Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation

Study Overview
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Brief Summary
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The purpose of this study is to determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. The patient populations that will be tested include: patients following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.

Official Title
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Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study

Conditions
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Renal Calculi, Ureteral Obstruction

Intervention / Treatment
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* Device: Ureteral Stent
* Device: Ureteral Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo ureteroscopy for any reason and require a ureteral stent post-operatively as determined by the surgeon (e.g. renal obstruction, ureteral edema, ureteral perforation, large stone fragments to pass, following ureteral dilation, ureteral trauma, solitary kidney, or any other reason left to the discretion of the surgeon). Patients undergoing extracorporeal shockwave lithotripsy (ESWL) who will require a stent as determined by the treating urologist (e.g. solitary kidney, ureteral stone > 1 cm, renal stone > 1.5 cm, significant renal obstruction, history of pyelonephritis, or any other reason left to the discretion of the surgeon). Patients who have or are going to have chronic ureteral stents, for any reason. Patients willing to return to St. Joseph's Hospital's Urology Clinic for follow-up. Exclusion Criteria: Age ≤ 17 years Patients unable to consent. Any patient requiring endocarditis or prosthetic device prophylaxis (e.g. fresh arthroplasty etc.). Pregnant females Immunocompromised patients Significant urinary symptoms (urgency, dysuria, strangury, hematuria) or other bladder pathology that may cause these symptoms (e.g. interstitial cystitis) Anyone in the investigator's opinion that would be unsuitable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Percuflex Plus Ureteral Stent | Device: Ureteral Stent<br>* Percuflex Plus Stent as the control<br>* Other names: Percuflex Plus Stent;|
| Experimental: 2<br>TRIUMPH stent (triclosan-eluting stent) | Device: Ureteral Stent<br>* triclosan-eluting ureteral stent<br>* Other names: TRIUMPH STENT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent. |  | at time of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture. |  | at time of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urolithiasis, ureteral stent, triclosan, drug eluting