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NCT Number: NCT07286071

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals, Department of Urology

Cairo, Cairo Governorate, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Stone-free rate

    Time frame: One month after surgery

    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.

Secondary outcomes

  1. Duration of surgery

    Time frame: During surgery

    Total time required to complete the surgical procedure, measured from the insertion of the ureteroscope until placement of the ureteral stent.

  2. Readmission after surgery

    Time frame: Within one month after surgery

    Number of participants requiring hospital readmission for pain, infection, or any complication related to the surgery.

  3. Need for an additional procedure

    Time frame: Within three months after surgery

    Proportion of participants requiring a second surgical intervention to remove remaining stone material.

  4. Urinary infection after surgery

    Time frame: Within one month after surgery

    Occurrence of laboratory-confirmed urinary infection requiring medical treatment, classified using the Clavien-Dindo system.

  5. Systemic infection after surgery

    Time frame: Within one month after surgery

    Occurrence of systemic infection requiring medical intervention, including antibiotic therapy or hospitalization, assessed using the Clavien-Dindo classification.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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