Noninvasive ultrasound assessment of bladder function
Noninvasive Ultrasound Assessment of Detrusor Dysfunction
This study is testing a new ultrasound method to see if it can help identify bladder problems in men with benign prostatic hyperplasia (BPH) and guide their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2023 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05652023 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new noninvasive ultrasound method called Quantitative Ultrasound Bladder Vibrometry (QUBV) for assessing detrusor overactivity and aiding in treatment selection for benign prostatic hyperplasia (BPH). Participants will undergo QUBV ultrasound concurrently with a urodynamic study as part of their routine clinical care. The goal is to determine if this innovative approach can reliably detect abnormal bladder function.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for urodynamic studies due to bladder dysfunction or over 45 scheduled for prostate treatment.
Not a fit: Patients with obesity, known neurologic diseases affecting bladder function, or those who have had significant prior pelvic surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer and more effective way to assess bladder dysfunction and guide treatment decisions.
How similar studies have performed: While this approach is innovative, similar noninvasive methods have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Azra Alizad, MD — Mayo Clinic
- Study coordinator: Azra Alizad, MD
- Email: alizad.azra@mayo.edu
- Phone: 5075381727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.