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NCT04128709 Clinical Trial

Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use

Urinary Bladder, Neurogenic Clinical Trial

Official title:
Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04128709
Other study ID # 201905843
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 19, 2019
Est. completion date December 2024

Study information
Verified date September 2023
Source University of Iowa
Contact Christopher S Cooper, MD
Phone 319-384-8922
Email christopher-cooper@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters that are used by patients with a neurogenic bladder on daily clean intermittent catheterization. The device has already been demonstrated to be accurate compared to the gold standard in clinic urodynamics. This study will assess the patients and care givers ability and experience using the device in a home setting.

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 attaches to the end of a standard urinary catheter. The investigators will be investigating if this device can be used by patients or their caregivers in a home setting. This study will enroll patients with neurogenic bladder that currently perform clean intermittent catheterization on a daily basis as part of their regular care. The patients will be asked to use the device at least twice a day for two weeks.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 99 Years
Eligibility Inclusion Criteria: - must have diagnosed neurogenic bladder Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Urodynamics Testing
The non-invasive device connects to the end of urinary catheter that the patient uses for routine daily catheterization. Once urine flows into the device the patient presses a single button in order to obtain a pressure measurement which is recorded and stored in the device along with the time and date. The measurement(s) can later be transmitted wirelessly to a smart phone that contains an app for the device.

Locations
Country Name City State
United States University of Iowa Hospital and Clinics Iowa City Iowa

Sponsors (1)
Lead Sponsor Collaborator
Christopher Cooper

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Home use of bladder pressure monitoring device Utilization study of novel external device Two weeks
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