Back to resultsReduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
Primary Purpose
Bacteriuria
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Silver-nitrate coated catheter ("Catheter A")
Degradable silver particle-coated catheter ("Catheter B")
Sponsored by
About this trial
This is an interventional treatment trial for Bacteriuria
Eligibility Criteria
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
Sites / Locations
- The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Catheter A
Catheter B
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01143116
Brief Title
Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
Official Title
Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wellspect HealthCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteriuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Catheter A
Arm Type
Experimental
Arm Description
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).
Arm Title
Catheter B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Silver-nitrate coated catheter ("Catheter A")
Intervention Description
Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
Intervention Type
Device
Intervention Name(s)
Degradable silver particle-coated catheter ("Catheter B")
Intervention Description
Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Primary Outcome Measure Information:
Title
Total Bacteria Count Change From Baseline and After 24 Hours.
Description
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
Title
Total Bacteria Count Change From Baseline and After 48 Hours.
Description
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
Title
Total Bacteria Count Change From Baseline and After 7-14 Days.
Description
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
Secondary Outcome Measure Information:
Title
Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours
Description
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
Title
Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours
Description
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
Title
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours
Description
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
Title
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours
Description
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
Title
Urine Silver Concentration Change From Baseline to 24 Hours
Description
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
Title
Urine Silver Concentration Change From Baseline and After 48 Hours
Description
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
Title
Urine Silver Concentration Change From Baseline to 7-14 Days
Description
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
Title
Blood Silver Concentration Change From Baseline and After 24 Hours
Description
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
Title
Blood Silver Concentration Change From Baseline and After 48 Hours
Description
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
Title
Blood Silver Concentration Change From Baseline and After 7-14 Days
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waigh El Masri, Mr
Organizational Affiliation
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
City
Oswestry
State/Province
Shropshire
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
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