Symptoms and SignsNCT03344120
Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial
A study testing Administration of USSQ Symptoms questionnaire after stent positioning 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
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptoms and Signs, Pain, Ureteral Calculi
- What is being tested?
- Administration of USSQ Symptoms questionnaire after stent positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2020to 16 Dec 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
- ureteral or renal stones < 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
- stone-free procedure and absence of intraprocedural complications
- WHO performance status 0-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial
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.
- Conditions
- Symptoms and Signs, Pain, Ureteral Calculi
- Being tested
- Administration of USSQ Symptoms questionnaire after stent positioning
- Keywords
- Symptoms and Signs, Pain, Ureteral Calculi, Ureteroscopy, Ureteral Stents
- Medical subject headings
- Signs and Symptoms, Pain, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of USSQ Symptoms questionnaire after stent positioningOther
Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
| Study group | Role | What they receive |
|---|---|---|
| suture stent | Active comparator | suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. Receives: Other: Administration of USSQ Symptoms questionnaire after stent positioning |
| conventional double-J stent | Active comparator | conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. Receives: Other: Administration of USSQ Symptoms questionnaire after stent positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (6)
USSQ domains' scores
to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery
Measured: 14 days
USSQ domains' scores
to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery
Measured: 2 days
USSQ single answers
to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery
Measured: 14 day
USSQ single answers
to compare USSQ single answers of suture stent and double J group, 2 days after surgery
Measured: 2 days
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
Measured: 6 weeks
complications and adverse events
to compare complications and adverse events of suture stent and double J group
Measured: 2 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 start8 Jan 2020
- Primary completion2 Nov 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 84 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, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344120
- Sponsor's protocol ID
- AOUCSSTURAB004
- Status last verified
- Dec 2020
- First submitted
- 11 Nov 2017
- Last updated
- 30 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03344120
- Acronym / sponsor ID
- AOUCSSTURAB004
- Conditions
- Symptoms and Signs, Pain, Ureteral Calculi
- Keywords
- Symptoms and Signs, Pain, Ureteral Calculi, Ureteroscopy, Ureteral Stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 16 Dec 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suture stent | Active comparator | Other: Administration of USSQ Symptoms questionnaire after stent positioningsuture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. |
| conventional double-J stent | Active comparator | Other: Administration of USSQ Symptoms questionnaire after stent positioningconventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ureteral or renal stones < 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
- stone-free procedure and absence of intraprocedural complications
- WHO performance status 0-2
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Administration of USSQ Symptoms questionnaire after stent positioningAdministration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy | Other | conventional double-J stent, suture stent |
Primary outcome
Urinary Symptom Index Score
Time frame: 14 days
to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.
6 secondary outcomes
USSQ domains' scores
Time frame: 14 days
USSQ domains' scores
Time frame: 2 days
USSQ single answers
Time frame: 14 day
USSQ single answers
Time frame: 2 days
2 weeks USSQ domains' subscores adjusted for baseline
Time frame: 6 weeks
complications and adverse events
Time frame: 2 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 30 Dec 2020.
- Derived from this study: PubMed 34337527Bosio 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.
- 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 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 Administration of USSQ Symptoms questionnaire after stent positioning 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 7 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 30 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?
Urinary Symptom Index Score (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344120, which also lists 1 linked publication.
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 30 Dec 2020.