MyelomeningoceleNCT04738539
Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
An observational study of Myelomeningocele and Neurogenic Bladder, run by University of Virginia at 1 site in United States.
Trial summary
The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelomeningocele, Neurogenic Bladder, Tethered Cord Syndrome
- What is being tested?
- Contrast Enhanced Voiding Urosonography with Urodynamic Testing and Urodynamic Testing
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 2 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics study.
Who may be able to join
- Age 0-17
- Must have had prior urodynamic study at UVA
Who cannot join
- Pregnant women (self-reported)
- Fetuses
- Neonates
- Prisoners
- Subjects with preexisting cardiac conditions (such as CHF and ventricular arrhythmias)
- Subjects with a known hypersensitivity to Lumason
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22911
Susan Leroy, MSN, 434-924-0123, svg5m@virginia.edu
About this study
The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.
Read the detailed description
Urodynamic studies routinely involve instillation of iohexol (OmnipaqueTM), a low osmolality contrast agent, into the bladder followed by fluoroscopic imaging to assess for reflux or variant anatomy of the genitourinary system. Recently, sulfur hexafluoride lipid-type A microspheres (LumasonTM), an ultrasound contrast agent, has been approved in the United States for intravesicular administration in the pediatric population. Contrast enhanced voiding urosonography (CEvUS) is being increasingly utilized in the place of voiding cystourethrograms, with the major advantages being decreased (zero) radiation for the patient, as well as decreased cost. Given the similarity in procedure between urodynamic studies (UDS) and voiding cystourethrograms, we hypothesize that a urodynamic study may be performed with contrast enhanced ultrasound instead of fluoroscopy. We plan to continue enrollment from our feasibility study and perform an efficacy study by recruiting a group of 105 patients under the age of 18, who are willing to undergo their normally schedule UDS using CEvUS to image the study in place of fluoroscopy. The UDS typically consists of two cycles of bladder filling and voiding; we intend replace the use of fluoroscopy and iohexel with ultrasound and sulfur hexafluoride lipid-type A microspheres. This will decrease the time commitment and eliminate radiation exposure for the patient. Data to be analyzed will include images from the study and patient/caregiver preference. Results from the ceVUS images will be compared to images obtained during previous tests imaged with fluoroscopy from the same patients currently enrolled in this study. Bladder shape and morphology, bladder neck configuration and performance, structure of the urethra, presence and degree of vesicoureteral reflux, and active voiding images will all be compared to fluoroscopy images from previous studies. The purpose of the study is to demonstrate that ceVUS is effective as an imaging technique for urodynamic studies, with an ultimate goal of using ceVUS instead of fluoroscopy in all urodynamic and voiding studies in order to decrease pediatric radiation exposure. The hypothesis is that ceVUS will be as effective for imaging urodynamics studies as fluoroscopy.
- Conditions
- Myelomeningocele, Neurogenic Bladder, Tethered Cord Syndrome, Bladder, Neurogenic, Urologic Diseases, Neurologic Dysfunction
- Being tested
- Contrast Enhanced Voiding Urosonography with Urodynamic Testing, Urodynamic Testing
- Keywords
- Contrast Enhanced Voiding Urosonography, Urodynamics, Neurogenic Bladder, Detrusor Sphincter Dyssynergia
- Medical subject headings
- Meningomyelocele, Urinary Bladder, Neurogenic, Neural Tube Defects, Urologic Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Voiding Urosonography with Urodynamic TestingDrug
Also called CeVUS, Contrast Enhanced Voiding Urosonography
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
Urodynamic TestingDiagnostic test
Also called Urodynamics
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
| Study group | Role | What they receive |
|---|---|---|
| Patients with or being evaluated for neurogenic bladder | Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics testing. Receives: Drug: Contrast Enhanced Voiding Urosonography with Urodynamic Testing; Diagnostic Test: Urodynamic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder shape and morphology
Comparison of previous fluroscopy images and ceVUS images
Measured: Procedure (At time of urodynamic investigation)
Bladder neck configuration
Comparison of previous fluroscopy images and ceVUS images
Measured: Procedure (At time of urodynamic investigation)
Structure of urethra
Comparison of previous fluroscopy images and ceVUS images
Measured: Procedure (At time of urodynamic investigation)
Presence and degree of VUR
Comparison of previous fluroscopy images and ceVUS images
Measured: Procedure (At time of urodynamic investigation)
Images of active voiding
Comparison of previous fluroscopy images and ceVUS images
Measured: Procedure (At time of urodynamic investigation)
Secondary outcomes (1)
Patient/caregiver preference
Comparison survey
Measured: Immediately following urodynamic investigation or up to 7 days after by phone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start2 Mar 2021
- Primary completion2 Mar 2022 (estimated)
- Study completion2 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyelomeningoceleStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Kern, MD, University of Virginia
- Investigators
- Nora G Kern, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738539
- Sponsor's protocol ID
- HSR200346
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drzewiecki BA, Bauer SB. Urodynamic testing in children: indications, technique, interpretation and significance. J Urol. 2011 Oct;186(4):1190-7. doi: 10.1016/j.juro.2011.02.2692. Epub 2011 Aug 16.
PubMed 21849190Fernbach SK, Feinstein KA, Schmidt MB. Pediatric voiding cystourethrography: a pictorial guide. Radiographics. 2000 Jan-Feb;20(1):155-68; discussion 168-71. doi: 10.1148/radiographics.20.1.g00ja12155.
PubMed 10682779Mane N, Sharma A, Patil A, Gadekar C, Andankar M, Pathak H. Comparison of contrast-enhanced voiding urosonography with voiding cystourethrography in pediatric vesicoureteral reflux. Turk J Urol. 2018 May;44(3):261-267. doi: 10.5152/tud.2018.76702. Epub 2018 Mar 6.
