N/A N=20 Randomized Triple-blind Treatment

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Bacteriuria

Bottom Line

View on ClinicalTrials.gov: NCT01143116 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Total Bacteria Count Change From Baseline and After 24 Hours. — -62519; 57448 CFU/mL — p=0.6250

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Silver-nitrate coated catheter ("Catheter A") (Device); Degradable silver particle-coated catheter ("Catheter B") (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wellspect HealthCare
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Bacteria Count Change From Baseline and After 24 Hours.	-62519; 57448	0.6250
PRIMARY Total Bacteria Count Change From Baseline and After 48 Hours.	-1980704; 2072657	0.8750
PRIMARY Total Bacteria Count Change From Baseline and After 7-14 Days.	12477797; 18650000	0.0254 sig
SECONDARY Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours	0; 74500	1.0
SECONDARY Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours	5113750; -4124000	1.0
SECONDARY Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours	333; 20997300	1.0000
SECONDARY Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours	-51498; 20999983	1.0000
SECONDARY Urine Silver Concentration Change From Baseline to 24 Hours	5.15; 6.20	0.0313 sig
SECONDARY Urine Silver Concentration Change From Baseline and After 48 Hours	-0.02; -0.02	0.7188
SECONDARY Urine Silver Concentration Change From Baseline to 7-14 Days	0.39; 0.10	0.4375
SECONDARY Blood Silver Concentration Change From Baseline and After 24 Hours	-.02; 0.39	0.5391
SECONDARY Blood Silver Concentration Change From Baseline and After 48 Hours	0.02; 0.27	0.4766
SECONDARY Blood Silver Concentration Change From Baseline and After 7-14 Days	0.31; -0.04	0.0625

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01143116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.