NCT07068087

Silodosin in Facilitating Flexible Uretroscopy

Efficacy of Pre-operative Silodosin on Facilitating Insertion of Ureteral Access SheathPrior to Retrograde Intra Renal Surgery: A Randomized Controlled Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.

Detailed description

This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.

Conditions

• Stone Ureter
• Stone, Kidney

Interventions

Type	Name	Description
PROCEDURE	Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS	group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively
PROCEDURE	ureteric access sheath insertion in RIRS without silodosin (Placebo)	group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-08-10
• Completion: 2025-09-01
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: Egypt