NCT03344107

Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents

Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective randomized controlled single-blind parallel-group trial in order to compare symptoms related to loop-tail (Polaris Loop) stents versus conventional double J (Vortek) stents after uncomplicated flexible URS.

Detailed description

Patients undergoing RIRS for a single renal stone \< 2 cm are asked to participate in a prospective randomized controlled single-blind parallel-group study. Ureteral stent is always placed after flexible URS. Patients are prospectively randomized into two groups with a 1:1 allocation: group LT receive loop-tail stents (Polaris ™ Loop - Boston Scientific, Natick, USA), while group DJ receive conventional double J stents (Vortek ® - Coloplast, Humlebaek, DK). Stent removal is planned 4 weeks after the procedure. Participants are asked to fill in the Italian validated version of the Ureteral Stent Symptoms Questionnaire (USSQ) 2 days and 4 weeks after surgery. The USSQ is further submitted 4 weeks after stent removal (8 weeks after surgery) and these results are used as baseline evaluation, on the assumption that SRS persist for a few days after removal.

Conditions

• Symptoms and Signs
• Pain
• Renal Calculi

Interventions

Type	Name	Description
OTHER	USSQ questionnaire administration after RIRS.	USSQ symptoms questionnaire administration after RIRS

Timeline

• Start date: 2018-01-10
• Primary completion: 2020-02-13
• Completion: 2020-04-17
• First posted: 2017-11-17
• Last updated: 2020-12-01

Locations

1 site across 1 country: Italy