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

Ain Shams University

Status: Completed

Conditions: Urolithiasis; Nephrolithiasis; Kidney Calculi

Treatments: Procedure: Retrograde intrarenal surgery using a ureteral access sheath with suction; Procedure: Retrograde intrarenal surgery using a traditional ureteral access sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT07286071

FMASU_MS401_2025

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Suction Ureteral Access Sheath Group

Experimental group

Description:

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.

Treatment:

Procedure: Retrograde intrarenal surgery using a ureteral access sheath with suction

Traditional Ureteral Access Sheath Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Retrograde intrarenal surgery using a traditional ureteral access sheath