Non-Interventional Study Among Users Of LoFric Origo

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.

Study Overview

• Status: Completed
• Conditions: Intermittent Catheterization
• Intervention / Treatment: Device: LoFric Origo

• Study Type: Observational
• Enrollment (Actual): 423

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Centre de Traumatologie et de Readaptation
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liége, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman
• France
  • Bordeaux, France, 33000
    • Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie
  • Garche, France, 92380
    • Hôpital Raymond Poincaré, Service de Neuro-Urologie, Urologie et Sexologie
  • Paris, France, 75020
    • Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales
  • St Genis Laval, France, 69230
    • Hôpital Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique
• Netherlands
  • Nijmegen, Netherlands, 6500
    • U.M.C. St. Radboud
  • Zuid-Holland
    • Gorinchem, Zuid-Holland, Netherlands, 4204 AA
      • Rivas zorggroep
• Norway
  • Lørenskog, Norway, 1478
    • Akershus Universitetssykehus HF Urologisk poliklinikk
  • Nesoddtangen, Norway, 1450
    • Sunnaas Sykehus HF Urodynamisk laboratorium
  • Oslo, Norway
    • Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk
  • Stavanger, Norway, 4068
    • Stavanger Universitetssjukehus, Urologisk poliklinikk
• Switzerland
  • Nottwil, Switzerland, 6207
    • Schweizer Paraplegiker-Zentrum, Neuro-Urologie
  • Sion, Switzerland, 1951
    • Clinique romande de réadaptation
• United Kingdom
  • Coventry, United Kingdom, CV2 2DX
    • University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital
  • Exeter, United Kingdom, EX2 5DW
    • Exeter RD&E Hospital
  • London, United Kingdom, WC1N 3GB
    • National Hospital for Neurology and Neurosurgery Queens Square
  • Somerset
    • Taunton, Somerset, United Kingdom, TA1 5DA
      • Musgrove Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients prescribed LoFric Origo for intermittent catheterization, attending any of the involved clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LoFric Origo	Device: LoFric Origo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Estimate): May 8, 2015
• Last Update Submitted That Met QC Criteria: May 7, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: LOF-0017