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

Not Applicable

Withdrawn

• Conditions: Catheter Related Infections
• Interventions: Procedure: bladder lavage

• Registration Number: NCT01772875
• Lead Sponsor: National Multiple Sclerosis Center

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Primary Completion: 2013-12
• Study Completion: 2014-01-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lavage Acetic Acid solution	bladder lavage	Patients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline
lavage with saline	bladder lavage	patients will receive during 5 consecutive days a bladder lavage with 100cc saline
lavage Urotainer Suby G	bladder lavage	patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G
lavage Isobetadine Dermicum solution	bladder lavage	Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline

Primary Outcome Measures

Name	Time	Method
urinary culture	day 2 and day 5 after last bladder lavage	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

Name	Time	Method
pyuria	day 2 and day 5 after the last bladder lavage	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.

Trial Locations

Locations (1)

National MS Center; 🇧🇪 Steenokkerzeel, Vlaams-Brabant, Belgium