Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

Renal Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833386
• Other study ID #: pre-FURS sildosin
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: August 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone

Intervention

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

Locations

Country	Name	City	State
Egypt	Urology department - AlAzhar university	Cairo

Sponsors (6)

Lead Sponsor	Collaborator
Al-Azhar University	Alexandria University, Benha University, Cairo University, Menoufia University, Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure rate of UAS insertion during FURS		2 hours
Secondary	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
Secondary	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
Secondary	Complications related to the procedure	will be graded using the modified Clavien-Dindo classification system.	3 months