ClinicalTrials.gg
CompletedNCT03344107Updated Dec 1, 2020

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

An interventional study of USSQ questionnaire administration after RIRS. in Symptoms and Signs, Pain and Renal Calculi, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-01.

Primary conditionPainRegistry: Signs and SymptomsReclassifiedWhy we changed it
Registry
Signs and Symptoms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pain
Why
  1. The study's listed conditions name Pain, a narrower term within Signs and Symptoms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by A.O.U. Città della Salute e della Scienza · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 213 studies in Pain with a site in Italy — 35 open to participants now, 41 under way, 1 of them phase 3. Pain · Italy.

Enrollment
89th of 156
68 · median 80
Started
2018
with 14 others
No phase
102 of 213
14 open now
Registered
80th of 213
by date

Among the 213 studies in Pain with a site in Italy, this one is the 89th largest by enrollment of the 156 interventional ones that give a count, is one of 15 that started in 2018, is one of 102 with no phase, and was the 80th registered.

Pain

10,066 studies on the registry are indexed under Pain; 1,651 are open to participants now.

Browse Pain studies →

Open to participants now

35 of the 213 studies in Pain with a site in Italy are open now. Recruiting first, the newest first:

30 more — sign in →

All 35 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 928 Pain studies recruiting now, 383 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 213 studies in Pain with a site in Italy, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Symptoms and Signs
  • Pain
  • Renal Calculi

Browse trials for

Keywords

  • Symptoms and Signs
  • Pain
  • Renal Calculi
  • Ureteral Stent
  • Ureteroscopy
04

In context

Pain Reclassified

10,066 studies on the registry are indexed under Pain; 1,651 are open to participants now.

This study's enrollment of 68 is close to the median of 66 across 8,502 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Signs and Symptoms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones \< 2 cm
  • given
  • WHO PS 0-2

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    Vortek double-J stent

    Vortek double-J stent after RIRS.

    Other: USSQ questionnaire administration after RIRS.

  • Active comparator
    Polaris Loop stent

    Polaris Loop ureteral stent after RIRS.

    Other: USSQ questionnaire administration after RIRS.

Interventions

  • OtherUSSQ questionnaire administration after RIRS.

    USSQ symptoms questionnaire administration after RIRS

07

What researchers measure

Primary outcomes

  1. USSQ Urinary symptoms scores

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

    Time frame: 4 weeks

Secondary outcomes

  1. USSQ domains scores

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

    Time frame: 4 weeks

  2. USSQ domains scores

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

    Time frame: 2 days

  3. USSQ domains' scores adjusted for baseline

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

    Time frame: 8 weeks

08

Study locations

1 site
  • AOU Città della Salute e della Scienza
    Torino, 10126, Italy
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Feb 2020, 25 months.

Of 3,738 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 25 months is above that.

Counting every sponsor, half of 3,837 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 11, 2017
First posted
Nov 17, 2017
StartActual
Jan 10, 2018
Primary completionActual
Feb 13, 2020
CompletionActual
Apr 17, 2020
Last update
Dec 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03344107
Lead sponsor
A.O.U. Città della Salute e della Scienza
Responsible party
Andrea Bosio (MD Urologist, PhD, A.O.U. Città della Salute e della Scienza) — Principal investigator
First posted
Nov 17, 2017
Start date
Jan 10, 2018
Primary completion
Feb 13, 2020
Completion
Apr 17, 2020
Last update
Dec 1, 2020

Study contacts

Andrea Bosio, MD
principal investigator · AOU Città della Salute e della Scienza, Torino

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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