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

Primary Purpose

Renal Calculi, Ureteral Obstruction

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ureteral Stent
Ureteral Stent
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Calculi focused on measuring urolithiasis, ureteral stent, triclosan, drug eluting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Urology, St. Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Percuflex Plus Ureteral Stent

TRIUMPH stent (triclosan-eluting stent)

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2005
Last Updated
December 19, 2013
Sponsor
Lawson Health Research Institute
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00250406
Brief Title
Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
Official Title
Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi, Ureteral Obstruction
Keywords
urolithiasis, ureteral stent, triclosan, drug eluting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Percuflex Plus Ureteral Stent
Arm Title
2
Arm Type
Experimental
Arm Description
TRIUMPH stent (triclosan-eluting stent)
Intervention Type
Device
Intervention Name(s)
Ureteral Stent
Other Intervention Name(s)
TRIUMPH STENT
Intervention Description
triclosan-eluting ureteral stent
Intervention Type
Device
Intervention Name(s)
Ureteral Stent
Other Intervention Name(s)
Percuflex Plus Stent
Intervention Description
Percuflex Plus Stent as the control
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Denstedt, MD, FRCSC
Organizational Affiliation
St. Joseph's Hospital, The University of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology, St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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

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