An interventional study of USSQ questionnaire administration after RIRS. in Symptoms and Signs, Pain and Renal Calculi, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by A.O.U. Città della Salute e della Scienza · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Vortek double-J stent after RIRS.
Other: USSQ questionnaire administration after RIRS.
Polaris Loop ureteral stent after RIRS.
Other: USSQ questionnaire administration after RIRS.
USSQ symptoms questionnaire administration after RIRS
USSQ Urinary symptoms scores
Evaluation of significant differences in Urinary symptoms score between the two groups
Time frame: 4 weeks
USSQ domains scores
Evaluation of significant differences in USSQ domains' scores between the two groups
Time frame: 4 weeks
USSQ domains scores
Evaluation of significant differences in USSQ domains' scores between the two groups
Time frame: 2 days
USSQ domains' scores adjusted for baseline
Evaluation of significant differences in USSQ domains' scores adjusted for baseline between the two groups
Time frame: 8 weeks
Plan to share: No
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A.O.U. Città della Salute e della Scienza