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

Phase 2

Completed

• Conditions: Ureteral Obstruction; Renal Calculi
• Interventions: Device: Ureteral Stent

• Registration Number: NCT00250406
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-04
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ureteral Stent	TRIUMPH stent (triclosan-eluting stent)
1	Ureteral Stent	Percuflex Plus Ureteral Stent

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.	at time of intervention

Trial Locations

Locations (1)

Urology, St. Joseph's Hospital; 🇨🇦 London, Ontario, Canada