Silver-Coated vs Standard Catheter for UTI Prevention

Study Overview
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Brief Summary
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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

Official Title
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Silver-coated Catheter Versus Standard Catheter for UTI Prevention in a Short-term Transurethral Indwelling Catheter Population After Pelvic Reconstructive Surgery: A Randomized Controlled Trial

Conditions
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UTI

Intervention / Treatment
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* Device: 2-Way Foley Urethral Urinary Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silver-Coated Catheter<br> | Device: 2-Way Foley Urethral Urinary Catheter<br>* Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates<br>|
| Placebo Comparator: Standard Catheter<br> | Device: 2-Way Foley Urethral Urinary Catheter<br>* Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of UTIs requiring treatment | Post-operative UTI rate | approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silver-coated catheter, UTI, Pelvic Reconstructive Surgery, Urogynecology