Urologic Diseases Clinical Trial
Official title:
Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
NCT number | NCT04738539 |
Other study ID # | HSR200346 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2, 2021 |
Est. completion date | March 2, 2022 |
The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | March 2, 2022 |
Est. primary completion date | March 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - Age 0-17 - Must have had prior urodynamic study at UVA Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
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. Review. — View Citation
Fernbach SK, Feinstein KA, Schmidt MB. Pediatric voiding cystourethrography: a pictorial guide. Radiographics. 2000 Jan-Feb;20(1):155-68; discussion 168-71. Review. — View Citation
Mane 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bladder shape and morphology | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | |
Primary | Bladder neck configuration | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | |
Primary | Structure of urethra | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | |
Primary | Presence and degree of VUR | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | |
Primary | Images of active voiding | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | |
Secondary | Patient/caregiver preference | Comparison survey | Immediately following urodynamic investigation or up to 7 days after by phone |
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