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

November 29, 2020 updated by: Andrea Bosio, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy, 10126
        • AOU Città della salute e della scienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Vortek double-J stent
Vortek double-J stent after RIRS.
Other: USSQ questionnaire administration after RIRS.
USSQ symptoms questionnaire administration after RIRS
ACTIVE_COMPARATOR: Polaris Loop stent
Polaris Loop ureteral stent after RIRS.
Other: USSQ questionnaire administration after RIRS.
USSQ symptoms questionnaire administration after RIRS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
USSQ domains scores
Time Frame: 4 weeks
Evaluation of significant differences in USSQ domains' scores between the two groups
4 weeks
USSQ domains scores
Time Frame: 2 days
Evaluation of significant differences in USSQ domains' scores between the two groups
2 days
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

  • Principal Investigator: Andrea Bosio, MD, AOU Città della Salute e della Scienza, Torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2018

Primary Completion (ACTUAL)

February 13, 2020

Study Completion (ACTUAL)

April 17, 2020

Study Registration Dates

First Submitted

November 11, 2017

First Submitted That Met QC Criteria

November 11, 2017

First Posted (ACTUAL)

November 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 29, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOUCSSTURAB003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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