Non-Interventional Study Among Users Of LoFric Origo

Intermittent Catheterization Clinical Trial

Official title: Non-Interventional Study Among Users Of LoFric Origo

Status Completed

Clinical Trial Summary

Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale

Secondary objectives:

• To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale

• To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale

• To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes.

Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users.

Medical Device: LoFric Origo

Study Variable(s):

• Primary variable: Use or No use of LoFric Origo after 8 weeks.

• Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intermittent Catheterization

• NCT number: NCT01796587
• Study type: Observational
• Source: Wellspect HealthCare
• Status: Completed
• Phase: N/A
• Start date: January 2013