Symptoms and SignsNCT03344107
Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents
A study testing USSQ questionnaire administration after RIRS. in people with Symptoms and Signs and Pain, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptoms and Signs, Pain, Renal Calculi
- What is being tested?
- USSQ questionnaire administration after RIRS.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2018to 17 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones < 2 cm
- given informed consent
- WHO PS 0-2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Symptoms and Signs, Pain, Renal Calculi
- Being tested
- USSQ questionnaire administration after RIRS.
- Keywords
- Symptoms and Signs, Pain, Renal Calculi, Ureteral Stent, Ureteroscopy
- Medical subject headings
- Signs and Symptoms, Pain, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USSQ questionnaire administration after RIRS.Other
USSQ symptoms questionnaire administration after RIRS
| Study group | Role | What they receive |
|---|---|---|
| Vortek double-J stent | Active comparator | Vortek double-J stent after RIRS. Receives: Other: USSQ questionnaire administration after RIRS. |
| Polaris Loop stent | Active comparator | Polaris Loop ureteral stent after RIRS. Receives: Other: USSQ questionnaire administration after RIRS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
USSQ Urinary symptoms scores
Evaluation of significant differences in Urinary symptoms score between the two groups
Measured: 4 weeks
Secondary outcomes (3)
USSQ domains scores
Evaluation of significant differences in USSQ domains' scores between the two groups
Measured: 4 weeks
USSQ domains scores
Evaluation of significant differences in USSQ domains' scores between the two groups
Measured: 2 days
USSQ domains' scores adjusted for baseline
Evaluation of significant differences in USSQ domains' scores adjusted for baseline between the two groups
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start10 Jan 2018
- Primary completion13 Feb 2020
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms and SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Bosio, A.O.U. Città della Salute e della Scienza
- Investigators
- Andrea Bosio, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344107
- Sponsor's protocol ID
- AOUCSSTURAB003
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2017
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones
- ClinicalTrials.gov ID
- NCT03344107
- Acronym / sponsor ID
- AOUCSSTURAB003
- Conditions
- Symptoms and Signs, Pain, Renal Calculi
- Keywords
- Symptoms and Signs, Pain, Renal Calculi, Ureteral Stent, Ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vortek double-J stent | Active comparator | Other: USSQ questionnaire administration after RIRS.Vortek double-J stent after RIRS. |
| Polaris Loop stent | Active comparator | Other: USSQ questionnaire administration after RIRS.Polaris Loop ureteral stent after RIRS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones < 2 cm
- given informed consent
- WHO PS 0-2
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USSQ questionnaire administration after RIRS.USSQ symptoms questionnaire administration after RIRS | Other | Polaris Loop stent, Vortek double-J stent |
Primary outcome
USSQ Urinary symptoms scores
Time frame: 4 weeks
Evaluation of significant differences in Urinary symptoms score between the two groups
3 secondary outcomes
USSQ domains scores
Time frame: 4 weeks
USSQ domains scores
Time frame: 2 days
USSQ domains' scores adjusted for baseline
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Bosio, MD principal investigator
A.O.U. Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USSQ questionnaire administration after RIRS. in people with Symptoms and Signs and Pain, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USSQ Urinary symptoms scores (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.