Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
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ClinicalTrials.gov Identifier: NCT00250406 |
Recruitment Status :
Completed
First Posted : November 8, 2005
Last Update Posted : December 20, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Calculi Ureteral Obstruction | Device: Ureteral Stent | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250406
Canada, Ontario | |
Urology, St. Joseph's Hospital | |
London, Ontario, Canada, N6A 4V2 |
Principal Investigator: | John D Denstedt, MD, FRCSC | St. Joseph's Hospital, The University of Western Ontario |
Responsible Party: | John Denstedt, Chair/Chief, Department of Surgery, Western University, Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00250406 |
Other Study ID Numbers: |
R-05-646 |
First Posted: | November 8, 2005 Key Record Dates |
Last Update Posted: | December 20, 2013 |
Last Verified: | December 2013 |
urolithiasis ureteral stent triclosan drug eluting |
Kidney Calculi Nephrolithiasis Ureteral Obstruction Calculi Pathological Conditions, Anatomical |
Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Ureteral Diseases |