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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00250406

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Calculi Ureteral Obstruction	Device: Ureteral Stent Device: Ureteral Stent	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Percuflex Plus Ureteral Stent	Device: Ureteral Stent Percuflex Plus Stent as the control Other Names: Percuflex Plus Stent
Experimental: 2 TRIUMPH stent (triclosan-eluting stent)	Device: Ureteral Stent triclosan-eluting ureteral stent Other Names: TRIUMPH STENT

Arm

Intervention/Treatment

Active Comparator: 1

Percuflex Plus Ureteral Stent

Device: Ureteral Stent

Percuflex Plus Stent as the control

Other Names:

Percuflex Plus Stent

Experimental: 2

TRIUMPH stent (triclosan-eluting stent)

Device: Ureteral Stent

triclosan-eluting ureteral stent

Other Names:

TRIUMPH STENT

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture. [at time of intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.