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

National Multiple Sclerosis Center

Status: Withdrawn

Conditions: Catheter Related Infections

Treatments: Procedure: bladder lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT01772875

BLLAV-1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

lavage Isobetadine Dermicum solution

Active Comparator group

Description:

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

Treatment:

Procedure: bladder lavage

lavage Acetic Acid solution

Active Comparator group

Description:

Patients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline

Treatment:

Procedure: bladder lavage

lavage with saline

Sham Comparator group

Description:

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

Treatment:

Procedure: bladder lavage

lavage Urotainer Suby G

Active Comparator group

Description:

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

Treatment:

Procedure: bladder lavage