Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients
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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. |
- 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.
- 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 |
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| Contact: Dirk De Ridder, PRof. | +32-16-346930 | dirk.deridder@uzleuven.be |
| Contact: Corinne Cuveliers, RN | +32-2-5978801 | corinne.cuveliers@mscenter.be |
| 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 | |
| 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 |
ClinicalTrials.gov processed this record on May 19, 2013