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Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

Primary Purpose

Renal Stone

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ureteral access sheath placement during flexible ureteroscope for renal stones
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Urology department - AlAzhar universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Silodosin group

Non premedicated group

Arm Description

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

None of this group will receive alpha blocker prior to surgery

Outcomes

Primary Outcome Measures

failure rate of UAS insertion during FURS

Secondary Outcome Measures

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.
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.
Complications related to the procedure
will be graded using the modified Clavien-Dindo classification system.

Full Information

First Posted
April 16, 2023
Last Updated
August 7, 2023
Sponsor
Al-Azhar University
Collaborators
Benha University, Alexandria University, Cairo University, Menoufia University, Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05833386
Brief Title
Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
Collaborators
Benha University, Alexandria University, Cairo University, Menoufia University, Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silodosin group
Arm Type
Active Comparator
Arm Description
all patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery
Arm Title
Non premedicated group
Arm Type
Active Comparator
Arm Description
None of this group will receive alpha blocker prior to surgery
Intervention Type
Procedure
Intervention Name(s)
Ureteral access sheath placement during flexible ureteroscope for renal stones
Intervention Description
Ureteral access sheath placement during flexible ureteroscope
Primary Outcome Measure Information:
Title
failure rate of UAS insertion during FURS
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Ureteral injuries after UAS insertion
Description
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.
Time Frame
3 hours
Title
Post operative pain
Description
a visual analog scale (VAS) score (0 = no pain to 10 = excruciating pain) to indicate the intensity of postoperative pain 12 h after surgery.
Time Frame
12 hours after surgery
Title
Complications related to the procedure
Description
will be graded using the modified Clavien-Dindo classification system.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Urology department - AlAzhar university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
Prof_mohamed_fawzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29410081
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.
Results Reference
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PubMed Identifier
33741297
Citation
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.
Results Reference
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PubMed Identifier
22982421
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.
Results Reference
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Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

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