Clinical trial NCT00250406: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Calculi
Ureteral Obstruction
Keywords: urolithiasis
ureteral stent
triclosan
drug eluting
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2005-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


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.

Primary outcomes:
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.
timeFrame: at time of intervention
Secondary outcomes:
measure: Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.
timeFrame: at time of intervention
Other outcomes:
Locations:
city: London
country: Canada
facility: Urology, St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: St. Joseph's Hospital, The University of Western Ontario
name: John D Denstedt, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: