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Non-Interventional Study Among Users Of LoFric Origo

NCT01796587 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 423

Last updated 2015-05-08

No results posted yet for this study

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

DEVICE

LoFric Origo

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-03-31

Countries

  • Belgium
  • France
  • Netherlands
  • Norway
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01796587 on ClinicalTrials.gov