Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Men and women, aged 18 years or above, practicing urethral intermittent catheterization. The patients should have used LoFric catheters ≥ 6 years for the purpose of urethral intermittent catheterization.
Not provided
Not provided
Not provided
Not provided
| 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 |