Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03456089|
Recruitment Status : Enrolling by invitation
First Posted : March 7, 2018
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Bladder, Neurogenic Urodynamics||Diagnostic Test: Urodynamics Testing||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing|
|Actual Study Start Date :||April 15, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Neurogenic Bladder Patients
Patients with neurogenic bladder undergoing urodynamics testing
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
- Bladder Pressure [ Time Frame: During UDS testing ]Pressure of the bladder at bladder capacity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456089
|United States, Iowa|
|University of Iowa Hospitals and Clinics, Department of Urology|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Chris Cooper, MD||MD|