Status:
UNKNOWN
Patient Reported Outcome Study on Long Term LoFric Users
Lead Sponsor:
Wellspect HealthCare
Conditions:
Urinary Catheters
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05359198
Start Date
June 1 2015
End Date
October 8 2024
Last Update
May 6 2023
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