Safety and Efficacy of Traditional Versus Suction Ureteral Access Sheath in Retrograde Intra-Renal Stone Surgery

NCT ID: NCT07286071

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-12-01

Brief 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

Keywords

Urolithiasis; Kidney Calculi; RIRS; UAS; Suction UAS; Endourology; Laser Lithotripsy; Stone-Free Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Suction Ureteral Access Sheath Group

Participants in this group underwent retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism. After anesthesia, a guide wire was placed and the ureter was evaluated. The suction ureteral access sheath was inserted over the guide wire and positioned inside the kidney near the stone. Controlled negative pressure was applied to improve removal of stone fragments and to maintain lower pressure inside the kidney during the procedure. Laser lithotripsy was performed, and stone fragments were aspirated through the suction system. A double-J ureteral stent was placed at the end of the procedure.

Group Type: EXPERIMENTAL

Retrograde intrarenal surgery using a ureteral access sheath with suction

Intervention Type: PROCEDURE

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.

Traditional Ureteral Access Sheath Group

Participants in this group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. After anesthesia and guide wire placement, the traditional ureteral access sheath was inserted and positioned below the junction between the ureter and the kidney. Laser lithotripsy was performed in the standard manner. Stone fragments were removed passively using irrigation and by repeatedly retrieving fragments with a basket. A double-J ureteral stent was placed at the end of the procedure.

Group Type: ACTIVE_COMPARATOR

Retrograde intrarenal surgery using a traditional ureteral access sheath

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults aged eighteen years or older
• Male or female participants
• Presence of a single kidney stone measuring up to twenty millimeters
• Candidate for retrograde intrarenal surgery according to clinical evaluation
• Able and willing to provide informed consent

Exclusion Criteria

• Active or untreated urinary infection
• History of open kidney surgery or kidney trauma
• Contraindications to anesthesia, including uncontrolled diabetes, severe cardiac disease, or significant coagulation disorders
• Presence of ureteral narrowing or obstruction at the junction between the ureter and the kidney
• Positive urine culture that does not resolve after appropriate treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hassan mahmoud hassan

Resident of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals, Department of Urology

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU_MS401_2025

Identifier Type: -

Identifier Source: org_study_id