Cystoealstometer (Bladder Monitor Device)-Home Use

NCT05232253 | Active Not Recruiting FDA Device

• 1 other identifier: 202010469
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder, Neurogenic

Keywords

urodynamics; neurogenic; bladder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Neurogenic Bladder Patient

EXPERIMENTAL

Patients with neurogenic bladder

Device: Cystoelastometer - Urodynamics Testing

Interventions

Cystoelastometer - Urodynamics Testing DEVICE

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.

Neurogenic Bladder Patient

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• phone which is not iOS compatible

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher S Cooper, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 9, 2022
• Study Start: January 18, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)