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Cystoealstometer (Bladder Monitor Device)-Home Use

NCT05232253 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Christopher S Cooper, MD · University of Iowa

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2026-02-01
Completion
2027-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232253 on ClinicalTrials.gov