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

Study Overview
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Brief Summary
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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).

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

Conditions
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Bacteriuria, Intermittent Catheterization

Intervention / Treatment
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* Device: Chlorhexidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine<br> | Device: Chlorhexidine<br>* Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with bacteriuria <10^3 CFU/ml | 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) | 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. | 7 days |