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

Overview

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.

Full Title of Study: “Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 13, 2020

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.

Interventions

  • Other: USSQ questionnaire administration after RIRS.
    • USSQ symptoms questionnaire administration after RIRS

Arms, Groups and Cohorts

  • Active Comparator: Vortek double-J stent
    • Vortek double-J stent after RIRS.
  • Active Comparator: Polaris Loop stent
    • Polaris Loop ureteral stent after RIRS.

Clinical Trial Outcome Measures

Primary Measures

  • USSQ Urinary symptoms scores
    • Time Frame: 4 weeks
    • Evaluation of significant differences in Urinary symptoms score between the two groups

Secondary Measures

  • USSQ domains scores
    • Time Frame: 4 weeks
    • Evaluation of significant differences in USSQ domains’ scores between the two groups
  • USSQ domains scores
    • Time Frame: 2 days
    • Evaluation of significant differences in USSQ domains’ scores between the two groups
  • USSQ domains’ scores adjusted for baseline
    • Time Frame: 8 weeks
    • Evaluation of significant differences in USSQ domains’ scores adjusted for baseline between the two groups

Participating in This Clinical Trial

Inclusion Criteria

  • patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones < 2 cm – given informed consent – WHO PS 0-2 Exclusion Criteria:

  • significant residual fragments at the end of the procedure – intraoperative complications (i.e. ureteral damage or ureteral stricture) – urinary tract infections – anatomic abnormalities – chronic diseases or medications potentially influencing pain perception and urinary symptoms (i.e. alpha blockers and antimuscarinics) – preoperative ureteral stenting.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrea Bosio, MD Urologist, PhD – Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Overall Official(s)
    • Andrea Bosio, MD, Principal Investigator, AOU Città della Salute e della Scienza, Torino

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