Study Evaluating the Helical Ureteral Stent
The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent|
- Percent of patients who have pain during the stent indwell period [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]The primary objective is to decrease the percent of patients who have pain during the stent indwell period beyond protocol-defined postoperative pain therapy from 25% for standard stents (the Control Stent in previous studies) to 10% for the Helical Stent. The previous clinical trial found that patients with Percuflex Plus stents had pain 25.2% of the time following stent insertion (J Urol 183:1037, 2010).
- Percent of patients requesting intervention during the stent indwell period [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
The secondary objective is to decrease the percent of patients requesting intervention during the stent indwell period.
Interventions are defined as the following actions taken due to pain:
- Unscheduled Clinic visit, or
- Change in Pain Medication, or
- Early Stent Removal
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Helical stent insertion
Study participants will receive the helical stent
Device: Stent insertion
The patient will receive the helical stent
Ureteral stents have been used for many years for a variety of clinical indications. Many surgeons routinely use ureteral stents after the endourologic removal of stones to facilitate in urine passage and facilitate excretion of any left over stones. There is a multitude of literature that reveals that most patients find ureteral stents to be uncomfortable. This discomfort often causes pain severe enough that patients anxiously anticipate stent removal, and often request early stent removal, and/or require use of pain medications that have many side effects and cause further discomfort to these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739725
|Contact: Olga Arsovska||6048754111 ext firstname.lastname@example.org|
|Canada, British Columbia|
|University of British Columbia||Recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: Olga Arsovska 6048754111 ext 62421 email@example.com|
|Principal Investigator: Ben Chew, MD|
|Sub-Investigator: Ryan Paterson, MD|
|Principal Investigator:||Ben Chew, MD||University of British Columbia|