Indwelling Stent Discoloration Project

Examining the Underlying Factors That Cause Ureteral Stent Discoloration in Japanese and Canadian Ureteral Stents

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02007980

Enrollment

Registered

2013-12-11

Start date

2013-12-31

Completion date

2023-09-29

Last updated

2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Urinary Stent, Hydronephrosis, Kidney Calculi, Urinary Tract Obstruction Due to Specified Cause, Urologic Injuries

Keywords

urological problems, indwelling urologic stent, kidney stone disease, urinary system obstruction, hydronephrosis, ureteral damage

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

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

Design outcomes

Primary

Measure	Time frame	Description
stent encrustation	at stent removal	Conditioning film components and encrustation

Secondary

Measure	Time frame	Description
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

Countries

Canada

Outcome results