Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion
NCT ID: NCT05833386
Last Updated: 2023-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2022-10-01
2026-08-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Silodosin group
all patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery
Ureteral access sheath placement during flexible ureteroscope for renal stones
Ureteral access sheath placement during flexible ureteroscope
Non premedicated group
None of this group will receive alpha blocker prior to surgery
Ureteral access sheath placement during flexible ureteroscope for renal stones
Ureteral access sheath placement during flexible ureteroscope
Interventions
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Ureteral access sheath placement during flexible ureteroscope for renal stones
Ureteral access sheath placement during flexible ureteroscope
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Benha University
OTHER
Alexandria University
OTHER
Cairo University
OTHER
Menoufia University
OTHER
Tanta University
OTHER
Responsible Party
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Mohamed Fawzy Abd Elfattah Salman
Director
Locations
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Urology department - AlAzhar university
Cairo, , Egypt
Countries
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Facility Contacts
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References
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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.
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.
Other Identifiers
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pre-FURS sildosin
Identifier Type: -
Identifier Source: org_study_id
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