N/A N=5

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

Urology

Bottom Line

View on ClinicalTrials.gov: NCT02746406 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary. — 65 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Peritron+ (Device)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: Laborie Medical Technologies Inc.
Primary completion: Jul 2016

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	—

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).

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

View full record on ClinicalTrials.gov →

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.