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

Renal Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250406
• Other study ID #: R-05-646
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2005
• Last updated: December 19, 2013
• Start date: November 2005
• Est. completion date: March 2009

Study information

• Verified date: December 2013
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Calculi
• Ureteral Obstruction

Intervention

Device:
• Ureteral Stent
triclosan-eluting ureteral stent
• Ureteral Stent
Percuflex Plus Stent as the control

Locations

Country	Name	City	State
Canada	Urology, St. Joseph's Hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Boston Scientific Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at time of intervention	No
Secondary	Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.		at time of intervention	No