urinary Obstruction. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.
Detailed description
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.
Primary outcome measures
- Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure [Time frame: time Frame: Up to study completion, an average of 1 year]
Secondary outcome measures (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]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT05652023 · 21-011734