Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents
Primary Purpose
Symptoms and Signs, Pain, Renal Calculi
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
USSQ questionnaire administration after RIRS.
Sponsored by
About this trial
This is an interventional treatment trial for Symptoms and Signs focused on measuring Symptoms and Signs, Pain, Renal Calculi, Ureteral Stent, Ureteroscopy
Eligibility Criteria
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.
Sites / Locations
- AOU Città della Salute e della Scienza
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vortek double-J stent
Polaris Loop stent
Arm Description
Vortek double-J stent after RIRS.
Polaris Loop ureteral stent after RIRS.
Outcomes
Primary Outcome Measures
USSQ Urinary symptoms scores
Evaluation of significant differences in Urinary symptoms score between the two groups
Secondary Outcome Measures
USSQ domains scores
Evaluation of significant differences in USSQ domains' scores between the two groups
USSQ domains scores
Evaluation of significant differences in USSQ domains' scores between the two groups
USSQ domains' scores adjusted for baseline
Evaluation of significant differences in USSQ domains' scores adjusted for baseline between the two groups
Full Information
NCT ID
NCT03344107
First Posted
November 11, 2017
Last Updated
November 29, 2020
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
1. Study Identification
Unique Protocol Identification Number
NCT03344107
Brief Title
Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents
Official Title
Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
April 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptoms and Signs, Pain, Renal Calculi
Keywords
Symptoms and Signs, Pain, Renal Calculi, Ureteral Stent, Ureteroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vortek double-J stent
Arm Type
Active Comparator
Arm Description
Vortek double-J stent after RIRS.
Arm Title
Polaris Loop stent
Arm Type
Active Comparator
Arm Description
Polaris Loop ureteral stent after RIRS.
Intervention Type
Other
Intervention Name(s)
USSQ questionnaire administration after RIRS.
Intervention Description
USSQ symptoms questionnaire administration after RIRS
Primary Outcome Measure Information:
Title
USSQ Urinary symptoms scores
Description
Evaluation of significant differences in Urinary symptoms score between the two groups
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
USSQ domains scores
Description
Evaluation of significant differences in USSQ domains' scores between the two groups
Time Frame
4 weeks
Title
USSQ domains scores
Description
Evaluation of significant differences in USSQ domains' scores between the two groups
Time Frame
2 days
Title
USSQ domains' scores adjusted for baseline
Description
Evaluation of significant differences in USSQ domains' scores adjusted for baseline between the two groups
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Bosio, MD
Organizational Affiliation
AOU Città della Salute e della Scienza, Torino
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Città della Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents
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