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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortek double-J stent | Active Comparator | Vortek double-J stent after RIRS. |
|
| Polaris Loop stent | Active Comparator | Polaris Loop ureteral stent after RIRS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USSQ questionnaire administration after RIRS. | Other | USSQ symptoms questionnaire administration after RIRS |
|
| Measure | Description | Time Frame |
|---|---|---|
| USSQ Urinary symptoms scores | Evaluation of significant differences in Urinary symptoms score between the two groups | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| USSQ domains scores | Evaluation of significant differences in USSQ domains' scores between the two groups | 4 weeks |
| USSQ domains scores | Evaluation of significant differences in USSQ domains' scores between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Bosio, MD | AOU Città della Salute e della Scienza Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza | Torino | 10126 | Italy |
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| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
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| 2 days |
| USSQ domains' scores adjusted for baseline | Evaluation of significant differences in USSQ domains' scores adjusted for baseline between the two groups | 8 weeks |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |