Status:

COMPLETED

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

Lead Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborating Sponsors:

Boston Scientific Corporation

Conditions:

Renal Calculi

Ureteral Obstruction

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 s...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00250406

Start Date

November 1 2005

End Date

March 1 2009

Last Update

December 20 2013

Active Locations (1)

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1

Urology, St. Joseph's Hospital

London, Ontario, Canada, N6A 4V2

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