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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by National Multiple Sclerosis Center
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Prof. dr. Dirk De Ridder, National Multiple Sclerosis Center
ClinicalTrials.gov Identifier:
NCT01772875
First received: January 17, 2013
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Catheter Related Infections
Procedure: bladder lavage
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by National Multiple Sclerosis Center:

Primary Outcome Measures:
  • urinary culture [ Time Frame: day 2 and day 5 after last bladder lavage ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • pyuria [ Time Frame: day 2 and day 5 after the last bladder lavage ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: bladder rincing

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772875

Contacts
Contact: Dirk De Ridder, PRof. +32-16-346930 dirk.deridder@uzleuven.be
Contact: Corinne Cuveliers, RN +32-2-5978801 corinne.cuveliers@mscenter.be

Locations
Belgium
National MS Center Not yet recruiting
Steenokkerzeel, Vlaams-Brabant, Belgium, 1820
Contact: Dirk De Ridder, Prof.       dirk.deridder@uzleuven.be   
Contact: Corinne Cuvelier, RN       corinne.cuvelier@mscenter.be   
Principal Investigator: Dirk De Ridder, MD, PhD         
Sponsors and Collaborators
National Multiple Sclerosis Center
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Dirk De Ridder, Prof. National MS Center Belgium & University Hospitals KU Leuven
  More Information

Additional Information:
Publications:
Responsible Party: Prof. dr. Dirk De Ridder, medical director, National Multiple Sclerosis Center
ClinicalTrials.gov Identifier: NCT01772875     History of Changes
Other Study ID Numbers: BLLAV-1
Study First Received: January 17, 2013
Last Updated: January 18, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by National Multiple Sclerosis Center:
urinary catheter
UTI
bladder lavage

Additional relevant MeSH terms:
Bacteriuria
Catheter-Related Infections
Urinary Tract Infections
Infection
Urologic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014