Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts antibacterial activity that will have an impact on bacteria quantity in the urine bladder among users of intermittent catheterization.

The study was designed as a prospective, randomized, double-blind, single-site study of 24 hours use of a silver coated antibacterial catheter, and 24 hours follow up, in subjects practicing intermittent catheterization.

Twenty male and female subjects using intermittent catheterization, having a confirmed significant bacteriuria were included in the study.

Inclusion Criteria:

• Provision of informed consent
• Female/male aged 18 years and over
• Practicing intermittent catheterization at least 4 times daily for at least 6 weeks
• A minimum of 104 CFU of bacteriuria

Exclusion Criteria:

• Ongoing, symptomatic UTI at enrollment
• Known urethral stricture
• Basic tumorous disease
• Previous prostate surgery
• Subjects known to be immunocompromised e.g. HIV or diabetes
• Treatment with antibiotics and/or intravesical antiseptics for the past 30 days before study start
• Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
• Pregnancy or breast feeding
• Previous enrolment or randomisation of treatment in the present study
• Participation in a clinical study that possibly might interfere with the present study, as deemed by the investigator
• Severe non-compliance to protocol as judged by the investigator and/or Astra Tech