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OpenTrials
Completed

NCT Number: NCT03344107

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

USSQ questionnaire administration after RIRS.

Other

USSQ symptoms questionnaire administration after RIRS

Primary outcomes

  1. USSQ Urinary symptoms scores

    Time frame: 4 weeks

    Evaluation of significant differences in Urinary symptoms score between the two groups

Secondary outcomes

  1. USSQ domains scores

    Time frame: 4 weeks

    Evaluation of significant differences in USSQ domains' scores between the two groups

  2. USSQ domains scores

    Time frame: 2 days

    Evaluation of significant differences in USSQ domains' scores between the two groups

  3. 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

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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