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Effect of Flexible and Navigable Suction Ureteral Access Sheath (FANS), Conventional Ureteral Access Sheath and Sheathless Approach on Intraoperative Parameters and Postoperative Clinical Outcomes in Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial
Sponsor study identifier
interventional
129
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Retrograde intrarenal surgery (RIRS) is a standard minimally invasive treatment for kidney stones up to 20 mm. During the procedure, irrigation fluid raises the pressure inside the kidney and laser energy raises the fluid temperature. High intrarenal pressure has been linked to postoperative pain, fever and infection. Ureteral access sheaths are used to improve fluid outflow, and newer flexible and navigable suction access sheaths (FANS) add active aspiration to keep pressure low and remove stone fragments. This randomized controlled trial compares three ureteral access strategies in adults undergoing RIRS: a flexible and navigable suction access sheath, a conventional ureteral access sheath, and no access sheath. The main question is whether the access strategy affects pain 6 hours after surgery. The study also compares intrarenal pressure and temperature during surgery, the amount of irrigation fluid used and retained, stone-free status on computed tomography (CT), and complications.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2026
Actual (reported)October 27, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Postoperative pain score
Pain intensity measured with a 0-10 visual analog scale (VAS); 0 = no pain, 10 = worst imaginable pain.
6 hours after surgery
Postoperative pain scores
1, 2 and 24 hours after surgery
Number of rescue analgesic doses
First 24 hours after surgery
A commercially available flexible and navigable suction ureteral access sheath with a flexible distal tip, placed over a guidewire under fluoroscopic guidance. Continuous aspiration of irrigation fluid and stone fragments is applied through the sheath at a standardized suction pressure during laser lithotripsy.
A commercially available standard (non-suction) ureteral access sheath, placed over a guidewire under fluoroscopic guidance with its tip at the level of the ureteropelvic junction. Irrigation fluid drains passively through the sheath around the ureteroscope.
A \[10/12\] Fr flexible and navigable suction ureteral access sheath (\[brand/model\]) with a flexible distal tip that follows the ureteroscope into the renal calyces. The side port is connected to a suction unit set at \[x\] mmHg, providing continuous aspiration of irrigation fluid and stone fragments during lithotripsy.
Ondokuz Mayis University, Samsun
Samsun, Turkey (Türkiye)
First Submitted
October 13, 2026
First Posted
October 27, 2026
Mean intrarenal pressure
Intraoperative
Maximum intrarenal pressure
Intraoperative
Time with intrarenal pressure above 30 mmHg
Intraoperative
Patients undergo retrograde intrarenal surgery without a ureteral access sheath. After diagnostic semirigid ureteroscopy and passive ureteral dilatation, the flexible ureteroscope is advanced directly over a guidewire into the collecting system. Irrigation fluid drains passively alongside the ureteroscope. All other surgical steps, irrigation settings, laser settings and postoperative care are identical to the other arms.
A \[10/12\] Fr standard (non-suction) ureteral access sheath (\[brand/model\]) placed with its tip at the level of the ureteropelvic junction. Irrigation fluid drains passively through the sheath around the ureteroscope.
Flexible ureteroscopy performed without a ureteral access sheath. The flexible ureteroscope is advanced over a guidewire after diagnostic semirigid ureteroscopy and passive ureteral dilatation.
Standardized retrograde intrarenal surgery under general anesthesia using a flexible ureteroscope with integrated intrarenal pressure sensing and Holmium:YAG laser lithotripsy with standardized settings. Intrarenal pressure and fluid temperature are recorded continuously, irrigation and outflow volumes are measured, and a double-J stent is placed at the end of the procedure in all patients.
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Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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