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This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.
The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Device | Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with bacteriuria <10^3 CFU/ml | Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample <10^3 CFU/ml within the 7 day treatment period will be evaluated. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) | Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The number of days until reduction of bacteriuria (<10^3 CFU/ml) will be evaluated. Maximum treatment period is 7 days. | 7 days |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Lena Rutberg, MD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spinal Cord Injury Unit, Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden | |||
| Spinal Cord Injury Unit, Skåne University Hospital |
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| ID | Term |
|---|---|
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Höör |
| Sweden |
| Spinal Cord Injury Unit, Linköping University Hospital | Linköping | Sweden |
| Neurocentrum, Neurorehab, Norrlands Universitetssjukhus | Umeå | 90185 | Sweden |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |