Non-Interventional Study Among Users Of LoFric Origo

Completed

• Conditions: Intermittent Catheterization
• Interventions: Device: LoFric Origo

• Registration Number: NCT01796587
• Lead Sponsor: Wellspect HealthCare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 423

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LoFric Origo	LoFric Origo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects still using LoFric Origo	8 weeks	Outcome variable is to measure the proportion of subjects still using LoFric Origo after 8 weeks through subjective assessment scales.

Secondary Outcome Measures

Name	Time	Method
Perception of LoFric Origo	8 weeks	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.
Discomfort	8 weeks	Evaluate subject's perceived discomfort associated with the use of the LoFric Origo, in terms of pain, burning sensation, bleeding and other discomfort.

Trial Locations

Locations (19)

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 Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique; 🇫🇷 St Genis Laval, France

Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales; 🇫🇷 Paris, France

Akershus Universitetssykehus HF Urologisk poliklinikk; 🇳🇴 Lørenskog, Norway

Rivas Zorggroep; 🇳🇱 Gorinchem, Zuid-Holland, Netherlands

U.M.C. St. Radboud; 🇳🇱 Nijmegen, Netherlands

Sunnaas Sykehus HF Urodynamisk laboratorium; 🇳🇴 Nesoddtangen, Norway

Stavanger Universitetssjukehus, Urologisk poliklinikk; 🇳🇴 Stavanger, Norway

University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital; 🇬🇧 Coventry, United Kingdom

Schweizer Paraplegiker-Zentrum, Neuro-Urologie; 🇨🇭 Nottwil, Switzerland

Exeter RD&E Hospital; 🇬🇧 Exeter, United Kingdom

Clinique romande de réadaptation; 🇨🇭 Sion, Switzerland

Musgrove Park Hospital; 🇬🇧 Taunton, Somerset, United Kingdom

National Hospital for Neurology and Neurosurgery Queens Square; 🇬🇧 London, United Kingdom

Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk; 🇳🇴 Oslo, Norway