Clinical trial NCT01143116: Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
Official title: Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteriuria
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Bacteria Count Change From Baseline and After 24 Hours.
timeFrame: Baseline and after 24 hours
measure: Total Bacteria Count Change From Baseline and After 48 Hours.
timeFrame: Baseline and after 48 hours
measure: Total Bacteria Count Change From Baseline and After 7-14 Days.
timeFrame: Baseline and after 7-14 days
Secondary outcomes:
measure: Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours
timeFrame: After first catheterization with study product and after 12 hours
measure: Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours
timeFrame: After first catheterization with study product and after 24 hours
measure: Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours
timeFrame: After first catheterization with study product and after 12 hours
measure: Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours
timeFrame: After first catheterization with study product and after 24 hours
measure: Urine Silver Concentration Change From Baseline to 24 Hours
timeFrame: Baseline to 24 hours
measure: Urine Silver Concentration Change From Baseline and After 48 Hours
timeFrame: After first catheterization with study product and after 48 hours
measure: Urine Silver Concentration Change From Baseline to 7-14 Days
timeFrame: At baseline and after 7-14 days
measure: Blood Silver Concentration Change From Baseline and After 24 Hours
timeFrame: After first catheterization with study product and after 24 hours
measure: Blood Silver Concentration Change From Baseline and After 48 Hours
timeFrame: After first catheterization with study product and after 48 hours
measure: Blood Silver Concentration Change From Baseline and After 7-14 Days
timeFrame: After first catheterization with study product and after 7-14 days
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
state: Shropshire
Study officials:
affiliation: The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
name: Waigh El Masri, Mr
role: PRINCIPAL_INVESTIGATOR
References: