Clinical trial NCT01796587: Non-Interventional Study Among Users Of LoFric Origo
Official title: Non-Interventional Study Among Users Of LoFric Origo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 423
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prescribed LoFric Origo for intermittent catheterization, attending any of the involved clinics.

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects still using LoFric Origo
timeFrame: 8 weeks
Secondary outcomes:
measure: Perception of LoFric Origo
timeFrame: 8 weeks
measure: Discomfort
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre de Traumatologie et de Readaptation
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liége
country: Belgium
facility: Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman
city: Bordeaux
country: France
facility: Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie
city: Garche
country: France
facility: Hôpital Raymond Poincaré, Service de Neuro-Urologie, Urologie et Sexologie
city: Paris
country: France
facility: Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales
city: St Genis Laval
country: France
facility: Hôpital Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique
city: Gorinchem
country: Netherlands
facility: Rivas Zorggroep
state: Zuid-Holland
city: Nijmegen
country: Netherlands
facility: U.M.C. St. Radboud
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus HF Urologisk poliklinikk
city: Nesoddtangen
country: Norway
facility: Sunnaas Sykehus HF Urodynamisk laboratorium
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk
city: Stavanger
country: Norway
facility: Stavanger Universitetssjukehus, Urologisk poliklinikk
city: Nottwil
country: Switzerland
facility: Schweizer Paraplegiker-Zentrum, Neuro-Urologie
city: Sion
country: Switzerland
facility: Clinique romande de réadaptation
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
state: Somerset
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital
city: Exeter
country: United Kingdom
facility: Exeter RD&E Hospital
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery Queens Square
Study officials:
References: