Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

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.

Study Overview

• Status: Completed
• Conditions: Bacteriuria
• Intervention / Treatment: Device: Silver-nitrate coated catheter ("Catheter A"); Device: Degradable silver particle-coated catheter ("Catheter B")

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter A; 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"); Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
Experimental: Catheter B; 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"); Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Waigh El Masri, Mr, The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria; Anti-Infective Agents, Local; Anti-Infective Agents; Silver Nitrate
• Other Study ID Numbers: YA-ABC-0003