NCT02673944

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 24, 2016

Completed
Last Updated

June 24, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

January 29, 2016

Results QC Date

April 12, 2016

Last Update Submit

May 17, 2016

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Peritron+

EXPERIMENTAL

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

Device: Peritron+

Interventions

Peritron+DEVICE

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

Peritron+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients normally indicated for urodynamic evaluation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Researcher
Organization
Laborie
sbitzos@laborie.com
905-612-1170

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 4, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 24, 2016

Results First Posted

June 24, 2016

Record last verified: 2016-05