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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Christopher Cooper
Study ID
NCT04128709
Status
Recruiting
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Conditions

  • Urinary Bladder, Neurogenic

Eligibility Criteria

Sex
ALL
Age
1 Year - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Urodynamics Testing — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 19, 2019
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Neurogenic Bladder Patient
    Patients with neurogenic bladder

Primary Outcome Measure

Home use of bladder pressure monitoring device [ Time Frame: Two weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospital and ClinicsIowa CityIowa52242
Denise Juhr
[email protected]
319-356-1111
Christoper S Cooper, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Iowa Hospital and Clinics· Iowa City, IA

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