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

Primary Purpose

Urinary Bladder, Neurogenic, Urodynamics

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Urodynamics Testing

About this trial

This is an interventional other trial for Urinary Bladder, Neurogenic focused on measuring urodynamics, neurogenic, bladder

Eligibility Criteria

1 Year - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-None

Sites / Locations

University of Iowa Hospitals and Clinics, Department of Urology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Neurogenic Bladder Patients

Arm Description

Patients with neurogenic bladder undergoing urodynamics testing

Outcomes

Primary Outcome Measures

Bladder Pressure

Pressure of the bladder at bladder capacity

Secondary Outcome Measures

Full Information

NCT ID

NCT03456089

First Posted

February 28, 2018

Last Updated

September 12, 2023

Sponsor

Christopher Cooper

1. Study Identification

Unique Protocol Identification Number

NCT03456089

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 15, 2018 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Christopher Cooper

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Neurogenic, Urodynamics

Keywords

urodynamics, neurogenic, bladder

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neurogenic Bladder Patients

Arm Type

Other

Arm Description

Patients with neurogenic bladder undergoing urodynamics testing

Intervention Type

Diagnostic Test

Intervention Name(s)

Urodynamics Testing

Intervention Description

Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance

Primary Outcome Measure Information:

Title

Bladder Pressure

Description

Pressure of the bladder at bladder capacity

Time Frame

During UDS testing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: must have diagnosed neurogenic bladder undergoing urodynamics testing as part of routine clinical care Exclusion Criteria: -None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris Cooper, MD

Organizational Affiliation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics, Department of Urology

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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