Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

Not Applicable

Completed

• Conditions: Urinary Tract Infection; Infection Associated With Catheter
• Interventions: Device: standard SPC; Device: silver SPC

• Registration Number: NCT01359046
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Study Start: 2011-07
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-09
• Status Verified: 2019-04
• Results First Submitted: 2019-04-04
• Results First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-25
• Results First Posted: 2019-04-26
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 288

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard SPC	standard SPC	subjects randomized to receive standard SPC.
silver SPC	silver SPC	Subjects randomized to receive silver-impregnated SPC.

Primary Outcome Measures

Name	Time	Method
Urinary Tract Infection Rate	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 Outcome Measures

Name	Time	Method
Risk of Urinary Tract Infections in Diabetics	within 6 weeks post surgery	Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States