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

Sponsor
Christopher Cooper (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03456089
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
62.5
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: Urodynamics Testing
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
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 :
Apr 15, 2018
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

  1. Bladder Pressure [During UDS testing]

    Pressure of the bladder at bladder capacity

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • must have diagnosed neurogenic bladder

  • undergoing urodynamics testing as part of routine clinical care

Exclusion Criteria:

-None

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Iowa Hospitals and Clinics, Department of Urology Iowa City Iowa United States 52242

Sponsors and Collaborators

  • Christopher Cooper

Investigators

  • Principal Investigator: Chris Cooper, MD, MD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Cooper, Associate Dean, University of Iowa
ClinicalTrials.gov Identifier:
NCT03456089
Other Study ID Numbers:
  • 201702822
First Posted:
Mar 7, 2018
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Christopher Cooper, Associate Dean, University of Iowa
urodynamics
neurogenic
bladder
Additional relevant MeSH terms:
Urinary Bladder, Neurogenic

Study Results

No Results Posted as of May 18, 2022