Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine|
- Proportion of patients with bacteriuria <10^3 CFU/ml [ Time Frame: 7 days ] [ Designated as safety issue: No ]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.
- Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) [ Time Frame: 7 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782404
|Spinal Cord Injury Unit, Sahlgrenska University Hospital|
|Göteborg, Sweden, 413 45|
|Spinal Cord Injury Unit, Skåne University Hospital|
|Spinal Cord Injury Unit, Linköping University Hospital|
|Neurocentrum, Neurorehab, Norrlands Universitetssjukhus|
|Umeå, Sweden, 90185|
|Principal Investigator:||Lena Rutberg, MD||Sahlgrenska University Hospital, Sweden|