Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
This study is enrolling participants by invitation only.
Sponsor:
Lawson Health Research Institute
Collaborator:
Boston Scientific Corporation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00250406
First received: November 4, 2005
Last updated: January 20, 2009
Last verified: January 2009
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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, patients who require chronic long-term stenting, 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | January 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
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: | Dr. John Denstedt, 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: | January 20, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Lawson Health Research Institute:
|
urolithiasis ureteral stent triclosan drug eluting |
Additional relevant MeSH terms:
|
Calculi Kidney Calculi Ureteral Obstruction Pathological Conditions, Anatomical Nephrolithiasis Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Ureteral Diseases Triclosan |
Hexachlorophene Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 21, 2013