N/A
Completed N=5
A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Urology
Source: ClinicalTrials.gov NCT02746406 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary. — 65 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary. |
65 | — |
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
Data sourced from ClinicalTrials.gov (NCT02746406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.