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

NCT00250406 | Completed Phase 2

• 1 other identifier: R-05-646
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Calculi; Ureteral Obstruction

Keywords

urolithiasis; ureteral stent; triclosan; drug eluting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.

  at time of intervention

Study Arms (2)

1

ACTIVE COMPARATOR

Percuflex Plus Ureteral Stent

Device: Ureteral Stent

2

EXPERIMENTAL

TRIUMPH stent (triclosan-eluting stent)

Device: Ureteral Stent

Interventions

Ureteral Stent DEVICE

triclosan-eluting ureteral stent

Also known as: TRIUMPH STENT

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Urology, St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Kidney Calculi; Ureteral Obstruction; Urolithiasis

Interventions

Stents

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• John D Denstedt, MD, FRCSC

  St. Joseph's Hospital, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair/Chief, Department of Surgery, Western University

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: November 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

CA (1)