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

December 19, 2013 updated by: John Denstedt, Lawson Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Urology, St. Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Percuflex Plus Ureteral Stent
Device: Ureteral Stent
triclosan-eluting ureteral stent
Other Names:
  • TRIUMPH 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
Device: Ureteral Stent
Percuflex Plus Stent as the control
Other Names:
  • Percuflex Plus Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at time of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at time of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: John D Denstedt, MD, FRCSC, St. Joseph's Hospital, The University of Western Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 8, 2005

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

December 19, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-05-646

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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