ClinicalTrials.gg
CompletedNCT03344120Updated Dec 30, 2020

Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial

An interventional study of Administration of USSQ Symptoms questionnaire after stent positioning in Symptoms and Signs, Pain and Ureteral 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 2020-12-30.

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

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

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
73rd of 156
84 · median 80
Started
2020
with 15 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 73rd largest by enrollment of the 156 interventional ones that give a count, is one of 16 that started in 2020, is one of 102 with no phase, and was the 80th registered.

Pain

10,060 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 929 Pain studies recruiting now, 384 (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

Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.

03

Conditions studied

  • Symptoms and Signs
  • Pain
  • Ureteral Calculi

Browse trials for

Keywords

  • Symptoms and Signs
  • Pain
  • Ureteral Calculi
  • Ureteroscopy
  • Ureteral Stents
04

In context

Pain Reclassified

10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.

This study's enrollment of 84 is above the median of 66 across 8,497 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

  • ureteral or renal stones \< 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
  • stone-free procedure and absence of intraprocedural complications
  • 0-2

Exclusion criteria

Exclusion Criteria:

  • significant residual fragments at the end of the procedure
  • intraprocedural complications (e.g. ureteral damage or stricture)
  • indwelling double J stent
  • acute kidney failure
  • urinary tract infection
  • urinary tract abnormalities
  • pathologies or medications potentially influencing voiding pattern and pain perception
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.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

06

Study design

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

Study arms

  • Active comparator
    suture stent

    suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

    Other: Administration of USSQ Symptoms questionnaire after stent positioning

  • Active comparator
    conventional double-J stent

    conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.

    Other: Administration of USSQ Symptoms questionnaire after stent positioning

Interventions

  • OtherAdministration of USSQ Symptoms questionnaire after stent positioning

    Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy

07

What researchers measure

Primary outcomes

  1. Urinary Symptom Index Score

    to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.

    Time frame: 14 days

Secondary outcomes

  1. USSQ domains' scores

    to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery

    Time frame: 14 days

  2. USSQ domains' scores

    to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery

    Time frame: 2 days

  3. USSQ single answers

    to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery

    Time frame: 14 day

  4. USSQ single answers

    to compare USSQ single answers of suture stent and double J group, 2 days after surgery

    Time frame: 2 days

  5. 2 weeks USSQ domains' subscores adjusted for baseline

    to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group

    Time frame: 6 weeks

  6. complications and adverse events

    to compare complications and adverse events of suture stent and double J group

    Time frame: 2 weeks

08

Study locations

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

References and documents

Publications

  • Bosio A, Alessandria E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Piana P, Fop F, Gontero P. Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial. Eur Urol Open Sci. 2021 May 10;29:1-9. doi: 10.1016/j.euros.2021.03.011. eCollection 2021 Jul. PubMed 34337527 ↗

Individual participant data

Plan to share: No

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 2020 to primary completion in Nov 2020, 9 months.

Of 3,734 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 9 months is close to that.

Counting every sponsor, half of 3,833 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 8, 2020
Primary completionActual
Nov 2, 2020
CompletionActual
Dec 16, 2020
Last update
Dec 30, 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 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03344120
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 8, 2020
Primary completion
Nov 2, 2020
Completion
Dec 16, 2020
Last update
Dec 30, 2020

Study contacts

Andrea Bosio
principal investigator · A.O.U. Città della Salute e della Scienza

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 Dec 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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