Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infection Associated With Catheter, Urinary Tract Infection

Intervention / Treatment
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* Device: silver SPC
* Device: standard SPC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver SPC<br>Subjects randomized to receive silver-impregnated SPC. | Device: silver SPC<br>* subject randomized to receive silver alloy impregnated catheter<br>|
| Active Comparator: standard SPC<br>subjects randomized to receive standard SPC. | Device: standard SPC<br>* subject randomized to receive standard catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Tract Infection Rate | 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. | within 6 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of Urinary Tract Infections in Diabetics | Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery. | within 6 weeks post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI, CAUTI