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NCT02673944 Clinical Trial

Portable Pves Study

Lower Urinary Tract Symptoms Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02673944
Other study ID # PLUS-PVES-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received January 29, 2016
Last updated February 1, 2016
Start date January 2016
Est. completion date February 2016

Study information
Verified date February 2016
Source Laborie Medical Technologies Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 12
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients normally indicated for urodynamic evaluation

Exclusion Criteria:

- Patients who suffer from bladder infections

- Patients who suffer from strictures in the urethra

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Laborie Medical Technologies Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Accurate Vesical PRessure To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position. During a routine urodynamic study (1 hr approx) No
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