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Portable Pves Study

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ClinicalTrials.gov Identifier: NCT02673944
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Device: Peritron+ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Accuracy Study to Assess the Performance of the Peritron+ in Measuring Vesical Pressure in Patients in Comparison With Standard Urodynamic Measurements
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Peritron+
Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter
Device: Peritron+
Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients normally indicated for urodynamic evaluation

Exclusion Criteria:

  • Patients who suffer from bladder infections
  • Patients who suffer from strictures in the urethra
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Responsible Party: Laborie Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT02673944    
Other Study ID Numbers: PLUS-PVES-01
First Posted: February 4, 2016    Key Record Dates
Results First Posted: June 24, 2016
Last Update Posted: June 24, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations