Skip to main content
OpenTrials
Completed

NCT Number: NCT01796587

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intermittent Catheterization

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Centre de Traumatologie et de Readaptation, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

LoFric Origo

Device

Primary outcomes

  1. Proportion of subjects still using LoFric Origo

    Time frame: 8 weeks

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

Secondary outcomes

  1. Perception of LoFric Origo

    Time frame: 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.

  2. Discomfort

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
First posted
Feb 22, 2013
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.