Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

Al-Azhar University

Status: Enrolling

Conditions: Renal Stone

Treatments: Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones

Study type: Interventional

Funder types: Other

Identifiers

NCT05833386

pre-FURS sildosin

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Silodosin group

Active Comparator group

Description:

all patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery

Treatment:

Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones

Non premedicated group

Active Comparator group

Description:

None of this group will receive alpha blocker prior to surgery

Treatment:

Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones