Bladder DysfunctionNUADDNCT05652023
Noninvasive Ultrasound Assessment of Detrusor Dysfunction
An observational study of Bladder Dysfunction and Overactive Bladder, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Dysfunction, Overactive Bladder, BPH With Urinary Obstruction
- How many people
- 2,023 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 20 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Katie Barthels, 507-538-5772, barthels.kathryn@mayo.edu
Azra Alizad, MD
About this study
The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.
Read the 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.
- Keywords
- Detrusor Pressure, Bladder Compliance, Ultrasound, Ultrasound Vibrometery
- Medical subject headings
- Urinary Bladder, Overactive
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure
Will be reported including 95% confidence intervals derived from the cross-validation procedure.
Measured: 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
Will be reported including 95% confidence intervals derived from the cross-validation
Measured: time Frame: Up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start20 Apr 2023
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,023 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azra Alizad, Mayo Clinic
- Investigators
- Azra Alizad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652023
- Sponsor's protocol ID
- 21-011734
- Acronym
- NUADD
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ultrasound Assessment of Detrusor Dysfunction
- ClinicalTrials.gov ID
- NCT05652023
- Acronym / sponsor ID
- NUADD / 21-011734
- Keywords
- Detrusor Pressure, Bladder Compliance, Ultrasound, Ultrasound Vibrometery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,023 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azra Alizad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Dysfunction and Overactive Bladder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azra Alizad, MD (5075381727, alizad.azra@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure (time frame: time Frame: Up to study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.