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OpenTrials
Completed

NCT Number: NCT01359046

Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

The purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silver SPC

Device

subject randomized to receive silver alloy impregnated catheter

standard SPC

Device

subject randomized to receive standard catheter

Primary outcomes

  1. Urinary Tract Infection Rate

    Time frame: within 6 weeks post surgery

    Number of subjects diagnosed with a urinary tract infection (UTI) within 6 weeks of surgery. A UTI is defined as any symptoms requiring antibiotic treatment, a urine culture with >10^5 cfu/mL, or a urine culture with >10^3 cfu/mL and evidence of pyuria.

Secondary outcomes

  1. Risk of Urinary Tract Infections in Diabetics

    Time frame: within 6 weeks post surgery

    Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
May 24, 2011
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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