A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Not Applicable
Completed
- Conditions
- Urology
- Interventions
- Device: Peritron+
- Registration Number
- NCT02746406
- Lead Sponsor
- Laborie Medical Technologies Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Peritron+ Peritron+ SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter
- Primary Outcome Measures
Name Time Method Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary. 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
- Secondary Outcome Measures
Name Time Method