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Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suture stent | Active Comparator | suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. |
|
| conventional double-J stent | Active Comparator | conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of USSQ Symptoms questionnaire after stent positioning | Other | Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Symptom Index Score | to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| USSQ domains' scores | to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery | 14 days |
| USSQ domains' scores | to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Bosio | A.O.U. Città della Salute e della Scienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza | Turin | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34337527 | Derived | Bosio A, Alessandria E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Piana P, Fop F, Gontero P. Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial. Eur Urol Open Sci. 2021 May 10;29:1-9. doi: 10.1016/j.euros.2021.03.011. eCollection 2021 Jul. |
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| 2 days |
| USSQ single answers | to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery | 14 day |
| USSQ single answers | to compare USSQ single answers of suture stent and double J group, 2 days after surgery | 2 days |
| 2 weeks USSQ domains' subscores adjusted for baseline | to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group | 6 weeks |
| complications and adverse events | to compare complications and adverse events of suture stent and double J group | 2 weeks |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D014514 | Ureteral Calculi |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| 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 |
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