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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Catheter Related Infections
• Intervention / Treatment: Procedure: bladder lavage

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Steenokkerzeel, Vlaams-Brabant, Belgium, 1820
      • National MS center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lavage Isobetadine Dermicum solution; Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline	Procedure: bladder lavage; the bladder is rinced through the urinary catheter with the lavage solution; Other Names: bladder rincing
Active Comparator: lavage Acetic Acid solution; 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; the bladder is rinced through the urinary catheter with the lavage solution; Other Names: bladder rincing
Sham Comparator: lavage with saline; patients will receive during 5 consecutive days a bladder lavage with 100cc saline	Procedure: bladder lavage; the bladder is rinced through the urinary catheter with the lavage solution; Other Names: bladder rincing
Active Comparator: lavage Urotainer Suby G; 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; Other Names: bladder rincing

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Multiple Sclerosis Center
• Collaborators: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Dirk De Ridder, Prof., National MS Center Belgium & University Hospitals KU Leuven

Publications and helpful links

General Publications

• 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.

Helpful Links

• website of the National MS Center, Belgium

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Actual): January 20, 2014

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimate): January 21, 2013

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: UTI; urinary catheter; bladder lavage
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria; Catheter-Related Infections
• Other Study ID Numbers: BLLAV-1