Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

Not Applicable

Recruiting

• Conditions: Renal Stone
• Interventions: Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones

• Registration Number: NCT05833386
• Lead Sponsor: Al-Azhar University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Study First Posted: 2023-04-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2026-05-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non premedicated group	Ureteral access sheath placement during flexible ureteroscope for renal stones	None of this group will receive alpha blocker prior to surgery
Silodosin group	Ureteral access sheath placement during flexible ureteroscope for renal stones	all patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery

Primary Outcome Measures

Name	Time	Method
failure rate of UAS insertion during FURS	2 hours

Secondary Outcome Measures

Name	Time	Method
Ureteral injuries after UAS insertion	3 hours	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.
Complications related to the procedure	3 months	will be graded using the modified Clavien-Dindo classification system.
Post operative pain	12 hours after surgery	a visual analog scale (VAS) score (0 = no pain to 10 = excruciating pain) to indicate the intensity of postoperative pain 12 h after surgery.

Trial Locations

Locations (1)

Urology department - AlAzhar university; 🇪🇬 Cairo, Egypt