Intermittent Catheterization Clinical Trial
Official title:
Non-Interventional Study Among Users Of LoFric Origo
NCT number | NCT01796587 |
Other study ID # | LOF-0017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | February 20, 2013 |
Last updated | May 7, 2015 |
Start date | January 2013 |
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.
Status | Completed |
Enrollment | 423 |
Est. completion date | |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Provision of informed consent. 2. Males, aged 18 years and over 3. Practice intermittent self-catheterization, at least one time daily 4. Subjects using LoFric Origo 5. Able to read and fill out a patient reported questionnaire as judge by the investigator 6. The prescription of/decision to use the medical device is separated from the decision to include the subject in the study. Exclusion Criteria 1. Simultaneous participation in any interfering clinical study 2. On-going, symptomatic urinary tract infection (UTI) at enrolment as judged by the investigator 3. Involvement in the planning and/or conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site) 4. Previous enrolment in the present study. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | Centre de Traumatologie et de Readaptation | Brussels | |
Belgium | UZ Leuven | Leuven | |
Belgium | Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman | Liége | |
France | Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie | Bordeaux | |
France | Hôpital Raymond Poincaré, Service de Neuro-Urologie, Urologie et Sexologie | Garche | |
France | Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales | Paris | |
France | Hôpital Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique | St Genis Laval | |
Netherlands | Rivas Zorggroep | Gorinchem | Zuid-Holland |
Netherlands | U.M.C. St. Radboud | Nijmegen | |
Norway | Akershus Universitetssykehus HF Urologisk poliklinikk | Lørenskog | |
Norway | Sunnaas Sykehus HF Urodynamisk laboratorium | Nesoddtangen | |
Norway | Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk | Oslo | |
Norway | Stavanger Universitetssjukehus, Urologisk poliklinikk | Stavanger | |
Switzerland | Schweizer Paraplegiker-Zentrum, Neuro-Urologie | Nottwil | |
Switzerland | Clinique romande de réadaptation | Sion | |
United Kingdom | University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital | Coventry | |
United Kingdom | Exeter RD&E Hospital | Exeter | |
United Kingdom | National Hospital for Neurology and Neurosurgery Queens Square | London | |
United Kingdom | Musgrove Park Hospital | Taunton | Somerset |
Lead Sponsor | Collaborator |
---|---|
Wellspect HealthCare |
Belgium, France, Netherlands, Norway, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8 weeks | No |
Secondary | 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. | 8 weeks | No |
Secondary | Discomfort | Evaluate subject's perceived discomfort associated with the use of the LoFric Origo, in terms of pain, burning sensation, bleeding and other discomfort. | 8 weeks | Yes |
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