Intermittent Catheterization
Conditions
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 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.
Interventions
DEVICELoFric Origo
Sponsors
Wellspect HealthCare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent. 2. Males, aged 18 years and over 3. Practice intermittent self-catheterization, at least one time daily 4. Subjects using LoFric Origo 5. Able to read and fill out a patient reported questionnaire as judge by the investigator 6. The prescription of/decision to use the medical device is separated from the decision to include the subject in the study.
Exclusion criteria
1. Simultaneous participation in any interfering clinical study 2. On-going, symptomatic urinary tract infection (UTI) at enrolment as judged by the investigator 3. Involvement in the planning and/or conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site) 4. Previous enrolment in the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects still using LoFric Origo | 8 weeks | Outcome variable is to measure the proportion of subjects still using LoFric Origo after 8 weeks through subjective assessment scales. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of LoFric Origo | 8 weeks | 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. |
| Discomfort | 8 weeks | Evaluate subject's perceived discomfort associated with the use of the LoFric Origo, in terms of pain, burning sensation, bleeding and other discomfort. |
Countries
Belgium, France, Netherlands, Norway, Switzerland, United Kingdom
Outcome results
None listed