Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
Information source: Lawson Health Research Institute
Information obtained from ClinicalTrials.gov on October 31, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Calculi; Ureteral Obstruction
Intervention: Ureteral Stent (Device); Ureteral Stent (Device)
Phase: Phase 2
Status: Recruiting
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s):
John D Denstedt, MD, FRCSC, Principal Investigator, Affiliation: St. Joseph's Hospital, The University of Western Ontario
Overall contact:
Linda Nott, Reg N, Phone: 519-646-6310, Email: Linda.Nott@sjhc.london.on.ca
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.
Clinical Details
Official title: Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Linda Nott, Reg N, Phone: 519-646-6310, Email: Linda.Nott@sjhc.london.on.ca
Urology, St. Joseph's Hospital, London, Ontario N6A 4V2, Canada; Recruiting
Linda Nott, Reg N, Phone: 519-646-6310, Email: Linda.Nott@sjhc.london.on.ca
John D Denstedt, MD, FRCSC, Principal Investigator
Additional Information
Starting date: November 2005
Ending date: December 2008
Last updated: August 14, 2008
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