Not provided
Not provided
Not provided
Not provided
Not provided
no clinical investigator present
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lavage Isobetadine Dermicum solution | Active Comparator | Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline |
|
| 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 |
|
| lavage with saline | Sham Comparator | patients will receive during 5 consecutive days a bladder lavage with 100cc saline |
|
| lavage Urotainer Suby G | Active Comparator | patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bladder lavage | Procedure | the bladder is rinced through the urinary catheter with the lavage solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pyuria | 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. | day 2 and day 5 after the last bladder lavage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dirk De Ridder, Prof. | National MS Center Belgium & University Hospitals KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National MS Center | Steenokkerzeel | Vlaams-Brabant | 1820 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23205350 | Background | 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. |
| Label | URL |
|---|---|
| website of the National MS Center, Belgium | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|