The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts antibacterial activity that will have an impact on bacteria quantity in the urine bladder among users of intermittent catheterization.
The study was designed as a prospective, randomized, double-blind, single-site study of 24 hours use of a silver coated antibacterial catheter, and 24 hours follow up, in subjects practicing intermittent catheterization. Twenty male and female subjects using intermittent catheterization, having a confirmed significant bacteriuria were included in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry, Shropshire, United Kingdom
Total Bacteria Count Change From Baseline and After 24 Hours.
Change from baseline (urine sample immediately before first catheterization with study product) and after 24 hours of intermittent catheterization with the randomised study catheter.
Time frame: Baseline and after 24 hours
Total Bacteria Count Change From Baseline and After 48 Hours.
Change from baseline (urine sample immediately before first catheterization with study product) and after 48 hours of intermittent catheterization. After the baseline sample the subject had 24 hours with study randomized catheter and then changed to 24 hours on non-study sterile intermittent catheterization.
Time frame: Baseline and after 48 hours
Total Bacteria Count Change From Baseline and After 7-14 Days.
Change from baseline and after 7-14 days. Change from baseline (urine sample immediately before first catheterization with study product) to after 7-14 days.
Time frame: Baseline and after 7-14 days
Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours
Escherichia coli mean bacteria count change from baseline (subjects with positive values) to after 12 hours. Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.
Time frame: After first catheterization with study product and after 12 hours
Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours
Escherichia coli mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.
Time frame: After first catheterization with study product and after 24 hours
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Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours
Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.
Time frame: After first catheterization with study product and after 12 hours
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours
Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.
Time frame: After first catheterization with study product and after 24 hours
Urine Silver Concentration Change From Baseline to 24 Hours
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: Baseline to 24 hours
Urine Silver Concentration Change From Baseline and After 48 Hours
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 48 hours
Urine Silver Concentration Change From Baseline to 7-14 Days
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: At baseline and after 7-14 days
Blood Silver Concentration Change From Baseline and After 24 Hours
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 24 hours
Blood Silver Concentration Change From Baseline and After 48 Hours
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 48 hours
Blood Silver Concentration Change From Baseline and After 7-14 Days
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 7-14 days