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

Not Applicable

• Conditions: Urinary Bladder, Neurogenic; Urodynamics
• Interventions: Diagnostic Test: Urodynamics Testing

• Registration Number: NCT03456089
• Lead Sponsor: Christopher Cooper

Brief 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.

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-07
• Study Start: 2018-04-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

-None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurogenic Bladder Patients	Urodynamics Testing	Patients with neurogenic bladder undergoing urodynamics testing

Primary Outcome Measures

Name	Time	Method
Bladder Pressure	During UDS testing	Pressure of the bladder at bladder capacity

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics, Department of Urology; 🇺🇸 Iowa City, Iowa, United States