Bacteriuria
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESilver-nitrate coated catheter (Catheter A)
Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
DEVICEDegradable silver particle-coated catheter (Catheter B)
Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Study subjects, study personnel and laboratory conducting the cultivations and analyses were blinded to the investigational products. The products had the same packaging and visual appearance. The treatment code was never broken during the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Female/male aged 18 years and over * Practicing intermittent catheterization at least 4 times daily for at least 6 weeks * A minimum of 104 CFU of bacteriuria
Exclusion criteria
* Ongoing, symptomatic UTI at enrollment * Known urethral stricture * Basic tumorous disease * Previous prostate surgery * Subjects known to be immunocompromised e.g. HIV or diabetes * Treatment with antibiotics and/or intravesical antiseptics for the past 30 days before study start * Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site) * Pregnancy or breast feeding * Previous enrolment or randomisation of treatment in the present study * Participation in a clinical study that possibly might interfere with the present study, as deemed by the investigator * Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Bacteria Count Change From Baseline and After 24 Hours. | 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. |
| Total Bacteria Count Change From Baseline and After 48 Hours. | 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. |
| Total Bacteria Count Change From Baseline and After 7-14 Days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours | After first catheterization with study product and after 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. |
| Urine Silver Concentration Change From Baseline to 24 Hours | 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). |
| Urine Silver Concentration Change From Baseline and After 48 Hours | After first catheterization with study product 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). |
| Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours | After first catheterization with study product and after 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. |
| Blood Silver Concentration Change From Baseline and After 24 Hours | After first catheterization with study product 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). |
| Blood Silver Concentration Change From Baseline and After 48 Hours | After first catheterization with study product 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). |
| Blood Silver Concentration Change From Baseline and After 7-14 Days | After first catheterization with study product 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). |
| Urine Silver Concentration Change From Baseline to 7-14 Days | At baseline and after 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). |
| Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours | After first catheterization with study product and after 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. |
| Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours | After first catheterization with study product and after 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Catheter A Silver-nitrate coated catheter (Catheter A): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization. | 10 |
| Catheter B Degradable silver particle-coated catheter (Catheter B): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Catheter A | Catheter B | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 8 | 40 years STANDARD_DEVIATION 8 | 44 years STANDARD_DEVIATION 9 |
| Region of Enrollment Sweden | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 3 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Total Bacteria Count Change From Baseline and After 24 Hours. | -62519 CFU/mL | Standard Deviation 9710767 |
| Catheter B | Total Bacteria Count Change From Baseline and After 24 Hours. | 57448 CFU/mL | Standard Deviation 9810360 |
p-value: 0.625Wilcoxon (Mann-Whitney)
p-value: 0.75Wilcoxon (Mann-Whitney)
Primary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Total Bacteria Count Change From Baseline and After 48 Hours. | -1980704 CFU/mL | Standard Deviation 6599515 |
| Catheter B | Total Bacteria Count Change From Baseline and After 48 Hours. | 2072657 CFU/mL | Standard Deviation 11673736 |
p-value: 0.875Wilcoxon (Mann-Whitney)
p-value: 0.625Wilcoxon (Mann-Whitney)
Primary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Total Bacteria Count Change From Baseline and After 7-14 Days. | 12477797 CFU/mL | Standard Deviation 10769480 |
| Catheter B | Total Bacteria Count Change From Baseline and After 7-14 Days. | 18650000 CFU/mL | Standard Deviation 6851389 |
p-value: 0.0254Wilcoxon (Mann-Whitney)
p-value: 0.0039Wilcoxon (Mann-Whitney)
Secondary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Blood Silver Concentration Change From Baseline and After 24 Hours | -.02 nmol Ag/L | Standard Deviation 0.28 |
| Catheter B | Blood Silver Concentration Change From Baseline and After 24 Hours | 0.39 nmol Ag/L | Standard Deviation 0.22 |
p-value: 0.5391Wilcoxon (Mann-Whitney)
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Blood Silver Concentration Change From Baseline and After 48 Hours | 0.02 nmol Ag/L | Standard Deviation 0.48 |
| Catheter B | Blood Silver Concentration Change From Baseline and After 48 Hours | 0.27 nmol Ag/L | Standard Deviation 0.25 |
p-value: 0.4766Wilcoxon (Mann-Whitney)
p-value: 0.0068Wilcoxon (Mann-Whitney)
Secondary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Blood Silver Concentration Change From Baseline and After 7-14 Days | 0.31 nmol Ag/L | Standard Deviation 0.54 |
| Catheter B | Blood Silver Concentration Change From Baseline and After 7-14 Days | -0.04 nmol Ag/L | Standard Deviation 0.61 |
p-value: 0.0625Wilcoxon (Mann-Whitney)
p-value: 0.418Wilcoxon (Mann-Whitney)
Secondary
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
Population: Subjects with positive values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours | 333 CFU/mL | Standard Deviation 612 |
| Catheter B | Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours | 20997300 CFU/mL | — |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
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
Population: Subjects with positive values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours | -51498 CFU/mL | Standard Deviation 73684 |
| Catheter B | Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours | 20999983 CFU/mL | — |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
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
Population: Subjects with positive values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours | 0 CFU/mL | Standard Deviation 0 |
| Catheter B | Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours | 74500 CFU/mL | Standard Deviation 166587 |
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
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
Population: Subjects with positive values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours | 5113750 CFU/mL | Standard Deviation 10227500 |
| Catheter B | Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours | -4124000 CFU/mL | Standard Deviation 9221544 |
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
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
Population: Per protocol 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Urine Silver Concentration Change From Baseline and After 48 Hours | -0.02 nmol Ag/mmol creatinine | Standard Deviation 0.11 |
| Catheter B | Urine Silver Concentration Change From Baseline and After 48 Hours | -0.02 nmol Ag/mmol creatinine | Standard Deviation 0.12 |
p-value: 0.7188Wilcoxon (Mann-Whitney)
p-value: 0.6406Wilcoxon (Mann-Whitney)
Secondary
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
Population: Per protocol, 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Urine Silver Concentration Change From Baseline to 24 Hours | 5.15 nmol Ag/mmol creatinine | Standard Deviation 9.7 |
| Catheter B | Urine Silver Concentration Change From Baseline to 24 Hours | 6.20 nmol Ag/mmol creatinine | Standard Deviation 5.26 |
p-value: 0.0313Wilcoxon (Mann-Whitney)
p-value: 0.0078Wilcoxon (Mann-Whitney)
Secondary
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
Population: Per protocol 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter A | Urine Silver Concentration Change From Baseline to 7-14 Days | 0.39 nmol Ag/mmol creatinine | Standard Deviation 0.53 |
| Catheter B | Urine Silver Concentration Change From Baseline to 7-14 Days | 0.10 nmol Ag/mmol creatinine | Standard Deviation 0.24 |
p-value: 0.4375Wilcoxon (Mann-Whitney)
p-value: 0.2969Wilcoxon (Mann-Whitney)