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

Christopher Cooper

Status: Invitation-only

Conditions: Urodynamics; Urinary Bladder, Neurogenic

Treatments: Diagnostic Test: Urodynamics Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03456089

201702822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must have diagnosed neurogenic bladder
• undergoing urodynamics testing as part of routine clinical care

Exclusion criteria

-None

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Neurogenic Bladder Patients

Other group

Description:

Patients with neurogenic bladder undergoing urodynamics testing

Treatment:

Diagnostic Test: Urodynamics Testing