An interventional study of bladder lavage in Catheter Related Infections, sponsored by National Multiple Sclerosis Center. Withdrawn at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by National Multiple Sclerosis Center · Not applicable, Interventional, and Prevention
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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.
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:
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.
112 studies on the registry are indexed under Catheter-Related Infections; 18 are open to participants now.
Browse Catheter-Related Infections studies →National Multiple Sclerosis Center is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline
Procedure: bladder lavage
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
patients will receive during 5 consecutive days a bladder lavage with 100cc saline
Procedure: bladder lavage
patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G
Procedure: bladder lavage
the bladder is rinced through the urinary catheter with the lavage solution
Also known as: bladder rincing
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.
Time frame: day 2 and day 5 after last bladder lavage
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.
Time frame: day 2 and day 5 after the last bladder lavage
Start is estimated for Jan 2013; primary completion for Dec 2013, 11 months later.
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This study is withdrawn, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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National Multiple Sclerosis Center