Cystoealstometer (Bladder Monitor Device)-Home Use

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Bladder, Neurogenic
• Intervention / Treatment: Device: Cystoelastometer - Urodynamics Testing

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neurogenic Bladder Patient; Patients with neurogenic bladder

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Christopher S Cooper, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: bladder; neurogenic; urodynamics
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 202010469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No