A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use

Laborie Medical Technologies Inc.5 enrolled

Overview

In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry method. In the home setting a human factor/usability study will be conducted to measure the subject's ability to perform a successful SMIP assessment at full and empty bladder with the Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean intermittent catheter (CIC).

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Urology

Interventions

Peritron+DEVICE

Peritron+ device to measure intravesical pressure

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children (2 to 18 years old) * Subjects who perform CIC regularly * Must be able to understand English instructions (written or oral) Exclusion Criteria: * Subjects suffering from symptomatic bladder infection

Outcomes

Primary Outcomes

Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.

Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group

Time frame: Through study completion, an average of 4 days

Data from ClinicalTrials.gov

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