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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter A | Experimental | Catheterization with Catheter A, which releases silver ions into the urethra and urinary bladder upon catheterization,. After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used. The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours). |
|
| Catheter B | Experimental | Catheterization with Catheter B, which releases both silver ions and degradable silver particles.. After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used. The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver-nitrate coated catheter ("Catheter A") | Device | Catheter A releases silver ions into the urethra and urinary bladder upon catheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline and after 7-14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After first catheterization with study product and after 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waigh El Masri, Mr | The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust | Oswestry | Shropshire | SY10 7AG | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter A | Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Catheter A | Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT | Posted | Mean | Standard Deviation | CFU/mL | Baseline and after 24 hours |
|
3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product.
Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h).
Observed by the Study personnel or spontaneously reported from the subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catheter A | Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Wellspect Health Care | +46313763000 | mace@wellspect.com |
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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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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.
| Degradable silver particle-coated catheter ("Catheter B") | Device | Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization. |
|
| 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. | After first catheterization with study product and after 24 hours |
| 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | After first catheterization with study product and after 7-14 days |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| 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. | ITT | Posted | Mean | Standard Deviation | CFU/mL | Baseline and after 48 hours |
|
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| 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. | ITT | Posted | Mean | Standard Deviation | CFU/mL | Baseline and after 7-14 days |
|
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| 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. | Subjects with positive values | Posted | Mean | Standard Deviation | CFU/mL | After first catheterization with study product and after 12 hours |
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| 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. | Subjects with positive values | Posted | Mean | Standard Deviation | CFU/mL | After first catheterization with study product and after 24 hours |
|
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| 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. | Subjects with positive values | Posted | Mean | Standard Deviation | CFU/mL | After first catheterization with study product and after 12 hours |
|
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|
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| 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. | Subjects with positive values | Posted | Mean | Standard Deviation | CFU/mL | After first catheterization with study product and after 24 hours |
|
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| 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). | 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. | Posted | Mean | Standard Deviation | nmol Ag/mmol creatinine | Baseline to 24 hours |
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| 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). | 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. | Posted | Mean | Standard Deviation | nmol Ag/mmol creatinine | After first catheterization with study product and after 48 hours |
|
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| 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). | 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. | Posted | Mean | Standard Deviation | nmol Ag/mmol creatinine | At baseline and after 7-14 days |
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| 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). | ITT | Posted | Mean | Standard Deviation | nmol Ag/L | After first catheterization with study product and after 24 hours |
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| 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). | ITT | Posted | Mean | Standard Deviation | nmol Ag/L | After first catheterization with study product and after 48 hours |
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| 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). | ITT | Posted | Mean | Standard Deviation | nmol Ag/L | After first catheterization with study product and after 7-14 days |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 3 | 10 |
| Headache | General disorders | Systematic Assessment |
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| Rash in the right leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Frequency of micturation increased | Renal and urinary disorders | Systematic Assessment |
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| Wrist pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Symptoms of urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Sensation of preassure in the bladder | Renal and urinary disorders | Systematic Assessment |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Other |
| Other |
| Other |
| Other |
| Other |
| Other |
| Other |
| Other |
| Other |
| Other |