Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients
Phase: NA
Conditions: Infection Associated With Catheter, Urinary Tract Infection
Sponsor: Mayo Clinic

 
 
Randomized Control Trial of 
Silver-Alloy Impregnated 
Suprapubic Catheters in 
Urogynecology Patients 
 
NCT# 01359046 
 
February 25, 2011 

 
Effective Date: 6/12/2009 
Page 1 of 6 
IRB 10272.002  
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Title:    
 
Randomized control trial of silver-alloy impregnated suprapubic catheters in urogynecology 
patients 
 
Protocol Version/Date: 
  1/February 25, 2011 
IRB#:    
10-007421 
 
 
 
PI: 
John Gebhart 
Abstract:     
Worldwide, 96 million indwelling urethral catheters sold annually; 24 million of which are sold 
in USA.1  25% of hospitalized patients have a urinary catheter placed at some point during their 
stay2.  Additionally, catheter-associated urinary tract infections (CAUTI) is the 2nd leading cause of 
nosocomial infections with 20% of hospital acquired bacteremia arising from urinary tract infection 
(UTI)3.  The incidence of bacteriuria is estimated to be 3 to 10%2, 4 per day of catheterization. 
 
Adverse consequences of CAUTI include local and systemic morbidity, secondary bacteriuria, 
death, increased antimicrobial-resistance, and increased health care costs.  Bacteremia complicating 
bacteriuria has been reported in up to 4% of patients.5, 6 Given the significant prevalence and 
morbidity of CAUTI, many strategies have been suggested to reduce CAUTI.  These have included 
irrigation of the bladder, instilling antimicrobial agents in the drainage bag and rigorously cleaning 
the meatus.  None of these strategies have proven to be effective. 7 
 
Other attempts to reduce CAUTI include the development of different types of catheters. 
Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, 
plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer 
hydromer8.  More recently, specialized catheters have been developed which involve coating the 
inner, outer or both surfaces of the catheter with antimicrobial materials9. 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 infections10.  
 
Previous studies of latex-based catheters have demonstrated that use of silver alloy impregnated 
catheters reduced the incidence of CAUTI.11.  The magnitude of this reduction has been reported to 
range from 27% to 73%12-15 in prospective randomized trials.  These numbers are strengthened by a 
recent meta-analysis which concluded that silver alloy catheters significantly reduced bacteriuria by 
3-fold compared with standard catheters16.  Although the previous work demonstrates encouraging 
results in decreasing CAUTI, the studies have varied in patient population, clinical indication and 
definition of outcomes.  Moreover, there are no previous studies evaluating the effectiveness of 
silver alloy impregnated catheters for suprapubic use.   
 

 
Effective Date: 6/12/2009 
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IRB 10272.002  
Urogynecology patients undergoing pelvic reconstructive surgery require bladder drainage in 
the immediate post-operative period.  This can be achieved by placement of either a transurethral or 
suprapubic catheter (SPC).  Although the SPC is more invasive compared to a transurethral 
catheter, the SPC is used routinely in many gynecologic surgical practices because of its’ many 
advantages.  These include prevention of urethral trauma and stricture formation, decreased UTI17, 
18,  increased patient satisfaction compared to chronic indwelling urethral catheters, less 
discomfort19, avoidance of urethritis20, maintained ability to void spontaneously, easier nursing 
care21, and shorter hospital stay18 .  Review of literature does not demonstrate any benefit with any 
particular type of SPC22. 
 
We hypothesize that this study will show a statistically significant decrease in UTI rate among the 
urogynecology patients undergoing suprapubic catheterization with a silver-alloy catheter 
compared to the standard catheter.  
 
Schematic Design of the Study: randomized control trial        
Aims:  
 
1) To compare the UTI rate among women undergoing urogynecological procedures with a silver-
alloy suprapubic catheter compared to the standard supra-pubic catheter.  
2) To identify risk factors predisposing patients to suprapubic CAUTI.  
Methods 
 
Description of Recruitment Methods: 
 
 
How will subjects be identified?  
 
Individuals who are being scheduled for a surgery which routinely requires 
placement of suprapubic catheter intraoperatively (i.e. abdominal sacrocolpopexy, anterior 
vaginal colporrhaphy, Burch colposuspension with and without mid-urethral sling), will be 
approached about participating in the study in the pre-operative urogynecology clinic.   
How will subjects be contacted?    
 
Subjects will be contacted in the Urogynecology clinic during the pre-operative 
visit.  They will also be contacted during their routine 6-week follow-up post-operative visit 
in Urogynecology clinic. Additionally, if a patient has symptoms of a UTI or seeks medical 
treatment for a UTI during the 6 week post-operative period, we will ask the patient to 
contact the study team. 
 
