Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients

Study Overview
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Brief Summary
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In patients with advanced multiple sclerosis, permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems. These catheters will lead to urinary tract infection, blocking of the catheter etc.. Especially infections with certain bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and pseudomonas can pose a problem for the hospital infection control and for the patient. This study wants to evaluate the potential role of regular bladder lavage with saline, a solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in the decontamination of these bladders and the prevention of clinically relevant urinary tract infections.

Detailed Description
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PAtients will be selected from the catheterised patient population of the National MS Center in Belgium for this prospective randomised comparative pilot studyon bladder lavage. The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use. According to the type of bacteria that is cultured from the urine, patients will be allocated to one of 4 subgroups: 30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution 20 patients will revieve bladder lavage with acetic acid solutions 10 patients will recieve bladder lavage with saline 10 patients will receive bladder lavage with Urotainer Suby G The effect will be measured by two repeat urine cultures after the bladder lavage( 2days and 5 days). From a safety perspective and to assess the irritation caused by the lavage, white blood cell counts in the urine will be done. Adverse events will be monitored according to GCP regulations.

Official Title
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Pilot Study to Evaluate the Efficacy of Antiseptic Bladder Lavage Versus Pulsatile Lavage With Physiologic Serum in Catheterized Patients With Asymptomatic Bacteriuria With Uropathogens.

Conditions
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Catheter Related Infections

Intervention / Treatment
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* Procedure: bladder lavage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with an indwelling catheter catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas willing and able to give informed consent to the study Exclusion Criteria: patients with a clinically relevant UTI ( fever, pain or cloudy urine) cognitively impaired patients patients not able or willing to give informed consent patients with allergies for ISobetadine dermicum or other substances used in the protocol patients who only have a catheter for less than 1 month patients taking systemic antibiotics during the last 48h

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lavage Isobetadine Dermicum solution<br>Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline | Procedure: bladder lavage<br>* the bladder is rinced through the urinary catheter with the lavage solution<br>* Other names: bladder rincing;|
| Active Comparator: lavage Acetic Acid solution<br>Patients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline | Procedure: bladder lavage<br>* the bladder is rinced through the urinary catheter with the lavage solution<br>* Other names: bladder rincing;|
| Sham Comparator: lavage with saline<br>patients will receive during 5 consecutive days a bladder lavage with 100cc saline | Procedure: bladder lavage<br>* the bladder is rinced through the urinary catheter with the lavage solution<br>* Other names: bladder rincing;|
| Active Comparator: lavage Urotainer Suby G<br>patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G | Procedure: bladder lavage<br>* the bladder is rinced through the urinary catheter with the lavage solution<br>* Other names: bladder rincing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary culture | After 5 consecutive days of bladder lavage, a urine culture will be taken at day 2 and 5. A count of <100.000 CFU/ml and is considered a positive result. The outcome will be considered positive if this positive result is found in more than 30% of subjects. | day 2 and day 5 after last bladder lavage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pyuria | changes in white blood cell count are monitored at day 2 and 5 afte 5 consecutive days of bladder lavage. This is an assessment of bladder irritation. | day 2 and day 5 after the last bladder lavage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary catheter, UTI, bladder lavage