NCT01143116

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacteriuria

Interventions

Type	Name	Description
DEVICE	Silver-nitrate coated catheter ("Catheter A")	Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-06-14
• Last updated: 2022-05-03
• Results posted: 2022-05-03

Locations

1 site across 1 country: United Kingdom