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

NCT06889051 | Not Yet Recruiting

• 1 other identifier: MD-290-2025
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nephrolithiasis; Urolithiasis; Endourology

Keywords

Flexible Ureteroscopy (FURS); Ureteral Access Sheath (UAS); Suction Ureteral Access Sheath (FANS); Antegrade Suction; Percutaneous Nephrostomy (PCN); Laser Lithotripsy

Outcome Measures

Primary Outcomes (1)

• Stone-Free Rate (SFR)

  The stone-free rate (SFR) will be assessed one month postoperatively using non-contrast computed tomography (NCCT) to determine the presence or absence of residual stone fragments ≥4 mm. A higher SFR indicates better effectiveness of the intervention.

  1 Month Postoperative

Secondary Outcomes (5)

• Operative Time

  During Surgery

• Intraoperative Bleeding Requiring Intervention

  During Surgery

• Ureteral Injury

  During Surgery

• Postoperative Hematuria

  Within 7 Days Postoperative

• Postoperative Urosepsis

  Within 7 Days Postoperative

Study Arms (2)

Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group

EXPERIMENTAL

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).

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

Antegrade Suction with Flexible Ureteroscopy (FURS) Group

ACTIVE COMPARATOR

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.

Procedure: Antegrade Suction via Percutaneous Nephrostomy

Interventions

Flexible & Navigable Suction Ureteral Access Sheath (FANS) PROCEDURE

The Flexible \& Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W).

Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group

Antegrade Suction via Percutaneous Nephrostomy PROCEDURE

This technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths.

Antegrade Suction with Flexible Ureteroscopy (FURS) Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

MeSH Terms

Conditions

Nephrolithiasis; Urolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Tamer Diab, MD

CONTACT

01003583264; tamer.diab@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial with no masking, as both the surgeon and patient will be aware of the assigned intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine.

Model Details: This is a randomized controlled trial comparing two different suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones. Participants will be assigned to one of two groups: * Group A (Intervention Group) - flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) * Group B (Control Group) - flexible ureteroscopy (FURS) with Antegrade Suction via percutaneous nephrostomy. The study will assess stone-free rates (SFR), operative time, and complications.

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: March 30, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: * Start Date: Upon publication of primary study results * End Date: Available for 5 years after study completion