Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- USSQ Urinary symptoms scores
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vortek double-J stent
Vortek double-J stent after RIRS.
Intervention: USSQ questionnaire administration after RIRS. (Other)
Polaris Loop stent
Polaris Loop ureteral stent after RIRS.
Intervention: USSQ questionnaire administration after RIRS. (Other)
Outcomes
Primary Outcomes
USSQ Urinary symptoms scores
Time Frame: 4 weeks
Evaluation of significant differences in Urinary symptoms score between the two groups
Secondary Outcomes
- USSQ domains' scores adjusted for baseline(8 weeks)
- USSQ domains scores(2 days)
- USSQ domains scores(4 weeks)
Investigators
Andrea Bosio
MD Urologist, PhD
A.O.U. Città della Salute e della Scienza