Status:
COMPLETED
Non-Interventional Study Among Users Of LoFric Origo
Lead Sponsor:
Wellspect HealthCare
Conditions:
Intermittent Catheterization
Eligibility:
MALE
18+ years
Brief 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 o...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Provision of informed consent.
- Males, aged 18 years and over
- Practice intermittent self-catheterization, at least one time daily
- Subjects using LoFric Origo
- Able to read and fill out a patient reported questionnaire as judge by the investigator
- The prescription of/decision to use the medical device is separated from the decision to include the subject in the study.
- Exclusion Criteria
- Simultaneous participation in any interfering clinical study
- On-going, symptomatic urinary tract infection (UTI) at enrolment as judged by the investigator
- Involvement in the planning and/or conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- Previous enrolment in the present study.
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT01796587
Start Date
January 1 2013
Last Update
May 8 2015
Active Locations (19)
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1
Centre de Traumatologie et de Readaptation
Brussels, Belgium, 1020
2
UZ Leuven
Leuven, Belgium, 3000
3
Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman
Liége, Belgium, 4000
4
Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie
Bordeaux, France, 33000