Portable Pves Study

NCT ID: NCT02673944

Last Updated: 2016-06-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Peritron+

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

Group Type EXPERIMENTAL

Peritron+

Intervention Type DEVICE

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

Interventions

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Peritron+

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients normally indicated for urodynamic evaluation

Exclusion Criteria

* Patients who suffer from bladder infections
* Patients who suffer from strictures in the urethra
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laborie Medical Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PLUS-PVES-01

Identifier Type: -

Identifier Source: org_study_id

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