Cystoealstometer (Bladder Monitor Device)-Home Use

  • STATUS
    Recruiting
  • End date
    Feb 1, 2025
  • participants needed
    30
  • sponsor
    University of Iowa
Updated on 21 March 2022

Summary

The investigators have developed a novel pressure monitoring device called a 'cystoelastometer' that connects to a drainage end ofastandard 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 in measuring bladder pressure compared to the gold standard urodynamics that are performed in the clinic or hospital. This study will assess the patients and care givers ability and experience using the cystoelastometer 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 and bladder volume monitoring device which is portable and attaches to the end of a standard urinary catheter and measures the pressure in the device and then assists in the drainage of the bladder and records the bladder volume. 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.

Details
Condition Urinary Bladder, Neurogenic
Treatment Cystoelastometer - Urodynamics Testing
Clinical Study IdentifierNCT05232253
SponsorUniversity of Iowa
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients seen in the University of Iowa Pediatric Urology Clinic with neurogenic bladder managed with clean intermittent catheterization
Patients who haven't had any change in management
Patients who had recently had UDS (urodynamic study) performed

Exclusion Criteria

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