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

ConditionUrinary Bladder, Neurogenic

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-99

SponsorChristopher Cooper

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

must have diagnosed neurogenic bladder

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Neurogenic Bladder PatientExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Home use of bladder pressure monitoring device

Utilization study of novel external device

Time frame

Two weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christopher Cooper

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov

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