Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01359046
Recruitment Status : Recruiting
First Posted : May 24, 2011
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):
John B. Gebhart, Mayo Clinic

Brief Summary:

Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.

There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections.

Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

Condition or disease Intervention/treatment Phase
Infection Associated With Catheter Urinary Tract Infection Device: silver SPC Device: standard SPC Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients
Study Start Date : July 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: silver SPC
Subjects randomized to receive silver-impregnated SPC.
Device: silver SPC
subject randomized to receive Bardex IC Silver impregnated catheter
Active Comparator: standard SPC
subjects randomized to receive standard SPC.
Device: standard SPC
subject randomized to receive standard catheter

Primary Outcome Measures :
  1. UTI rate [ Time Frame: 6 weeks following surgery, plus or minus 1 week ]

    CDC (2009) definition of Catheter-associated urinary Tract Infections (CAUTI):

    • presence of bladder catheter or removed within 48 hours
    • symptoms of UTI
    • other causes ruled out -≥105 cfu/mL of <3 bacterial species OR ≥103 cfu/mL if positive dipstick (leukocyte and/or nitrites)

Secondary Outcome Measures :
  1. Medical treatment of UTI symptoms [ Time Frame: 6 weeks after surgery, +/- 1 week ]
    • presence of bladder catheter or removed within 48 hours
    • symptoms of UTI
    • antibiotic therapy prescribed with or without urine culture result

Information from the National Library of Medicine

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

Inclusion Criteria:

  • patients requiring intra-operative placement of suprapubic catheters as part of routine post-operative care for repair of vaginal anterior compartment prolapse i.e. patients undergoing anterior colporrhaphy, Burch colposuspension, with or without mid-urethral sling

Exclusion Criteria:

  • Known UTI at time of surgery
  • Unable to provide informed consent
  • Use of chronic intermittent self-catheterization pre-operatively
  • Use of chronic prophylactic antibiotics
  • Use of antibiotics for any indication other than UTI during peri-operative and 6-week post-operative period
  • Presence of fistula involving urogenital tract
  • Use of chronic steroids or immunosuppressant
  • Immunocompromised patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359046

Contact: Ruchira Singh, MBBS (507)284-2511
Contact: John B Gebhart, MD, MSc (507)266-7711

United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ruchira Singh, MBBS    507-284-2511   
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: John Gebhart, MD Mayo Clinic

Responsible Party: John B. Gebhart, PI, Mayo Clinic Identifier: NCT01359046     History of Changes
Other Study ID Numbers: 10-007421
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by John B. Gebhart, Mayo Clinic:

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Catheter-Related Infections
Urologic Diseases