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.
Study Type
OBSERVATIONAL
Enrollment
98
Document urological complications
Number of UTIs last 12 months
Time frame: 5 years
Document urological complications
Hospitalization due to UTI last 12 months
Time frame: 5 years
Document urological complications
Urethral stricture last 12 months
Time frame: 5 years
Document urological complications
Reflux last 12 months
Time frame: 5 years
Document urological complications
Urosepsis last 12 months
Time frame: 5 years
Document urological complications
Prostatitis last 12 months
Time frame: 5 years
Document urological complications
Epididymitis last 12 months
Time frame: 5 years
Document urological complications
Bladder stone(s) last 12 months
Time frame: 5 years
Document urological complications
Incontinence
Time frame: 5 years
Document urological complications
Other urological complications last 12 months
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Compliance/non-compliance to LoFric
PRO variables Type of catheter used collected during study period
Time frame: 5 years