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

This study is currently recruiting participants.
Study NCT00250406.   Last updated on August 14, 2008.   Information provided by Lawson Health Research Institute

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Descriptive Information Fields
Brief Title  Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
Official Title  Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study
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, 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.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  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 Measure  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 ]
Condition  Renal Calculi
Ureteral Obstruction
Intervention  Device: Ureteral Stent
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  30
Start Date  November 2005
Completion Date December 2008
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Linda Nott, Reg N     519-646-6310     Linda.Nott@sjhc.london.on.ca    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00250406
Organization ID R-05-646
Secondary IDs ††
Study Sponsor  Lawson Health Research Institute
Collaborators †† Boston Scientific Corporation
Investigators 
Principal Investigator:     John D Denstedt, MD, FRCSC     St. Joseph's Hospital, The University of Western Ontario    
Information Provided By Lawson Health Research Institute
Verification Date August 2008
First Received Date  November 4, 2005
Last Updated Date August 14, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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