NCT05833386

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2022Aug 2026

Study Start

First participant enrolled

October 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3.6 years

First QC Date

April 16, 2023

Last Update Submit

August 7, 2023

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

  • failure rate of UAS insertion during FURS

    2 hours

Secondary Outcomes (3)

  • Ureteral injuries after UAS insertion

    3 hours

  • Post operative pain

    12 hours after surgery

  • Complications related to the procedure

    3 months

Study Arms (2)

Silodosin group

ACTIVE COMPARATOR

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

Non premedicated group

ACTIVE COMPARATOR

None of this group will receive alpha blocker prior to surgery

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

Interventions

Ureteral access sheath placement during flexible ureteroscope for renal stonesPROCEDURE

Ureteral access sheath placement during flexible ureteroscope

Non premedicated groupSilodosin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath

You may not qualify if:

  • Paediatric age group (less than 18 year)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department - AlAzhar university

Cairo, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29410081BACKGROUND

  • 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.

    PMID: 33741297BACKGROUND

  • 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.

    PMID: 22982421BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 27, 2023

Study Start

October 1, 2022

Primary Completion

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations

EG(1)