Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359046
• Other study ID #: 10-007421
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: March 9, 2018

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: March 9, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• Communicable Diseases
• Infection
• Infection Associated With Catheter
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Device:
• silver SPC
subject randomized to receive silver alloy impregnated catheter
• standard SPC
subject randomized to receive standard catheter

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials