Patient Reported Outcome Study on Long Term LoFric Users

Urinary Catheters Clinical Trial

Official title:

Patient Reported Outcome Study on Long Term LoFric Users

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05359198
• Other study ID #: LOF-0027
• Status: Active, not recruiting
• Start date: June 1, 2015
• Est. completion date: October 8, 2024

Study information

• Verified date: April 2023
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: October 8, 2024
• Est. primary completion date: October 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Catheters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document urological complications	Number of UTIs last 12 months	5 years
Primary	Document urological complications	Hospitalization due to UTI last 12 months	5 years
Primary	Document urological complications	Urethral stricture last 12 months	5 years
Primary	Document urological complications	Reflux last 12 months	5 years
Primary	Document urological complications	Urosepsis last 12 months	5 years
Primary	Document urological complications	Prostatitis last 12 months	5 years
Primary	Document urological complications	Epididymitis last 12 months	5 years
Primary	Document urological complications	Bladder stone(s) last 12 months	5 years
Primary	Document urological complications	Incontinence	5 years
Primary	Document urological complications	Other urological complications last 12 months	5 years
Primary	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
Primary	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
Primary	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
Primary	Compliance/non-compliance to LoFric	PRO variables Type of catheter used collected during study period	5 years