Non-Interventional Study Among Users Of LoFric Origo

Intermittent Catheterization Clinical Trial

Official title:

Non-Interventional Study Among Users Of LoFric Origo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796587
• Other study ID #: LOF-0017
• Status: Completed
• Phase: N/A
• First received: February 20, 2013
• Last updated: May 7, 2015
• Start date: January 2013

Study information

• Verified date: May 2015
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeNorway: Regional Ethics Commitee
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intermittent Catheterization

Intervention

Device:
• LoFric Origo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  Norway,  Switzerland,  United Kingdom, 

Outcome

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