Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

NCT ID: NCT05833386

Last Updated: 2023-08-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-08-01

Brief Summary

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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

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Conditions

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Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Silodosin group

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

Group Type ACTIVE_COMPARATOR

Ureteral access sheath placement during flexible ureteroscope for renal stones

Intervention Type PROCEDURE

Ureteral access sheath placement during flexible ureteroscope

Non premedicated group

None of this group will receive alpha blocker prior to surgery

Group Type ACTIVE_COMPARATOR

Ureteral access sheath placement during flexible ureteroscope for renal stones

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Benha University

OTHER

Sponsor Role collaborator

Alexandria University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role collaborator

Menoufia University

OTHER

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role collaborator

Responsible Party

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Mohamed Fawzy Abd Elfattah Salman

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Urology department - AlAzhar university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Mohamed F Salman, MD

Role: primary

+201111788996

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.

Reference Type BACKGROUND
PMID: 29410081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33741297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22982421 (View on PubMed)

Other Identifiers

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pre-FURS sildosin

Identifier Type: -

Identifier Source: org_study_id

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