Recruiting

Urodynamic Studies

Sponsor:

University of Virginia

Code:

NCT04738539

Conditions

Myelomeningocele

Neurogenic Bladder

Tethered Cord Syndrome

Bladder, Neurogenic

Urologic Diseases

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Contrast Enhanced Voiding Urosonography with Urodynamic Testing

Urodynamic Testing

Study Details

Brief summary:

The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.

Conditions

Myelomeningocele

Neurogenic Bladder

Tethered Cord Syndrome

Bladder, Neurogenic

Urologic Diseases

Study ID

NCT04738539

Start date

Mar 2, 2021

Status verified date

Apr, 2021

Completion date

Mar 2, 2022

Anticipated

Primary completion date

Mar 2, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

105 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with or being evaluated for neurogenic bladder

Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics testing.

Interventions

Contrast Enhanced Voiding Urosonography with Urodynamic Testing

We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.

Urodynamic Testing

We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.

Primary outcome measure

  • Bladder shape and morphology [ Time Frame: Procedure (At time of urodynamic investigation) ]
  • Bladder neck configuration [ Time Frame: Procedure (At time of urodynamic investigation) ]
  • Structure of urethra [ Time Frame: Procedure (At time of urodynamic investigation) ]
  • Presence and degree of VUR [ Time Frame: Procedure (At time of urodynamic investigation) ]
  • Images of active voiding [ Time Frame: Procedure (At time of urodynamic investigation) ]

Central Contacts and Locations

Central contacts

Susan V Leroy, MSN

434-924-0123svg5m@virginia.edu

Nora G Kern, MD

434-924-0123ngl2z@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22911

Contacts

Susan Leroy, MSN

434-924-0123svg5m@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Keywords

  • Contrast Enhanced Voiding Urosonography
  • Urodynamics
  • Neurogenic Bladder
  • Detrusor Sphincter Dyssynergia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2021-04-28.