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

Catheter Related Infections Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01772875
• Other study ID #: BLLAV-1
• Status: Withdrawn
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 20, 2014

Study information

• Verified date: August 2020
• Source: National Multiple Sclerosis Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 20, 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacteriuria
• Catheter Related Infections
• Catheter-Related Infections

Intervention

Procedure:
• bladder lavage
the bladder is rinced through the urinary catheter with the lavage solution

Locations

Country	Name	City	State
Belgium	National MS Center	Steenokkerzeel	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
National Multiple Sclerosis Center	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   website of the National MS Center, Belgium