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Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents

NCT ID: NCT03344107

Last Updated: 2020-12-01

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2020-04-17

Brief Summary

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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

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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

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Symptoms and Signs Pain Renal Calculi

Keywords

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Symptoms and Signs Pain Renal Calculi Ureteral Stent Ureteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vortek double-J stent

Vortek double-J stent after RIRS.

Group Type ACTIVE_COMPARATOR

USSQ questionnaire administration after RIRS.

Intervention Type OTHER

USSQ symptoms questionnaire administration after RIRS

Polaris Loop stent

Polaris Loop ureteral stent after RIRS.

Group Type ACTIVE_COMPARATOR

USSQ questionnaire administration after RIRS.

Intervention Type OTHER

USSQ symptoms questionnaire administration after RIRS

Interventions

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USSQ questionnaire administration after RIRS.

USSQ symptoms questionnaire administration after RIRS

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Andrea Bosio

MD Urologist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Bosio, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Città della Salute e della Scienza, Torino

Locations

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AOU Città della Salute e della Scienza

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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AOUCSSTURAB003

Identifier Type: -

Identifier Source: org_study_id