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

NCT ID: NCT03456089

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Urinary Bladder, Neurogenic Urodynamics

Keywords

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urodynamics neurogenic bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Neurogenic Bladder Patients

Patients with neurogenic bladder undergoing urodynamics testing

Group Type OTHER

Urodynamics Testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Urodynamics Testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-None
Minimum Eligible Age

1 Year

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christopher Cooper

OTHER

Sponsor Role lead

Responsible Party

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Christopher Cooper

Associate Dean

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chris Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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University of Iowa Hospitals and Clinics, Department of Urology

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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201702822

Identifier Type: -

Identifier Source: org_study_id