Non-Interventional Study Among Users Of LoFric Origo

Wellspect HealthCare423 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

423

Conditions

Intermittent Catheterization

Interventions

LoFric OrigoDEVICE

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

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 Tenon, Service de Neuro-Urologie et Explorations Périnéales

Paris, France

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

Saint-Genis-Laval, France

Rivas Zorggroep

Gorinchem, South Holland, Netherlands

U.M.C. St. Radboud

Nijmegen, Netherlands

Akershus Universitetssykehus HF Urologisk poliklinikk

Lørenskog, Norway

...and 9 more locations

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 8 weeks