NCT07286071

Safety and Efficacy of Traditional Versus Flexible and Navigable Suction Sheath in Retrograde Intra-Renal Stone Surgery

Safety and Efficacy of Using Traditional Ureteral Access Sheath Versus Flexible and Navigable Suction Sheath in Retrograde Intra-Renal Stone Surgery for Renal Stones ≤ 20 mm: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares two techniques used during RIRS for the treatment of kidney stones measuring up to 20 mm. During RIRS, surgeons often use a device called a UAS to help pass instruments into the urinary system and to assist with the removal of stone fragments. A traditional UAS allows irrigation fluid and small fragments to flow out passively. A newer type, known as a suction UAS, applies controlled negative pressure to help clear stone fragments more effectively and may reduce pressure inside the kidney during the procedure. The purpose of this study is to determine whether the suction UAS offers better clinical outcomes than the traditional UAS. The main outcomes assessed include the SFR, the duration of surgery, and complications after the procedure such as fever, sepsis, urinary infection, calyceal injury, or ureteral injury. In this randomized study, adult patients undergoing RIRS for a single renal stone were assigned to either the suction UAS or the traditional UAS. All patients were followed after surgery to assess stone clearance and any complications. The results of this study aim to provide evidence on whether suction UAS improves safety or effectiveness in RIRS compared with the traditional approach.

Conditions

• Urolithiasis
• Kidney Calculi
• Nephrolithiasis

Interventions

Type	Name	Description
PROCEDURE	Retrograde intrarenal surgery using a ureteral access sheath with suction	This intervention involves performing retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism that applies controlled negative pressure to help remove stone fragments and manage pressure inside the kidney during the procedure.
PROCEDURE	Retrograde intrarenal surgery using a traditional ureteral access sheath	This intervention involves performing retrograde intrarenal surgery using a conventional ureteral access sheath without suction, relying on irrigation flow and basket retrieval for stone fragment removal.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-12-16
• Last updated: 2026-02-11

Locations

1 site across 1 country: Egypt