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

• ClinicalTrials.gov Identifier: NCT00250406
• Recruitment Status: Completed
• First Posted: November 8, 2005
• Last Update Posted: December 20, 2013
• Sponsor: Lawson Health Research Institute
• Collaborator: Boston Scientific Corporation
• Information provided by (Responsible Party): John Denstedt, Lawson Health Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Renal Calculi; Ureteral Obstruction	Device: Ureteral Stent	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study
• Study Start Date: November 2005
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Percuflex Plus Ureteral Stent	Device: Ureteral Stent; Percuflex Plus Stent as the control; Other Name: Percuflex Plus Stent
Experimental: 2; TRIUMPH stent (triclosan-eluting stent)	Device: Ureteral Stent; triclosan-eluting ureteral stent; Other Name: TRIUMPH STENT

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: at time of intervention ]

Secondary Outcome Measures :

1. Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture. [ Time Frame: at time of intervention ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Canada, Ontario

Urology, St. Joseph's Hospital

London, Ontario, Canada, N6A 4V2

Sponsors and Collaborators

Lawson Health Research Institute

Boston Scientific Corporation

Investigators

• Principal Investigator: John D Denstedt, MD, FRCSC; St. Joseph's Hospital, The University of Western Ontario

More Information

• Responsible Party: John Denstedt, Chair/Chief, Department of Surgery, Western University, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT00250406
• Other Study ID Numbers: R-05-646
• First Posted: November 8, 2005
• Last Update Posted: December 20, 2013
• Last Verified: December 2013

Keywords provided by John Denstedt, Lawson Health Research Institute:

urolithiasis; ureteral stent; triclosan; drug eluting

Additional relevant MeSH terms:

Kidney Calculi; Nephrolithiasis; Ureteral Obstruction; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Urolithiasis; Urinary Calculi; Ureteral Diseases