Non-Interventional Study Among Users Of LoFric Origo | NCT01796587

Studies
Non-Interventional Study Among Users Of LoFric Origo

NCT01796587

Sponsor

Wellspect HealthCare

Status

Completed

Last Update Posted

May 8, 2015Estimated

Enrollment

423Actual

Phase

Not provided

Conditions

Intermittent Catheterization

Interventions

LoFric Origo

Countries

Belgium
France
Netherlands
Norway
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Mar 2015Actual

Completion Date

Not provided

First Submitted Date

Feb 20, 2013

First Submission Date that Met QC Criteria

Feb 20, 2013

First Posted Date

Feb 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2015

Last Update Posted Date

May 8, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

423Actual

Label	Type	Description	Intervention Names
LoFric Origo			Device: LoFric Origo

Name	Type	Description	Arm Group Labels	Other Names
LoFric Origo	Device		LoFric Origo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Traumatologie et de Readaptation		Brussels		1020	Belgium
UZ Leuven

Type	Date	Date Unknown
Release	Jul 18, 2019
Reset	Aug 27, 2019