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Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)

This study has been completed.
Bactiguard AB, Sweden
Information provided by:
Region Skane Identifier:
First received: January 14, 2010
Last updated: January 20, 2010
Last verified: January 2010
This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).

Condition Intervention
Urinary Tract Infection Device: Bactiguard Infection Protection (BIP) Cathter. Device: Silicone Urinary Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery

Resource links provided by NLM:

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery. [ Time Frame: At catheter withdrawal (normally 1-3 days after catheter insertion). ]

Secondary Outcome Measures:
  • Patient´s evaluation of the catheterization and overall satisfaction. [ Time Frame: At catheter withdrawal and 7-10 days after catheter withdrawal. ]

Enrollment: 511
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silver alloyed urinary catheter Device: Bactiguard Infection Protection (BIP) Cathter.
Placebo Comparator: Silicone urinary catheter Device: Silicone Urinary Catheter


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults in elective surgery requiring urinary catheterization

Exclusion Criteria:

  • Patients who has or recently (within 3 weeks) had a urinary catheter
  • Signs of urinary tracts infection
  • Previous radiation therapy in lower pelvis
  • Latex allergy
  • Cognitive impaired
  • Do not understand Swedish language.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01054690

Ortopedkliniken, Hässleholms Sjukhus
Hässleholm, Sweden, 281 25
Ortopedklinien, Lunds Hospital
Lund, Sweden, 221 85
Ortopedkliniken Lasarettet i Trelleborg
Trelleborg, Sweden, 231 52
Sponsors and Collaborators
Region Skane
Bactiguard AB, Sweden
Principal Investigator: Karin Stenzelius, PhD Nurse Department Urology, University Hospital in Lund, Sweden
  More Information

Responsible Party: Karin Stenzelius, PhD Nurse, Department of Urology, University Hospital in Lund Identifier: NCT01054690     History of Changes
Other Study ID Numbers: H15 315/2007
Study First Received: January 14, 2010
Last Updated: January 20, 2010

Keywords provided by Region Skane:
Urinary Tract Infection
Elective Surgery

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases processed this record on August 16, 2017