Pain, Renal Calculi, Symptoms and Signs
Conditions
Keywords
Symptoms and Signs, Pain, Renal Calculi, Ureteral Stent, Ureteroscopy
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.
Interventions
OTHERUSSQ questionnaire administration after RIRS.
USSQ symptoms questionnaire administration after RIRS
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| USSQ Urinary symptoms scores | 4 weeks | Evaluation of significant differences in Urinary symptoms score between the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| USSQ domains scores | 4 weeks | 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 |
Countries
Italy
Outcome results
None listed