Patient Reported Outcome Study on Long Term LoFric Users

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 Overview

• Status: Active, not recruiting
• Conditions: Urinary Catheters

• Study Type: Observational
• Enrollment (Actual): 98

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Anticipated): October 8, 2024
• Study Completion (Anticipated): October 8, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LOF-0027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No