A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urology
- Sponsor
- Laborie Medical Technologies Inc.
- Enrollment
- 5
- Primary Endpoint
- Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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.
Time Frame: Through study completion, an average of 4 days
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