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The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.
The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of >95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm with Oxys-Cathter | Experimental | The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder. |
|
| Control-arm with commercial catheter | Other | The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxys Catheter | Device | The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Significant bacteriuria assessed by weekly bacterial cultures. | every week during 4 weeks | |
| Clinically symptomatic catheter associated lower urinary infections. | 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Scharf, MD | Contact | ++41763322969 | christoph.scharf@gmail.com | |
| Christine Tivig, MD | Contact | +41 787358855 | ki.tivig@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Kessler, MD | Universitätsklinik Balgrist Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Balgrist | Recruiting | Zurich | Canton of Zurich | 8008 | Switzerland |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Covidien Mona-Therm Foley catheter | Device | The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien. |
|
| occurence of adverse events |
safety endpoint |
| within 4 weeks |