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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
John Denstedt, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00250406
First received: November 4, 2005
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Renal Calculi
Ureteral Obstruction
Device: Ureteral Stent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

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. [ Time Frame: at time of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture. [ Time Frame: at time of intervention ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Percuflex Plus Ureteral Stent
Device: Ureteral Stent
Percuflex Plus Stent as the control
Other Name: Percuflex Plus Stent
Experimental: 2
TRIUMPH stent (triclosan-eluting stent)
Device: Ureteral Stent
triclosan-eluting ureteral stent
Other Name: TRIUMPH STENT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250406

Locations
Canada, Ontario
Urology, St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Boston Scientific Corporation
Investigators
Principal Investigator: John D Denstedt, MD, FRCSC St. Joseph's Hospital, The University of Western Ontario
  More Information

No publications provided

Responsible Party: John Denstedt, Chair/Chief, Department of Surgery, Western University, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00250406     History of Changes
Other Study ID Numbers: R-05-646
Study First Received: November 4, 2005
Last Updated: December 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
urolithiasis
ureteral stent
triclosan
drug eluting

Additional relevant MeSH terms:
Kidney Calculi
Ureteral Obstruction
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 18, 2014