 
Recruitment Materials (if applicable):  
n/a 
 
Subject Population: 
 
 
Number (total, each subgroup) 444 total, 222 per group 
 
 
Gender:   
Male  
0     
 
 
Female 
444       
 
 
Ages:  18 to 
99 years 
Inclusion Criteria:   
- 
patients requiring intra-operative placement of suprapubic catheters as part of 
routine post-operative care for repair of 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 

 
Effective Date: 6/12/2009 
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IRB 10272.002  
- 
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  
        
 
Step-by-Step Schedule (include all procedures, therapies – attach a table or flow chart if there are 
multiple procedures or visits and indicate the window of number of days in which the participant 
may return for follow-up visits): 
1. Informed consent obtained pre-operatively to participate in study 
2. Collection of baseline information including demographics, stage of prolapse, past medical 
history, past surgical history, history of past UTI, laboratory studies including collection of 
urine for urinalysis and bacterial gram stain and culture. 
3. Computer-generated randomization of subjects to either the control group (standard non-
latex foley catheter) or the treatment group (silver alloy-impregnated catheter), in blocks of 
4.  Patients and study staff involved in outcome assessment will be blinded to type of 
treatment allocation. 
4. Removal of catheter per standard post-operative catheter care (adequate urinary output over 
24 hours, lack of gross hematuria, able to void voluntarily) 
5. If a patient has symptoms of a UTI or seeks medical treatment for a UTI during the 6 week 
post-operative period, we will ask the patient to contact the study team. 
6. Review of patient and medical records at 6 week follow-up visit for UTI and laboratory 
evidence, if available. 
7. If suprapubic catheter still in place, sending urine sample obtained by catheter for 
urinalysis, bacterial gram stain and culture. 
 
Biospecimen (types, number, volume, processing, storage): n/a 
 
 
Plan for Dose Modification if Toxicity occurs (if applicable):  n/a 
 
      
 Statistical Considerations 
 
Endpoints 
 
 
Primary:  
UTI rate  
UTI is defined as: 
(1) any symptoms (fever > 38°C, suprapubic tenderness, costovertebral angle tenderness, or 
otherwise unexplained systemic symptoms such as altered mental status, hypotension, or 
evidence of a systemic inflammatory response syndrome) requiring antibiotic treatment  
(2) urine culture with > 105 cfu / mL 
(3) urine culture with > 103 cfu/ mL and evidence of pyuria (dipstick positive for leukocyte 
esterase and/or nitrite, microscopic pyuria, or presence of microbes seen on Gram stain of 
unspun urine)22     
 
 
 
 
Secondary:  
        
Power Statement:      
 

 
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Previous studies of transurethral latex catheters have demonstrated a reduction in CAUTI 
incidence of ranging from 27% to 73%12-15 with use of silver-impregnated catheters compared to 
standard latex foley catheters.  Additionally, a previously published data from our center reported a 
CAUTI rate of 19%23 with use of standard foley catheters used for SPC in a postoperative 
urogynecology population.  Therefore, since there are no previous studies evaluating the CAUTI 
rate of silver-impregnated SPC use, a conservative estimate of 10% reduction will be used in our 
sample size calculation.   
To obtain 80% power, with a difference in UTI rate of 10%, then the sample size per group 
that we hope to recruit is 400.  However, we anticipate 10% drop-out so we will plan to recruit 222 
per group, summing 444 total participants.      
Data Analysis: 
Continuous variables will be compared using a two sided t-test with alpha ≤0.05 considered 
statistically significant.  Binary outcomes (UTI vs. no UTI) will be compared using Fisher’s exact 
test.  Descriptive statistics will be used to describe continuous variables for the two types of 
catheters.  Multiple logistic regression will be used to adjust for confounders such as prior UTI, 
duration of catheterization, type of surgery performed, age, BMI, and comorbid conditions. 
Strength of association between UTI rate and confounders will be assessed by calculating odds 
ratios and their corresponding 95% confidence intervals. 
      
 
Human Safety Aspects 
Risks:    The literature review does not reveal any added adverse effects of using silver-
alloy catheters, above standard non-silver-alloy coated catheters.  Since all patients, regardless of 
study participation, will have SPCs placed post-operatively as part of routine care, we do not 
anticipate any additional risks to participants.  
Individual Subject Stopping Rules (if applicable):    n/a 
DSMB (if applicable): 
Members:   
 
n/a 
Charter:  
 
n/a 
 
Stopping Rules for Efficacy and Safety (if applicable):      
n/a 
Questionnaires that ask about Depression (if applicable) 
Included in study?    Yes 
   No  
 
If “Yes”, state the plan of management for subjects with possible depression: 
      
 
 
 
 
 
 
 
 
 
 

 
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References 
 
1. 
Saint S, Veenstra DL, Sullivan SD, Chenoweth C, Fendrick AM. The potential 
clinical and economic benefits of silver alloy urinary catheters in preventing 
urinary tract infection. Archives of internal medicine. 2000; 160(17): 2670-5. 
2. 
Haley RW, Hooton TM, Culver DH, Stanley RC, Emori TG, Hardison CD, et al. 
Nosocomial infections in U.S. hospitals, 1975-1976: estimated frequency by 
selected characteristics of patients. Am J Med. 1981; 70(4): 947-59. 
3. 
Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA. Guideline for 
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4. 
Warren JW, Platt R, Thomas RJ, Rosner B, Kass EH. Antibiotic irrigation 
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5. 
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