User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.

Wellspect HealthCare

Status: Terminated

Conditions: Bladder Voiding Dysfunction

Treatments: Device: LoFric® OrigoTM and LoFric® SenseTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT04703413

LOF-0036

Details and patient eligibility

About

An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For inclusion in the study, subjects must fulfil all of the following criteria:

1. Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form
2. Aged 18 years and over, both gender
3. Bladder dysfunction, all diagnosis practicing IC at least 2 times daily
4. Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip)
5. Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start
6. Adults able to read, write and understand information given to them regarding the investigation

Exclusion criteria

Any of the following is regarded as a criterion for exclusion from the study:

1. Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
2. Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
3. Involvement in the planning and conduct of the investigation (applies to both Wellspect/site staff).
4. Previous enrolment in the present investigation.
5. Simultaneous participation in another clinical investigation that may impact the primary endpoint.
6. Expected or severe non-compliance to the CIP as judged by the investigator and/or Wellspect.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

LoFric® OrigoTM or LoFric® SenseTM

Experimental group

Description:

Hydrophilic male (LoFric Origo) and female (LoFric Sense) urinary catheters for single use. Target subject population are subjects suffering from bladder voiding dysfunction and are experienced in intermittent catheterization (IC).

Treatment:

Device: LoFric® OrigoTM and LoFric® SenseTM