Infection Associated With Catheter, Urinary Tract Infection
Conditions
Keywords
CAUTI, UTI
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.
Interventions
DEVICEsilver SPC
subject randomized to receive silver alloy impregnated catheter
DEVICEstandard SPC
subject randomized to receive standard catheter
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Tract Infection Rate | within 6 weeks post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Urinary Tract Infections in Diabetics | within 6 weeks post surgery | Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silver SPC Subjects randomized to receive silver-impregnated SPC.
silver SPC: subject randomized to receive silver alloy impregnated catheter | 137 |
| Standard SPC subjects randomized to receive standard SPC.
standard SPC: subject randomized to receive standard catheter | 127 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive allocated intervention | 6 | 6 |
| Overall Study | Physician Decision | 1 | 11 |
Baseline characteristics
| Characteristic | Silver SPC | Standard SPC | Total |
|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 10.5 | 66.3 years STANDARD_DEVIATION 10.4 | 65.5 years STANDARD_DEVIATION 10.4 |
| Body Mass Index | 27.6 kg/m^2 STANDARD_DEVIATION 5 | 27.8 kg/m^2 STANDARD_DEVIATION 5.2 | 27.7 kg/m^2 STANDARD_DEVIATION 5.1 |
| Race/Ethnicity, Customized Non-white | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 131 Participants | 124 Participants | 255 Participants |
| Region of Enrollment United States | 137 participants | 127 participants | 264 participants |
| Sex: Female, Male Female | 137 Participants | 127 Participants | 264 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 127 |
| other Total, other adverse events | 0 / 137 | 0 / 127 |
| serious Total, serious adverse events | 3 / 137 | 3 / 127 |
Outcome results
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.
Time frame: within 6 weeks post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silver SPC | Urinary Tract Infection Rate | 24 Participants |
| Standard SPC | Urinary Tract Infection Rate | 29 Participants |
p-value: 0.3Wilcoxon (Mann-Whitney)
Secondary
Risk of Urinary Tract Infections in Diabetics
Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery.
Time frame: within 6 weeks post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silver SPC | Risk of Urinary Tract Infections in Diabetics | 4 Participants |
| Standard SPC | Risk of Urinary Tract Infections in Diabetics | 8 Participants |
p-value: 0.68Wilcoxon (Mann-Whitney)