Portable Pves Study

A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional urodynamics the two sources of Pves will be collected concurrently.

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients normally indicated for urodynamic evaluation

Exclusion criteria

Patients who suffer from bladder infections
Patients who suffer from strictures in the urethra

Treatment and study plan

Peritron+

Device

Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure

Primary outcomes

Accurate Vesical PRessure

Time frame: During a routine urodynamic study (1 hr approx)

To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.

Sponsors and collaborators

Lead sponsor

Laborie Medical Technologies Inc.

Industry

Registry information

Official study title

An Accuracy Study to Assess the Performance of the Peritron+ in Measuring Vesical Pressure in Patients in Comparison With Standard Urodynamic Measurements

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Feb 4, 2016
Registry last updated: Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed