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

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)

Overall Status

Completed

CT.gov ID

NCT03344107

Collaborator

(none)

Enrollment

Location

Arms

27.2

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Symptoms and Signs Pain Renal Calculi	Other: USSQ questionnaire administration after RIRS.	N/A

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

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Feb 13, 2020

Actual Study Completion Date :

Apr 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vortek double-J stent Vortek double-J stent after RIRS.	Other: USSQ questionnaire administration after RIRS. USSQ symptoms questionnaire administration after RIRS
Active Comparator: Polaris Loop stent Polaris Loop ureteral stent after RIRS.	Other: USSQ questionnaire administration after RIRS. USSQ symptoms questionnaire administration after RIRS

Arm

Intervention/Treatment

Active Comparator: Vortek double-J stent

Vortek double-J stent after RIRS.

Other: USSQ questionnaire administration after RIRS.

USSQ symptoms questionnaire administration after RIRS

Active Comparator: Polaris Loop stent

Polaris Loop ureteral stent after RIRS.

Other: USSQ questionnaire administration after RIRS.

USSQ symptoms questionnaire administration after RIRS

Outcome Measures

Primary Outcome Measures

USSQ Urinary symptoms scores [4 weeks]
Evaluation of significant differences in Urinary symptoms score between the two groups

Secondary Outcome Measures

USSQ domains scores [4 weeks]
Evaluation of significant differences in USSQ domains' scores between the two groups
USSQ domains scores [2 days]
Evaluation of significant differences in USSQ domains' scores between the two groups
USSQ domains' scores adjusted for baseline [8 weeks]
Evaluation of significant differences in USSQ domains' scores adjusted for baseline between the two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.