Cystoealstometer (Bladder Monitor Device)-Home Use

Urinary Bladder, Neurogenic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05232253
• Other study ID #: 202010469
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

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:

• phone which is not iOS compatible

Related Conditions & MeSH terms

• Urinary Bladder, Neurogenic

Intervention

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

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Home use of bladder pressure and volume monitoring device- Cystoelastometer	Utilization study of novel external cystoelastometer device - Home bladder pressure and volume monitor recorded in terms of cm H2O pressure and urine evacuation device with volume measurement in terms of milliliters.	Two weeks