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

NCT07286071 | Completed

• 1 other identifier: FMASU_MS401_2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Stone-free rate

  The stone-free rate represents the proportion of participants who show no residual stone fragments or only clinically insignificant small fragments on postoperative imaging. Imaging is performed using non-contrast computed tomography. Findings are classified into four categories based on fragment size: complete clearance, fragments up to two millimeters, fragments between two point one and four millimeters, and fragments larger than four millimeters. The outcome is expressed as the percentage of participants achieving complete clearance or clinically insignificant fragments.

  One month after surgery

Secondary Outcomes (5)

• Duration of surgery

  During surgery

• Readmission after surgery

  Within one month after surgery

• Need for an additional procedure

  Within three months after surgery

• Urinary infection after surgery

  Within one month after surgery

• Systemic infection after surgery

  Within one month after surgery

Study Arms (2)

Suction Ureteral Access Sheath Group

EXPERIMENTAL

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.

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

Traditional Ureteral Access Sheath Group

ACTIVE COMPARATOR

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.

Procedure: Retrograde intrarenal surgery using a traditional ureteral access sheath

Interventions

Retrograde intrarenal surgery using a ureteral access sheath with suction 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.

Suction Ureteral Access Sheath Group

Retrograde intrarenal surgery using a traditional ureteral access sheath 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.

Traditional Ureteral Access Sheath Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals, Department of Urology

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Nephrolithiasis

Interventions

Suction

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: Two groups of participants were assigned in parallel. One group underwent retrograde intrarenal surgery using a ureteral access sheath with suction. The other group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. Both groups were followed to compare safety and effectiveness outcomes.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available starting six months after publication of the main study results. The data will remain accessible for a period of five years from the date of release.
• Access Criteria: Researchers who wish to access the data must submit a written request that includes a summary of the research objectives and the intended use of the data. Approval will require review by the study investigators. Upon approval, data will be shared through a secure data transfer method. Recipients must agree not to attempt to reidentify participants and must use the data only for the approved research purpose.

Locations

EG (1)