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

This study is currently recruiting participants.
Verified by Lawson Health Research Institute, August 2008

Sponsors and Collaborators: Lawson Health Research Institute
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

ChemIDplus related topics:   Triclosan    Hexachlorophene   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study

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:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Percuflex Plus Ureteral Stent
Device: Ureteral Stent
Percuflex Plus Stent as the control
2: Experimental
TRIUMPH stent (triclosan-eluting stent)
Device: Ureteral Stent
triclosan-eluting ureteral 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

Contacts
Contact: Linda Nott, Reg N     519-646-6310     Linda.Nott@sjhc.london.on.ca    

Locations
Canada, Ontario
Urology, St. Joseph's Hospital     Recruiting
      London, Ontario, Canada, N6A 4V2
      Contact: Linda Nott, Reg N     519-646-6310     Linda.Nott@sjhc.london.on.ca    
      Principal Investigator: John D Denstedt, MD, FRCSC            

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:   Lawson Health Research Institute ( Dr. John Denstedt )
Study ID Numbers:   R-05-646
First Received:   November 4, 2005
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00250406
Health Authority:   Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
urolithiasis  
ureteral stent  
triclosan  
drug eluting  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Hexachlorophene
Urolithiasis
Ureteral Obstruction
Ureteral Diseases
Kidney Diseases
Calculi
Triclosan
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Anti-Infective Agents, Local
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




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