Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Not Applicable

Completed

Conditions: Bacteriuria

Interventions: Device: Silver-nitrate coated catheter ("Catheter A")
Device: Degradable silver particle-coated catheter ("Catheter B")

Registration Number: NCT01143116

Lead Sponsor: Wellspect HealthCare

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter A	Silver-nitrate coated catheter ("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).
Catheter B	Degradable silver particle-coated catheter ("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).

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Secondary Outcome Measures

Name	Time	Method
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).
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 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.
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.
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 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).
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).
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).