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Patient Reported Outcome Stud...

Patient Reported Outcome Study on Long Term LoFric Users

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2024-10-08

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.

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Detailed Description

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Conditions

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Urinary Catheters

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Provision of informed consent.
2. Female or male aged 18 years or older at time of signing informed consent.
3. Use of LoFric catheters for urethral intermittent catheterization for ≥ 6 years and currently using LoFric.
4. Able to read and write.
5. By investigator judged as able to comprehend and answer study questionnaires.

Exclusion Criteria

1. Use of other catheter brand(s) than LoFric for \> 8 weeks in total during the past 12 months.
2. Simultaneous participation in any interfering clinical study as judged by the investigator.
3. Involvement in the planning and/or conduct of the NIS (applies to both Wellspect HealthCare staff and staff at the study site).
4. Previous enrolment in the present NIS.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers