NCT03344107

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

November 11, 2017

Last Update Submit

November 29, 2020

Conditions

Symptoms and SignsPainRenal Calculi

Keywords

Symptoms and SignsPainRenal CalculiUreteral StentUreteroscopy

Outcome Measures

Primary Outcomes (1)

  • USSQ Urinary symptoms scores

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

    4 weeks

Secondary Outcomes (3)

  • USSQ domains scores

    4 weeks

  • USSQ domains scores

    2 days

  • USSQ domains' scores adjusted for baseline

    8 weeks

Study Arms (2)

Vortek double-J stent

ACTIVE COMPARATOR

Vortek double-J stent after RIRS.

Other: USSQ questionnaire administration after RIRS.

Polaris Loop stent

ACTIVE COMPARATOR

Polaris Loop ureteral stent after RIRS.

Other: USSQ questionnaire administration after RIRS.

Interventions

USSQ questionnaire administration after RIRS.OTHER

USSQ symptoms questionnaire administration after RIRS

Polaris Loop stentVortek double-J stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Signs and SymptomsPainKidney Calculi

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsNeurologic ManifestationsNephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, Anatomical

Study Officials

  • Andrea Bosio, MD

    AOU Città della Salute e della Scienza Torino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Urologist, PhD

Study Record Dates

First Submitted

November 11, 2017

First Posted

November 17, 2017

Study Start

January 10, 2018

Primary Completion

February 13, 2020

Study Completion

April 17, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)