Cystoealstometer (Bladder Monitor Device)-Home Use

Not Applicable

Active, not recruiting

• Conditions: Urinary Bladder, Neurogenic
• Interventions: Device: Cystoelastometer - Urodynamics Testing

• Registration Number: NCT05232253
• Lead Sponsor: University of Iowa

Brief 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.

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 Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-29
• Study First Posted: 2022-02-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• phone which is not iOS compatible

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurogenic Bladder Patient	Cystoelastometer - Urodynamics Testing	Patients with neurogenic bladder

Primary Outcome Measures

Name	Time	Method
Home use of bladder pressure and volume monitoring device- Cystoelastometer	Two weeks	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.

Trial Locations

Locations (1)

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States