Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.

Dentsply

Status: Completed

Conditions: Intermittent Urethral Catheterization

Treatments: Device: Treatment Period Two; Device: Treatment Period One

Study type: Interventional

Funder types: Industry

Identifiers

NCT03684941

LOF-0034

Details and patient eligibility

About

This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent.
• Males, aged 18 years and over.
• Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
• Practice CIC at least 2 times daily.
• Using catheters in the size CH 12 or CH 14, Nelaton tip, and able to use catheter length of 40 cm.
• Experienced users of CIC defined as a minimum of three months on therapy.
• Adults able to read, write and understand information given to them regarding the study.

Exclusion criteria

• 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.
• Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
• Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
• Previous enrolment or randomisation of treatment in the present study.
• Simultaneous participation in another clinical study that may impact the primary endpoint.
• Severe non-compliance to protocol as judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Treatment Period One

Experimental group

Description:

LoFric, hydrophilic urinary catheter for single use. The study device is based on commercially available hydrophilic urinary catheters for intermittent catheterization, but with a different coating process than the comparator. Treatment Period One will last 1 week.

Treatment:

Device: Treatment Period One

Treatment Period Two

Active Comparator group

Description:

CE-marked LoFric®, hydrophilic urinary catheter for single use. The comparator product is today commercially available and produced by WHC. Treatment Period Two will last 1 week.

Treatment:

Device: Treatment Period Two