Portable Pves Study

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Device: Peritron+

• Registration Number: NCT02673944
• Lead Sponsor: Laborie Medical Technologies Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-04-12
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-17
• Last Update Submitted: 2016-05-17
• Results First Posted: 2016-06-24
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peritron+	Peritron+	Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter

Primary Outcome Measures

Name	Time	Method
Accurate Vesical PRessure	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.