Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

Inclusion criteria

• Provision of informed consent
• Female or male spinal cord injured subject aged 18 years and over
• Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit
• Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month)
• Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator

Exclusion criteria

• Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
• Ongoing antibiotic treatment
• Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
• Subject with severe catheterisation difficulties, as judged by investigator
• Known hypersensitivity to chlorhexidine
• Use of other instillation products
• Pregnancy
• Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate)
• Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
• Previous enrolment or allocation of treatment in the present study.
• Simultaneous participation in another clinical study that may interfere with the present study.
• Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare