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NCT04128709NARecruiting

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

Christopher Cooper

Start Date

11/19/2019

Completion Date

12/1/2026

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.

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 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.

Eligibility Criteria

Age Range: 1 years to 99 years

Inclusion Criteria: * must have diagnosed neurogenic bladder Exclusion Criteria: * None

Interventions

DEVICE

Urodynamics Testing

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Conditions

Urinary Bladder, Neurogenic

Locations

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242

United States