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

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ClinicalTrials.gov Identifier: NCT03456089
Recruitment Status : Enrolling by invitation
First Posted : March 7, 2018
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Cooper, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Urinary Bladder, Neurogenic Urodynamics Diagnostic Test: Urodynamics Testing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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, 2019
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Bladder Pressure [ Time Frame: During UDS testing ]
    Pressure of the bladder at bladder capacity



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-None


Information from the National Library of Medicine

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


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics, Department of Urology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Christopher Cooper
Investigators
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Principal Investigator: Chris Cooper, MD MD

Additional Information:

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Responsible Party: Christopher Cooper, Associate Dean, University of Iowa
ClinicalTrials.gov Identifier: NCT03456089     History of Changes
Other Study ID Numbers: 201702822
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Christopher Cooper, University of Iowa:
urodynamics
neurogenic
bladder

Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms