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

NCT04128709 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-22

No results posted yet for this study

Summary

The investigators have developed a novel pressure monitoring device that hooks to standard 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 compared to the gold standard in clinic urodynamics. This study will assess the patients and care givers ability and experience using the device in a home setting.

Conditions

  • Urinary Bladder, Neurogenic

Interventions

DEVICE

Urodynamics Testing

The non-invasive device connects to the end of urinary catheter that the patient uses for routine daily catheterization. Once urine flows into the device the patient presses a single button in order to obtain a pressure measurement which is recorded and stored in the device along with the time and date. The measurement(s) can later be transmitted wirelessly to a smart phone that contains an app for the device.

Sponsors & Collaborators

  • Christopher Cooper

    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
1 Year
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2026-12-31
Completion
2026-12-31
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 NCT04128709 on ClinicalTrials.gov