Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
423 participants
OBSERVATIONAL
2013-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LoFric Origo
LoFric Origo
Interventions
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LoFric Origo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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Wellspect HealthCare
INDUSTRY
Responsible Party
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Locations
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Centre de Traumatologie et de Readaptation
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman
Liége, , Belgium
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
Saint-Genis-Laval, , France
Rivas Zorggroep
Gorinchem, South Holland, Netherlands
U.M.C. St. Radboud
Nijmegen, , Netherlands
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, , Norway
Schweizer Paraplegiker-Zentrum, Neuro-Urologie
Nottwil, , Switzerland
Clinique romande de réadaptation
Sion, , Switzerland
University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital
Coventry, Coventry, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Exeter RD&E Hospital
Exeter, , United Kingdom
National Hospital for Neurology and Neurosurgery Queens Square
London, , United Kingdom
Countries
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Other Identifiers
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LOF-0017
Identifier Type: -
Identifier Source: org_study_id
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