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ACTIVE NOT RECRUITING
NCT05232253
NA

Cystoealstometer (Bladder Monitor Device)-Home Use

Sponsor: University of Iowa

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Months - 99 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-01-18

Completion Date

2027-02-01

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

DEVICE

Cystoelastometer - Urodynamics Testing

The non-invasive cystoelastometer device connects to the drainage end of urinary catheter that the patient uses for routine daily catheterization. Once urine flows into the device a pressure measurement is recorded and stored in the device along with the time and date. The remaining urine is then evacuated through the catheter and device and the cystoelastometer records the volume of urine evacuated. The measurement(s) of bladder pressure and volume as well as the time and date can later be transmitted wirelessly to a smart phone that contains an app for the device.

Locations (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States