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Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

NCT01143116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-03

Study results available
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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.

Conditions

  • Bacteriuria

Interventions

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.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Waigh El Masri, Mr · The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143116 on ClinicalTrials.gov