Clinical trial NCT06889051: Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones
Official title: Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nephrolithiasis
Urolithiasis
Endourology
Keywords: Flexible Ureteroscopy (FURS)
Ureteral Access Sheath (UAS)
Suction Ureteral Access Sheath (FANS)
Antegrade Suction
Percutaneous Nephrostomy (PCN)
Laser Lithotripsy
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stone-Free Rate (SFR)
timeFrame: 1 Month Postoperative
Secondary outcomes:
measure: Operative Time
timeFrame: During Surgery
measure: Intraoperative Bleeding Requiring Intervention
timeFrame: During Surgery
measure: Ureteral Injury
timeFrame: During Surgery
measure: Postoperative Hematuria
timeFrame: Within 7 Days Postoperative
measure: Postoperative Urosepsis
timeFrame: Within 7 Days Postoperative
Other outcomes:
Locations:
Study officials:
References: