NCT01772875

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.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Multiple Sclerosis Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Catheter Related Infections

Interventions

Type	Name	Description
PROCEDURE	bladder lavage	the bladder is rinced through the urinary catheter with the lavage solution

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2014-01-20
• First posted: 2013-01-21
• Last updated: 2020-08-05

Locations

1 site across 1 country: Belgium