Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

Study Overview
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Brief Summary
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The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery. Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm. Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²

Official Title
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Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion for Flexible Ureteroscope in Treating Renal Stones; A Prospective, Multicentre, Randomized Trial

Conditions
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Renal Stone

Intervention / Treatment
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* Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath Exclusion Criteria: Paediatric age group (less than 18 year)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silodosin group<br>all patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery | Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones<br>* Ureteral access sheath placement during flexible ureteroscope<br>|
| Active Comparator: Non premedicated group<br>None of this group will receive alpha blocker prior to surgery | Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones<br>* Ureteral access sheath placement during flexible ureteroscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate of UAS insertion during FURS |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ureteral injuries after UAS insertion | Ureter wall injury will be classified according to the following five grades: Grade 0: No lesion or only mucosal petechiae. Grade 1: Mucosal erosion or a mucosal flap without smooth muscle injury. Grade 2: Erosion involving the mucosa and smooth muscle but sparing the adventitia. Grade 3: Ureteral perforation involving the full thickness of the ureteral wall, including the adventitia. Grade 4: Total ureteral avulsion with a complete rupture of ureteral continuity. | 3 hours | 
| Post operative pain | a visual analog scale (VAS) score (0 = no pain to 10 = excruciating pain) to indicate the intensity of postoperative pain 12 h after surgery. | 12 hours after surgery | 
| Complications related to the procedure | will be graded using the modified Clavien-Dindo classification system. | 3 months |