Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones

Benha University

Status: Not yet enrolling

Conditions: Urolithiasis; Endourology; Nephrolithiasis

Treatments: Procedure: Flexible & Navigable Suction Ureteral Access Sheath (FANS); Procedure: Antegrade Suction via Percutaneous Nephrostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06889051

MD-290-2025

Details and patient eligibility

About

This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible & Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible & Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥18 years old)
• Patients diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)
• Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach
• Patients with no active urinary tract infection (UTI) at baseline
• Patients who provide written informed consent

Exclusion criteria

• Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)
• Patients with a single functioning kidney
• Pregnant women
• Patients with a history of urological malignancy
• Patients with active bleeding disorders or those on anticoagulant therapy that cannot be safely discontinued
• Patients at high risk for anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group

Experimental group

Description:

Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with the Flexible \& Navigable Suction Ureteral Access Sheath (FANS). The FANS facilitates continuous suctioning, improving stone fragment evacuation, reducing intrarenal pressure, and optimizing stone-free rates (SFR).

Treatment:

Procedure: Flexible & Navigable Suction Ureteral Access Sheath (FANS)

Antegrade Suction with Flexible Ureteroscopy (FURS) Group

Active Comparator group

Description:

Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with antegrade suction, using a percutaneous nephrostomy (PCN) access for suctioning from the kidney during the procedure. This method aims to enhance stone fragment clearance and reduce intrarenal pressure without using a ureteral access sheath.

Treatment:

Procedure: Antegrade Suction via Percutaneous Nephrostomy