Urinary CathetersNCT05359198
Patient Reported Outcome Study on Long Term LoFric Users
An observational study of Urinary Catheters, run by Wellspect HealthCare.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Catheters
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 8 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Document urological complications
Number of UTIs last 12 months
Measured: 5 years
Document urological complications
Hospitalization due to UTI last 12 months
Measured: 5 years
Document urological complications
Urethral stricture last 12 months
Measured: 5 years
Document urological complications
Reflux last 12 months
Measured: 5 years
Document urological complications
Urosepsis last 12 months
Measured: 5 years
Document urological complications
Prostatitis last 12 months
Measured: 5 years
Document urological complications
Epididymitis last 12 months
Measured: 5 years
Document urological complications
Bladder stone(s) last 12 months
Measured: 5 years
Document urological complications
Incontinence
Measured: 5 years
Document urological complications
Other urological complications last 12 months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Compliance/non-compliance to LoFric
PRO variables Type of catheter used collected during study period
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jun 2015
- Primary completion8 Oct 2024 (estimated)
- Study completion8 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CathetersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359198
- Sponsor's protocol ID
- LOF-0027
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2022
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcome Study on Long Term LoFric Users
- ClinicalTrials.gov ID
- NCT05359198
- Acronym / sponsor ID
- LOF-0027
- Conditions
- Urinary Catheters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 8 Oct 2024 (estimated)
- Study completion
- 8 Oct 2024 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Document urological complications
Time frame: 5 years
Number of UTIs last 12 months
Document urological complications
Time frame: 5 years
Hospitalization due to UTI last 12 months
Document urological complications
Time frame: 5 years
Urethral stricture last 12 months
Document urological complications
Time frame: 5 years
Reflux last 12 months
Document urological complications
Time frame: 5 years
Urosepsis last 12 months
Document urological complications
Time frame: 5 years
Prostatitis last 12 months
Document urological complications
Time frame: 5 years
Epididymitis last 12 months
Document urological complications
Time frame: 5 years
Bladder stone(s) last 12 months
Document urological complications
Time frame: 5 years
Incontinence
Document urological complications
Time frame: 5 years
Other urological complications last 12 months
Quality of Life Data
Time frame: 5 years
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.
Patient perception of therapy
Time frame: 5 years
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.
Patient perception of LoFric
Time frame: 5 years
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.
Compliance/non-compliance to LoFric
Time frame: 5 years
PRO variables Type of catheter used collected during study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Catheters, run by Wellspect HealthCare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document urological complications (time frame: 5 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.