Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Bacteriuria Clinical Trial

Official title:

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143116
• Other study ID #: YA-ABC-0003
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2022
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteriuria

Intervention

Device:
• Silver-nitrate coated catheter ("Catheter A")
Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
• 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.

Locations

Country	Name	City	State
United Kingdom	The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust	Oswestry	Shropshire

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and after 24 hours
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.	Baseline and after 48 hours
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.	Baseline and after 7-14 days
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.	After first catheterization with study product and after 12 hours
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.	After first catheterization with study product and after 24 hours
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.	After first catheterization with study product and after 12 hours
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.	After first catheterization with study product and after 24 hours
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).	Baseline to 24 hours
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).	After first catheterization with study product and after 48 hours
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).	At baseline and after 7-14 days
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).	After first catheterization with study product and after 24 hours
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).	After first catheterization with study product and after 48 hours
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).	After first catheterization with study product and after 7-14 days