Indwelling Stent Discoloration Project

• Conditions: Disorder of Urinary Stent; Urinary Tract Obstruction Due to Specified Cause; Hydronephrosis; Urologic Injuries; Kidney Calculi

• Registration Number: NCT02007980
• Lead Sponsor: University of British Columbia

Brief Summary

The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents.

Detailed Description

The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents observed in some patients, particularly those from Japan. We will also test and compare them to stents from Canadian patients. Furthermore, we will determine whether the discolouration promotes bacterial adhesion and/or encrustation of the stent.

Study Timeline

• Study First Submitted: 2013-11-12
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
• Patient has indwelling ureteral stent

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Exclusion Criteria

• Pregnancy
• Positive Urine Culture
• Active cancer
• Recurrent urinary infections
• Gross hematuria
• Inability to provide informed consent
• Physician/Surgeon refuses to enter patient into study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stent encrustation	at stent removal	Conditioning film components and encrustation

Secondary Outcome Measures

Name	Time	Method
characterize the components that discolour the Percuflex material	bench top testing of stents
Bacterial Adhesion, Colonization, and Biofilm formation	at 4, 24, and 48 hours post stent removal	Stent pieces from the stent that has been in the patient will be exposed to bacteria and artificial urine to mimic ureter environment in order to find information on: bacterial adhesion, colonization and biofilm formation

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada