Patient Reported Outcome Study on Long Term LoFric Users

Study Overview
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Brief Summary
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A prospective, observational cohort study evaluating Patient Reported Outcome in subjects with a long term experience from intermittent catheterization using the LoFric catheter. Prescription and use of LoFric catheters fall within current practice and is not dictated within this Non-Interventional Study.

Official Title
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Patient Reported Outcome Study on Long Term LoFric Users

Conditions
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Urinary Catheters

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent. Female or male aged 18 years or older at time of signing informed consent. Use of LoFric catheters for urethral intermittent catheterization for ≥ 6 years and currently using LoFric. Able to read and write. By investigator judged as able to comprehend and answer study questionnaires. Exclusion Criteria: Use of other catheter brand(s) than LoFric for > 8 weeks in total during the past 12 months. Simultaneous participation in any interfering clinical study as judged by the investigator. Involvement in the planning and/or conduct of the NIS (applies to both Wellspect HealthCare staff and staff at the study site). Previous enrolment in the present NIS.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document urological complications | Number of UTIs last 12 months | 5 years | 
| Document urological complications | Hospitalization due to UTI last 12 months | 5 years | 
| Document urological complications | Urethral stricture last 12 months | 5 years | 
| Document urological complications | Reflux last 12 months | 5 years | 
| Document urological complications | Urosepsis last 12 months | 5 years | 
| Document urological complications | Prostatitis last 12 months | 5 years | 
| Document urological complications | Epididymitis last 12 months | 5 years | 
| Document urological complications | Bladder stone(s) last 12 months | 5 years | 
| Document urological complications | Incontinence | 5 years | 
| Document urological complications | Other urological complications last 12 months | 5 years | 
| Quality of Life Data | EQ-5D variables QoL data will be collected at each measuring point using the validated instrument EQ-5D-3L (EQ-5D). The EQ-5D, consisting of a questionnaire and a visual analogue scale (VAS), is a standardized health-related quality of life questionnaire developed by the EuroQoL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The VAS is a self-rated health status scale and records the subject's perception of his/her own current overall health and can be used to monitor changes over time. The questionnaire is a self-reported description of the subject's current health in 5 dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to grade their own current level of function in each dimension on a three-graded scale (i.e. no problems, some problems or severe problems) and the combination of these creates a unique health state. | 5 years | 
| Patient perception of therapy | PRO variables Four questions regarding perception of subject's intermittent catheter therapy. Response on a 4 graded scale; Strongly agree, agree, disagree, strongly disagree. Changes will be followed during study period. | 5 years | 
| Patient perception of LoFric | PRO variables Eight questions regarding perception of subject's catheter. Response on a 4 graded scale; Strongly agree, agree, disagree, strongly disagree. Changes will be followed during study period. | 5 years | 
| Compliance/non-compliance to LoFric | PRO variables Type of catheter used collected during study period | 5 years |