NCT03456089

Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Christopher Cooper · Academic / Other
• Sex: All
• Age: 1 Year – 99 Years
• Healthy volunteers: Not accepted

Summary

The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

Detailed description

For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions. This study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool. This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.

Conditions

• Urinary Bladder, Neurogenic
• Urodynamics

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urodynamics Testing	Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance

Timeline

• Start date: 2018-04-15
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2018-03-07
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study