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OpenTrials
Completed

NCT Number: NCT00250406

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ureteral Stent

Device

triclosan-eluting ureteral stent

Other names: TRIUMPH STENT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 8, 2005
Registry last updated
Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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