Non-Interventional Study Among Users Of LoFric Origo

Study Overview
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Brief Summary
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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.

Official Title
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Non-Interventional Study Among Users Of LoFric Origo

Conditions
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Intermittent Catheterization

Intervention / Treatment
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* Device: LoFric Origo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LoFric Origo<br> | Device: LoFric Origo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects still using LoFric Origo | Outcome variable is to measure the proportion of subjects still using LoFric Origo after 8 weeks through subjective assessment scales. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of LoFric Origo | Perception is a subjective sensation/impression which may be expressed in different ways. The concept of Perception, in this observational study, reflects each subject's own experience when using LoFric Origo and the subjects will evaluate the catheters with respect to a number of predetermined variables. | 8 weeks | 
| Discomfort | Evaluate subject's perceived discomfort associated with the use of the LoFric Origo, in terms of pain, burning sensation, bleeding and other discomfort. | 8 weeks |