Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Conditions
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Bacteriuria

Intervention / Treatment
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* Device: Silver-nitrate coated catheter (Catheter A)
* Device: Degradable silver particle-coated catheter (Catheter B)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter A<br>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). | Device: Silver-nitrate coated catheter (Catheter A)<br>* Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.<br>|
| Experimental: Catheter B<br>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). | Device: Degradable silver particle-coated catheter (Catheter B)<br>* Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |