Intermittent CatheterizationNCT01796587
Non-Interventional Study Among Users Of LoFric Origo
An observational study of Intermittent Catheterization, run by Wellspect HealthCare at 19 sites in 6 countries.
Trial summary
Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale Secondary objectives: To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intermittent Catheterization
- What is being tested?
- LoFric Origo
- Type of treatment
- Medical device
- How many people
- 423 participants
- Where
- 19 sitesin 6 countries
- Study dates
- Jan 2013to Mar 2015
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients prescribed LoFric Origo for intermittent catheterization, attending any of the involved clinics.
Who may be able to join
- Provision of informed consent.
- Males, aged 18 years and over
- Practice intermittent self-catheterization, at least one time daily
- Subjects using LoFric Origo
- Able to read and fill out a patient reported questionnaire as judge by the investigator
- The prescription of/decision to use the medical device is separated from the decision to include the subject in the study.
Who cannot join
- Simultaneous participation in any interfering clinical study
- On-going, symptomatic urinary tract infection (UTI) at enrolment as judged by the investigator
- Involvement in the planning and/or conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- Previous enrolment in the present study.
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
France4 sites
Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie
Bordeaux, 33000
Hôpital Raymond Poincaré, Service de Neuro-Urologie, Urologie et Sexologie
Garche, 92380
Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales
Paris, 75020
Hôpital Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique
Saint-Genis-Laval, 69230
Norway4 sites
Akershus Universitetssykehus HF Urologisk poliklinikk
Lørenskog, 1478
Sunnaas Sykehus HF Urodynamisk laboratorium
Nesoddtangen, 1450
Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk
Oslo
Stavanger Universitetssjukehus, Urologisk poliklinikk
Stavanger, 4068
United Kingdom4 sites
University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital
Coventry, Coventry, CV2 2DX
Exeter RD&E Hospital
Exeter, EX2 5DW
National Hospital for Neurology and Neurosurgery Queens Square
London, WC1N 3GB
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Belgium3 sites
Centre de Traumatologie et de Readaptation
Brussels, 1020
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman
Liége, 4000
Netherlands2 sites
Rivas Zorggroep
Gorinchem, South Holland, 4204 AA
U.M.C. St. Radboud
Nijmegen, 6500
Switzerland2 sites
Schweizer Paraplegiker-Zentrum, Neuro-Urologie
Nottwil, 6207
Clinique romande de réadaptation
Sion, 1951
About this study
Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale
Secondary objectives:
Read more
- To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale
- To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale
- To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes.
Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users.
Medical Device: LoFric Origo
Study Variable(s):
- Primary variable: Use or No use of LoFric Origo after 8 weeks.
- Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.
- Conditions
- Intermittent Catheterization
- Being tested
- LoFric Origo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFric OrigoDevice
| Study group | Role | What they receive |
|---|---|---|
| LoFric Origo | Not described Receives: Device: LoFric Origo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects still using LoFric Origo
Outcome variable is to measure the proportion of subjects still using LoFric Origo after 8 weeks through subjective assessment scales.
Measured: 8 weeks
Secondary outcomes (2)
Perception of LoFric Origo
Perception is a subjective sensation/impression which may be expressed in different ways. The concept of Perception, in this observational study, reflects each subject's own experience when using LoFric Origo and the subjects will evaluate the catheters with respect to a number of predetermined variables.
Measured: 8 weeks
Discomfort
Evaluate subject's perceived discomfort associated with the use of the LoFric Origo, in terms of pain, burning sensation, bleeding and other discomfort.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent CatheterizationStudies 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
- 423 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
- NCT01796587
- Sponsor's protocol ID
- LOF-0017
- Status last verified
- May 2015
- First submitted
- 20 Feb 2013
- Last updated
- 8 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study Among Users Of LoFric Origo
- ClinicalTrials.gov ID
- NCT01796587
- Acronym / sponsor ID
- LOF-0017
- Conditions
- Intermittent Catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- First posted
- 22 Feb 2013 (estimated)
- 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.
Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale
Secondary objectives:
- To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale
- To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale
- To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes.
Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users.
Medical Device: LoFric Origo
Study Variable(s):
- Primary variable: Use or No use of LoFric Origo after 8 weeks.
- Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LoFric Origo | – | Device: LoFric Origo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prescribed LoFric Origo for intermittent catheterization, attending any of the involved clinics.
Key inclusion criteria (6 listed)
- Provision of informed consent.
- Males, aged 18 years and over
- Practice intermittent self-catheterization, at least one time daily
- Subjects using LoFric Origo
- Able to read and fill out a patient reported questionnaire as judge by the investigator
Key exclusion criteria (4 listed)
- Simultaneous participation in any interfering clinical study
- On-going, symptomatic urinary tract infection (UTI) at enrolment as judged by the investigator
- Involvement in the planning and/or conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- Previous enrolment in the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoFric Origo | Device | LoFric Origo |
Primary outcome
Proportion of subjects still using LoFric Origo
Time frame: 8 weeks
Outcome variable is to measure the proportion of subjects still using LoFric Origo after 8 weeks through subjective assessment scales.
2 secondary outcomes
Perception of LoFric Origo
Time frame: 8 weeks
Discomfort
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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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.
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intermittent Catheterization, run by Wellspect HealthCare at 19 sites in 6 countries.
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 6 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: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Norway, United Kingdom, Belgium, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects still using LoFric Origo (time frame: 8 weeks). 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 8 May 2015.