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

NCT01772875 | Withdrawn DMC

• 1 other identifier: BLLAV-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Related Infections

Keywords

urinary catheter; UTI; bladder lavage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pyuria

  day 2 and day 5 after the last bladder lavage

Study Arms (4)

lavage Isobetadine Dermicum solution

ACTIVE COMPARATOR

Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline

Procedure: bladder lavage

lavage Acetic Acid solution

ACTIVE COMPARATOR

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

lavage with saline

SHAM COMPARATOR

patients will receive during 5 consecutive days a bladder lavage with 100cc saline

Procedure: bladder lavage

lavage Urotainer Suby G

ACTIVE COMPARATOR

patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G

Procedure: bladder lavage

Interventions

bladder lavage PROCEDURE

the bladder is rinced through the urinary catheter with the lavage solution

Also known as: bladder rincing

lavage Acetic Acid solution; lavage Isobetadine Dermicum solution; lavage Urotainer Suby G; lavage with saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with an indwelling catheter
• catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas
• willing and able to give informed consent to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• National Multiple Sclerosis Center: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

National MS Center

Steenokkerzeel, Vlaams-Brabant, 1820, Belgium

Location

Related 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.

  PMID: 23205350 BACKGROUND

Related Links

• website of the National MS Center, Belgium

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Dirk De Ridder, Prof.

  National MS Center Belgium & University Hospitals KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Research

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 20, 2014
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

BE (1)