Bacteriuria, Intermittent Catheterization
Conditions
Brief summary
This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days. The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).
Interventions
DEVICEChlorhexidine
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
Sponsors
Wellspect HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent 2. Female or male spinal cord injured subject aged 18 years and over 3. Bacteriuria of \>10\^5 CFU/mL of \>1 bacterial species verified during screening visit 4. 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) 5. Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator
Exclusion criteria
1. Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator. 2. Ongoing antibiotic treatment 3. Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator 4. Subject with severe catheterisation difficulties, as judged by investigator 5. Known hypersensitivity to chlorhexidine 6. Use of other instillation products 7. Pregnancy 8. Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate) 9. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site) 10. Previous enrolment or allocation of treatment in the present study. 11. Simultaneous participation in another clinical study that may interfere with the present study. 12. Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with bacteriuria <10^3 CFU/ml | 7 days | Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample \<10\^3 CFU/ml within the 7 day treatment period will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) | 7 days | Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The number of days until reduction of bacteriuria (\<10\^3 CFU/ml) will be evaluated. Maximum treatment period is 7 days. |
Countries
Sweden
Outcome results
None listed