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

Lawson Health Research Institute

Status and phase

Completed

Phase 2

Conditions

Ureteral Obstruction

Renal Calculi

Treatments

Device: Ureteral Stent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00250406

R-05-646

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.