Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

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

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

Study Overview

• Status: Recruiting
• Conditions: Renal Stone
• Intervention / Treatment: Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Urology department - AlAzhar university
    • Contact: Mohamed F Salman, MD; Phone Number: +201111788996; Email: Prof_mohamed_fawzy@yahoo.com
    • Principal Investigator: Mohamed F Salman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Silodosin group; 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; Ureteral access sheath placement during flexible ureteroscope
Active Comparator: Non premedicated group; None of this group will receive alpha blocker prior to surgery	Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones; Ureteral access sheath placement during flexible ureteroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Alexandria University; Cairo University; Menoufia University; Benha University; Tanta University

Publications and helpful links

General Publications

• Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.
• Koo KC, Yoon JH, Park NC, Lee HS, Ahn HK, Lee KS, Kim DK, Cho KS, Chung BH, Hong CH. The Impact of Preoperative alpha-Adrenergic Antagonists on Ureteral Access Sheath Insertion Force and the Upper Limit of Force Required to Avoid Ureteral Mucosal Injury: A Randomized Controlled Study. J Urol. 2018 Jun;199(6):1622-1630. doi: 10.1016/j.juro.2017.09.173. Epub 2018 Feb 2.
• Kim JK, Choi CI, Lee SH, Han JH, Shim YS, Choo MS; Young Endourological Study group. Silodosin for Prevention of Ureteral Injuries Resulting from Insertion of a Ureteral Access Sheath: A Randomized Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):572-579. doi: 10.1016/j.euf.2021.03.009. Epub 2021 Mar 23.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: pre-FURS sildosin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No