UTI
Conditions
Keywords
Silver-coated catheter, UTI, Pelvic Reconstructive Surgery, Urogynecology
Brief summary
Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery Secondary Aims: To assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter
Interventions
DEVICE2-Way Foley Urethral Urinary Catheter
Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.
Exclusion criteria
* Unwilling or unable to participate in the study. * Unwilling or unable to do a catheter self-removal at home. * Inability to understand English. * Pregnant women * Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids. * Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis * Active urinary tract infection. * Intraoperative bladder injury or cystotomy * Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms * Reported allergy to silver metal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of UTIs requiring treatment | approximately 4 weeks | Post-operative UTI rate |
Secondary
| Measure | Time frame |
|---|---|
| Assess the types of bacterial uropathogens isolated from the urine cultures | approximately 4 weeks |
| Adverse symptoms possibly causes by silver-coated catheter | approximately 4 weeks |
Countries
United States
Outcome results
None listed