Clinical trial NCT01359046: Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology
Official title: Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Associated With Catheter
Urinary Tract Infection
Keywords: CAUTI
UTI
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary Tract Infection Rate
timeFrame: within 6 weeks post surgery
Secondary outcomes:
measure: Risk of Urinary Tract Infections in Diabetics
timeFrame: within 6 weeks post surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John Gebhart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh R, Hokenstad ED, Wiest SR, Kim-Fine S, Weaver AL, McGree ME, Klingele CJ, Trabuco EC, Gebhart JB. Randomized controlled trial of silver-alloy-impregnated suprapubic catheters versus standard suprapubic catheters in assessing urinary tract infection rates in urogynecology patients. Int Urogynecol J. 2019 May;30(5):779-787. doi: 10.1007/s00192-018-3726-z. Epub 2018 Aug 25.