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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344107
• Other study ID #: AOUCSSTURAB003
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: April 17, 2020

Study information

• Verified date: November 2020
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 17, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Pain
• Renal Calculi
• Symptoms and Signs

Intervention

Other:
• USSQ questionnaire administration after RIRS.
USSQ symptoms questionnaire administration after RIRS

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	USSQ Urinary symptoms scores	Evaluation of significant differences in Urinary symptoms score between the two groups	4 weeks
Secondary	USSQ domains scores	Evaluation of significant differences in USSQ domains' scores between the two groups	4 weeks
Secondary	USSQ domains scores	Evaluation of significant differences in USSQ domains' scores between the two groups	2 days
Secondary	USSQ domains' scores adjusted for baseline	Evaluation of significant differences in USSQ domains' scores adjusted for baseline between the two groups	8 weeks