Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05833386

Enrollment

2000

Registered

2023-04-27

Start date

2022-10-01

Completion date

2026-08-01

Last updated

2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone

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

Interventions

PROCEDUREUreteral access sheath placement during flexible ureteroscope for renal stones

Ureteral access sheath placement during flexible ureteroscope

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
failure rate of UAS insertion during FURS	2 hours

Secondary

Measure	Time frame	Description
Ureteral injuries after UAS insertion	3 hours	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	12 hours after surgery	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	3 months	will be graded using the modified Clavien-Dindo classification system.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026