MedDataX Logo

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

NCT ID: NCT03344120

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2020-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Symptoms and Signs Pain Ureteral Calculi

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Symptoms and Signs Pain Ureteral Calculi Ureteroscopy Ureteral Stents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

suture stent

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

Group Type ACTIVE_COMPARATOR

Administration of USSQ Symptoms questionnaire after stent positioning

Intervention Type OTHER

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

conventional double-J stent

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

Group Type ACTIVE_COMPARATOR

Administration of USSQ Symptoms questionnaire after stent positioning

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Administration of USSQ Symptoms questionnaire after stent positioning

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* WHO performance status 0-2

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Bosio

MD Urologist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrea Bosio

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Città della Salute e della Scienza

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Città della Salute e della Scienza

Turin, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34337527 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AOUCSSTURAB004

Identifier Type: -

Identifier Source: org_study_id