NCT01796587

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for all trials

Geographic Reach
6 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

February 20, 2013

Last Update Submit

May 7, 2015

Conditions

Intermittent Catheterization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Perception of LoFric Origo

    8 weeks

  • Discomfort

    8 weeks

Study Arms (1)

LoFric Origo

Device: LoFric Origo

Interventions

LoFric OrigoDEVICE
LoFric Origo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Provision of informed consent.
  • Males, aged 18 years and over
  • Practice intermittent self-catheterization, at least one time daily
  • Subjects using LoFric Origo
  • Able to read and fill out a patient reported questionnaire as judge by the investigator
  • The prescription of/decision to use the medical device is separated from the decision to include the subject in the study.

You may not qualify if:

  • Simultaneous participation in any interfering clinical study
  • On-going, symptomatic urinary tract infection (UTI) at enrolment as judged by the investigator
  • Involvement in the planning and/or conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
  • Previous enrolment in the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Centre de Traumatologie et de Readaptation

Brussels, 1020, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman

Liége, 4000, Belgium

Location

Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie

Bordeaux, 33000, France

Location

Hôpital Raymond Poincaré, Service de Neuro-Urologie, Urologie et Sexologie

Garche, 92380, France

Location

Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales

Paris, 75020, France

Location

Hôpital Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique

Saint-Genis-Laval, 69230, France

Location

Rivas Zorggroep

Gorinchem, South Holland, 4204 AA, Netherlands

Location

U.M.C. St. Radboud

Nijmegen, 6500, Netherlands

Location

Akershus Universitetssykehus HF Urologisk poliklinikk

Lørenskog, 1478, Norway

Location

Sunnaas Sykehus HF Urodynamisk laboratorium

Nesoddtangen, 1450, Norway

Location

Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk

Oslo, Norway

Location

Stavanger Universitetssjukehus, Urologisk poliklinikk

Stavanger, 4068, Norway

Location

Schweizer Paraplegiker-Zentrum, Neuro-Urologie

Nottwil, 6207, Switzerland

Location

Clinique romande de réadaptation

Sion, 1951, Switzerland

Location

University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital

Coventry, Coventry, CV2 2DX, United Kingdom

Location

Musgrove Park Hospital

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Exeter RD&E Hospital

Exeter, EX2 5DW, United Kingdom

Location

National Hospital for Neurology and Neurosurgery Queens Square

London, WC1N 3GB, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

NO(4)NL(2)CH(2)FR(4)BE(3)GB(4)