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Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

This study is currently recruiting participants.
Verified February 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
John B. Gebhart, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01359046
First received: May 20, 2011
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, 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 Intervention
Infection Associated With Catheter
Urinary Tract Infection
 Device: silver SPC
Device: standard SPC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • UTI rate [ Time Frame: 6 weeks following surgery, plus or minus 1 week ] [ Designated as safety issue: Yes ]

    CDC (2009) definition of 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 (leuks and/or nitrites)


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


Estimated Enrollment: 444
Study Start Date: July 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359046

Contacts
Contact: Shunaha Kim-Fine, MD (507)284-2511 kimfine.shunaha@mayo.edu
Contact: John B Gebhart, MD, MSc (507)266-7711 gebhart.john@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shunaha Kim-Fine, MD     507-284-2511     kimfine.shunaha@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Director: Shunaha Kim-Fine, MN Mayo Clinic, Female Pelvic Medicine and Reconstructive Surgery
  More Information

No publications provided

Responsible Party: John B. Gebhart, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01359046     History of Changes
Other Study ID Numbers: 10-007421
Study First Received: May 20, 2011
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
CAUTI
UTI

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

ClinicalTrials.gov processed this record on June 17, 2013