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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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 is eligible to participate?

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

Last updated:

4/8/2014

NCT ID:

NCT01359046

IRB Number:

10-007421