Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation - Full Text View

Sponsor:	Lawson Health Research Institute
Collaborator:	Boston Scientific Corporation
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00250406

Purpose

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, patients who require chronic long-term stenting, 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	Intervention	Phase
Renal Calculi Ureteral Obstruction	Device: Ureteral Stent	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Hexachlorophene Triclosan

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	November 2005
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250406

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

No publications provided

Responsible Party:	Dr. John Denstedt, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00250406 History of Changes
Other Study ID Numbers:	R-05-646
Study First Received:	November 4, 2005
Last Updated:	January 20, 2009
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

urolithiasis
ureteral stent
triclosan
drug eluting

Additional relevant MeSH terms:

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

Hexachlorophene
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 12, 2012