Silodosin in Facilitating Flexible Uretroscopy

Not Applicable

Active, not recruiting

• Conditions: Stone Ureter; Stone, Kidney

• Registration Number: NCT07068087
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-06-10
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-08-10
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• adult male or female
• single renal or ureteric stone
• 1 to 2 cm in size.

Exclusion Criteria

• pregnant women
• Untreated urinary tract infections
• Uncorrected bleeding disorders or coagulopathies
• Bilateral ureteric stones or multiple ipsilateral ureteric stones
• ureteral stricture,
• Patients who had previous ureteric stenting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess success of ureteric access sheath placement.	during the operation in the OR	assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.

Secondary Outcome Measures

Name	Time	Method
Operative time	from time of induction of anaesthesia in surgery till the end of procedure.
Cost of the procedure	from admission and through study completion	Overall cost of each procedure included cost of standard procedure of flexible URS added to cost of medication prior to operations. If any case needed ureteral dilatation, the cost of dilators was added. Also, in case of complications occurred, additional cost of management of these complications was added. Finally, in cases of failed UAS insertion, the cost of auxiliary procedure was added. Cost was calculated initially in Egyptian pounds and was converted to U.S dollars for standardization.
complications	Perioperative and up to 24 weeks	Assess postoperativePain, fever and Residual stones

Trial Locations

Locations (1)

Ain Shams University hospitals (Demerdash); 🇪🇬 Cairo, Abasia, Egypt