Catheter Related Infections
Conditions
Keywords
urinary catheter, UTI, bladder lavage
Brief summary
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
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.
Interventions
PROCEDUREbladder lavage
the bladder is rinced through the urinary catheter with the lavage solution
Sponsors
Universitaire Ziekenhuizen KU Leuven
National Multiple Sclerosis Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary culture | day 2 and day 5 after last bladder lavage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pyuria | day 2 and day 5 after the last bladder lavage | 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. |
Countries
Belgium
Outcome results
None listed