Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
|ClinicalTrials.gov Identifier: NCT01782404|
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : August 13, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Bacteriuria, Intermittent Catheterization||Device: Chlorhexidine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
- Proportion of patients with bacteriuria <10^3 CFU/ml [ Time Frame: 7 days ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|