PubMed 29733800
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
- ClinicalTrials.gov ID
- NCT04738539
- Acronym / sponsor ID
- HSR200346
- Conditions
- Myelomeningocele, Neurogenic Bladder, Tethered Cord Syndrome, Bladder, Neurogenic, Urologic Diseases, Neurologic Dysfunction
- Keywords
- Contrast Enhanced Voiding Urosonography, Urodynamics, Neurogenic Bladder, Detrusor Sphincter Dyssynergia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 2 Mar 2022 (estimated)
- Study completion
- 2 Mar 2022 (estimated)
- First posted
- 4 Feb 2021 (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 investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.
Detailed description
Urodynamic studies routinely involve instillation of iohexol (OmnipaqueTM), a low osmolality contrast agent, into the bladder followed by fluoroscopic imaging to assess for reflux or variant anatomy of the genitourinary system. Recently, sulfur hexafluoride lipid-type A microspheres (LumasonTM), an ultrasound contrast agent, has been approved in the United States for intravesicular administration in the pediatric population. Contrast enhanced voiding urosonography (CEvUS) is being increasingly utilized in the place of voiding cystourethrograms, with the major advantages being decreased (zero) radiation for the patient, as well as decreased cost. Given the similarity in procedure between urodynamic studies (UDS) and voiding cystourethrograms, we hypothesize that a urodynamic study may be performed with contrast enhanced ultrasound instead of fluoroscopy. We plan to continue enrollment from our feasibility study and perform an efficacy study by recruiting a group of 105 patients under the age of 18, who are willing to undergo their normally schedule UDS using CEvUS to image the study in place of fluoroscopy. The UDS typically consists of two cycles of bladder filling and voiding; we intend replace the use of fluoroscopy and iohexel with ultrasound and sulfur hexafluoride lipid-type A microspheres. This will decrease the time commitment and eliminate radiation exposure for the patient. Data to be analyzed will include images from the study and patient/caregiver preference. Results from the ceVUS images will be compared to images obtained during previous tests imaged with fluoroscopy from the same patients currently enrolled in this study. Bladder shape and morphology, bladder neck configuration and performance, structure of the urethra, presence and degree of vesicoureteral reflux, and active voiding images will all be compared to fluoroscopy images from previous studies. The purpose of the study is to demonstrate that ceVUS is effective as an imaging technique for urodynamic studies, with an ultimate goal of using ceVUS instead of fluoroscopy in all urodynamic and voiding studies in order to decrease pediatric radiation exposure. The hypothesis is that ceVUS will be as effective for imaging urodynamics studies as fluoroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with or being evaluated for neurogenic bladder | – | Drug: Contrast Enhanced Voiding Urosonography with Urodynamic Testing, Diagnostic Test: Urodynamic TestingPediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics testing. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics study.
Key inclusion criteria (2 listed)
- Age 0-17
- Must have had prior urodynamic study at UVA
Key exclusion criteria (6 listed)
- Pregnant women (self-reported)
- Fetuses
- Neonates
- Prisoners
- Subjects with preexisting cardiac conditions (such as CHF and ventricular arrhythmias)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced Voiding Urosonography with Urodynamic TestingAlso: CeVUS, Contrast Enhanced Voiding UrosonographyWe will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder. | Drug | Patients with or being evaluated for neurogenic bladder |
| Urodynamic TestingAlso: UrodynamicsWe will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder. | Diagnostic test | Patients with or being evaluated for neurogenic bladder |
Primary outcome
Bladder shape and morphology
Time frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Bladder neck configuration
Time frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Structure of urethra
Time frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Presence and degree of VUR
Time frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Images of active voiding
Time frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
1 secondary outcome
Patient/caregiver preference
Time frame: Immediately following urodynamic investigation or up to 7 days after by phone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 21849190Drzewiecki BA, Bauer SB. Urodynamic testing in children: indications, technique, interpretation and significance. J Urol. 2011 Oct;186(4):1190-7. doi: 10.1016/j.juro.2011.02.2692. Epub 2011 Aug 16.
- Background: PubMed 10682779Fernbach SK, Feinstein KA, Schmidt MB. Pediatric voiding cystourethrography: a pictorial guide. Radiographics. 2000 Jan-Feb;20(1):155-68; discussion 168-71. doi: 10.1148/radiographics.20.1.g00ja12155.
- Background: PubMed 29733800Mane N, Sharma A, Patil A, Gadekar C, Andankar M, Pathak H. Comparison of contrast-enhanced voiding urosonography with voiding cystourethrography in pediatric vesicoureteral reflux. Turk J Urol. 2018 May;44(3):261-267. doi: 10.5152/tud.2018.76702. Epub 2018 Mar 6.
- Feasibility of Using Contrast Enhanced Voiding Urosonography (CeVUS) During Urodynamic Studies (NCT04170413)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Myelomeningocele
Active, not recruitingPhase 1
Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
Neural Tube Defects
Recruiting
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Spina Bifida
Recruiting
tSCS in Children With Spina Bifida
Spina Bifida, Myelomeningocele
Active, not recruiting
Fetoscopic NEOX Cord 1K® Spina Bifida Repair
Spina Bifida, Myelomeningocele
Enrolling by invitation
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Cerebral Palsy, Myelomeningocele
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. This study is not recruiting at the moment.
Nora G Kern, MD principal investigator
University of Virginia
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 Myelomeningocele and Neurogenic Bladder, run by University of Virginia 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan V Leroy, MSN (434-924-0123, svg5m@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder shape and morphology (time frame: Procedure (At time of urodynamic investigation)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738539, which also lists 3 linked publications.
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 28 Apr 2021.