NCT01796587

Non-Interventional Study Among Users Of LoFric Origo

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 423 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intermittent Catheterization

Interventions

Type	Name	Description
DEVICE	LoFric Origo

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-03-01
• First posted: 2013-02-22
• Last updated: 2015-05-08

Locations

19 sites across 6 countries: Belgium, France, Netherlands, Norway, Switzerland, United Kingdom