Patient Reported Outcome Study on Long Term LoFric Users

NCT05359198 | Unknown

• 1 other identifier: LOF-0027
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

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 of LoFric catheters fall within current practice and is not dictated within this Non-Interventional Study.

Conditions

Urinary Catheters

Outcome Measures

Primary Outcomes (14)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: June 1, 2015
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-04