Clinical trial NCT01772875: Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients
Official title: Pilot Study to Evaluate the Efficacy of Antiseptic Bladder Lavage Versus Pulsatile Lavage With Physiologic Serum in Catheterized Patients With Asymptomatic Bacteriuria With Uropathogens.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Catheter Related Infections
Keywords: urinary catheter
UTI
bladder lavage
Lead sponsor: National Multiple Sclerosis Center
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2013-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: urinary culture
timeFrame: day 2 and day 5 after last bladder lavage
Secondary outcomes:
measure: pyuria
timeFrame: day 2 and day 5 after the last bladder lavage
Other outcomes:
Locations:
city: Steenokkerzeel
country: Belgium
facility: National MS Center
state: Vlaams-Brabant
Study officials:
affiliation: National MS Center Belgium & University Hospitals KU Leuven
name: Dirk De Ridder, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaggi N, Sissodia P. Multimodal supervision programme to reduce catheter associated urinary tract infections and its analysis to enable focus on labour and cost effective infection control measures in a tertiary care hospital in India. J Clin Diagn Res. 2012 Oct;6(8):1372-6. doi: 10.7860/JCDR/2012/4229.2362.