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

Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study

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.

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