Non-Interventional Study Among Users Of LoFric Origo

Wellspect HealthCare

Status: Completed

Conditions: Intermittent Catheterization

Treatments: Device: LoFric Origo

Study type: Observational

Funder types: Industry

Identifiers

NCT01796587

LOF-0017

Details and patient eligibility

About

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.

Enrollment: 423 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

423 participants in 1 patient group

LoFric Origo

Treatment:

Device: LoFric Origo